Gilead and Merck Pause Enrollment for Phase 2 HIV Study Evaluating Islatravir Days After Merck Stops Islatravir Combination Study Due to Safety Concerns

Gilead and Merck Pause Enrollment for Phase 2 HIV Study Evaluating Islatravir Days After Merck Stops Islatravir Combination Study Due to Safety Concerns

Gilead and Merck announced they are temporarily pausing enrollment in a phase 2 study evaluating a once-weekly oral combination treatment regimen of islatravir and lenacapavir in patients with HIV who are virologically suppressed on antiretroviral therapy. This pause follows Merck’s announcement on November 18 that dosing in the Phase 2 IMAGINE-DR trial evaluating the once-weekly combination of MK-8507 and islatravir will be stopped due to safety concerns. Decreases in total lymphocyte and CD4+ T-cell counts were observed in patients randomized to receive the combination treatment. 

No safety issues were observed in the Gilead-Merck trial, and the temporary pause was implemented as a precautionary measure to allow the companies to consider potential protocol adjustments. Patients currently enrolled in this trial will continue to receive the study drug and be monitored per the current protocol. Clinical investigators have been informed of this action and will be notified as soon as any potential protocol adjustments are made. 

Islatravir (MK-8591) is a nucleoside reverse transcriptase translocation inhibitor.

Gilead and Merck entered into a collaborative agreement in ...

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