FDA Approves New Once-a-Day Combination Pill for HIV
The Food and Drug Administration (FDA) has approved Stribild, a new once-a-day pill to treat HIV-1 infection in adults who have not been treated with other HIV drugs. This anti-HIV pill, marketed by Gilead Sciences Inc., is a combination of four different HIV drugs. The pill contains 2 previously approved HIV drugs such as emtricitabine and tenofovir disoproxil fumarate, plus 2 new drugs such as elvitegravir and cobicistat.
In a statement, the FDA said that the new 4-in-1 pill is a complete treatment regimen for HIV infection, to be taken only once a day. "Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens. New combination HIV drugs like Stribild help simplify treatment regimens," said Dr. Edward Cox, director of the Office of Antimicrobial Products, FDA's Center for Drug Evaluation and Research, Maryland.
In 2 double-blind clinical trials of 1,408 adult patients, the safety and effectiveness of Stribild was evaluated. Results showed that about 88 to 90% of patients treated with the 4-in-1 pill had an undetectable amount of HIV in their blood after 48 weeks of treatment. The common side effects that were observed in clinical trials include nausea and diarrhea. Serious side effects include decreased bone mineral density, new or worsening kidney problems, changes in the immune system and fat redistribution.
The FDA said Stribild will carry a boxed warning to alert patients that the drug can cause dangerous side effects, including build-up of lactic acid in the blood and severe liver problems. The warning will also state that Stribild is not approved for the treatment of chronic hepatitis B virus infection. The FDA said, as part of the approval, Gilead must conduct additional studies to further determine the safety of Stribild in women and children, how resistance develops to Stribild, and the possibility of interactions with other drugs.
In a statement, Gilead CEO John C. Martins says, "Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen for the healthcare and patient communities."
Stribild will cost about $28,500 a year. Michael Weinstein, president of the AIDS Healthcare Foundation, criticized that the new pill is priced far too high. "It's just unsustainable at these levels," he said. However, Gilead spokesperson Erin Rau said that the pricing of Stribild reflects a reasonable return on their product development investment. Rau also said that the company will provide discounts to State AIDS Drug Assistance Programs. Gilead has granted certain Indian drug manufacturers the right to develop generic versions of Stribild for distribution in poor countries.