Shortly after approving OraQuick, the first at-home HIV test, the Food and Drug Administration gives one more clearance in the field. The first HIV prevention pill was approved by the FDA today, marking a milestone in the prevention and treatment of infections.
First HIV prevention pill’s producer Gilead Sciences has long been a medicine source for HIV positive patients in need of treatment. Truvada, the treatment approved by the FDA this week, got cleared for intake back in 2004, and ever since then, combined with antiretroviral drugs it was used in the treatment of HIV patients over 12.
FDA Commissioner Dr. Margaret A. Hamburg, said the administration’s approval of the first HIV prevention pill is “an important milestone in our fight against HIV”. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test and care for people living with the disease” she said.
“New treatments as well as prevention methods are needed to fight the HIV epidemic in this country” added Margaret A. Hamburg. In previous studies, HIV prevention pill was found to cut the risk of HIV infection among heterosexual couples with one partner infected by 75 percent. The 2010 data showed Truvada cut HIV infection risk in healthy homosexuals and bisexuals by 42 percent.
For Gilead Sciences, FDA’s approval for the first HIV prevention pill comes with a promise for huge earnings. Until last year, Truvada brought Gilead Sciences $2.9 billion. Norbert Bischofberger, Gilead Sciences chief scientific, said: “Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world”.
Both the FDA and the producer warn that Truvada is part of a major prevention strategy. “Truvada alone should not be used to prevent HIV infection” warns FDA’s Debra Birnkrant, chief of the antiviral products division at the Center for Drug Evaluation and Research. So, Gilead Sciences will offer vouchers for free HIV testing and condoms.
But there are some who worry FDA’s approval is a mistake. Among them there is Michael Weinstein, AIDS Healthcare Foundation L.A. director. “The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people” warned Michael Weinstein.