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Merck Presents Interim Data From Phase 2a Trial Of Treatment For Pre-exposure Prophylaxis

Merck (MRK) Tuesday announced new interim data from the Phase 2a trial in adults evaluating the safety, tolerability and pharmacokinetics of islatravir, the company's investigational oral nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis.

Pre-exposure prophylaxis or PrEP is a way for people who do not have HIV but who are at very high risk of getting HIV to prevent HIV infection by taking a pill every day.

Interim findings demonstrate that once-monthly oral islatravir achieved the pre-specified efficacy PK threshold for PrEP at both of the two doses studied.

In the interim analysis using blinded data, both monthly doses of islatravir were found to have an acceptable tolerability profile.

"These results provide support for further study of islatravir as a once-monthly oral PrEP regimen," said Sharon Hillier, Ph.D., senior investigator at the Magee-Womens Research Institute, and professor of obstetrics, gynecology and reproductive sciences of the University of Pittsburgh, the study's lead investigator. "There is an urgent need for additional, longer acting HIV prevention options to help a wider range of people protect themselves."

In the ongoing Phase 2a trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned to one of three oral once-monthly therapy groups.

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