Tuesday, April 9, 2019

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

Read the full press release:

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

The U.S. Food and Drug Administration . . .

"approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 
“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated 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, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”"


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