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Ashton, living with HIV.
Receiving CABENUVA.

Individuals featured on this website have
been compensated by ViiV Healthcare.
Patients featured are either on every-2-month
or once-monthly CABENUVA.

Every 2-Month CABENUVA Is Here1

Cabenuva Home Page Banner Desktop

Ashton, living with HIV.
Receiving CABENUVA.

Individuals featured on this website have
been compensated by ViiV Healthcare.
Patients featured are either on every-2-month
or once-monthly CABENUVA.

Every 2-Month CABENUVA Is Here1

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.

CABENUVA is administered as 2 intramuscular injections by a healthcare professional every month or every 2 months. Adherence to the dosing schedule is strongly recommended.

Initiation injections (cabotegravir 600 mg/3 mL and rilpivirine 900 mg/3 mL) are required for both the once-monthly and every-2-month regimens. For the every-2-month regimen, additional initiation injections should be administered 1 month after the first initiation injections.

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Transform the Treatment Experience With Every-2-Month CABENUVA

First and only long-acting complete injectable treatment regimen for HIV-1 administered as few as 6 times a year*

Durable virologic suppression through 96 weeks1-3†
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 was 2% for every-2-month CABENUVA vs 1% for once-monthly CABENUVA (non-inferior treatment difference: 0.8% [95% CI: -0.6, 2.2]) and was 2% for every-2-month CABENUVA vs 1% for once-monthly CABENUVA (non-inferior treatment difference: 1.0% (95% CI: -0.6, 2.5) at Week 96.

Every-2-month CABENUVA was preferred by 9 of 10 trial patients3‡

In a secondary endpoint, at Week 48 in ATLAS-2M, 92% (300/327) of patients preferred every-2-month CABENUVA vs 1% (4/327) who preferred oral cabotegravir and rilpivirine that was taken as the oral lead-in, as required.
These results are descriptive in nature and should not be used to infer clinical significance.

*Initiation injections (cabotegravir 600 mg/3 mL and rilpivirine 900 mg/3 mL) are required for both the once-monthly and every-2-month regimens. For the every-2-month regimen, additional initiation injections should be administered 1 month after the first initiation injections.

HIV-1 RNA <50 copies/mL.1

Based on a phase 3, open-label, non-inferiority trial (ATLAS-2M) in virologically suppressed (HIV-1 RNA <50 copies/mL) adults ≥18 years with HIV-1.1,2 In ATLAS 2-M, patients with prior once-monthly CABENUVA experience (n=391) and patients with no prior once-monthly CABENUVA experience (n=654) were randomized 1:1 to receive either once-monthly CABENUVA (n=523) or every-2-month CABENUVA (n=522).1 Patients transitioning from the ATLAS trial must have been on once-monthly CABENUVA or their current oral regimen for at least 52 weeks and had plasma HIV-1 RNA <50 copies/mL.1 Patients with no prior experience with once-monthly CABENUVA were suppressed for ≥6 months (HIV-1 RNA <50 copies/mL), with suppression defined as HIV-1 RNA <50 copies/mL. Patients with prior once-monthly CABENUVA experience received either 400-mg cabotegravir and 600-mg rilpivirine once-monthly or 600-mg cabotegravir and 900-mg rilpivirine every 2 months. Patients with no prior experience with once-monthly CABENUVA received an oral lead-in regimen and then initiation injections followed by once-monthly or every-2-month injections.1 Patients were excluded if they were pregnant or breastfeeding, had moderate to severe hepatic impairment, or evidence of HBV infection at screening.1 At baseline for ATLAS-2M, the median age was 42 both for patients randomized to every-2-month and once-monthly CABENUVA.1 In both arms, 7% of patients had a CD4+ T-cell count <350 cells/mm3.2 Non-inferiority of CABENUVA would be shown if the upper bound of the 95% CI for the treatment difference was <4%.2

Patient preference data collected from ATLAS-2M clinical trial participants with no prior experience with long-acting cabotegravir plus rilpivirine randomized to every-2-month CABENUVA who completed a questionnaire assessing their preference for CABENUVA vs cabotegravir and rilpivirine that was taken as the oral lead-in, as required.2

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.

CI=confidence interval; FDA=Food and Drug Administration; HBV=hepatitis B virus.

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Resources

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Access & Patient Support

ViiVConnect provides comprehensive patient support programs as well as resources for healthcare providers

"With CABENUVA, I now have 2 months between appointments.

This allows me to say yes to things where I don't really have to worry about taking a pill every day. I look forward to making it to my appointment every 2 months because I get to check in with my medical team and feel like I'm taking care of my health. So, that's important to me."

Jayson, living with HIV.

      Receiving CABENUVA.

For Your Practice

Clinical Trials

Learn about ATLAS, FLAIR, and ATLAS-2M 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

References:

  1. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
  2. Data on File, ViiV Healthcare.
  3. Jaeger H, Overton ET, Richmond G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. Published online October 11, 2021. doi: 10.1016/S2352-3018(21)00185-5
  4. 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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