Hear what experts say about treating patients with CABENUVA.
Speakers are compensated by ViiV Healthcare.
Transcript: Uncovering Patient Challenges With Taking Daily HIV Treatment
PM-US-CBR-VID-230023
VISUAL: CABENUVA and ViiV logos, series title and video title are on screen over Dr Bettacchi and then move off screen.
AUDIO: Faint background music plays throughout video
SUPER:
Expert Perspectives: Conversations on CABENUVA
Uncovering Patient Challenges With Taking Daily HIV Treatment
CABENUVA Logo
ViiV Healthcare Logo
Dr Bettacchi: Hello, my name is Dr Christopher Bettacchi. I am an infectious disease specialist in Dallas, Texas. Please join me for a discussion on Unmet Needs of Patients on Daily HIV Treatment.
Before we begin, let us review Important Safety Information for CABENUVA.
VISUAL: Speaker on frame; graphics animate on screen
SUPER:
Speaker has been compensated by ViiV Healthcare
Christopher Bettacchi, MD
CABENUVA Logo
VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
VISUAL: ISI animates on screen
SUPER:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr Bettacchi: For over a decade, I have been part of a team of infectious disease specialists that treat a large and diverse population of people living with HIV. In our practice, which includes about 1000 people living with HIV, I participate in an LGBTQ+ health and wellness clinic, which is a primary care–focused resource center for our patients within that community.
Dr Bettacchi: The last few years of the COVID-19 pandemic have truly brought to light the power of conversations with my patients. Like many other clinics across the country, we transitioned briefly to primarily telehealth visits in 2020, and it actually was a great experience for our practice in terms of being able to spend more time speaking with patients.
It didn't take very long in these conversations to learn that a patient, who otherwise would have come in and quickly said, “I'm doing fine,” actually may be dealing with challenges taking their oral antiretroviral therapy. Although we have transitioned to a hybrid mix of in-person and telehealth clinic visits, that experience in 2020 uncovered my passion for these types of discussions with my patients. This approach helps to reveal their unmet needs with taking daily oral HIV therapy.
Dr Bettacchi: My approach to initiating conversations is through patient education, and that starts with us as providers. I start by discussing what is going on in the HIV treatment landscape. I think it is incumbent upon anyone who cares for patients with HIV to share this knowledge with patients. I stay abreast of the changing treatment landscape. This allows me to share an alternative therapy with a different method of HIV drug delivery, such as CABENUVA. Usually, this information sparks an interest in my patients, and they say, “tell me more.” From there, I probe to see if they have challenges with taking their current regimen.
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SUPER:
Uncovering patients’ unmet needs in HIV treatment
- Patient education
- HIV treatment landscape
- Latest treatment options
- Taking daily oral HIV therapy
CABENUVA Logo
Dr Bettacchi: On the other hand, some patients start the conversation by asking about CABENUVA. In those instances, I share the clinical data that support CABENUVA’s efficacy, safety, and tolerability.
Dr Bettacchi: When I discuss with my patients the challenges that they experience with taking daily oral therapy, there are several topics that are often mentioned. First is that they worry about others unintentionally discovering their HIV status, and that comes in different varieties. Whereas it was once about being seen in a pharmacy picking up HIV medication, today unintentional discovery of their HIV status means so much more when viewed through the lens of social media, and my patients have expressed this concern. My patients also worry over having to take a pill every day and possibly forgetting to take their HIV medication. Another common challenge is that taking oral HIV medication every day is an uncomfortable reminder of their HIV status and the circumstances around their initial diagnosis. As diverse as our patient population is, I find that challenges around use of daily oral therapy cut across all patient demographics.
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SUPER:
What are the challenges patient face with taking daily oral therapy?
- Unintentionally having their HIV status discovered
- Forgetting to take their HIV medication
- Uncomfortable reminder of their HIV status
CABENUVA Logo
Dr Bettacchi: We need to consider the different challenges people living with HIV face, which may be constant concerns in their lives, even if they are virologically suppressed.
Most recently, the phase 3b trial of CABENUVA, the SOLAR study, compared the efficacy and safety of switching to every-2-month CABENUVA versus remaining on BIKTARVY through 12 months in patients who were virologically suppressed on BIKTARVY for at least 6 months prior to the study. In addition, the SOLAR study had a baseline survey to address whether patients entering the trial experienced challenges with taking their daily oral therapy as an exploratory endpoint.
For a detailed discussion of SOLAR, please watch the video titled, “SOLAR: a head-to-head switch study of CABENUVA vs BIKTARVY,” which is hosted by Dr Moti Ramgopal, an investigator of SOLAR.
Dr Bettacchi: I think it is important to grasp how much these challenges can impact patients’ lives, whether it’s someone who is traveling and worries about inadvertently disclosing their HIV status because of their medication or that they might forget to take their daily oral therapy.
One must also be aware that patients may hesitate to voice these concerns because they don’t want to burden their healthcare providers. I have been treating several of my patients for many years, and some have a hard time admitting to challenges that they have with adherence because they don’t want to “let us down.” These patients often feel guilty about speaking of their challenges with daily oral therapy because they know it used to be a lot harder than it is now.
Dr Bettacchi: I think the best way to help patients express the challenges they live with in their HIV treatment is to initiate a comfortable conversation with the patients, which starts with us as their providers. If that can be accomplished, we can begin to bring down the barriers around awareness of unmet patient needs. I find it helps to ask specific questions to see if they relate to certain challenges, which can then be identified and discussed further. For example, I might ask my patients if they hide their medication from those around them, if it is difficult to remember to take their oral treatment every day, or if they feel that their HIV medication is an uncomfortable reminder of their status.
VISUAL: Speaker on frame; split screen graphic animates on left-hand side; icons and content animate on screen as Dr. Bettacchi speaks
SUPER:
Start a conversation with a patient who may be struggling with taking daily oral therapy
- Do you hide your medication from those around you?
- Is it difficult to remember to take your oral treatment every day?
