Roughly 1.1 million people in the U.S. live with HIV with 15 percent of that population unaware they are infected. Treating these individuals must be highly effective to suppress the viral load in the blood that is needed to prevent disease progression. Now, the U.S. Food and Drug Administration has granted approval for the two-drug, fixed-dose, complete regimen for HIV-infected adults—the drug is called Dovato (dolutegravir and lamivudine).
“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.”
Dovato was proven successful in clinical trials when the treatment maintained low-levels (less than 50 copies/mL) of HIV RNA in the blood for at least 48 weeks.
However, Dovato comes with warning to those patients infected with both HIV and hepatitis B—that they must seek additional treatment for their hepatitis B or possibly a different drug regimen. Additionally, those patients with both HIV and hepatitis B who take other treatments containing lamivudine--an ingredient in Dovato--have developed variants of hepatitis B that is associated with resistance to lamivudine and may cause severe liver problems, including liver failure after they stop taking stop taking drugs containing lamivudine. Therefore, patients with HIV and hepatitis B virus, who stop using Dovato, should closely monitor with their physician.
Additionally, patients are strongly recommend to avoid Dovato treatment at the time of conception through the first trimester of pregnancy because there is a known risk for neural tube defects with dolutegravir. Other adverse effects of Dovato include most commonly headache, diarrhea, nausea, insomnia and fatigue.
The approval of Dovato was granted to ViiV Healthcare.
Source: FDA
