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AHF Challenges FDA Move to Fast Track Gilead's 'HIV Prevention' Drug Linked to Kidney Disease

February 15, 2012
Business Wire - February 15, 2012

Decision to grant expedited review of drug application comes just days after release of study showing the drug, Truvada, is associated with significant risk of kidney damage and disease that increases over time LOS ANGELES - AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration's (FDA) decision to grant an expedited review for Gilead Sciences' application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people. AHF has long voiced concerns that such a use would actually increase HIV infections, and the announcement comes just days after researchers reported that a component of Truvada (which is a combination containing two Gilead drugs--tenofovir DF + emtricitabine--in one tablet), is linked to a significant risk of kidney disease and damage. Most alarmingly, the risk remains even after people stop taking the drug.

"The more we learn about Truvada as an idea for preventing HIV, the worse the idea is," said Tom Myers, AHF's General Counsel. "That the FDA would expedite this process, and thereby limit additional review and a better understanding of this drug is simply beyond belief. The FDA should not be trafficking in willful ignorance." Gilead is seeking FDA approval to market the drug as a means of Pre-Exposure Prophylaxis, or PrEP. The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS. While early studies saw some initial potential, more recent studies have been halted because the drug has shown little or no preventative effect. And last week, additional news stories surfaced reporting that researchers[http://www.ucsf.edu/news/2012/02/11508/tenofovir-lead ing-hiv-medication-linked-risk-kidney-damage] have found a significant risk of kidney disease and damage from taking Truvada. None of this has deterred Gilead, which stands to gain a new market of millions of customers, from pushing this as quickly as possible.

AHF has long been critical that PrEP will not work on a large-scale basis because, consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed. Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection.

"The idea of giving healthy people a toxic drug that will damage their kidneys in order to possibly prevent HIV - when simple condom use is 95% effective - is the height of irresponsibility and corporate greed," said Michael Weinstein, AHF's President. "Widespread use of PrEP has all the makings of a public health disaster - increased HIV infections, drug resistant strains of HIV, and tens of thousands of damaged kidneys. And the FDA, in expediting its review and limiting further research, appears hell-bent on bringing this about as quickly as possible." Despite repeated requests, FDA Commissioner Margaret Hamburg has refused to meet with AHF to discuss this matter. "The FDA is not interested in seeing or hearing anything that may contradict its own settled course," commented Weinstein.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 125,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Contacts AIDS Healthcare Foundation Ged Kenslea Communications Director Work: (323) 308-1833, Cell: (323) 791-5526 gedk@aidshealth.org or Lori Yeghiayan Friedman Assoc. Dir. of Communications Work: (323) 308-1834, Cell: (323) 377-4312 loriy@aidshealth.org

www.aegis.org