- Do you feel that your HIV medication is an uncomfortable reminder of your HIV status?
CABENUVA Logo
Dr Bettacchi: To summarize our conversation today, some patients living with HIV may experience challenges regarding the use of daily oral antiretroviral therapy. As their providers, it’s important to meet our patients where they are and help them both recognize and overcome these challenges together.
On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about patient unmet needs and some strategies to uncover them.
Continue watching for additional Important Safety Information.
VISUAL: Speaker on frame; graphic animates on screen
SUPER:
Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
CABENUVA Logo
VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
CABENUVA Logo
VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
CABENUVA Logo
VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
CABENUVA Logo
VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr. Bettacchi: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA”.
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SUPER:
Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor. CBRVID230023 January 2024 Produced in USA.
For US Healthcare Professionals only.
Uncovering Patient Challenges Taking Daily Oral Therapy
Christopher Bettacchi, MD
Dr. Bettacchi describes his patients’ most common challenges taking daily oral therapy and shares techniques for starting conversations about compliance with patients.
Transcript: HIV Treatment Decision Factors
PM-US-CBR-VID-230022
VISUAL: CABENUVA and ViiV logos, series title and video title are on screen over Dr Bettacchi and then move off screen
AUDIO: Faint background music plays throughout video
SUPER:
Expert Perspectives: Conversations on CABENUVA
HIV Treatment Decision Factors
CABENUVA Logo
ViiV Healthcare Logo
Dr Bettacchi: Hello, my name is Dr Christopher Bettacchi. I am an infectious disease specialist in Dallas, Texas. Please join me for a discussion on HIV Treatment Decision Factors.
Before we begin, let us review Important Safety Information for CABENUVA.
VISUAL: Speaker on frame; graphics animate on screen
SUPER:
Speaker has been compensated by ViiV Healthcare
Christopher Bettacchi, MD
CABENUVA Logo
VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
VISUAL: ISI animates on screen
SUPER:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr Bettacchi: For over a decade, I have been part of a team of infectious disease specialists that treats a large and diverse population of people living with HIV. We are currently treating about 1000 people living with HIV. In our practice, I also participate in an LGBTQ+ health and wellness clinic, which is a primary care–focused resource center for our patients within that community.
Dr Bettacchi: I believe that establishing and maintaining a trusting patient-physician relationship is essential and starts with me as the practitioner. I impress upon my patients living with HIV that we are on the journey together, which I demonstrate through listening, asking the right questions, and engaging in an open conversation with them. This allows them to share their challenges with me. Whether it’s the use of their current HIV therapy, or the social impact of their HIV diagnosis, I try to respond with compassion, empathy, and understanding. I also try to be transparent in terms of how I discuss a test result or a new treatment option. I believe all these approaches help lay the foundation for building and maintaining a trusting patient-physician relationship.
In almost all instances, my patient’s feedback directly informs my recommendation to prescribe CABENUVA. If there are challenges with taking daily oral antiretroviral therapy, then it is my responsibility to educate the patient about alternative treatment options, like every-2-month CABENUVA.
Dr Bettacchi: Regarding the use of daily oral therapy, I’ve heard patients express concerns about how oral pills are a daily reminder of their HIV status and the circumstances around their initial diagnosis. Other common challenges are the fear of disclosure and worrying about remembering to take their daily oral medication. When virologically suppressed patients, whose HIV is well-controlled by their current oral therapy, express any of these challenges, I talk to them about the possibility of CABENUVA as a treatment option.
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SUPER:
Common Patient Challenges
- Daily reminder of HIV status
- Fear of disclosure
- Forgetting to take their daily oral medication
CABENUVA Logo
Dr Bettacchi: Treatment optimization, for me, is a recognition of the options we have available to treat HIV. It means choosing a regimen that is the best fit for my patient’s routine. The priority with any given therapy is to ensure that the viral load remains undetectable.
Dr Bettacchi: For virologically suppressed patients wishing to switch to an alternative HIV regimen because of challenges regarding taking daily oral therapy, such as fear of disclosure, my treatment goals are to ensure that the viral load remains suppressed and that their concerns are effectively addressed after switching to CABENUVA.
There are several factors I assess before prescribing CABENUVA, including the patient’s HIV and treatment history and whether they meet treatment eligibility criteria. Patient factors, such as treatment compliance, are also vital to consider and something I discuss carefully with the patient so they understand their responsibilities. With this information, we can make an informed decision whether to switch.
Dr Bettacchi: It starts with us as providers to be a constant source of education for our patients regarding the disease and status of therapies. This is an incredible time in the HIV therapeutic landscape, especially with innovations such as every-2-month CABENUVA treatment. I think that ongoing patient education from the provider is paramount regarding HIV therapy. This begins with staying up-to-date with the HIV treatment landscape and understanding the clinical data that support the efficacy and safety of antiretroviral regimens like CABENUVA. We can then translate that information into a language that the patient can understand and use to make informed decisions.
Dr Bettacchi: At times, there are certain challenges that healthcare providers face that might discourage them from discussing the latest treatment options with their patients. I believe that one challenge may be an unfamiliarity with the latest developments in the HIV treatment landscape. If you are not as familiar with a particular treatment modality, you're going to be less likely to initiate a conversation with a patient about that treatment.
Another challenge is the perceived obstacles that may be associated with implementing an alternative treatment delivery, such as CABENUVA, within their practice. In my experience, those perceived obstacles seem more complex than they actually are. The time for interaction with the patient may also be limited, which can make it challenging to get these types of conversations started.
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SUPER:
Challenges for Healthcare Providers
- Unfamiliarity with the latest developments in the HIV treatment landscape
- Perceived implementation obstacles for an alternative treatment modality
- Limited time with patient during an office visit
CABENUVA Logo
Dr Bettacchi: Education might help providers overcome those challenges. Learning more about the science behind the alternative treatment, as well as about the patient's perspective, would be beneficial. I think, as HIV healthcare providers, we would benefit from understanding patients in terms of how living with HIV impacts their lives, which may not be revealed in a routine lab test.
