DOVATO (Dolutegravir and Lamivudine) Approved for HIV-1

April 8, 2019

First-ever dual-drug, single tablet for HIV offers lighter treatment regimen. 

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The FDA has approved a new treatment regimen for patients suffering from HIV-1.

Dovato (dolutegravir and lamivudine) is a first ever two-drug single-tablet treatment regimen indicated for the virus. Previously, treatment regimens have consisted of three drugs in separate dosage forms.

Dovato, unlike the antiretroviral drugs it contains, is indicated only for adults diagnosed with HIV-1, but who have not taken previous antiretroviral treatments and who do not have any suspected substitutions associated with resistance to either dolutegravir or lamivudine.

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The most common side effects reported in clinical trials were headache, diarrhea, nausea, insomnia, and fatigue.

“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,” says Debra Birnkrant, MD, FDA's 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.”

According to the CDC, nearly 1.1 million people living with HIV in the United States, though 15% of those are unaware that they are infected.

Dovato carries a boxed warning cautioning that patients infected with both HIV and hepatitis B should have additional treatment for hepatitis B or be considered for 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 lamivudine. Patients who have both HIV and hepatitis B virus who stop using Dovato should be closely monitored by their healthcare provider.