April 21 (Reuters) – The U.S. Food and Drug Administration has approved Merck’s once-daily, oral, combination regimen for HIV infections, the health regulator’s website showed on Tuesday.
The two-drug combination of doravirine and islatravir was approved to replace the current antiretroviral regimen for treating Human Immunodeficiency Virus-1 infection in some adults.
While islatravir is an experimental treatment, Merck’s doravirine is already approved and sold in the U.S. under the brand name Pifeltro for HIV-1 treatment in combination with other antiretrovirals, and as a single-tablet regimen, Delstrigo.
About 40.8 million people are living with HIV globally, and about 1.3 million new infections occur annually, according to National Institutes of Health data.
The drugmaker did not immediately respond to Reuters requests for comment.
In two late-stage studies with more than 1,000 patients, the treatment combination met the main goal of significantly suppressing replication of the HIV-1 in adults receiving another form of therapy.
Last year, Merck’s oral drug combo was found to be non-inferior to Gilead’s top-selling drug, Biktarvy, achieving similar HIV-1 suppression to the current standard of care.
HIV-1 is the most common strain of the retrovirus that causes Acquired Immunodeficiency Syndrome, commonly known as AIDS.
Islatravir is now being tested in multiple trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1.
(Reporting by Christy Santhosh and Sriparna Roy in Bengaluru; Editing by Sahal Muhammed and Shinjini Ganguli)
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