Collaborating with other healthcare providers who treat HIV may help overcome the perception of obstacles surrounding a long-acting treatment modality.
Dr Bettacchi: To summarize our conversation today, I believe it is our duty to advocate for our patients when it comes to decisions around their HIV therapy, and the impact those decisions may have.
On behalf of ViiV Healthcare, I would like to thank you for joining me today and taking the time to learn about HIV treatment decision factors.
Continue watching for additional Important Safety Information.
VISUAL: Speaker on frame; graphic animates on screen
SUPER:
Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
CABENUVA Logo
VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
CABENUVA Logo
VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
CABENUVA Logo
VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding.
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
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Dr. Bettacchi: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA”.
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Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor. CBRVID230022 January 2024 Produced in USA.
For US Healthcare Professionals only.
HIV Treatment Decision Factors
Christopher Bettacchi, MD
Dr. Bettacchi discusses his approach to individualizing HIV treatment by including patients in treatment decisions.
Transcript: SOLAR: A Head-to-Head Switch Study of CABENUVA vs Continuing BIKTARVY
PM-US-CBR-VID-230020
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Expert Perspectives: Conversations on CABENUVA
SOLAR : A Head-To-Head Switch Study Of CABENUVA vs Continuing BIKTARVY
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Dr Ramgopal: Hello, my name is Dr Moti Ramgopal. I am a board-certified internal medicine and infectious disease doctor in Florida. Please join me for a discussion on the SOLAR clinical study, a head-to-head switch study of CABENUVA vs continuing daily oral BIKTARVY in which I served as an investigator. Before we begin, let us review some Important Safety Information for CABENUVA.
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Speaker has been compensated by ViiV Healthcare
Moti Ramgopal, MD
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VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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Dr Ramgopal: I’m the founder and director of Midway Immunology Research Center in Fort Pierce, Florida, which in the last 15 years has been involved in over 300 clinical trials predominantly in HIV. I’m also the medical director of an organization of 15 clinics throughout Florida. Our patient population is an underserved community with a diverse multi-ethnic background.
Dr Ramgopal: Today’s presentation will cover patient perspectives of patients entering the SOLAR study. We’ll then go over the SOLAR study design and key efficacy and safety outcomes. Finally, we’ll discuss clinical considerations for CABENUVA and my approach to identifying appropriate patients.
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Today we’ll discuss:
- Patient Perspectives
- SOLAR Study Design and Outcomes
- Clinical Considerations for CABENUVA
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Dr Ramgopal: Let’s start our discussion with an overview of the patient perspective questionnaire at the beginning of SOLAR.
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SOLAR: Patient Perspectives
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Dr Ramgopal: The previous FLAIR, ATLAS, and ATLAS-2M trials all established the efficacy and safety of CABENUVA, which led to the approval of CABENUVA once-monthly and every-2-month dosing regimens.
Dr Ramgopal: Compared to the previous trials, SOLAR is the first and only study to date that compared switching to CABENUVA with continuing daily oral BIKTARVY. BIKTARVY was selected due to its common usage in patients living with HIV-1. The SOLAR study also evaluated the patient treatment preference as a secondary endpoint.
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SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY
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Dr Ramgopal: Patients who entered SOLAR were asked 3 baseline questions about their previous experience with taking daily oral therapy.
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Patients entering SOLAR on BIKTARVY revealed challenges with taking daily oral therapy at baseline
On Day 1 (exploratory endpoint), all patients entering SOLAR on BIKTARVY (n=670; mITT-E) responded to three baseline questions about their previous experience on a daily oral therapy
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Dr Ramgopal: 47% of the patients reported experiencing at least one of the following challenges, either always or often. They were worried about people unintentionally discovering their HIV status or they were worried about forgetting to take their HIV medication, or they felt that taking their HIV medication was an uncomfortable reminder of their HIV status.
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47% of patients in SOLAR reported experiencing at least one of the following challenges always or often:
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: If you include those who sometimes agreed with at least one of the challenges, the percentage increased to 80%.
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80% of patients in SOLAR reported experiencing one of these same challenges always, often or sometimes:
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: Now that we have reviewed some of the challenges that patients have experienced with taking daily oral therapy prior to the start of the SOLAR study, let’s dive into the study overview.
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SOLAR: Study Design
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Dr Ramgopal: The SOLAR study was a Phase 3b, open-label, noninferiority trial that compared switching to every-2-month CABENUVA with continuing once-daily BIKTARVY in virologically suppressed adult patients who were 18 years of age and older with HIV-1.
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SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY
A large phase 3b, open-label, noninferiority study of virologically suppressed adults (greater than or equal to 18 years) with HIV-1
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Dr Ramgopal: Patients came into the study virologically suppressed on BIKTARVY for at least 6 months and at screening.
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Dr Ramgopal: Patients were randomized 2 to 1 either to switch to every-2-month CABENUVA, or to continue daily oral BIKTARVY. Patients that were randomized to CABENUVA were given the option of 1-month oral lead-in or to start long-acting intramuscular injections with CABENUVA directly.
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Dr Ramgopal: The primary endpoint was the proportion of patients with HIV-1 RNA at least 50 copies per mL in the Month 12 analysis.
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Dr Ramgopal: A key secondary endpoint was the proportion of patients with HIV-1 RNA with less than 50 copies per mL in the Month 12 analysis. Key exclusion criteria included history of virologic failure, known or suspected presence of resistance mutations to the individual components of BIKTARVY or CABENUVA, hepatitis B virus infection at screening, moderate to severe hepatic impairment, and women who were pregnant or breastfeeding or planned to become pregnant or breastfeed.
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Dr Ramgopal: The efficacy analyses, baseline questionnaire, and preference calculation were based on the modified intent-to-treat population, mITT-E, which includes 670 patients. The safety analyses were based on the intent-to-treat population, ITT-E, where 681 patients were enrolled. The reason behind the modified intent-to-treat population is that 11 participants at a single study site were excluded from the ITT-E population due to significant and persistent non-compliance to protocol requirements.
