The first two-drug complete regimen for treatment-naive HIV patients was approved on Monday, the FDA announced. Dovato (ViiV Healthcare) is a combination of integrase inhibitor dolutegravir (Tivicay) and lamivudine (3TC). It is a two-drug, fixed-dose complete regimen for the treatment of HIV infection in adults who have no antiretroviral therapy (ART) history and no known or suspected resistance to the individual components of the drug. "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, MD, director of the FDA's Division of Antiviral Products in a statement. The approval was based on the GEMINI trials in 1,433 HIV-infected adults with no prior ART history. The results of these trials, first presented at the 2018 International AIDS Conference, found that one tablet containing dolutegravir and lamivudine was non-inferior to a three-drug regimen of dolutegravir along with tenofovir and emtricitabine (Truvada). The FDA noted that the treatment was considered successful if the patient maintained low levels (<50 copies/mL) of HIV RNA in their blood for >48 weeks. Back in July, Linda-Gail Bekker, MBChB, PhD, International AIDS Society president, told MedPage Today that this two-drug regimen "gives us a chance to simplify treatment." "I think there are significant numbers of patients who find drug burden a problem," said Bekker, of the Desmond Tutu HIV Centre in Cape Town, South Africa. The FDA noted that Dovato will contain a boxed warning cautioning patients who are co-infected with HIV and hepatitis B to "add additional treatment for hepatitis B or consider a different drug regimen," as these types of patients "may have developed hepatitis B variants resistant to lamivudine and may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine." The agency said that patients with HIV and hepatitis B who stop using Dovato should be "closely monitored" by their healthcare provider. In addition, the FDA noted that Dovato contains dolutegravir, and per a previous FDA Drug Safety Communication, patients are "advised to avoid the use of Dovato at the time of conception through the first trimester of pregnancy," due to the risk of neural tube defects. Source
