The investigational therapy has demonstrated promising results utilizing subcutaneous injections every 6 months.
People with multi-drug resistant (MDR) HIV have limited therapy options, which can leave their disease management very challenging. And there are only a couple of treatment options for these patients.
However, an investigational therapy in development has shown some promising data in addressing MDR HIV. Lenacapavir is a first-in-class, investigational long-acting HIV capsid inhibitor being developed for the treatment and prevention of HIV infection. Lenacapavir is manufactured by Gilead, and the company announced today its 1-year results from the ongoing phase 2/3 CAPELLA trial evaluating the investigational therapy.
The trial showed 83% (n=30/36) of participants receiving lenacapavir in combination with an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 52.
In addition to its study results, lenacapavir has its Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date on February 28. If the investigational therapy is FDA approved at the end of the month, clinicians will have another treatment option for patients.
CAPELLA is a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir when administered every 6 months as a subcutaneous injection in heavily treatment-experienced (HTE) people with MDR HIV infection.
Overall, 72 participants were enrolled with 36 in each of the 2 cohorts. In terms of the makeup of the participants, 25% were female, 38% Black, the median age 52 years, 19% had VL > 100k c/mL, 64% had CD4 <200 cells/μL, 46% had HIV-1 resistant to all 4 major classes (NRTI, NNRTI, PI, INSTI), and 17% did not have any fully active agents in the optimized background regimen (OBR).
In cohort 1 (randomized group), participants were assigned (2:1) to add oral lenacapavir or placebo to their failing regimen (600 mg on Day 1[D] and 2 and 300 mg on D8). At Day 15, those on oral lenacapavir received subcutaneous (SC) lenacapavir 927 mg every 6 months; those on placebo started the 2 week oral lead-in, followed by SC Q6M. All randomized participants initiated an investigator-selected, OBR at D15 the investigators explained.
In cohort 2 (non-randomized group), the participants started OBR concurrent with lenacapavir (oral lead-in → SC). The investigators reported the secondary endpoint of W52 efficacy by FDA-snapshot algorithm in the randomized cohort and additional available efficacy and safety from both cohorts.
Onyema Ogbuagu, MD, FACP, director of HIV Clinical Trials program at Yale School of Medicine was the principal investigator for the CAPELLA study, and he and his fellow investigators wrote a poster on the subject, Long acting lenacapavir in people with multi-drug resistant HIV-1: Week 52 results, based on their research which was presented virtually at the 2022 Annual Conference on Retroviruses and Opportunistic Infection (CROI).
Contagion spoke to Ogbuagu about the CAPELLA study including its efficacy and safety profile as well as what the potential FDA approval of the therapy might mean for patients.