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Cabenuva combines cabotegravir and rilpivirine as two injections at each monthly or every-two-month visit and is a complete HIV treatment regimen. Its FDA-approved use is a switch for eligible people with viral suppression. Sunlenca injections are used every 26 weeks with other HIV medicines for heavily treatment-experienced adults with multidrug-resistant HIV. Yeztugo is lenacapavir for HIV prevention, not a treatment regimen.[1][4][5]
Cabenuva: the first complete injectable regimen
FDA approved Cabenuva on January 21, 2021 as the first complete long-acting injectable HIV regimen, initially with monthly injections, and approved oral cabotegravir (Vocabria) for the lead-in. Under the current Cabenuva label, the oral lead-in is optional.[1][2]
The Cabenuva label covers adults and adolescents aged 12 or older weighing at least 35 kg, with HIV RNA below 50 copies/mL on a stable regimen, no history of treatment failure and no known or suspected resistance to either drug. Separately, NIH allows case-by-case use in selected people with persistent viremia despite intensive support with oral ART, without CAB/RPV resistance and through shared decision-making. That is a specialist decision outside the standard labeled switch population and requires close follow-up.[9][1][3]
How it's given, and how flexible the schedule is
Cabenuva is given as gluteal intramuscular injections only — two injections at the same visit, at separate sites on opposite sides or at least 2 cm apart, with the ventrogluteal site recommended. Longer needles may be needed at a BMI over 30, and you will be observed for about 10 minutes afterward because of rare post-injection reactions[1].
Two schedules exist[1]:
- Monthly — 600/900 mg to initiate, then 400/600 mg every month
- Every 2 months — 600/900 mg at Month 1 and Month 2, then every two months from Month 4
You can start with an optional oral lead-in — cabotegravir 30 mg plus rilpivirine 25 mg daily with a meal for at least 28 days, to check tolerability — or go direct-to-injection. And life is allowed to happen: injections may be given up to 7 days before or after the scheduled date[1].
What the trials showed
Three trials support the regimen[1]:
- FLAIR — 94% on injections vs 93% on oral therapy had HIV RNA under 50 copies/mL at Week 48
- ATLAS (n=616) — 93% vs 95% suppressed at Week 48
- ATLAS-2M (n=1,045) — 94% in each dosing arm had HIV RNA below 50 copies/mL at week 48. The reported difference of 0.8 percentage points (95% CI −0.6 to 2.2) concerned the primary endpoint of HIV RNA at or above 50 copies/mL, not the suppression percentages.
Resistance is uncommon but real. Among 8 confirmed virologic failures on cabotegravir plus rilpivirine in pooled FLAIR and ATLAS data, 7 of 8 developed NNRTI-resistance substitutions and 5 of 8 developed integrase-inhibitor substitutions[1].
The trade-offs, missed injections, and stopping safely
Injection-site reactions are common — 83% of participants in pooled FLAIR and ATLAS data reported them (pain or discomfort 79%, nodules 14%), with a median duration of 3 days; 1% stopped treatment because of them. Other common reactions included fever, fatigue, headache, musculoskeletal pain, nausea, sleep problems, dizziness, and rash. Labeled warnings include serious hypersensitivity reactions (including SJS/TEN and DRESS), hepatotoxicity, depressive disorders, and rare post-injection reactions[1].
A missed injection needs a prompt plan with the clinic. For a planned delay beyond seven days, the label permits oral cabotegravir plus rilpivirine for up to two months, or another fully suppressive oral regimen. Unplanned gaps require reassessment. The restart threshold is more than two months since the last injection on the monthly schedule; on the every-two-month schedule it is more than two months if the second initiation visit is missed, and more than three months for injection 3 or later. These thresholds guide clinician-directed restarting, not permission to delay a scheduled visit.[1][3]
Stopping requires a fully suppressive replacement regimen. The Cabenuva label says it must start no later than one month after the last injections on monthly dosing or two months after the last injections on every-two-month dosing; suspected virologic failure needs a switch as soon as possible. Residual drug can persist for a year or longer. Agree on the exact date and regimen with the clinic before stopping.[1][3]
Sunlenca — twice-yearly, for multidrug-resistant HIV
Sunlenca injections contain lenacapavir, a capsid inhibitor approved in December 2022 with other antiretrovirals for heavily treatment-experienced adults with multidrug-resistant HIV whose regimen is failing because of resistance, intolerance or safety concerns. Initiation includes oral loading; maintenance injections are every 26 weeks, with a two-week window. The current label permits clinician-directed weekly oral bridging for some planned injection delays. If more than 28 weeks pass without oral bridging, clinical reassessment and reinitiation are required. Residual drug can persist for a year or longer, so the other active medicines in the regimen and an eventual replacement plan remain essential.[4]
In CAPELLA’s randomized cohort, 21 of 24 participants receiving lenacapavir versus 2 of 12 receiving placebo had a viral-load reduction of at least 0.5 log10 during the initial 14-day comparison. After addition of an optimized background regimen, 30 of 36 participants (83%) had HIV RNA below 50 copies/mL at week 52. The longer-term outcome reflects combination treatment, not lenacapavir used alone.[4]
One clean distinction: twice-yearly lenacapavir marketed as Yeztugo was FDA-approved in June 2025 for PrEP — reducing the risk of sexually acquired HIV in people who do not have HIV — and is not an HIV treatment regimen[5]. Same molecule, different job. Other injectable or infused antiretrovirals HHS lists for specific situations include zidovudine, enfuvirtide, and ibalizumab (2,000 mg IV loading, then 800 mg IV every 14 days)[3].
