s******a
发帖数: 472 | 1 http://www.philly.com/philly/health/HealthDay668074_20120827_FD
MONDAY, Aug. 27 (HealthDay News) -- A new pill to treat HIV infection that
combines four medicines and only has to be taken once a day was approved by
the U.S. Food and Drug Administration on Monday.
Stribild, which will be marketed by maker Gilead Sciences, contains the HIV
drugs elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil
fumarate. It will be prescribed to people who have never been treated for
HIV infection, the agency said in a statement.
Two of the drugs, elvitegravir and cobicistat, are new, the FDA noted.
Elvitegravir interferes with one of the enzymes that HIV needs to multiply,
while cobicistat inhibits an enzyme that metabolizes certain HIV drugs and
so prolongs the effect of elvitegravir. The combination of emtricitabine and
tenofovir disoproxil fumarate is already marketed as Truvada, and they work
in concert to block another enzyme that HIV needs to replicate.
"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."
Earlier this year, the agency approved the first over-the-counter rapid HIV
test for home use and gave its blessing to the first drug to be used to
prevent HIV infection when used together with safe sex practices.
Two clinical trials found between 88 percent and 90 percent of patients
treated with Stribild had an undetectable amount of HIV in their blood after
48 weeks of treatment, the FDA said.
The drug will carry a boxed warning that says it can cause a build-up of
lactic acid in the blood and severe liver problems, both of which can be
fatal. In the clinical trials, common side effects included nausea and
diarrhea. Serious side effects include new or worsening kidney problems,
decreased bone mineral density, fat redistribution and changes in the immune
system, the FDA said.
Gilead, which is based in Foster City, Calif., must conduct more research to
further determine the drug's safety in women and children, how resistance
develops to Stribild and possible interactions with other drugs, the FDA
said. |
|