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Dr Ramgopal: Now, let's jump into the baseline patient characteristics of the SOLAR study. When we look at the spectrum of patients in each treatment arm, I think it's important to recognize that SOLAR enrolled a broad range of patients. The median age of patients in the study was 37 years old, and about 20% of patients were age 50 or older. The majority of the patients were male, approximately 20% were female, and roughly 20% were Black or African American. In addition, patients were on treatment with BIKTARVY for almost 2 years prior to study enrollment.
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SOLAR included a broad range of patients
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Dr Ramgopal: Now that we have gone over the SOLAR study design, let’s review the main efficacy findings of the SOLAR study.
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SOLAR: Key Efficacy Results
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Dr Ramgopal: The SOLAR primary endpoint was met. Every-2-month CABENUVA was proven to be noninferior to BIKTARVY through the Month 12 analysis. Results from the key secondary endpoint demonstrated that rates of virologic suppression were also found to be similar between treatment arms.
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SOLAR: Every-2-month CABENUVA was noninferior to daily oral therapy with BIKTARVY
FDA snapshot virologic outcomes through Month 12 analysis: every-2-month CABENUVA noninferior to BIKTARVY
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Dr Ramgopal: Confirmed virologic failure was observed in 2 patients receiving CABENUVA, representing 0.4% of patients in the mITT-E population. There was one additional patient on CABENUVA who developed CVF in the ITT-E population. All 3 of these patients were subsequently resuppressed on other alternative HIV medications. There were no confirmed virologic failures in the BIKTARVY group.
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SOLAR: Confirmed virologic failures were seen in 2 patients receiving CABENUVA (in mITT-E)
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Dr Ramgopal: We also found that drug-related adverse events were more frequent in the CABENUVA arm. And this is not unexpected since this is a switch study, where patients had come into the study already virologically suppressed on BIKTARVY for almost 2 years. The most common drug-related adverse events in the CABENUVA arm were injection-site reactions which were identified in previous studies as well. Additionally, the patient discontinuation rate due to drug-related adverse events in the CABENUVA arm was 4%, of which 2% of CABENUVA patients discontinued treatment due to injection-related reasons.
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SOLAR: Safety Profile
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Dr Ramgopal: Now that we have gone over drug-related adverse events in the SOLAR study, let’s take a look at the incidence of injection-site reactions reported by visit. We can see by the figure that ISRs decreased over time. I think it is important to note that self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the study. The majority of these ISR events were Grades 1-2, or mild to moderate in severity and occurred over a median of 3 days.
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SOLAR: Incidence of ISRs (All Grades) Reported by Visit
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Dr Ramgopal: At the Month 12 analysis or study withdrawal, CABENUVA-treated patients in the mITT-E population were asked to respond to a question about which regimen they preferred. 90% of the patients who responded to the survey preferred CABENUVA over daily oral therapy with BIKTARVY, 5% preferred BIKTARVY, and 5% had no preference. 22 patients did not respond to the survey.
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Every-2-month CABENUVA was preferred by 9 out of 10 survey respondents vs daily oral therapy with BIKTARVY
SOLAR: Survey Respondents’ Preference
- At the Month 12 analysis or study withdrawal (secondary endpoint), all CABENUVA treated patients in SOLAR (mITT-E; n=447) were asked to respond to a question about which regimen they preferred. 22 patients did not respond
- Respondents were asked to compare their experience using CABENUVA vs BIKTARVY, to select the treatment they preferred
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: The reasons for their preference were largely consistent with the challenges we observed with the baseline survey that was discussed earlier. The most common response was being worried about remembering to take their medication every day, followed by the convenience of every-2-month injections, not having to carry medication with them, not having to think about HIV status, and not having to worry about others seeing or finding their HIV pills.
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SOLAR: Survey Respondents’ Preference
CABENUVA-treated patients from SOLAR who preferred CABENUVA to BIKTARVY (n=382) were offered a list of responses to explain why
- The most commonly chosen responses were:
- 85%: “I do not have to worry as much about remembering to take HIV medication every day”
- 83%: “It is more convenient for me to receive injections every 2 months”
- 74%: “I do not have to carry my HIV medication with me”
- 61%: “I do not have to think about my HIV status every day”
- 59%: “I do not have to worry about others seeing or finding my HIV pills”
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: Now that we have gone through a summary of the study’s key findings, I want to talk about how the SOLAR study has not only impacted my clinical practice, but the treatment landscape as well.
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Clinical Considerations for CABENUVA
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Dr Ramgopal: A key question here is, what do physicians need to think about when moving forward with an injectable treatment option? While virologic suppression remains the most important goal of antiretroviral therapy, I think it’s also important that we consider what challenges patients might experience with their medicines.
Dr Ramgopal: I think providers need to start asking their patients questions such as, “do you hide your medication from those around you?”
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Potential Questions to Ask Your Patients Who May Be Struggling with Taking Daily Oral Therapy
- Do you hide your medication from those around you?
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Dr Ramgopal: Is it difficult to remember to take your oral treatment every day?
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- Is it difficult to remember to take your oral treatment every day?
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Dr Ramgopal: Do you feel that your HIV medication is an uncomfortable reminder of your HIV status? And once these questions are introduced to the patient, they have to think about the answer, even though they might have been taking their pills for some time. And that can reveal another element of patient care.
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- Do you feel that your HIV medication is an uncomfortable daily reminder of your HIV status?
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Dr Ramgopal: Even though a patient may seem comfortable with taking an oral medication and is virologically suppressed, this should not prevent providers from asking these types of questions. This is because taking an oral medication can be one of the many challenges that patients may already have, helping them alleviate even one challenge by offering CABENUVA as an alternative to daily oral treatment is very important to me.
As I've had these conversations, more and more patients have expressed interest in CABENUVA. I have patients who have been on CABENUVA for almost two years, and they are very comfortable receiving this medication. And I think my experience is reflective of what we saw in the SOLAR study in which 90% of the survey respondents preferred CABENUVA.
