[ad_1]
The US Food and Drug Administration today approved Dovato (dolutegravir and lamivudine) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults without known or suspected antiretrovirals or substitutions associated with resistance to individual Dovato components. This is the first full-dose, FDA approved, two-drug regimen for HIV-infected adults who have never received treatment for HIV.
"Currently, the standard treatment 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 the additional toxicity and potential drug interactions of a third drug, said Debra Birnkrant, MD, director of the Division of Antiviral Products. "Having a saver treatment that uses fewer drugs is beneficial for patients who may have problems taking multiple medications over a long period of time."
In the United States, about 1.1 million people are living with HIV. About 15% of them (1 in 7) do not know that they are infected. Effective treatment is important to reduce the amount of virus in the blood. A suppressed viral load in people living with HIV prevents the progression of the disease and helps them live longer and healthier lives. In addition, people living with HIV who take prescribed anti-HIV medications on a daily basis and maintain an undetectable viral load have no risk of sexually transmitting HIV to their HIV-negative partners.
The Dovato labeling includes a boxed warning, which warns patients infected with HIV and hepatitis B to add additional treatment to their hepatitis B or to consider a different treatment regimen. Patients with HIV and hepatitis B who are taking products containing lamivudine, an ingredient of Dovato, have developed hepatitis B variants associated with resistance to lamivudine and may present with severe liver problems, including liver failure, when they stop taking lamivudine-containing medications. HIV-positive patients with hepatitis B virus who stop using Dovato should be closely monitored by their health care provider.
The efficacy and safety of Dovato, one tablet daily, has been demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no history of antiretroviral therapy. The trials showed that a regimen containing dolutegravir and lamivudine had a similar effect on reducing the amount of HIV in the blood compared to another regimen including dolutegravir, emtricitabine and tenofovir. Treatment was considered successful if the patient maintained low levels (less than 50 copies / ml) of HIV RNA in the blood for at least 48 weeks.
The most common side effects with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. Given the known risk of neural tube defects associated with dolutegravir, it is advisable for patients to avoid the use of Dovato at the time of conception during the first trimester of pregnancy. In May 2018, the FDA published a Drug Safety Communication on congenital anomalies reported by neural tube defects in infants born to women treated with dolutegravir.
In February 2019, the US Department of Health and Human Services announced a new initiative, Ending the HIV Epidemic: A Plan for America, a Unique Opportunity to Eliminate New HIV Infections in our country. This initiative will provide the hardest hit communities with the expertise, technology and additional resources needed to combat the HIV epidemic in their communities, focusing on certain geographic hotspots. The goal is to reduce new infections by 75% over the next five years and by 90% over the next ten years, avoiding more than 250,000 HIV infections during this period.
The FDA has approved Dovato from ViiV Healthcare.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
###
[ad_2]
Source link