Fixed-Dose HIV Combo Therapy tentatively approved by FDA

February 21st 2018
Laurie Toich, Associate Editor
Laurie Toich, Associate Editor

Officials with the FDA have granted tentative approval to dolutegravir, emtricitabine, and tenofovir alafenamide(DTG/FTC/TAF) tablets, 50-mg/200-mg/25-mg, under the US President’s Emergency Plan for AIDS Relief (PEPFAR) program.

Officials with the FDA have granted tentative approval to dolutegravir, emtricitabine, and tenofovir alafenamide(DTG/FTC/TAF) tablets, 50-mg/200-mg/25-mg, under the US President’s Emergency Plan for AIDS Relief (PEPFAR) program, according to a Mylan press release.

Under the PEPFAR program, the antiretroviral (ARV) combination will be available in developing countries as a treatment for patients with HIV/AIDS.

DTG/FTC/TAF is a once-daily combination of the individual components that make up ViiV Healthcare's Tivicay and Gilead's Descovy, according to the release. Mylan produces the fixed-dose combination under licenses from the Medicines Patent Pool and Gilead.

This is the first tentative approval granted to tenofovir alafenamide, which first gained FDA approval 2 years ago.

The combination ARVs are currently a "Recommended Initial Regimen for Most People with HIV" under guidelines issued by the Department of Health and Human Services, according to Mylan.

The treatment will be the smallest single-tablet ARV regimen for patients worldwide. Mylan noted DTG/FTC/TAF will be offered in a 30- and 90-day packages, which may allow patients to visit the clinic less, according to Mylan.

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