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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
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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 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 28th of 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, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms or DRESS, have been reported with CABENUVA or its components. 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, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with CABENUVA or its components. 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.
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 (incidence ≥2%, Grades 1 to 4) with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
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 full 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 full 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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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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