Investigational two-drug regimen safe, effective for patients with HIV
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Key takeaways:
- Overall, 94.2% of patients treated with ISL+LEN and 92.3% with B/F/TAF maintained viral suppression through week 24.
- In total, 75% and 73.1%, respectively, reported adverse events.
DENVER — Phase 2 study data showed that a once-weekly oral regimen of an investigational two-drug HIV treatment was well tolerated among patients with HIV and allowed them to maintain viral suppression.
These data were reported at the Conference on Retroviruses and Opportunistic Infections.
“Through the collaboration between Merck and Gilead, announced in March 2021, the companies seek to build on their legacies of transforming HIV care by focusing on long-acting therapies, which may represent a meaningful innovation in HIV drug development,” Amy Colson, MD, MPH, research director of Community Resource Initiative, told Healio.
“While daily, single-tablet oral regimens are available for people living with HIV, oral or injectable regimen options that allow for less frequent dosing have the potential to address preference considerations, as well as issues associated with stigma, adherence, and privacy,” she said.
To evaluate the safety and efficacy of an investigational oral weekly regimen of Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir (ISL), in combination with Gilead’s capsid inhibitor, lenacapavir (LEN), Colson and colleagues conducted a phase 2, open-label, active-controlled study.
One hundred and four virologically suppressed adults on bictegravir/emtricitabine/tenofovir alafenamide fumarate (B/F/TAF) were randomly assigned 1:1 to either continue B/F/TAF or switch to the investigational oral weekly regimen (ISL+LEN). The primary endpoint of the study was the proportion of patients with HIV RNA viral load of 50 c/mL or more at week 24. Adverse events (AEs) were also evaluated.
In total, 104 participants were were randomly assigned 52 to each group and treated. Among these patients, one in the ISL+LEN group — who had a baseline HIV RNA of 251 copies/mL — had HIV RNA of more than 50 copies/mL at week 24 and suppressed on ISL+LEN, whereas no patients in the B/F/TAF group had HIV RNA of greater than 50 copies/mL at week 24.
According to the study, in both treatment groups 94.2% of patients maintained viral suppression through week 24.
AEs occurred in 39 participants (75%) being treated with ISL+LEN and 38 (73.1%) being treated with B/F/TAF. The most common AEs in participants taking ISL+LEN included diarrhea (13.5%), upper respiratory infection (11.5%), arthralgia, pain in extremity and fatigue (5.8% each).
“These data support the continued investigation of ISL+LEN oral once weekly as a potential long-acting treatment for viral suppression in people with HIV,” Colson concluded.
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Colson A, et al. Abstract 208. Presented at: Conference on Retroviruses and Opportunistic Infections; March 3-6, 2024; Denver.
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