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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.
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.
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.
†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
CI=confidence interval; FDA=Food and Drug Administration; HBV=hepatitis B virus.
"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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"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
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Learn about ATLAS, FLAIR, and ATLAS-2M Phase 3 clinical trials in virologically suppressed adult patients with HIV-1
Risks & Side Effects
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References:
- 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
- Data on File, ViiV Healthcare.
- 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
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