Lenacapavir shows promise as long-acting HIV treatment
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Another long-acting agent has shown promise as a treatment option for HIV. This one is given in subcutaneous injections every 6 months.
A researcher at the Conference on Retroviruses and Opportunistic Infections reported “incredibly encouraging” results from a small trial of lenacapavir (Gilead Sciences) that was conducted among heavily treatment-experienced people with HIV.
Almost three-quarters of patients in the phase 2/3 CAPELLA trial who received a subcutaneous injection of the investigational HIV capsid inhibitor achieved an undetectable viral load by week 26.
The results offer support for continued evaluation of lenacapavir for HIV-1 treatment and prevention, researchers said.
“We are in a very exciting era of long-acting agents and injectables and lenacapavir, with this data in a heavily treatment-experienced population, brings forward what an important piece it is in this story and how it can transform our options in HIV care,” Sorana Segal-Maurer, MD, an infectious disease physician at New York-Presbyterian Queens Hospital, told Healio.
“Lenacapavir can meet significant unmet medical needs and provide new mechanisms of action for heavily treatment-experienced people with multidrug-resistant HIV,” Segal-Maurer said during a presentation. “Its long half-life can lead to a reduction of daily pill burden and less frequent dosing for treatment and prevention.”
Segal-Maurer and colleagues conducted a double-blind, placebo-controlled study of 36 heavily treatment-experienced patients with HIV who were failing their current regimen and who had documented resistance to two or more agents from three or more of the major antiretroviral classes.
They randomly assigned 24 participants to add lenacapavir to their failing regimen for 2 weeks, and the other 12 participants to add a placebo. They analyzed the proportion of patients who had a decline in viral load of at least 0.5 log10 c/mL by day 15 of the study.
At baseline, the average patient’s viral load was 4.27 log10 c/mL, and the median patient age was 54 years. A total of 88% (21 of 24) of patients who received lenacapavir experienced a significant decrease in viral load compared with 17% (2 of 12) of patients in the placebo arm (95% CI, 35%-90%; P > .0001). The median change in viral load was –2 log10 c/mL (95% CI, –3.29 to –0.29) in the treatment arm and –0.08 log10 c/mL (95% CI, –1.93 to 0.31) in the placebo arm.
On day 15, participants in the treatment arm received a subcutaneous injection of lenacapavir and participants in the placebo arm started a 2-week oral lead-in of the medication followed by an injection. Segal-Maurer and colleagues selected an “optimized” background treatment regimen for each participant.
Among 26 patients who reached week 26 since the first injection, 73% (n=19) experienced a viral load of less than 50 copies/mL, according to Segal-Maurer.
“Achieving an undetectable viral load in heavily treatment-experienced population is remarkable and incredibly encouraging,” she said during a press conference reporting the results.
Segal-Maurer said the lack of adverse events is promising for patients’ quality of life.
“Something can be amazing, but if it doesn't help with quality of life, we need to rethink it,” she told Healio. “The fact that we made such an impact in this heavily treatment-experienced population with limited treatment options, and it was well tolerated with no discontinuations due to adverse events — that is unusual.”
The FDA in January approved the first long-acting injectable regimen for HIV, Cabenuva, which includes shots of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals) given once a month. Researchers are also studying multiple long-acting medications for HIV PrEP, including lenacapavir.
“Lenacapavir has the potential to become an important agent for heavily treatment-experienced persons with HIV with multidrug resistance,” Segal-Maurer said. “These data support the ongoing evaluation of lenacapavir.”
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Segal-Maurer S, et al. Abstract 127. Presented at: Conference on Retroviruses and Opportunistic Infections; March 6-10, 2021 (virtual meeting).
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