FDA approves two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment – Drug Information Update

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.

The Dovato labeling includes a Boxed Warning, which cautions that patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different drug regimen. Patients with both HIV and hepatitis B who take products containing lamivudine, an ingredient in Dovato, have developed hepatitis B variants associated with resistance to lamivudine and may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine. Patients who have both HIV and hepatitis B virus who stop using Dovato should be closely monitored by their health care provider.

The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia and fatigue. As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy. In May 2018, the FDA released a Drug Safety Communicationregarding reported neural tube birth defects in babies born to women treated with dolutegravir.

For more information, please visit: Dovato.