Merck’s phase 3 trials of fixed dose HIV-1 therapy achieve primary endpoint

USA – Merck has announced a positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens. The drugmaker has announced that the trials met their safety and efficacy endpoints at 48 weeks in adults with HIV-1 infection who are currently receiving antiretroviral therapy. According to the company, the endpoint is defined as a percentage of participants with HIV-1 RNA levels greater than 50 copies per…

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Gilead files with the US Food and Drug Administration for approval of its HIV drug lenacapavir

US – The American biopharmaceutical company, Gilead Sciences has filed its investigational long -acting HIV therapy, lencapavir with the US Food and Drug Administration (USFDA) for approval as therapy for patients with multi-drug resistant infection. In its submission, Gilead has included data from the Phase II/III CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously (under the skin) every six months in combination with an optimized antiretroviral background regimen. The FDA has already granted lenacapavir a breakthrough therapy designation for the treatment of HIV-1 infection in this…

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