Gilead, Merck Report 48-Week Phase 3 Success for Once-Weekly HIV Pill
Updated
Updated · Merck · Jun 8
Gilead, Merck Report 48-Week Phase 3 Success for Once-Weekly HIV Pill
3 articles · Updated · Merck · Jun 8
Summary
Two Phase 3 trials met their primary 48-week endpoint, with islatravir 2 mg/lenacapavir 300 mg keeping virologically suppressed HIV patients controlled after switching from daily regimens.
ISLEND-1 found the once-weekly single tablet statistically non-inferior to Biktarvy, while ISLEND-2 showed non-inferiority against other daily standard-of-care antiretroviral regimens.
Safety was generally comparable to the comparator treatments in both studies, and Gilead and Merck said no new safety concerns were identified.
The companies plan global regulatory filings and future scientific presentations, positioning the regimen as a potential first approved long-acting oral HIV treatment taken once weekly.
Can a once-weekly HIV pill dethrone the daily regimen that currently dominates the market?
This weekly pill promises convenience, but what are the potential long-term safety trade-offs?
Islatravir and Lenacapavir Once-Weekly HIV Treatment: Clinical Advances, Market Impact, and Access Strategies
Overview
Gilead and Merck have recently announced positive topline results from two Phase 3 studies evaluating an investigational oral once-weekly HIV treatment that combines islatravir and lenacapavir. This new regimen holds substantial promise by addressing adherence challenges often seen with daily HIV-1 treatments and potentially simplifying the lives of people living with HIV. The announcement of these positive Phase 3 results marks a critical step forward, paving the way for potential regulatory submissions. As a result, Gilead and Merck are expected to move forward with discussions with regulatory bodies, and initial filings could be anticipated in the near future.