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ViiVs Dovato HIV pill approved in EU

July 03, 2019 / Richard Staines

The new regimen, dubbed Dovato, is approved in adults and adolescents above 12 years of age with HIV-1, and is based on a combination of dolutegravir and lamivudine given as a single pill once daily. Patients must weigh at least 40 kg and have no known suspected resistance to integrase inhibitors or lamivudine. Approval is based on the GEMINI pivotal trials that showed Dovato was comparable in efficacy and safety compared with dolutegravir taken together with Gilead’s Truvada (tenofovir disoproxil fumarate+emtricitabine). Dolutegravir is the active ingredient in ViiV’s already-marketed HIV drug Tivicay, and is usually taken in combination with another “backbone” pill such as Truvada. The new approval does away with the need for two pills, and using only two active ingredients could also help to limit side effects. HIV medicines have for years been based on three-drug regimens based on an integrase inhibitor such as dolutegravir, and two nucleoside reverse transc...