The U.S. Food and Drug Administration (FDA) has reportedly approved a new pill to treat HIV infection that combines four of the most effective HIV drugs on the market.
The drug, which would be administered once a day, falls under the label Stribild and will be marketed by maker Gilead Sciences, contains the drugselvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate. Scientists say the drug could provide a major breakthrough in combating HIV, the virus that causes AIDS.
In a statement released Tuesday, the FDA said that recent research into the drug provided enough evidence to support transitioning from a multi-pill regimens to a single pill regimens.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said in the agency statement. “New combination HIV drugs like Stribild help simplify treatment regimens.”
The safety and effectiveness of Stribild were evaluated in clinical studies involving 1,408 adults, FDA officials noted. Of those treated with the new drug, between 88 percent and 90 percent had undetectable levels of HIV in their blood, compared with roughly 84 percent who continued to have undetectable levels among those treated with other anti-HIV drugs.
While the FDA approved the drug for adult males, it did note that additional tests will take place in the coming months to test the drug’s effects on women and children. Future testing will also seek to understand how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs.
Stribild’s approval is the latest HIV/AIDS-related action taken by the FDA this year. Other actions include approval of the first over-the-counter home-use rapid HIV test; approval of the first drug for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk; and commemoration of the full or tentative approvals of more than 150 antiretroviral products for the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those in countries most affected by the HIV/AIDS epidemic.