Merck's Investigational Two-Drug Regime Matches Gilead's Three-Drug Tablet For HIV Treatment

Merck & Co. Inc. (NYSE:MRK) on Wednesday shared topline results from the Phase 3 trial of an investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve).

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The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF].

Gilead Science Inc (NASDAQ:GILD) sells bictegravir/emtricitabine/tenofovir alafenamidei as Biktarvy.

The primary safety objective of the trial was also met, with the safety profile of DOR/ISL being comparable to BIC/FTC/TAF.

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for DOR/ISL for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen and has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA).

Also Read: Merck’s New HIV Treatment Works As Well As Top Drug In Late Trials

In the U.S., 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; doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF)].

In March, Merck presented results from two Phase 3 trials of DOR/ISL in adults with HIV-1 infection who are virologically suppressed on BIC/FTC/TAF in trial MK-8591A-052 or antiretroviral therapy (bART) in trial MK-8591A-051.

In both trials, DOR/ISL met the primary efficacy success criterion for non-inferiority to comparator antiretroviral therapies and primary safety objectives at week 48.

MRK Price Action: Merck stock is down 1.48% at $95 at publication on Wednesday.

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