FOSTER CITY, Calif. & RAHWAY, N.J. - Gilead Sciences Inc. (NASDAQ:GILD) and Merck (NYSE:MRK) announced today that their investigational once-weekly oral HIV treatment met the primary efficacy endpoint in two Phase 3 trials.
The ISLEND-1 and ISLEND-2 trials evaluated islatravir 2 mg/lenacapavir 300 mg in people with HIV who are virologically suppressed. ISLEND-1 compared the once-weekly regimen to daily Biktarvy in patients previously on Biktarvy, while ISLEND-2 compared it to standard of care antiretroviral regimens.
Both trials measured the percentage of participants with HIV-1 RNA levels of 50 copies/mL or higher at Week 48 using the FDA snapshot algorithm. The once-weekly regimen was found to be statistically non-inferior to the comparator treatments in both trials, according to the press release statement.
The safety profile of the combination was generally comparable to the comparator regimens studied, with no new safety concerns identified, the companies said.
Islatravir is a nucleoside analog developed by Merck that blocks HIV-1 replication through multiple mechanisms. Lenacapavir is a capsid inhibitor from Gilead designed to disrupt HIV at multiple stages of its lifecycle.
The companies plan to file the Phase 3 data with regulatory authorities globally and submit detailed findings for presentation at a future scientific congress. If approved, the combination would represent the first long-acting oral HIV treatment taken once weekly. InvestingPro data indicates Gilead currently trades below its Fair Value, placing it among undervalued healthcare stocks. Investors can access a comprehensive Pro Research Report on Gilead, one of 1,400+ US equities covered with detailed analysis.
Islatravir and lenacapavir in combination are investigational and not approved for use. There is currently no cure for HIV or AIDS.
The ISLEND-1 trial was a randomized, double-blind study, while ISLEND-2 was an open-label trial. Both studies will continue to evaluate participants through Week 96.
In other recent news, Gilead Sciences has announced the discontinuation of a Phase 3 trial evaluating Trodelvy in combination with Merck’s Keytruda for treating metastatic non-small cell lung cancer. This decision was based on recommendations from an external Data Monitoring Committee following an analysis of the trial’s progression-free and overall survival data. Additionally, Gilead and Lakefront Biotherapeutics have completed their acquisition of Ouro Medicines for $1,675 million, with potential milestone payments of up to $500 million, to advance T cell engager therapies for autoimmune diseases.
Gilead Sciences also reported positive results from its Phase 3 IDEAL study, where its drug Livdelzi met the primary endpoint in treating primary biliary cholangitis by normalizing alkaline phosphatase levels in patients. Meanwhile, RBC Capital has reiterated a Sector Perform rating for Gilead Sciences, maintaining a price target of $122.00, citing the company’s position in the in vivo CAR-T therapy space and its HIV franchise outlook. These developments reflect Gilead’s ongoing efforts in advancing its therapeutic pipeline and strategic acquisitions.
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