Merck's Investigational Two-Drug Regime For HIV Meets Primary Goal In Two Late-Stage Trials

On Thursday, Merck & Co Inc MRK revealed topline results from two pivotal Phase 3 trials of a two-drug regimen of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection.

The trials included patients who were virologically suppressed on different antiretroviral therapy regimens, including antiretroviral therapy regimens [baseline antiretroviral therapy (bART) and Bictegravir/​Emtricitabine/​Tenofovir Alafenamide (BIC/​FTC/​TAF).

DOR/ISL was demonstrated to be non-inferior to bART in open-label trial MK-8591A-051 and non-inferior to BIC/FTC/TAF in double-blind trial MK-8591A-052.

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Trial MK-8591A-052 did not meet the superiority criteria, but both trials also met the primary safety objectives.

The company plans to present detailed findings from these trials at a future scientific congress and file the data with regulatory authorities.

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)].

Islatravir (MK-8591), Merck’s investigational drug, is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for the treatment of HIV-1.

In addition to the MK-8591A-051 and MK-8591A-052 trials, ongoing Phase 3 trials of DOR/ISL include MK-8591A-053 in people with HIV who had not previously received treatment (treatment-naïve) and MK-8591A-054 evaluating open-label DOR/ISL in individuals who participated in earlier Phase 3 trials of DOR/ISL.

Price Action: MRK stock is up 1.18% at $99.50 at last check Thursday.

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Photo: HIV/AIDS ribbon via Shutterstock.