Dr Ramgopal: Additionally, providers may think that the initial startup to implement CABENUVA into their practice will be time-consuming. And while it does take some extra work to implement, I find that the end result is worth it once I see my patients looking forward to their next appointment for a CABENUVA treatment. Patients come into the clinic, get their CABENUVA injection, and then I check-in and monitor the patients before they leave. I have found that creating a system for CABENUVA implementation has been very helpful for my practice.
Dr Ramgopal: To summarize our conversation today, we discussed the challenges that patients may face with taking daily oral HIV therapy. We also reviewed that the SOLAR study is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY.
The study found that every-two-month CABENUVA was noninferior to daily oral therapy with BIKTARVY. In addition, nine out of 10 survey respondents in the CABENUVA arm preferred CABENUVA over daily therapy with BIKTARVY.
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Today we discussed:
- Challenges to address
- Remove challenges of taking daily oral HIV therapy
- Proven efficacy
- Noninferior vs daily oral therapy with BIKTARVY
- Patient preference
- Preferred by 9 out of 10 survey respondents over daily oral therapy with BIKTARVY
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Dr Ramgopal: On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about the SOLAR study and how offering CABENUVA has impacted my clinical practice as well as the treatment landscape for HIV.
Continue watching for additional Important Safety Information.
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SUPER: Continue watching for additional Important Safety Information.
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WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
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VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
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VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
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VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding.
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
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Dr. Ramgopal: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA.”
VISUAL: Full-screen image animates on screen then fades to black
SUPER:
Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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ViiV Healthcare Logo
Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor. CBRVID230020 January 2024 Produced in USA.
For US Healthcare Professionals only.
A Head-to-Head Switch Study
Moti Ramgopal, MD
A key investigator presents an overview of the study design and key efficacy and safety results from SOLAR, a phase 3b study comparing CABENUVA to continuing daily oral BIKTARVY. Patient perspectives revealed in the study are also discussed.
Transcript: Patient and Physician Perspectives
PM-US-CBR-VID-230021
VISUAL: CABENUVA and ViiV logos, series title and video title are on screen over Dr. Overton and Marvin and then move off screen.
AUDIO: Faint background music plays throughout video.
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Expert Perspectives: Conversations on CABENUVA
Patient and Physician Perspectives
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Dr Overton: Hello, my name is Dr Turner Overton. I am a regional medical director at ViiV Healthcare and an infectious disease specialist. Please join me for a discussion between my former patient and myself about CABENUVA.
Before we begin, let us review some Important Safety Information for CABENUVA.
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Turner Overton, MD
Regional Medical Director for ViiV Healthcare
CABENUVA Logo
VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr Overton: As we begin, I would like to introduce Marvin, a previous patient of mine.
Marvin: Hi, my name is Marvin, and I am an HIV patient ambassador from Louisiana and one of Dr Overton’s former patients.
Dr Overton: Thank you so much for joining us today.
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Marvin
Marvin is a real patient receiving CABENUVA. Marvin has been compensated by ViiV Healthcare.
Turner Overton, MD
Regional Medical Director for ViiV Healthcare
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Dr Overton: Now, I’d like to provide a little more of my background. As an infectious disease specialist, I have spent over a decade working with patients living with HIV. Even though I now work for ViiV Healthcare, I still practice at a Ryan White–funded clinic. This gives me the privilege of working with a diverse patient population from all walks of life. My approach to HIV care is patient-centered and comprehensive, and we strive to meet patients, like Marvin, where they are. I am passionate about meeting patients’ needs by having access to current treatments for HIV, so I participate in HIV-focused clinical research, and I was a clinical investigator for the CABENUVA clinical trials.
Dr Overton: Now that I’ve introduced myself, let’s hear your story, Marvin. Would you please tell us about your journey living with HIV?
Marvin: Thank you, Dr Overton, and of course! My journey with HIV started before my diagnosis. I was involved in HIV advocacy in my community, and I knew about the disease, its statistics, and how it disproportionately impacts people in the South and people of color. However, the summer of 2012 was both liberating and important for me. I divorced my wife and started living true to myself. A year later, I was diagnosed with HIV and had start living with another truth. Upon my diagnosis, using a daily oral therapy daily was a constant reminder of my HIV status.
Dr Overton: Thank you for sharing that, Marvin. At the end, you said that taking your oral medication every day was a constant reminder of your diagnosis. Can you share any other challenges that you experienced when you took daily oral antiretroviral therapy?
Marvin: Yes, through my advocacy work, I was a very active member of my community and on days when I had to go advocate and educate others about HIV, safe-sex practices, and general health education, it was challenging remembering to take my oral HIV medication before walking out the door.
Dr Overton: You’re definitely not the only one who forgets to take their medication, Marvin. Could you tell us a little bit more about why you decided to switch from oral therapy to CABENUVA?
Marvin: I remember the first time I heard about CABENUVA. I was on advisory boards and worked in the HIV field as a consultant in telemedicine, so I had heard about ongoing clinical trials for CABENUVA. I asked you about it and you explained it to me thoroughly, but it wasn’t available yet and when it became available, and the opportunity came to switch, I started CABENUVA under my new doctor because I relocated.
I have a busy schedule with my advocacy work in the community, and CABENUVA is the right fit for me because I can get it once every other month.
Dr Overton: Marvin’s story certainly resonates a lot with what I see in practice. Many people living with HIV can achieve virologic suppression with oral therapy, but it doesn’t mean they don’t have other challenges associated with their oral regimen. Some of my patients have very busy schedules and hectic lives, so an alternative to daily oral treatment like an injection just 6 times a year could be a better fit for them.
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Injections are administered as few as 6 times a year after two initiation injections one month a part.
