FDA Approves Two-Drug, Fixed-Dose, Complete Regimen HIV-1 Treatment

Pharmaceutical Technology Editors

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of 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.

FDA announced on April 8, 2019 that the agency has approved Dovato (dolutegravir and lamivudine), a two-drug, fixed-dose, complete regimen treatment of 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. 

“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, MD, director of the Division of Antiviral Products, in a press release. “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.”

Two identical, randomized, double-blind, controlled clinical trials, which included 1433 HIV-infected adults with no prior antiretroviral treatment history, showed that a drug regimen containing dolutegravir and lamivudine reduced the amount of HIV in the blood similar to that of another drug regimen, which included dolutegravir, emtricitabine, and tenofovir. Adverse reactions include headache, diarrhea, nausea, insomnia, and fatigue. 

Dovato is a tablet taken once daily and comes with a Boxed Warning cautioning that patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different treatment. According to FDA, “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.”

Source: FDA