ViiV's CLARITY trial to post 6-month CAB LA vs lenacapavir acceptability data
A Phase 1 crossover study already showed cabotegravir beat lenacapavir on early injection-site acceptability; the AIDS 2026 poster extends that comparison to six months.
Executive Summary
- ViiV Healthcare will present six-month follow-up data from a Phase 1 crossover study comparing its long-acting injectable cabotegravir against Gilead's lenacapavir for HIV prevention, extending a comparison that already produced a preliminary result.
- An earlier readout from the same trial showed participants rated cabotegravir injections more acceptable than lenacapavir shortly after a single dose, with lenacapavir carrying a higher injection-site reaction burden.
- Long-acting injectables are emerging as the preferred format for HIV prevention, and tolerability differences between the two leading options shape which drug clinicians and patients choose once both are available for PrEP.
- The study is a small, non-registrational Phase 1 comparison already fully enrolled, so the presentation is a maturation of existing data rather than a new pivotal test.
The catalyst
ViiV Healthcare, the HIV-focused company majority owned by GSK, plans to present six-month results from the Phase 1 CLARITY study comparing its long-acting cabotegravir (CAB LA) with Gilead Sciences' lenacapavir as a poster at the 26th International AIDS Conference in Rio de Janeiro on July 29, 2026. The trial, registered as NCT06970223, is an open-label, randomized crossover study in 65 HIV-negative healthy adults testing which of the two long-acting injectables patients find more tolerable and acceptable. Its primary endpoint measures the percentage of participants rating local injection-site reactions as very acceptable or totally acceptable, a tolerability endpoint rather than an efficacy measure. ViiV+1ViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults; alongside INSTI-powered long-acting injectable innovation at AIDS 2026Jul 21, 2026A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIVNCT06970223
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the interim data showed
The trial already delivered an initial readout at the European AIDS Conference in October 2025: seven days after a single dose, 69% of participants rated cabotegravir injections as totally or very acceptable, versus 48% for lenacapavir, a gap the sponsor reported as statistically significant (p=0.019). Lenacapavir carried a higher injection-site reaction burden in that analysis, though no serious drug-related adverse events or discontinuations were reported for either drug. The July 29 poster will extend that single-dose comparison through six months of follow-up, along with participant-reported outcomes intended to inform how clinicians sequence long-acting injectables when initiating PrEP. ViiVViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults; alongside INSTI-powered long-acting injectable innovation at AIDS 2026Jul 21, 2026
Trial design and status
The study finished enrollment at 65 participants, above its original 60-participant target, and moved to Active, not recruiting status in July 2025 as enrollment closed. Both cabotegravir and lenacapavir are dosed intramuscularly or subcutaneously in the trial's two-arm crossover design. The trial is not registrational; it is designed to generate tolerability and acceptability data rather than to support an approval on its own. NCT06970223A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIVNCT06970223
The competitive backdrop
Cabotegravir is approved in the United States as Apretude for HIV pre-exposure prophylaxis, while lenacapavir's PrEP use remains investigational; Gilead has multiple Phase 3 lenacapavir prevention trials running, including NCT07683000. Both companies are also advancing next-generation long-acting candidates: ViiV's VH4524184 is in Phase 2 and Gilead's GS-3242 is in Phase 2/3 testing. The CLARITY comparison sits in a field where cabotegravir already holds a marketed prevention indication and lenacapavir is the newer entrant seeking one, making tolerability a relevant differentiator as both companies pursue overlapping patient populations for long-acting PrEP.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.