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FDA recommends use of drug that prevents HIV transmission
By Catholic Online (NEWS CONSORTIUM)
May 11th, 2012
Catholic Online (www.catholic.org)
May 11th, 2012
Catholic Online (www.catholic.org)
An outside panel of experts with the U.S. Food and Drug Administration
has recommended Gilead Sciences Inc's Truvada as a treatment for
preventing HIV infection among people most at risk for contracting AIDS,
including homosexual and bisexual men. However - some doctors say the
drug does not benefit all at risk for HIV, the virus that causes AIDS.
The panel also approved Truvada's use for the domestic partners of HIV-infected people and others at risk for sexual transmission.
Several members warn that there should be more data on the drug's efficacy to justify its use in the wider population.
Dr. Lauren Wood of the National Cancer Institute says she opposes all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people. African-Americans are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs.
"I don't think that is adequate when you're talking about the population that is most at risk," she said.
The recommendation will be forwarded to FDA regulators, who must decide whether to give Truvada final approval as the first drug for use as a preventive treatment for HIV in the United States.
Nearly 1.2 million Americans are infected with HIV. Clinical research has proved that Truvada is most effective at preventing the spread of HIV among people who take the pill daily. The medication has raised hopes that the United States could stem the growth of a national HIV epidemic that has stubbornly generated 50,000 new infection cases a year for the past two decades.
Clinical studies have shown Truvada to be more than 90 percent effective at preventing HIV infection among test subjects who took the drug as prescribed, but only 44 percent effective among test populations that included intermittent use.
"If taken, it works," Dr. John Mellors, chief of the infections diseases division at the University of Pittsburgh said. Mellors spoke as part of Gilead's presentation.
"Existing interventions have not reduced the number of new infections annually and new measures are needed," he said.
Some said drug recipients should be required to undergo regular HIV screening to them from becoming HIV positive while taking the treatment and unknowingly passing drug-resistant HIV strains to their sexual partners.
"The potential for harm here is stupendous. If we were not to pay attention to that, we would have the potential as an advisory committee to do more harm than good," panel chairwoman, Dr. Judith Feinberg of the University Of Cincinnati College Of Medicine said.
The committee voted after hearing from nearly three-dozen public witnesses from HIV community activists, who warned that the drug's promise could backfire by discouraging the use of condoms and offering false hope to healthy people unlikely put up with side-effects in order to maintain the daily dosage.
"They'll take the drug when they think they need it," Dr. Catherine Chien said, who like many of the meeting's 38 public witnesses works with the nonprofit AIDS Healthcare Foundation, a global organization that says it helps nearly 170,000 HIV and AIDS sufferers.
"This will lead to higher rates of HIV infection and higher rates of HIV drug resistance," she said.
© 2012, Catholic Online. Distributed by NEWS CONSORTIUM.