FDA approves pill to prevent spread of HIV

The first daily HIV preventative medicine was approved by the Food and Drug Administration, but not all HIV advocacy groups are pleased with the development. Gilead Sciences’ Truvada medication was approved for some high-risk populations as part of a way to prevent the spread of HIV through sexual transmission.

The pill is only part of a larger approach to safe sex and should not be relied on solely to prevent the spread of HIV, said Norbert Bischofberger, a Gilead spokesperson. Truvada was originally approved in 2004 in combination with other antiretroviral agents as a treatment of HIV-1 infection in adults and is currently the most-prescribed antiretroviral product in the United States.

“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, and Gilead is proud to have been a partner in this effort,” Bischofberger said. “This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide.”

It’s estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention tools such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men. In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.

The AIDS Healthcare Foundation fought the approval and even published anti-Truvada ads in a California newspaper near the Gilead headquarters and sent a mailer to more than 50,000 homes in that area. All groups involved acknowledge that the long-term effects of a daily HIV medication by uninfected persons are not yet fully known.

“On the surface it’s something amazing, you can prevent HIV with a pill,” Kevin Robert Frost, chief executive officer of amfAR, The Foundation for AIDS Research, told the San Francisco Chronicle. “But then you start to dig deeper and it gets really complicated. When I get to the question of who pays for this I am completely dumbfounded. In developing countries, most of them can’t afford to give pills to those who are HIV positive.”

HIV killed 1.8 million people in 2010 and of the 15 million who needed treatment, just 6.6 received the medication necessary to combat the virus, according to UNAIDS, the United Nation’s HIV/AIDS taskforce. To deliver the drugs around the world would cost $6 billion, in addition to the $16 billion already spent fighting the virus each year.

No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.

As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.

Truvada is not cheap. A month’s supply costs about $1,200.

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