Dr Overton: Another challenge my patients commonly express is fear of disclosure, disclosure within the family, workplace, or community, and that can leave them feeling isolated. There is still a lot of stigma around HIV and as healthcare providers, we need to be open-minded. It’s not enough to look at a patient’s viral load, check the box if it is undetectable, and move on. In our practice, for instance, we collect data on patient-reported outcomes at every visit. The patient responds to a few questions centered around challenges they may be experiencing. Even if a patient answers “no” to the question “Have you missed any doses within the last week or month?”, the conversation does not end there for us. On the other hand, if the answer is yes, we probe further to better understand what the challenges may be. We ask open-ended questions that allow for a robust patient-provider dialogue.
It’s also not uncommon for the social worker on our team to provide additional insights on challenges a patient may be facing, challenges such as a recent job loss or housing challenges, which can impact adherence. So, it is a combination of a team approach and creating a safe space where patients feel comfortable enough to speak up and disclose the challenges they may be experiencing.
Dr Overton: Marvin, do you remember the questions that you asked me during our conversation before getting started on CABENUVA?
Marvin: Of course, Dr Overton! Having a safe space is crucial for me. I felt you were treating a person living with HIV rather than just HIV, and this made me feel comfortable enough to ask questions before I got started once-monthly on CABENUVA. I wanted to understand the administration of CABENUVA and the information supporting its use. I also wanted to understand what side effects have been reported before getting started. You addressed my questions and discussed the possible side effects of CABENUVA, and then I got started once it became available. And at that point, I was under care of my new doctor because I had moved.
Dr Overton: Marvin brings up some great points. From my experience, our perceptions as providers sometimes differs from the patient’s perspective. Asking those open-ended questions helps me identify patients who may be interested in an alternative HIV therapy. If a patient is interested and meets the treatment criteria for CABENUVA, we tell them about it. Word of mouth also generated inquiries from several patients who asked about CABENUVA--either because they heard about it from someone else or from a commercial. Though they may be initially nervous about an alternative approach to administering their HIV treatment, in those instances, we counsel patients about what to expect. For example, we educate patients about reported adverse reactions they may expect from CABENUVA.
Dr Overton: Marvin, what’s been your experience with the CABENUVA injection process, and can you share any treatment-day routines you may have?
Marvin: Yes. I started with the 30-day optional oral lead-in and remember counting down to my first injections. It was a lot of anticipation, and I was quite excited. I was also a bit nervous, but I felt prepared, so I knew what to expect. I started with the once-monthly treatment and since then, I’ve switched to every-two-month CABENUVA once it became available.
In terms of my injections, I was able to choose the time of my appointments, so I go first thing in the morning, which is always followed by a self-care routine that includes celebrating not having to think about my HIV treatment until my next appointment.
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The oral lead-in is optional. When used, prescribe cabotegravir 30-mg tablets and rilpivirine 25-mg tablets, taken together once daily with a meal for 28 days.
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Dr Overton: Thank you, Marvin. You know, I’ve heard similar experiences from other patients as well. In practice, I often see that once a patient has been on CABENUVA for a while and knows that it’s working for them, what we hear them say is that they feel liberated knowing that they don’t have to take daily oral HIV medicines anymore.
I’ve also observed a difference in the clinic experience visit. My patients who are on CABENUVA tell me they associate their visit to the clinic with a positive experience because they appreciate more opportunities to interact with their healthcare team. So, I have heard positive feedback from my patients on CABENUVA.
Dr Overton: Marvin, have you ever used the treatment window while scheduling your appointments? If so, how did that work?
Marvin: Well, I travel quite often, and I have lots of irons in the fire as I try to show up to life. On instances when my injection appointment falls on a day when I am scheduled to travel, or if it falls after a trip and is impacted by a flight delay, I don’t have any worry or frustration that would usually come with unanticipated changes in plans. I just call my current doctor’s office and we reschedule for another day within the treatment window.
I can live my life while being compliant with my regimen to keep me healthy. I know it’s important to get my injections on my scheduled treatment date, but it’s nice to have the flexible treatment window available, should I need to use it.
Dr Overton: In Marvin’s case and many others, knowledge is power, and that starts with us as healthcare practitioners. We educate patients on what their role is in order to have a successful CABENUVA treatment experience.
Dr. Overton: We emphasize the importance of receiving their injections on the Target Treatment Date. However, we know that life happens, so we inform patients about the treatment window for their injections in case they miss the Target Treatment Date. At any given visit, we schedule patients for the next 2 injection visits. In addition, there’s an ongoing dialogue between our patients and their case manager. So, they get a reminder text, email, or phone call 48 hours prior to the treatment date to remind them of their visit. On the injection day, to expedite the visit as much as possible, we advise that patients inform us as soon as they arrive so we can prepare the medicine.
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- CABENUVA Dosing Schedule
- Target Treatment Date (select a specific date between the 1st and 28thof the month as their Target Treatment Date every 2 months to help your patients be on track)
- Dosing Window (7 days before or 7 days after Target Treatment Date) for dosing flexibility
- [The 29th, 30th & 31st] Not recommended for Target Treatment Date due to varying number of days in each month
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Dr Overton: For patients who know that they will miss an injection, we plan for that, and it’s worked really well in my practice. We try to schedule the injection within the flexible window. So far, very few of my patients have had to miss their injection. I was able to cover these missed injections with oral therapy until their injections were restarted.
Dr Overton: It’s been incredibly helpful to hear Marvin’s experience and I’d like to share another 2 powerful CABENUVA stories. The first is from one of my patients who works both day and night and has an irregular sleep cycle and a busy life. Although he was adherent to his daily oral medication, he still had challenges remembering to take it every day. After he switched to CABENUVA, he told me that he felt a sense of relief, relief because receiving his CABENUVA injections every 2 months liberated him from using daily oral HIV therapy.
My second CABENUVA story is from my patient who lives with roommates. For her, it was a matter of being nervous that her roommates were going to find her medication and, by extension, her positive HIV status. She said that since switching to CABENUVA, she no longer has to keep up with using oral medications every day.
Dr Overton: Marvin, how would you describe your overall experience with CABENUVA? And please tell us a little bit about your hopes for the future.
