FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves Two-Drug Regimen for HIV

April 16, 2019
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The FDA has given the go-ahead for Glaxo’s Dovato (dolutegravir and lamivudine), a two-part regimen for HIV patients who have not previously used an antiretroviral treatment.

The current standard of care for HIV patients who have never been treated is a three-drug regimen. With this approval, patients “have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," said Debra Birnkrant, director of CDER’s division of antiviral products.

Dovato requires a boxed warning alerting HIV patient with hepatitis B to add additional hep B treatments or consider not taking the regimen.

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