Florida: covered by ADAP, with real-world barriers documented
Both injectables are covered. The Florida ADAP formulary dated July 2026 lists Cabenuva as an integrase-inhibitor/NNRTI combination and Sunlenca as a capsid inhibitor[7], and Florida DOH posts a lenacapavir prior authorization form alongside its ADAP materials (Help Desk 844-381-2327)[8]. Coverage is not the same as convenience, though, and site-by-site availability varies — ask your clinic or case manager directly whether they administer injections on site.
Florida researchers asked people what actually gets in the way. A qualitative study published in AIDS Patient Care and STDs in June 2024 interviewed 16 people living with HIV and 11 HIV care providers across Florida, described as a high-prevalence setting. People living with HIV saw long-acting cabotegravir/rilpivirine as effective, but named real barriers: getting an injection, needing more clinic visits, and “a feeling that this made HIV the center of one's life.” Providers added concerns about integrase resistance. Outside the clinic, both groups pointed to transportation, stigma, access inequities, and payor problems; inside clinics, providers named staffing needs and added burden on existing staff[6]. None of that is a reason not to ask — it is a list of things worth solving out loud with your care team.
Related questions
Can I switch from pills to injections?
You may be eligible for the labeled Cabenuva switch if you are at least 12, weigh at least 35 kg, have HIV RNA below 50 copies/mL on a stable regimen and meet the treatment-history and resistance criteria. NIH also describes limited specialist-directed use in selected people with persistent viremia despite intensive support; this is not an automatic option for every failing regimen.[1][9]
How often do I need injections?
What happens if I miss an injection appointment?
Contact the clinic as early as possible. A planned gap may be covered by oral treatment, and an unplanned gap may require restarting injections. The rules depend on the product, schedule and whether an initiation visit was missed. Do not use a general two- or three-month cutoff to decide on your own that a delay is safe.[1][4]
Do injections hurt?
Injection-site reactions occurred in 83% of participants in the pooled monthly Cabenuva FLAIR and ATLAS trials, most often pain or discomfort. Median duration was three days and about 1% stopped because of these reactions. Individual experience varies; discuss troublesome symptoms with the clinic.[1]
Related from RiseUpToHIV
References & Sources
- FDA — Cabenuva (cabotegravir; rilpivirine) prescribing information, label revised November 2025. Indication, gluteal IM administration, both dosing schedules, ±7-day window, FLAIR/ATLAS/ATLAS-2M results, adverse reactions, missed-dose management, and the 12-month drug tail. ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩ ↩
- HIV.gov — FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV. The January 21, 2021 Cabenuva approval and the simultaneous approval of oral cabotegravir for the lead-in. ↩
- HHS/NIH — Discontinuation or Interruption of Antiretroviral Therapy. Guidance on bridging, transitioning off long-acting therapy within 4 weeks, and other parenteral antiretrovirals. ↩ ↩ ↩ ↩
- Sunlenca prescribing information, revised August 2026, hosted by DailyMed. Injectable treatment indication, initiation, bridging, missed-dose management and CAPELLA results. Source. ↩↩ ↩ ↩ ↩
- Gilead — Yeztugo (lenacapavir) approved for HIV prevention (June 2025). Confirms Yeztugo is a PrEP product, not an HIV treatment regimen. ↩ ↩
- Fisk-Hoffman et al., AIDS Patient Care and STDs (2024) — Florida qualitative study of 16 people with HIV and 11 providers. Full paper in PubMed Central. Source. ↩
- Florida Department of Health — ADAP Formulary, July 2026. Confirms Cabenuva and Sunlenca coverage under Florida's AIDS Drug Assistance Program. ↩
- Florida Department of Health — AIDS Drug Assistance Program. ADAP contacts, eligibility, and the posted lenacapavir prior authorization form. ↩
- NIH Adult and Adolescent ARV Guidelines — Virologic Failure; limited case-by-case use of injectable CAB/RPV with persistent viremia. Source. Checked September 21, 2026. ↩ ↩
Community publications like POZ, Positively Aware, and TheBody inform framing and lived-experience context on RiseUpToHIV. Every clinical, epidemiological, or public-health claim above is anchored to a primary source.