FDA Approves First Two-drug Complete Regimen for HIV-infected Patients Who Have Never Received Antiretroviral Treatment

Cross-posted from FDA Newsroom

On April 8, 2019, the U.S. Food and Drug Administration approved Dovato (dolutegravir and lamivudine), as a complete 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. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.

“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.”

Approximately 1.1 million people in the U.S. are living with HIV. About 15 percent of them (1 in 7) are unaware they are infected. Effective treatment is important in reducing the amount of virus in the blood. A suppressed viral load in people living with HIV prevents disease progression, and helps them live 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.

The Dovato labeling includes a Boxed Warning, which cautions that patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different drug regimen. Patients with both HIV and hepatitis B who take products containing lamivudine, an ingredient in Dovato, have developed hepatitis B variants associated with resistance to lamivudine and may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine. Patients who have both HIV and hepatitis B virus who stop using Dovato should be closely monitored by their health care provider.

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.

In Feb. 2019, the U.S. 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. This initiative will provide the hardest hit communities with the additional expertise, technology and resources required to address the HIV epidemic in their communities, focusing on certain geographic hotspots. The aim is to reduce new infections by 75 percent in the next five years and by 90 percent in the next ten years, averting more than 250,000 HIV infections in that span.

The FDA granted approval of Dovato to ViiV Healthcare.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.