Marvin: You know, as a life coach, an empowerment speaker, and advocate, a common thread in my life is empowerment. I wake up every day, show up, do what I love, and coach people to live their best life. My hope for the future is others can experience the liberation from daily oral therapy with CABENUVA, just like I have.
Dr Overton: Certainly, Marvin, like you, I hope we can do the same. And as we wrap up, I’d like to thank you, Marvin. Thank you for taking the time out of your day to speak with me today about CABENUVA.
Marvin: It was my pleasure, Dr. Overton, and thank you.
Dr Overton: Please continue watching for additional Important Safety Information for CABENUVA.
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Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
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VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
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VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
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VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding.
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
Dr. Overton: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA”.
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SUPER:
Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
CABENUVA Logo
ViiV Healthcare Logo
Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor. CBRVID230021 January 2024 Produced in USA.
For US Healthcare Professionals only.
Patient and Physician Perspectives on CABENUVA
Turner Overton, MD, with Marvin, Patient Ambassador
A physician and patient discuss why they switched to CABENUVA, as well as their experiences with every-2-month dosing.
Transcript: Dosing and Administration: Every-2-Month Dosing Schedule
PM-US-CBR-VID-230024
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Expert Perspectives: Conversations on CABENUVA
Dosing and Administration: Every-2-Month Dosing Schedule
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Dr Bettacchi: Hello, my name is Dr Christopher Bettacchi. I am an infectious disease specialist in Dallas, Texas. Please join me for a discussion on Dosing and Administration for every-2-month CABENUVA.
Before we begin, let us review some Important Safety Information for CABENUVA.
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Speaker has been compensated by ViiV Healthcare
Christopher Bettacchi, MD
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VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr Bettacchi: In my clinical practice, we treat about 1000 people living with HIV. We also participate in an LGBTQ+ health and wellness clinic, which is a primary care–focused resource center for our patients within that community.
Dr Bettacchi: Now that I’ve introduced myself, let’s start our discussion with the dosing kits and the storage recommendations for CABENUVA.
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CABENUVA: Dosing Kits and Storage
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Dr Bettacchi: CABENUVA is available in 2 separate dosing kits. There is only one kit, the 3-mL dosing kit, needed for every-2-month CABENUVA.
Both kits come with 1.5" safety needles.
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CABENUVA is available in 2 separate dosing kits, co-packaged as follows:
A complete dose of CABENUVA requires administration of both cabotegravir and rilpivirine.
Longer needle lengths may be required for patients with higher BMI (example: >30 kg/m2) to ensure that injections are administered intramuscularly as opposed to subcutaneously.
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Dr Bettacchi: CABENUVA should be stored in the refrigerator in the original carton. Once a carton is removed from the refrigerator, it must be used within 6 hours or discarded. It’s important to note that CABENUVA should never be frozen or mixed with any other product.
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CABENUVA storage and handling
Store CABENUVA in the refrigerator at 2 degrees Celsius to 8 degrees Celsius (36 degrees Fahrenheit to 46 degrees Fahrenheit) in the original carton until ready to use.
- Prior to administration, vials should be brought to room temperature (not to exceed 25 degrees Celsius [77 degrees Fahrenheit]). Do not use any heating methods other than using the warmth of your hands
- The vials may remain in the carton at room temperature for up to 6 hours; do not put back into the refrigerator. If not used within 6 hours, the medication must be discarded
- Once CABENUVA has been drawn into the syringe(s), it can remain for up to 2 hours before injection. The filled syringe(s) should not be placed in the refrigerator. If 2 hours are exceeded, the filled syringe(s) and needle(s) must be discarded
- Do not freeze. Do not mix with any other product or diluent
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Dr Bettacchi: Let’s continue with the clinical and patient considerations for CABENUVA.
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CABENUVA: Clinical and Patient Considerations
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Dr Bettacchi: Being able to identify appropriate patients for therapy is the first step to starting CABENUVA, and it begins with you as a practitioner. Before we discuss how CABENUVA is dosed, let’s examine which patients are appropriate for CABENUVA. We've already discussed the indication for CABENUVA at the beginning of this video. Now let's discuss patient considerations for CABENUVA, which include the ability to adhere to and agree to the required injection appointments. Appropriate patients also may have expressed interest in less frequent dosing, alternatives to daily oral therapy, or concerns associated with taking daily oral therapy, such as potential stigma and the disclosure of their HIV status.
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Patient identification for CABENUVA
Patient Considerations
- Able to adhere to and agree to required injection appointments
- May express interest in:
- Less frequent dosing
- Alternative to daily oral therapy
- Decreasing concerns associated with taking daily oral therapy such as:
- Potential stigma
- Disclosure
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Dr Bettacchi: For my patients who are on CABENUVA, the decision to switch is based on conversations about their HIV therapy prior to starting CABENUVA. Those conversations give me an opportunity to educate my patients about CABENUVA, as well as share clinical and safety data. From those conversations, I can identify patients who meet the treatment criteria, and we make a mutual decision to proceed with CABENUVA.
Dr Bettacchi: Next, we’ll discuss every-2-month dosing for CABENUVA.
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CABENUVA: Every-2-Month Dosing
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Dr Bettacchi: Prior to starting CABENUVA, healthcare providers should carefully select patients who agree to the required every-2-month dosing schedule and counsel patients about the importance of adherence to scheduled dosing visits.
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Dosing schedule for starting patients on every-2-month CABENUVA
Before initiation of CABENUVA, ensure patients agree to the required every-2-month dosing schedule and counsel patients about the importance of adherence to scheduled dosing visits.
See the full Prescribing Information for more information on the monthly dosing regimen.
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Dr Bettacchi: For every-2-month dosing, patients receive a single 3-mL intramuscular injection of cabotegravir and a single 3-mL intramuscular injection of rilpivirine on the last day of their current antiretroviral therapy or oral lead-in, if used, and again 1 month later. This is followed by 3-mL injections of each medicine, every 2 months thereafter.
