Press release
Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24
– Week 24 Results Support Continued Development as a Potential Long-Acting Oral Combination Treatment Option in Virologically Suppressed People with HIV – –
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Week 24 Results Support Continued Development as a Potential Long-Acting Oral Combination Treatment Option in Virologically Suppressed People with HIV –\n\n\n– Novel Investigational Combination Regimen has the Potential to be the First Oral Weekly HIV Treatment, Helping to Address Unmet Needs –\n\n\n FOSTER CITY, Calif., & RAHWAY, N.J.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections (CROI). Prior to the late-breaker oral presentation, the key findings were featured in a CROI press conference.\n\n\nAt 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA 50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30.\n\n\nThe potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen. Single-tablet daily oral therapies have helped to transform HIV care, but options that allow for less frequent dosing have the potential to address adherence, stigma and other challenges faced by some individuals taking daily oral antiretroviral therapy.\n\n\n“HIV treatment is not one size fits all – developing once-weekly treatment options could help meet the needs of each individual, aiming toward maximizing long-term outcomes for people with HIV,” said Jared Baeten, Vice President, MD, PhD, HIV Clinical Development, Gilead Sciences. “These promising data presented at CROI help bring us one step closer to our goal of providing a wide range of options that may help transform the HIV treatment landscape.”\n\n\nIn this open-label, active-controlled study (NCT05052996), virologically suppressed adults (n=104) on Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) were randomly allocated in a 1:1 ratio to receive either oral islatravir 2 mg an...