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New Daily HIV Pill Moves Closer to Approval

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A Phase 3 clinical study from Merck will look at the use of islatravir for treatment after it was studied for preventative use.

Global healthcare company Merck recently announced that they will begin a Phase 3 clinical study on the use of the drug islatravir for the treatment of people infected with HIV-1.

The new studies will evaluate a combination of doravirine 100 mg and a lower dose of islatravir, designed for use as a daily pill. One study will focus on previously untreated patients with HIV-1. The other two studies will determine the efficacy of patients replacing this treatment with antiretroviral therapy (ART). Patients previously treated with the higher dose of islatravir can also transition into this study with lower doses.

The company reinstated this study after the U.S. FDA suspended 13 trials for islatravir, including using it as a form of pre-exposure prophylaxis (PrEP) and combining it with Gilead’s lenacapavir for treatment of HIV.

While the studies for islatravir’s use of PrEP have discontinued, Phase 2 of the tests with Gilead will resume studying the combination of lenacapavir under an amended protocol with lower doses of islatravir.

With their belief in the potential nucleoside reverse transcriptase translocation inhibitor (NRTTI) mechanism, they’ll also commence a Phase 1b study on MK-8527 for adults infected with HIV-1.

Participants in the Phase 3 study of islatravir as a once-monthly oral use of PrEP will continue to be monitored. Although this particular study has been suspended, the company continues to search for long-acting HIV prevention.

Dr. Eliav Barr, senior vice president and head of global clinical development stated, “We continue to believe in the potential of the NRTTI mechanism and we are evaluating additional candidates with the goal of helping to address unmet needs in HIV prevention.”

Part of this research includes a continued partnership with the Bill & Melinda Gates Foundation to evaluate potential long-acting PrEP opportunities.

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