FDA  approves fixed dose combo for first time HIV patients

The U.S. Food and Drug Administration has for approved Dovato (dolutegravir and lamivudine), a complete treatment course for treating human immunodeficiency virus type 1 (HIV-1) infection for adults receiving HIV medicines for the first time.This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.

The FDA has granted approval of Dovato to ViiV Healthcare.

The efficacy and safety of Dovato, one tablet taken daily, 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 dolutegravir and lamivudine 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.

The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia and fatigue. As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy. In May 2018, the FDA released a Drug Safety Communication regarding reported neural tube birth defects in babies born to women treated with dolutegravir.

At present about 1.1 million people in the U.S. are living with HIV and almost 15 percent of them (1 in 7) are unaware that they are infected. Effective treatment may therefore help prevent disease progression, and help patients live a longer, healthier lives. Also, people living with HIV who take HIV medication daily as prescribed and maintain an undetectable viral load have effectively no risk of sexually transmitting HIV to their HIV-negative partners.

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," said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. "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."