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Pivotal phase III trials of MK 8591 + Pifeltro meet endpoints in HIV.

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Last updated:26th Oct 2021
Published:26th Oct 2021
Merck Inc announced positive top-line results from two pivotal Phase III trials of the investigational, once-daily oral fixed dose combination pill of MK 8591 + Pifeltro (islatravir + doravirine) (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B).

At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels of at least 50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). The safety and tolerability profile of DOR/ISL during the trials to date are consistent with the previously reported Phase II studies.

Doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals, as a single agent (PIFELTRO) and a component of a single-tablet regimen (DELSTRIGO; DOR/3TC/TDF). Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of people living with HIV-1 infection in combination with other antiretrovirals. Detailed findings from these studies will be presented at a future scientific congress and will form the basis of global regulatory applications.

Condition: HIV/AIDS
Type: drug

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