Michael, living with HIV.

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CABENUVA is administered as 2 intramuscular injections by a healthcare professional. Adherence to the monthly dosing schedule is strongly recommended.1

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

First and only once-monthly, complete treatment regimen for HIV-11

More about Dosing >

Proven as effective as continuing a daily oral regimen1‡
Primary endpoint: proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 via FDA Snapshot Algorithm. Proportion of patients with HIV‑1 RNA ≥50 copies/mL at Week 48 in pooled analysis was 2% for CABENUVA vs 2% for daily oral comparator (non-inferior treatment difference: 0.2% [95% CI: -1.4, 1.7])

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Preferred by 9 out of 10 patients in clinical trials2-4§

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.

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*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-1.1-4 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.1,3 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.1,4 At baseline, in FLAIR and ATLAS, respectively, 24% and 31% of patients were nonwhite.1,2 In both studies, 7% had CD4+ T-cell count <350 cells/mm3.1 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 HBV infection at screening.3,4 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.2-4

§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.

3TC=lamivudine; ABC=abacavir; ARV=antiretroviral; CI=confidence interval; DTG=dolutegravir; FDA=Food and Drug Administration; HBV=hepatitis B virus; 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.

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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."

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References:

  1. CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.
  2. Rizzardini G, Overton ET, Orkin C, et al. Long-acting injectable cabotegravir + rilpivirine for HIV maintenance therapy: week 48 pooled analysis of phase 3 ATLAS and FLAIR trials. J Acquir Immune Defic Syndr. 2020;85(4):498-506.
  3. Data on File, ViiV Healthcare.
  4. Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-suppression. N Engl J Med. 2020;382(12):1112-1123.
  5. Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV‑1 infection. N Engl J Med. 2020;382(12):1124-1135.

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