FDA Clears New Drug-Sparing Option for HIV Infection

Megan Brooks

April 08, 2019

The US Food and Drug Administration (FDA) today approved the first two-drug, fixed-dose, complete regimen for HIV-infected adults.

Dovato, from ViiV Healthcare, contains dolutegravir (50 mg) and lamivudine (300 mg) and is indicated for adults with no history of antiretroviral treatment and with no known or suspected substitutions associated with resistance to dolutegravir and lamivudine.

"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," Debra Birnkrant, MD, director of the Division of Antiviral Products at FDA, said in a news 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," she continued.

The efficacy and safety of Dovato, a single tablet taken daily, were demonstrated in two identical, randomized, double-blind, controlled clinical trials (GEMINI 1 and 2) that included more than 1400 HIV-infected adults with no prior antiretroviral treatment history.

In these studies, Dovato was non-inferior based on plasma HIV-1 RNA <50 copies/mL, a standard measure of HIV-1 control, at week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate/emtricitabine).

The safety results for Dovato were consistent with the product labeling for both drugs separately. The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. No patient who experienced virologic failure in either treatment group developed treatment-emergent resistance.

"People are now living longer with HIV and will spend a lifetime taking drugs to suppress their virus. The approval of the fixed dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1," GEMINI principal investigator Pedro Cahn, MD, PhD, said in a news release from ViiV Healthcare.

"The approval of Dovato is a welcome paradigm shift, as it brings an innovative treatment approach to newly diagnosed adults with HIV-1. By exposing patients to fewer drugs at the start of treatment, the hope is to help address concerns arising from overall management of prolonged [antiretroviral] therapy," added Jeff Berry, of the Test Positive Aware Network.

The Dovato labeling includes a boxed warning regarding the emergence of lamivudine-resistant hepatitis B virus (HBV) and exacerbations of HBV in patients co-infected with HIV and HBV. 

Patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy given the known risk for neural tube defects with dolutegravir.

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