Today the U.S. Food and Drug Administration granted approval of Dovato to ViiV Healthcare for adults with no antiretroviral treatment history. Dovato (dolutegravir and lamivudine) is a two-drug regimen in a single tablet that can eliminate additional toxicity and potential issues with a third drug. A three-drug regimen is the current standard for people who have never been treated.
Effective treatment is important in reducing the amount of virus in the blood, which prevents disease progression, and helps people live longer, healthier lives. Those who take HIV medication daily and maintain an undetectable viral load have effectively no risk of sexually transmitting HIV to HIV-negative partners.
Efficacy and safety were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history. The trials showed that a drug regimen containing Dovato had a similar effect of reducing the amount of HIV in the blood compared to another drug regimen, which included dolutegravir, emtricitabine, and tenofovir. The 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.