FDA clears first 2-drug HIV-1 regimen

April 9, 2019

FDA cleared Dovato (ViiV Healthcare), the first 2-drug regimen to treat HIV-1 in adults with no antiretroviral treatment history.

FDA cleared Dovato (ViiV Healthcare), the first 2-drug regimen to treat HIV-1 in adults with no antiretroviral treatment history.

The once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg, is the lowest-priced treatment in its class with a wholesale acquisition cost of $2,295 per month, according to a company statement to FormularyWatch.

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Dovato will be available at the end of April 2019, according to the pharma maker.

The 2-drug regimen reduces exposure to the number of ARVs [antiretrovirals] from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based 3-drug regimen.

“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 FDA’s Division of Antiviral Products, in a statement from the agency. “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.”

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Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine, said Deborah Waterhouse, CEO of ViiV Healthcare, in a company statement.

The approval of Dovato is supported by the global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, DTG + 3TC demonstrated non-inferiority based on plasma HIV-1 RNA <50 copies per milliliter (c/ml), a standard measure of HIV-1 control, at Week 48 when compared to a 3-drug regimen of DTG and 2 nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults.

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