March 09, 2021
2 min read
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Segal-Maurer S. et al. Abstract 127. Presented at: Conference on Retroviruses and Opportunistic Infections; 6-10 March 2021 (virtual meeting).
Disclosure:
Segal-Maurer reports receiving consulting fees from Gilead Sciences, Janssen Therapeutics and ViiV Healthcare, payments for lectures from US HealthConnect, and payments for presentations from Bastian Brands, Gilead and Janssen.
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Another long-acting agent has shown promise as a treatment option for HIV. This 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 study of lenacapavir (Gilead Sciences) conducted among highly treatment-experienced people with HIV.
Source: Barnabas R, et al. Abstract 111. Presented at: Conference on Retroviruses and Opportunistic Infections; 6-10 March 2021 (virtual meeting).
Almost three-quarters of the patients in the CAPELLA Phase 2/3 study who received subcutaneous injection of the HIV capsid inhibitor had undetectable viral loads by week 26.
The results provide support for further evaluation of lenacapavir for the treatment and prevention of HIV-1, the researchers said.
“Lenacapavir can meet significant unmet medical needs and provide new mechanisms of action for highly treatment-experienced people with multidrug-resistant HIV.” Soran Segal Mason, MD, an infectious disease doctor at New York’s Presbyterian Queens Hospital said during a presentation. “Its long half-life can lead to a reduction in daily pill exposure and less frequent dosing for treatment and prevention.”
Segal-Maurer et al. Conducted a double-blind, placebo-controlled study of 36 highly treatment-experienced HIV patients who were not following their current treatment regimen and who had documented resistance to two or more drugs from three or more of the major antiretroviral classes.
They randomly assigned 24 participants to add lenacapavir to their failed regimen for 2 weeks and the other 12 participants to add a placebo. They analyzed the proportion of patients in whom the viral load decreased by at least 0.5 log10 c / ml on day 15 of the study.
At baseline, the patient’s mean viral load was 4.27 log10 c / ml and the patient’s mean age was 54 years. A total of 88% (21 of 24) of the patients who received lenacapavir showed a significant decrease in viral load compared to 17% (2 of 12) of the 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).
On day 15, participants in the treatment arm received a subcutaneous injection of lenacapavir, and participants in the placebo arm began a two-week oral introduction of the drug followed by an injection. Segal-Maurer and colleagues chose an “optimized” background treatment scheme for each participant.
Of 26 patients who reached week 26 since the first injection, 73% (n = 19) had a viral load less than 50 copies / ml, according to Segal-Maurer.
“Achieving undetectable viral load in a heavily treatment-savvy population is remarkable and incredibly encouraging,” she said during a press conference where she shared the results.
The FDA approved the first long-acting injectable regimen for HIV in January, Cabenuva, which contains once-monthly cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals). The researchers are also investigating several long-acting drugs for HIV-PrEP, including lenacapavir.
“Lenacapavir has the potential to become an important drug for highly treatment-experienced people with HIV with multidrug resistance,” said Segal-Maurer. “These data support the ongoing evaluation of lenacapavir.”
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Conference on Retroviruses and Opportunistic Infections (CROI)
