FDA approves HIV treatment that combines four medications into one daily pill
(CBS/AP) WASHINGTON - A new drug that contains four different medications to help treat HIV infection has been approved by the Food and Drug Administration.
Gilead Sciences' Stribild is a once-a-day treatment that can help control the virus that causes AIDS. It is intended to be used on people who have not previously been treated for infection.
"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 a statement. "New combination HIV drugs like Stribild help simplify treatment regimens."
The pill contains two previously approved antiviral drugs currently sold as the combination pill Truvada, which contains both emtricitabine and tenofovir disoproxil fumarate. Those drugs are combined with two new drugs, elvitegravir and cobicistat. Elvitegravir interferes with one of the enzymes that HIV needs to multiply. Cobicistat helps prolong the effect of elvitegravir and stops an enzyme that metabolizes some kinds of HIV drugs.
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Company studies of 1,408 adult patients not previously treated for HIV showed that 88 to 90 percent of patients taking Stribild had an undetectable level of HIV in their blood after 48 weeks, compared with 84 and 87 percent for patients taking older HIV drugs.
Like most other HIV drugs, Stribild will carry a boxed warning about potentially dangerous side effects, which include nausea and diarrhea. Serious side effects observed in the clinical trials were new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system. The manufacturer has also placed a warning on the medication's box stating that Stribild is not intended to treat people with chronic hepatitis B virus infection.
According to AIDS.gov, about 1.7 million people have been infected with HIV since June 1981. More than 619,000 people have died from the disease. More than one in five people who have been infected with HIV are unaware that they have the disease.
Recently, the FDA has also approved over-the-counter home-use rapid HIV tests and the first drug intended to treat pre-exposure to HIV in order to combat the AIDS epidemic.