Drugs

Merck Hold Lifted to Permit New HIV Trials

FDA has lifted a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with HIV-1 infection. The studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). The clinical hold on this IND and other related INDs was due to observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies, Merck said at the time (see story).

“One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed,” Merck says. “Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose.”

Merck notes that the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program. A Phase 2 clinical trial (NCT05052996) studying islatravir and Gilead’s lenacapavir in adults with HIV-1 infection who are virologically suppressed will also resume under an amended protocol with a lower dose of islatravir. Merck further says that the IND under which the combination islatravir and lenacapavir once-weekly treatment regimen is being investigated remains under a partial clinical hold for any studies that would use islatravir doses higher than the doses considered for the revised clinical program.

Additionally, Merck says it will discontinue the development of once-monthly oral islatravir for HIV-1 pre-exposure prophylaxis (PrEP). “Participants in the ongoing Phase 3 PrEP once-monthly oral studies will continue to be monitored,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome