Merck Says Its Two-Drug Regimen For HIV Treatment Proven Non-Inferior To Gilead’s Biktarvy In Study

Merck said the combination achieved suppression of the HIV virus at week 48, similar to Biktarvy in the late-stage study.

• The safety profile of the regimen was also found to be comparable to Biktarvy. 
• Merck now intends to present findings from the trial at a future science congress and submit applications to health authorities with this data.
• The FDA is expected to decide on Merck’s application for the single-tablet regimen of Doravirine and Islatravir by April 28, 2026. 
  

Merck (MRK) on Thursday said that its investigational once-daily, oral, two-drug, single-tablet regimen of Doravirine and Islatravir was found to be non-inferior to Gilead Sciences’ FDA-approved Biktarvy in treating HIV patients who had not previously received treatment in a study.

Merck said that the combination achieved suppression of the HIV virus at week 48, similar to Biktarvy in the late-stage study. Further, the safety profile of the regimen was also found to be comparable to Biktarvy.

Steps Ahead

Merck now intends to present findings from the trial at a future science congress and submit applications to health authorities with this data.

The U.S. Food and Drug Administration has already accepted the company’s application for approval of the two-drug regimen for the treatment of an HIV infection in adults who are on an antiretroviral regimen. The FDA is now expected to decide on the application by April 28, 2026.

In the two-drug regimen, Doravirine is already approved for the treatment of adults with HIV-1 in combination with other antiretrovirals under the brand name Pifeltro and as a component of a single-tablet regimen called Delstrigo. Islatravir, meanwhile, is an investigational drug from Merck under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around MRK fell from 'extremely bullish' to 'bullish' territory over the past 24 hours, while message volume fell from 'extremely high' to 'high' levels.

MRK stock is down by 4.5% this year and by about 2% over the past 12 months. 

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