People with multidrug-resistant (MDR) HIV have limited treatment options, which can make managing their disease very difficult. And there are only a few treatment options for these patients.
However, an experimental therapy in development has shown promise in the fight against multidrug-resistant HIV. Lenacapavir is an investigational, first-in-class, long-acting HIV capsid inhibitor being developed for the treatment and prevention of HIV infection. Lenacapavir is manufactured by Gilead, and the company today announced 1-year results from the ongoing Phase 2/3 CAPELLA trial evaluating the investigational treatment.
The trial showed that 83% (n=30/36) of participants receiving lenacapavir in combination with optimized background therapy achieved an undetectable viral load (
In addition to its study results, lenacapavir has its Prescription Drug User Fee Act (PDUFA) date from the Food and Drug Administration (FDA) on February 28. If the experimental treatment is approved by the FDA at the end of the month, clinicians will have another treatment option for patients.
The CAPELLA study
CAPELLA is a global, multicenter, double-blind, placebo-controlled study designed to evaluate the antiviral activity of lenacapavir when administered every 6 months by subcutaneous injection in heavily pretreated persons (HTE) with HIV infection. multidrug-resistant HIV.
A total of 72 participants were enrolled, including 36 in each of the 2 cohorts. In terms of participant composition, 25% were female, 38% black, median age was 52 years, 19% had CV > 100 kc/mL, 64% had CD4
In Cohort 1 (randomized group), participants were assigned (2:1) to add oral lenacapvir or placebo to their failing treatment (600 mg on day 1[D] and 2 and 300 mg on D8). On day 15, people taking oral lenacapvir received 927 mg of lenacapvir subcutaneously (SC) every 6 months; those on placebo began the 2-week oral initiation, followed by SC Q6M. All randomized participants initiated an investigator-selected OBR on D15, the investigators explained.
In Cohort 2 (non-randomized group), participants started OBR at the same time as lenacapavir (oral initiation → SC). The investigators reported the secondary efficacy endpoint of W52 by the FDA snapshot algorithm in the randomized cohort and the additional efficacy and safety available in both cohorts.
Onyema Ogbuagu, MD, FACP, director of the HIV clinical trials program at Yale School of Medicine was the principal investigator of the CAPELLA study, and he and his fellow researchers wrote a poster on the topic, Lenacapavir to Action prolonged in people with HIV-1 multidrug resistance: week 52 results, based on their research that was presented virtually at the 2022 Annual Conference on Retroviruses and Opportunistic Infections (CROI).
Contagion spoke to Ogbuagu about the Capella study, including its efficacy and safety profile, as well as what the therapy’s potential FDA approval could mean for patients.