FDA pauses several trials of Merck’s investigational HIV drug

pharmafile | December 16, 2021 | News story | Business Services  

The FDA has placed holds on several clinical trials for the oral and implant formulations of investigation drug 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.

Six studies related to islatravir are now on full clinical hold, while seven are on partial clinical hold. Islatravir is an inhibitor of nucleoside reverse transcriptase translocation, designed to be administered once every month to patients at increased risk of, or suffering from, Human Immunodeficiency Virus (HIV) infection.

The FDA’s decision is based on reports of a drop in T-cell counts in some participants receiving the drug.

T-cells are integral to proper functioning of the immune system, which helps the body fight infections upon encountering pathogens. Studies have showed a decline in total lymphocyte and CD4+ T-cell counts across different company-sponsored trials of islatravir at varying dose levels. There was a dose-dependent reduction in lymphocyte counts in a Phase II study of patients at low risk of HIV-1, though this did not cause clinical adversities.

Dr. Joan Butterton, vice president, infectious diseases, global clinical development at Merck Research Laboratories said, “We are grateful to the participants and the study investigators for their ongoing contributions to this research. Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

Merck has commented that the temporary enrolment pause would enable it to conduct further analyses of the two Phase III trials, alongside other ongoing studies.

Lina Adams

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