FDA Approves 2-Drug HIV Therapy for Previously Untreated Patients


With this approval, patients who have never been treated have the option of a 2-drug regimen in a single tablet, as opposed to the standard-of-care 3-drug regimen for HIV.

Officials with the FDA have approved the first 2-drug complete HIV treatment regimen, dolutegravir and lamivudine (Dovato, ViiV Healthcare), for adults who have never received HIV therapy, according to a press release.

To be eligible for dolutegravir and lamivudine, patients must have no history of antiretroviral therapy (ART) and no known or suspected substitutions associated with resistance to the individual components of the regimen.

With this approval, patients who have never been treated have the option of a 2-drug regimen in a single tablet, as opposed to the standard-of-care 3-drug regimen for HIV.

“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,” Debra Birnkrant, MD, director of the Division of Antiviral Products, said in a statement.

The approval is based on efficacy and safety clinical trial data from the GEMINI 1 and 2 studies for dolutegravir and lamivudine. The studies, which included 1433 adults with HIV with no prior ART history, showed that the drug regimen produced similar efficacy in reducing the amount of HIV in the blood compared with a 3-drug, first-line regimen of dolutegravir plus emtricitabine and tenofovir.

According to the study, treatment was considered successful if the patient maintained low levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.

The labeling for dolutegravir and lamivudine includes a Boxed Warning recommending that patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different drug regimen.

The most common adverse effects reported in the trial for dolutegravir and lamivudine included headache, diarrhea, nausea, insomnia, and fatigue. Patients are also advised to avoid use of dolutegravir and lamivudine at the time of conception through the first trimester of pregnancy, due to a known risk for neural tube defects with dolutegravir, according to the FDA.


FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment [news release]. Silver Spring, MD; April 8, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635526.htm. Accessed April 8, 2019.

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