FOSTER CITY, Calif. & RAHWAY, N.J. - Gilead Sciences, Inc. (NASDAQ: NASDAQ:GILD) and Merck (NYSE: MRK) have announced positive results from a Phase 2 clinical trial evaluating a novel combination of HIV treatments. The investigational regimen, which combines islatravir and lenacapavir, showed promising results in maintaining viral suppression in virologically suppressed adults with HIV.
The study, which involved 104 participants, demonstrated a high rate of viral suppression with 94.2% of participants maintaining HIV-1 RNA levels below 50 copies/mL after 24 weeks. This outcome serves as the study's secondary endpoint. The primary endpoint, which was the proportion of individuals with HIV-1 RNA levels of 50 copies/mL or higher at week 24, revealed only one participant (1.9%) with a viral load above this threshold; however, the individual achieved suppression by week 30.
Islatravir and lenacapavir are being developed as a potential once-weekly oral therapy, which could offer an alternative to the daily oral antiretroviral therapies currently in use. This could be particularly beneficial for those facing challenges with adherence or stigma associated with daily medication.
The trial also assessed safety, with the most common treatment-related adverse events in the islatravir and lenacapavir group being dry mouth and nausea. No severe adverse events related to the study drug were reported, and only two participants discontinued due to adverse events not related to the drug.
Although the combination is still investigational and has not been approved globally, lenacapavir is already approved in several countries under the brand name Sunlenca®, for the treatment of multi-drug resistant HIV in combination with other antiretrovirals.
The companies plan to continue the study through 48 weeks, with further results expected to be presented at future scientific conferences. The information in this article is based on a press release statement from the companies involved.
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