“Part of the Lenacapavir Story”: Expanding Treatments to People with Multidrug-Resistant HIV

This is Part 2 of an interview with Sorana Segal-Maurer, MD, lead author and principal investigator of the study “Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection.” Click here to catch up on Part 1!

In research published yesterday in the New England Journal of Medicine, Sorana Segal-Maurer, MD, and fellow investigators presented their findings of lencapavir for multidrug-resistant HIV infection.

The participants in the phase 3 CAPELLA trial had extremely difficult-to-treat HIV infection, with extensive histories of treatment failure. Given the prevalence of resistant HIV in this study cohort, it is all the more exciting that the lenacapavir recipients maintained a decrease in viral load of at least 0.5 log10 copies per milliliter, with most demonstrating a 2 log10 drop.

Additionally, at week 14 of the study, 81% of participants were undetectable with a viral load of less than 50 copies per milliliter. Segal-Maurer notes that this change was sustained through week 26 of the study.

However, no results are complete without context. In this second segment of the video interview, Segal-Maurer dives into the adverse event profile of the cohort. Because lenacapavir is an injectable, administered every 6 month, Segal-Maurer said that just under two-thirds of the cohort had injection site reactions. All of these reactions were mild, and did not cause any of the cohort to stop treatment.

“Efficacy is wonderful, but if lots of people stop because they can’t tolerate something…you’re not in real life,” Segal-Maurer said.

Segal-Maurer originally shared data from the CAPELLA trial at the 2021 Annual Conference on Retroviruses and Opportunistic Infections (CROI). However, she says, the significance of the trial results cannot be fully understood until they reached the 26-week endpoint.

With this new publication, the promising results are accompanied by the efficacy, safety, resistance, tolerability, and more.

The next steps are to publish the 52-week data. Additionally, Segal-Maurer discussed plans to examine lenacapavir in treatment-naïve patients, as well as for HIV pre-exposure prophylaxis (PrEP).

The New England Journal of Medicine published results of lenacapavir for multidrug-resistant HIV is “just part of the overall lenacapavir story.” Segal-Maurer said.

Segal-Maurer ends by noting that this study was conducted amidst the COVID-19 pandemic. She says this speaks to the dedication and resilience of the trial participants and researchers.