Therapy Areas: AIDS & HIV
The US FDA announces approval of first two-drug complete regimen for HIV-infected patients
9 April 2019 -

Public health agency the US Food and Drug Administration announced Monday that it has authorised the marketing of Dovato (dolutegravir and lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

The approval of Dovato was awarded to ViiV Healthcare.

Dovato (dolutegravir and lamivudine) is a complete two drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato, added the agency.

This is reportedly the first US FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.

Efficacy and safety of the company's Dovato, one tablet taken daily, was demonstrated in two identical, randomised, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history. The treatment is successful if the patient maintained less than 50 copies/ml of HIV RNA in their blood for at least 48 weeks.

In February 2019, the US Department of Health and Humans Services announced a new initiative, Ending the HIV Epidemic: A Plan for America, a once-in-a-generation opportunity to eliminate new HIV infections in our nation. Approximately 1.1m people in the US are living with HIV.

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