Launching today & scheduled to run in eight markets, “Gilead’s Truvada as Prevention - Just the Facts” print ad lays out data on use of Gilead’s HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP), raising questions about FDA-approval for new prevention use
“It is Gilead Sciences’ obligation, as the manufacturer of Truvada, to make certain that their drug when used for prevention does no harm to the individual or the overall public health,” says AHF in the ad
LOS ANGELES--(BUSINESS WIRE)-- AIDS Healthcare Foundation (AHF) unveiled a new print ad today that lays out data on the use of Gilead’s blockbuster HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the U.S. Food & Drug Administration (FDA) for this new use of the drug. The information detailed in the “Gilead’s Truvada as Prevention - Just the Facts” ad illuminates the reasons why it is premature for the U.S. Food & Drug Administration to consider approval of Truvada as PrEP. In the ad, AHF also calls on Gilead “to make certain that their drug when used for prevention does no harm to the individual or the overall public health.”
The ad is scheduled to begin running this week in eight publications aimed at an LGBT (Lesbian, Gay, Bisexual and Transgender) audience: Bay Area Reporter in San Francisco, California; GA Voice in Atlanta, Georgia: Gay City News in New York, New York; South Florida Gay News in Miami/Ft. Lauderdale, Florida; Washington Blade in Washington, D.C.; and Windy City Times in Chicago, Illinois. It will begin running next week in the following publications: Frontiers Magazine in Los Angeles, California and Out Front in Denver, Colorado.
The push for FDA approval of PrEP has increased since November 2010 when the results of the iPrEx study were released. The study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 42%. Since then many have raised concerns about the consequences of widespread use of PrEP and its possible affect on behavior. Letters signed by 618 doctors and advocates have been sent to the FDA and to drug-maker Gilead Sciences urging a halt to pursuit of FDA approval for use of Gilead’s blockbuster AIDS treatment drug Truvada as PrEP. In the letter sent by doctors—spearheaded by AHF—the doctors expressed concern that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections. Lack of real-world data has also been cited as a concern.
The first fact introduced in the “Just the Facts” ad states: “The iPrEx study of MSMs (men who have sex with men) showed that giving Truvada to HIV- men was only 42% effective in reducing HIV new infections, because more than half of the men didn’t take the drug. Among men below 25, only 28% took the medicine. Whereas, HPTN052, a study that treated the positive partner, was 96% effective in protecting the negative partner.”
“It is distressing that PrEP is being hailed as a ‘magic HIV prevention pill’ when its effectiveness is 42%, while the fact that treating people who are HIV-positive—shown to be 96% effective at reducing transmission—is being virtually ignored as a breakthrough prevention method,” said Michael Weinstein, President of AIDS Healthcare Foundation. “When the facts are laid out about Gilead’s Truvada as PrEP, it is clear that pushing prematurely for FDA approval is not in the best interest of patients or the public health. AHF calls on Gilead to fund continued research to answer the important questions raised in this ad. It is Gilead’s responsibility to do so, as it stands to profit so richly if this new use for its blockbuster HIV treatment drug is approved.”
The latest ad campaign is part of a public-awareness raising effort surrounding the need for more studies before the FDA considers approval of Truvada as PrEP. Other ads have included Giving Up on Gay Men, There is no magic pill, Gilead’s Greedy Gamble and Hands Off HIV Prevention.
Among the information that the “Just the Facts” ad details are concerns that the iPrEx study did not resemble a real world situation: “All study subjects were tested monthly and received intensive adherence counseling. In addition, participants were paid to participate and all services were free without co-pays or deductibles.”
The ad continues: “In a survey of 822 men conducted by AHF, 59% of respondents said they would not take the drug if it required a co-pay of $60 a month for lab and doctor visits; 66% said no to the pill once they heard about possible side effects; and 71% said no when they heard about the possibility of future drug resistance.”
AHF expresses concerns shared by many that widespread use of PrEP would have a negative impact on condom use. Referring to the iPrEx study, the ad states: “Study participants self-reported that they continued to use condoms. Self-reporting is highly unreliable, as can be seen by the fact that most study subjects said they were taking their medication, even though blood and hair samples indicated that the majority did not.”
The ad concludes: “All of the questions raised by these studies must be carefully studied and answered prior to the granting of FDA approval of Truvada for PrEP. It is Gilead Sciences’ obligation, as the manufacturer of Truvada, to make certain that their drug when used for prevention does no harm to the individual or the overall public health. AHF supports further research, paid for by Gilead, to answer these questions.” Viewers are then directed to visit www.nomagicpills.org where they have the ability to send an eletter to Gilead CEO John C. Martin asking him to halt any further pursuit of FDA approval of Truvada as PrEP.
Background on Gilead’s Truvada
Truvada, a drug compound that consists of Gilead’s drugs Viread (tenofovir DF) and Emtriva (emtricitabine), is currently FDA-approved for use as part of antiretroviral therapy combinations for individuals already living with HIV or AIDS. FDA-approval for pre-exposure use as a possible form of HIV prevention for those NOT infected with the virus would be a first for the FDA, and a move that AHF and many other AIDS advocates believe would set a dangerous precedent.
In 2010, Truvada was Gilead’s second-best selling product generating over $2.6 billion in revenue. One analyst told Bloomberg that FDA-approval to prescribe the drug for pre-exposure prophylaxis may add $1 billion to Gilead’s sales of Truvada.
To view the ad, please click here or go to: http://www.nomagicpills.org/docs/PrEP_Just_the_Facts.pdf.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 181,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe. www.aidshealth.org.
AHF Associate Director of Communications
Telephone: (323) 308-1834 Mobile: (323) 377-4312
E-Mail: [email protected]
AHF Communications Director
Telephone: (323) 308-1833 Mobile: (323) 791-5526
E-Mail: [email protected]
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