Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults - Seite 2

The Phase 2 study is designed to evaluate the safety and antiviral effect of an oral weekly regimen of Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, in combination with Gilead’s investigational capsid inhibitor, lenacapavir. The primary endpoint is the proportion of study participants with HIV-1 RNA viral load ≥ 50 c/mL at Week 24.

Lenacapavir and islatravir, alone and in combination, are investigational and not approved anywhere globally. Their safety and efficacy have not yet been established.

There is currently no cure for HIV or AIDS.

About NCT05052996

This Phase 2, open-label, active-controlled, multicenter study is designed to evaluate the safety and antiviral effect of an oral weekly regimen of islatravir in combination with lenacapavir in virologically suppressed people with HIV. Participants age 18 years and older will be enrolled in this study, which is being conducted at 25 sites in the United States.

In the trial, 75 participants who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive oral weekly islatravir (20 mg) administered with oral lenacapavir (300 mg) on day 8 following a loading dose of islatravir (40 mg) and lenacapavir (600 mg) on days 1 and 2 or oral daily B/F/TAF (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets). Participants will receive study drugs for 48 weeks.

Following completion of the Week 48 visit, participants in Treatment Group 1 will continue to receive an oral weekly regimen of islatravir in combination with oral lenacapavir and be evaluated every 12 weeks. Participants in Treatment Group 2 will switch from daily oral B/F/TAF tablets to an oral weekly regimen of islatravir in combination with oral lenacapavir (starting with the loading doses over 2 days) and continue the study with visits every 12 weeks thereafter.

For further information, please see: https://clinicaltrials.gov/ct2/show/NCT05052996

About Lenacapavir

Lenacapavir is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle.