WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, today announced that has filed what is known as a citizen’s petition with the Food and Drug Administration (FDA) asking the FDA to ‘delay or deny’ approval of an application by Gilead Sciences for expedited review of its blockbuster AIDS drug Truvada for expanded use as a method of preventing HIV infection in non-infected people. An article in today’s Wall Street Journal (3/7/12) reports on AHF’s innovative citizen petition method seeking to halt FDA approval of Gilead’s supplemental New Drug Application (sNDA) for use of Truvada as an HIV prevention pill. AHF officials will host a press conference, Thursday, March 8th, at the National Press Club in Washington at 12:30 pm on the filing of its citizen’s petition.
| WHAT: |
Press Conference & Teleconference—AHF files citizen’s petition with FDA to ‘delay or deny’ expedited approval of Gilead’s AIDS drug Truvada as an HIV prevention pill. |
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| WHEN: | Thursday, March 8th - 12:30 pm | |||
| WHERE: |
National Press Club, MURROW ROOM |
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| 529 14th Street NW, 13th Floor, Washington D.C. 20045 | ||||
| TELECONFERENCE: |
Dial in: 1-877-411-9748 |
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Access Code: 7931503 |
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| WHO: |
Tom Myers, Chief of Public Affairs & General Counsel, AIDS Healthcare Foundation |
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Michael Weinstein, President, AIDS Healthcare Foundation (via teleconference) |
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| AHF CONTACTS: |
Ged Kenslea: 323-791-5526 mobile, 323-308-1833 work |
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Lori Yeghiayan Friedman: 323-377-4312 mobile, 323-308-1834 work |
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In its citizen’s petition, signed by Tom Myers, General Counsel for AIDS Healthcare Foundation, AHF, “…respectfully asks that the Food and Drug Administration (FDA) not approve a pending sNDA submitted by Gilead Sciences, Inc. (Gilead) on or about December 15, 2011, which seeks permission to market once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV transmission in uninfected adults.”
AHF filed the citizen’s petition with the FDA in Rockville, MD, on Wednesday, March 7th, under Section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. §355(q), and 21 C.F.R. §10.30. Under law, the FDA has 180 days to respond to AHF’s complaint; however, the FDA can approve Gilead’s supplemental New Drug Application for expanded use of Truvada during that same time window.
In February, Gilead announced that the FDA granted a 180-day expedited review of its application for use of Truvada as an HIV prevention pill. According to a Gilead press release (2/13/12), Gilead Sciences, Inc. (Nasdaq: GILD) announced, “…today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.”
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.
Separately, on March 1st, the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) issued a position statement stating that the organizations believe that PrEP needs more study before being provided or offered to patients on demand.
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 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.
“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.”
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.