Michael, living with HIV.

Individuals featured on this website have
been compensated by ViiV Healthcare.

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 trials

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.

You May Also Be Interested In

Talking To Your Patients

Key points to discuss with your HIV-1 patients for a better understanding of CABENUVA

Patient Testimonials

Hear what patients have to say about CABENUVA

Patient Support

Patient support options are available for prescribed CABENUVA

"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

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.

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:

  1. CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2019.
  2. 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.
  3. Data on File. ViiV Healthcare group of companies. Research Triangle Park, NC.
  4. 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.
  5. 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.

CBRWCNT190001