FDA Tentatively OKs Fixed-Dose HIV Combo Therapy

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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