Indication
CABENUVA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
*Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess tolerability.1
Once-monthly treatment has arrived*
Introducing CABENUVA
The first and only, long-acting, complete treatment regimen for virologically suppressed adults with HIV-11†
First and only once-monthly, complete treatment regimen for HIV-11
Proven as effective as continuing a daily oral regimen1‡
Preferred by 9 out of 10 patients in clinical trials2§
In an exploratory endpoint, at Week 48, 88% (523/591) of ITT-E population preferred CABENUVA vs 2% (9/591) who preferred their previous oral regimen; data not available for 59 patients. These results are descriptive in nature and should not be used to infer clinical significance.
*Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess tolerability.1
†HIV-1 RNA <50 copies/mL.1
‡Based on a pooled analysis from two Phase 3, international, randomized, non-inferiority trials (ATLAS and FLAIR) in virologically suppressed (HIV-1 RNA <50 copies/mL) adults ≥18 years with HIV-1.1-3 In ATLAS, 616 treatment-experienced, virologically suppressed (for ≥6 months) patients on 2 NRTIs + an INSTI, NNRTI, or PI were randomized 1:1 to receive either CABENUVA (after a 4-week oral lead-in of cabotegravir 30 mg and rilpivirine 25 mg) or to remain on their current therapy.1,2 In FLAIR, patients without previous ARV exposure were given ABC/DTG/3TC (or DTG + 2 NRTIs if HLA-B*5701-positive) for 20 weeks to achieve suppression for 4 weeks and then randomized 1:1 (N=566) to receive either CABENUVA (after a 4-week oral lead-in of cabotegravir 30 mg and rilpivirine 25 mg) or to remain on their current regimen.1,2 At baseline, in FLAIR and ATLAS, respectively, 24% and 31% of patients were nonwhite.1,2 In both studies, 7% had CD4+ cell count <350 cells/mm3. In ATLAS, baseline third-agents were: 50% NNRTIs, 33% INSTIs, or 17% PIs.1 Patients were excluded if they were pregnant or breastfeeding, had moderate to severe hepatic impairment, or evidence of HBC infection at screening.3 Non-inferiority of CABENUVA would be shown if the upper bound of the 95% CI for the treatment difference was <6% for the individual studies.4,5
§Patient preference data collected from clinical trial participants from ATLAS and FLAIR randomized to long-acting arm, completing a single-item question assessing their preference for CABENUVA compared to their previous oral regimens.
"With CABENUVA injections, I feel a sense of independence from not having to take a pill at the same time every day and fearing that I missed it.
Instead of stressing about daily treatment, I can focus on treatment once a month. Even though it's just a few seconds a day to take a pill, I now don't have to remember to take my HIV treatment until my next appointment."
— Mark, clinical trial participant and patient ambassador
Patient experiences with CABENUVA after receiving 1 month of oral lead-in of cabotegravir and rilpivirine. Individual patient experiences are not indicative of all patient experiences or clinical trial results.
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"Until I stopped taking the daily HIV pill, I didn't appreciate how much it impacted my every day.
Now, I don't have to worry about taking treatment every day, instead, once a month. Being liberated from taking HIV medication daily makes life different in a way - you're not a different person, but it changes your day-to-day living with the disease. I do have to plan for appointments around work, and that was a change, but now I'm used to the process."
— Jayson, clinical trial participant and patient ambassador
For Your Practice
Clinical Trials
Learn about ATLAS and FLAIR: Phase 3 clinical trials in virologically suppressed adult patients with HIV-1
Risks & Side Effects
Review risks and side effects information, including safety and tolerability data, for CABENUVA
Dosing & Drug Interactions
Get information on dosing and administering CABENUVA, as well as potential drug interactions
3TC=lamivudine; ABC=abacavir; ARV=antiretroviral; CI=confidence interval; DTG=dolutegravir; HBC=Hepatitis B core; HLA-B=human leukocyte antigen complex B; INSTI=integrase strand transfer inhibitor; ITT-E=intent-to-treat efficacy; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; PI=protease inhibitor.
References:
- CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2019.
- Overton ET, Orkin C, Swindells S, et al. Monthly long-acting cabotegravir and rilpivirine is noninferior to oral ART as maintenance therapy for HIV-1 infection: week 48 pooled analysis from the phase 3 ATLAS and FLAIR studies. Poster presented at: 10th IAS Conference on HIV Science: July 21-24, 2019; Mexico City, Mexico. Poster MOPEB257.
- Data on File. ViiV Healthcare group of companies. Research Triangle Park, NC.
- Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting cabotegravir + rilpivirine for maintenance therapy: ATLAS week 48 results. Presented at: Conference on Retroviruses and Opportunistic Infections: March 4-7, 2019; Seattle, WA.
- Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir + rilpivirine for HIV maintenance: FLAIR week 48 results. Presented at: Conference on Retroviruses and Opportunistic Infections: March 4-7, 2019; Seattle, WA.
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