AHF Files FDA Complaint Against Gilead for Promoting Truvada as PrEP

Advocates from AIDS Healthcare Foundation (AHF) stepped up efforts to ensure that Gilead Sciences, Inc. be held accountable for promoting off-label use of Truvada for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection. AHF also wants Gilead to be compelled to promote and market use of its AIDS treatment in accordance with FDA statute and regulations as well as other applicable law.

AHF sent a letter to Dr. Stepehn Ostroff, M.D., Acting Commissioner of the U.S. Food and Drug Administration (FDA), alerting him to the fact that Gilead financed a video ad campaign promoting situational use of its AIDS treatment, Truvada, for PrEP, misleading viewers into believing that Truvada is safe and effective for use on a situational basis, despite knowing that the drug is not FDA-approved for such off-label use.�

AHF's letter to the FDA came about following publication of a news article on Australia's 'Gay News Network' titled, "New US PrEP Ads Target Men Who Like to Party," which focuses on a video ad� that appears to promote situational -- rather than daily -- use of Truvada for PrEP for "...men who enjoy recreational sex and drug use but do not test regularly for HIV."

The article noted, "The campaign is supported by Gilead Sciences, manufacturer of Truvada."�The TV ad, titled, "I Like to Party," also includes a slate at the end of the spot reading: "Supported by funding from Gilead Sciences." The ad also credits Public Health Solutions, a New York City-based non-profit and Connected Health Solutions, a Brooklyn-based "organizational development consultancy" on the slate at the end of the ad.

"Gilead, which we believe has been deliberately mounting an under-the-FDA-radar, guerilla-style marketing and media campaign for PrEP for the past three years by funding scores of community and AIDS groups across the nation to promote PrEP, has run afoul of the FDA by funding this ad promoting off-label use of PrEP," said Michael Weinstein, President of AIDS Healthcare Foundation, which has criticized and cautioned against the widespread deployment of PrEP as a community wide public health strategy, such as the CDC's recommendation that 1.2 million individuals go on PrEP, but supports its use on a case-by-case basis decided upon between a medical provider and his or her patient.

PrEP is a prevention strategy that includes use of Truvada to prevent HIV infection in non-infected individuals. Truvada's FDA-approved labeling for a PrEP indication clearly indicates the drug is to be taken daily and that "Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk."

"FDA labeling for Truvada as PrEP is very clear: the drug is to be taken daily and used in conjunction with other safer sex practices, such as condoms, and not on an intermittent basis as the Gilead-financed ad suggests," added Weinstein.

Gilead's Truvada was first approved for treatment of HIV/AIDS patients in August 2004. The FDA formally approved use of Truvada as PrEP on July 16, 2012. Guidelines issued by the FDA for PrEP for individuals include 1) an initial baseline negative HIV test; 2) daily adherence to the Truvada medication; 3) ongoing periodic HIV testing to ensure the individual on PrEP remains HIV-negative; and 4) continued use of other prevention methods, such as condoms.

AHF's letter to the FDA about Gilead's promotion of situational use of PrEP notes, "In contravention of statute and regulations, Gilead launched an ad campaign to mislead viewers into believing that Truvada is safe and effective for use on a situational basis despite knowing that the drug is not approved for such use. Consequently, the ad campaign constitutes impermissible off-label promotion, and we urge the FDA to take immediate action to (1) require Gilead to cease and desist all such off-label promotion; (2) require Gilead to publically correct the misinformation disseminated by the ad campaign; and (3) impose any sanctions permitted by law."

A copy of the letter was also sent to the U.S. Department of Health and Human Services Office of Inspector General.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 575,000 individuals in 35 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe.