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Thanks for nothing: iPrEX volunteers shut out of PrEP’s success

Saturday, 10 May 2014 Written by // Guest Authors - Revolving Door Categories // As Prevention , Current Affairs, Health, International , Treatment, Revolving Door, Guest Authors

On PrEP, POZ reports most foreign volunteers who participated in the clinical trial that first proved Truvada prevents HIV no longer have access to the drug.

Thanks for nothing: iPrEX volunteers shut out of PrEP’s success

The full text of this story by Benjamin Ryan originally appeared in POZ magazine here.    

Proving for the first time that Truvada (emtricitabine/tenofovir) reduces the risk of contracting HIV was a global effort. The landmark iPrEX study, which ran between 2007 and 2009 and which examined the drug’s use in 2,500 high-risk HIV-negative MSM and transgender women who have sex with men, had sites in the United States, Peru, Ecuador, Brazil, Thailand and South Africa. 

The benefits of the trial, however, have been more localized. After the drug was approved as pre-exposure prophylaxis (PrEP) in the United States in 2012, American iPrEX volunteers who wanted to keep taking the daily pill enjoyed the benefits of a cohesive system that referred them to various means of obtaining affordable or even free Truvada, as well as follow-up care. Meanwhile, the volunteers in the remaining iPrEX countries have largely been left out in the cold.

South Africa is the only other country in the world in which Gilead Sciences, which manufactures Truvada, has even applied for approval for the drug’s use as a preventative measure. South African MSM also have something of a leg up because, as they await approval of PrEP, they can seek out an off-label prescription (since Truvada is approved as a treatment for HIV) for about $20 a month, a cost sometimes covered by insurance.

Mitchell Warren, executive director of the global HIV advocacy group AVAC, says, “One of the top priorities has got to be—and we’ve raised this over and over again—that Gilead should be applying, at least for registration [of Truvada as PrEP], in each of the countries where any of the PrEP trials took place. As with most things in ethics, reasonable people disagree in terms of where the ethical requirement is. But as a matter of good conduct, we believe that those communities and countries that supported the trials should be prioritized.”

Read the rest of the article here.