FDA Approves HIV Combo Treatment Dolutegravir/Lamivudine

The US Food and Drug Administration (FDA) has approved Dovato, a new treatment regimen for HIV type 1 that combines 50 mg of dolutegravir and 300 mg lamivudine. The treatment is indicated for the treatment of HIV-1 infection in adults with no history of antiretroviral treatment and no known or suspected resistance to dolutegravir or lamivudine.

"Currently, the standard of care for patients who have never been treated is a 3-drug regimen. With this approval, patients who have never been treated have the option of taking a 2-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, FDA. "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."

The label for Dovato includes a Boxed Warning recommending that patients coinfected with HIV and hepatitis B should receive treatment for their hepatitis B infection or use an alternative antiretroviral regimen for their HIV infection.

The FDA’s decision to approve Dovato was supported by results from 2 phase 3 double-blind, controlled trials. The GEMINI-1 and -2 trials included 1433 adults with HIV infection who had no prior antiretroviral treatment. Treatment with Dovato was compared to treatment with a 3-drug regimen of dolutegravir, tenofovir, and emtricitabine.

Results from the GEMINI studies were presented at the 22nd International AIDS Conference in Amsterdam and indicated that Dovato is non-inferior to the 3-drug regimen.

"For the last 15 to 20 years, the standard of care for HIV has revolved around 3-drug regimens. Now that we have more potent drugs, the focus is shifting to tolerability and convenience," said principle investigator Pedro Cahn, MD, PhD, at the time of the conference. "The (GEMINI) studies have the potential to expand the treatment paradigm for first-line therapy of people living with HIV."

The most commonly reported adverse events associated with Dovato use were headache, diarrhea, nausea, insomnia and fatigue. There is a risk of neural tube defects associated with dolutegravir, and as such, Dovato is not recommended for use from the time of conception through the first trimester of pregnancy and providers are advised to perform pregancy tests before initiating therapy with Dovato in patients with childbearing potential.