Merck-Gilead's weekly HIV combo maintains viral suppression
Merck Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection
Last week, Merck & Co announced it is discontinuing a program to study monthly oral doses of islatravir as pre-exposure prophylaxis (PrEP) therapy.
Sept 20 (Reuters) - Merck & Co Inc (MRK.N) said on Tuesday it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.
The FDA has placed holds on several clinical trials for the oral and nimplant formulations of investigation drug islatravir (MK-8591), for nHIV-1 pre-exposure prophylaxis (PrEP), the injectable formulation of nislatravir for HIV-1 treatment and prophylaxis and the oral ndoravirine/islatravir (DOR/ISL) HIV-1 once-daily treatment.
Dec 13 (Reuters) - Merck & Co (MRK.N) said on Monday the U.S. Food and Drug Administration has placed clinical holds on trials testing the company's HIV drug islatravir.
U.S. FDA puts Merck’s HIV drug trials on hold
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has placed clinical holds on the investigational new drug applications (INDs) for the oral and implant formulations of islatravir (MK-8591) for HIV-1 pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for HIV-1 treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) HIV-1 once-daily treatment. The FDA’s clinical hold is based on previously announced observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies. As previously announced, Merck has stopped dosing in the Phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507 (MK-8591-013) and paused enrollment in the once-monthly Phase 3 PrEP studies, (MK-8591-022 and MK-8591-024) (see announcements here and here). With the FDA’s clinical hold, no new studies may be initiated. Participants who are currently receiving islatravir as part of the studies for PrEP, including oral and implant formulations, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug; CD4+ T-cell and total lymphocyte counts will be monitored for recovery (full clinical hold). Participants in the PrEP studies will be offered approved, once-daily, oral PrEP. Additionally, participants in studies of DOR/ISL who were started on treatment will continue to receive study medication (partial clinical hold). No new participants will be screened or randomized in DOR/ISL studies for treatment during the partial clinical hold. Investigators have been informed of these actions.
Are the foundations of Merck’s broad HIV development program crumbling? Having already paused combination work in response to a red flag, Merck has now temporarily stopped enrollment in phase 3 studies that are testing the backbone of its HIV strategy as a monotherapy.
Gilead and Merck announced they are temporarily pausing enrollment in a nphase 2 study evaluating a once-weekly oral combination treatment nregimen of islatravir and lenacapavir in patients with HIV who are nvirologically suppressed on antiretroviral therapy. This pause follows nMerck’s announcement on November 18 that dosing in the Phase 2 nIMAGINE-DR trial evaluating the once-weekly combination of MK-8507 and nislatravir will be stopped due to safety concerns. Decreases in total nlymphocyte and CD4+ T-cell counts were observed in patients randomized nto receive the combination treatment.