Both initiation and continuation injections of cabotegravir and rilpivirine should be administered at separate gluteal injection sites (on opposite sides or at least 2 cm apart) during the same visit.
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Dosing schedule for starting patients on every-2-month CABENUVA (continued)
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Dr Bettacchi: Setting a consistent injection date, the Target Treatment Date, can help you keep your patients on track.
It is recommended that patients receive their injections on the same date, so the Target Treatment Date should fall between the 1st and 28th of each month.
If the injections cannot be given on the Target Treatment Date, CABENUVA has dosing flexibility, allowing for continuation injections to be given up to 7 days before or up to 7 days after the Target Treatment Date.
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Setting a Target Treatment Date for every-2-month dosing
- Target Treatment Date (select a specific date between the 1st and 28thof the month to be the Target Treatment Date every 2 months)
- Dosing Window (7 days before or 7 days after Target Treatment Date) for dosing flexibility
- [The 29th, 30th & 31st] Not recommended for Target Treatment Date due to varying number of days in each month
If the injections cannot be given on the Target Treatment Date, CABENUVA has dosing flexibility, allowing for injections to be given up to 7 days before or up to 7 days after the Target Treatment Date.
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Dr Bettacchi: Patients switching from a once-monthly CABENUVA to an every-2-month continuation injection dosing schedule should receive a single 3-mL intramuscular injection of cabotegravir and a single 3‑mL intramuscular injection of rilpivirine administered 1 month after the last monthly continuation injection and then every 2 months thereafter.
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Switching from once-monthly to every-2-month CABENUVA
- Recommendations when switching from once-monthly to every-2-month dosing of CABENUVA
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Dr Bettacchi: Lastly, we’ll review the treatment approaches for planned and unplanned missed injections.
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CABENUVA: Dosing Scenarios for Missed Injections
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Dr Bettacchi: If a patient plans to miss a scheduled injection visit by more than 7 days, use any fully suppressive oral antiretroviral regimen until injections are resumed.
Alternatively, use oral cabotegravir 30 mg in combination with oral rilpivirine 25 mg once daily for up to 2 consecutive months to cover a planned missed injection visit.
The first dose of oral therapy should be taken approximately 1 month or approximately 2 months after the last injection dose of CABENUVA, depending on the dosing regimen being used, until the day injection dosing is restarted.
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Oral therapy for planned missed dose
- If a patient plans to miss a scheduled injection visit by more than 7 days:
- Any fully suppressive oral antiretroviral regimen may be used until injections are resumed, or
- Oral cabotegravir (30-mg tablet) in combination with rilpivirine (25-mg tablet) both once daily may be used for up to 2 consecutive months to cover a planned missed injection visit
- The first dose of oral therapy should be taken approximately 1 month or approximately 2 months after the last injection dose of CABENUVA, depending on the dosing regimen being used, until the day injection dosing is restarted
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Dr Bettacchi: In this example, following initiation injections at months 1 and 2 and continuation injections at month 4, a patient plans to miss their next every-2-month CABENUVA injection.
In this hypothetical treatment plan, the healthcare provider initiates oral therapy approximately 2 months after the last injection doses and continues it for 1 month then waits to resume injections on the last day of the oral therapy. So how do you restart the injections?
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Oral therapy for planned missed dose (continued)
- Hypothetical treatment plan if a patient plans to miss their injections for 1 month
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Dr Bettacchi: Determine how much time has passed since the missed Target Treatment Date. If it has been 1 month or less, such as in our example, resume the every-2-month injection dosing schedule as soon as possible. If it has been longer than a month, reinitiate therapy with CABENUVA by administering initiation injections 1 month apart, then continuing injections every 2 months thereafter.
Adherence to scheduled injection visits is strongly recommended. Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate.
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Restarting every-2-month CABENUVA after planned missed injection
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Dr Bettacchi: What do you do if a patient misses an injection visit and oral therapy has not been prescribed?
Clinically reassess the patient to determine whether CABENUVA remains appropriate. If the every-2-month dosing schedule will be continued, determine the time since the missed Target Treatment Date. If it has been 1 month or less, resume injections as soon as possible. Continue with the every-2-month dosing schedule thereafter.
If it has been longer than a month since the missed Target Treatment Date, repeat initiation injections as soon as possible; 1 month apart for 2 consecutive months. Continue the every-2-month dosing schedule thereafter.
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Restarting after unplanned missed injection for patients on every-2-month CABENUVA
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Dr Bettacchi: As of today, I have many patients on CABENUVA and it has been an overall positive experience. Patients have shared how impactful switching to CABENUVA has been for them, and I find those testimonials very satisfying professionally and personally in terms of my patients’ journeys with HIV. Before we start patients on CABENUVA, we discuss what their role is in terms of adherence to injection appointments, and we have been very fortunate with compliance for these appointments.
Dr Bettacchi: To summarize our conversation today, we discussed the key considerations for identifying appropriate patients for CABENUVA, the dosing schedule for every-2-month CABENUVA and how to set a Target Treatment Date, and how to handle missed injections.
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Today we discussed:
- Key considerations for identifying appropriate patients for CABENUVA
- Dosing schedule for every-2-month CABENUVA and how to set a Target Treatment Date
- Treatment approaches for missed injections
Please click the link to view the Prescribing Information for CABENUVA for more information on the monthly dosing regimen.
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Dr. Bettacchi: On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about how CABENUVA is dosed and administered and how to identify patients in your practice.
Continue watching for additional Important Safety Information.
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SUPER: Continue watching for additional Important Safety Information
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
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VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
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VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
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VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding.
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
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Dr. Bettacchi: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA.”
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Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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©2024 ViiV Healthcare or licensor. CBRVID230024 January 2024 Produced in USA.
For US Healthcare Professionals only.
Dosing and Administration of CABENUVA
Christopher Bettacchi, MD
Dr. Bettacchi reviews the dosing of every-2-month CABENUVA and approaches to planned and unplanned missed injections.
