AHF unveils new national advertising campaign about AIDS drugs

AIDS Healthcare Foundation (AHF) today unveiled a new national advertising campaign headlined, "There Is No Magic Pill," an advocacy and awareness campaign to educate and prompt discussion among gay men and others regarding Gilead Sciences and its likely plans to seek Food and Drug Administration (FDA) approval for use of its blockbuster AIDS drug Truvada as a form a 'pre-exposure prophylaxis' (PrEP) to prevent HIV transmission. 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 other AIDS advocates believe would set a dangerous precedent.

Gilead's likely pursuit of FDA approval for expanding the use of its best selling $35-per-day AIDS drug to include use as a form of HIV prevention comes following a recent and widely reported study of 2,500 high risk gay men using Truvada which showed a 44% effectiveness rate in preventing HIV transmission.

"First and foremost, Truvada lacks effectiveness in preventing the transmission of HIV. A rate of 44% preventive effectiveness is much too low to merit FDA approval. If we were talking about protecting the general population with a treatment that was only 44% effective, would we be celebrating?" said AHF President Michael Weinstein. "Secondly, at this time, real-world information is lacking. The participants who received a benefit from Truvada took—or were instructed to take—the drug daily, were intensively counseled monthly and were tested frequently for sexual infections. This is in no way representative of the real world."

AHF's "There is No Magic Pill" ads will begin running this week starting Wednesday, March 9^th, in a dozen gay media outlets nationwide, including Frontiers Newsmagazine (Los Angeles), South Florida Gay News (Miami), Windy City Times (Chicago), The Washington Blade (DC), Bay Area Reporter (SF), Echo Magazine (Phoenix), Out Front (Denver), GA Voice (Atlanta), Gay City News (NY), OutSmart (Houston), Dallas Voice and Seattle Gay News. The ads note that "…such modest [study] results are insufficient to support FDA approval of Truvada as an HIV prevention tool for gay men," adding that "It is logical to assume that if patients are taking a drug that they believe will prevent them from becoming HIV-positive, they will be more lax in their use of condoms." The ads also encourage readers to send an e-letter to John C. Martin, Chairman and CEO of Gilead Sciences, Inc., expressing their concerns about Gilead's intentions to promote Truvada as a form of HIV prevention.

"I am deeply concerned about the possibility of increased risk that could come with the use of Truvada as PrEP. How likely are uninfected men to take pills every day for the rest of their lives to prevent a possible HIV infection?" said Homayoon Khanlou, M.D., AHF's Chief of Medicine/U.S. "The consequences of patients who take Truvada haphazardly are that they will become infected, develop drug resistance, and spread drug-resistant virus to others. This is a very serious matter that could significantly set back efforts to fight the epidemic."

Following is the full text of AHF's 'There is No Magic Pill' ad, followed by the text of the e-letter readers of the ad can send to Gilead's John C. Martin:

'There Is No Magic Pill'

AIDS Healthcare Foundation takes the matter of HIV prevention very seriously. We are concerned about the implications of a recent study of pre-exposure prophylaxis (PrEP) using Gilead Sciences, Inc.'s drug Truvada using 2,500 gay men and showing a 44% effectiveness rate in preventing HIV transmission.

Such modest results are insufficient to support FDA approval of Truvada as an HIV prevention tool for gay men because:

• Lack of effectiveness - 44% preventive effectiveness is much too low to merit approval
• Real world information is lacking - The 44% who received a benefit from Truvada were intensively counseled monthly and tested frequently for sexual infections. This is in no way representative of the real world.
• Increased risk - How likely are uninfected men to take pills every day for the rest of their lives to prevent a possible HIV infection? The consequences of patients who take Truvada haphazardly are that they will become infected, develop drug resistance, and spread drug-resistant virus to others.
• Potential decrease on condom-use - It is logical to assume that if patients are taking a drug that they believe will prevent them from becoming HIV-positive, they will be more lax in their use of condoms. There may be men who are currently using condoms 100% of the time who will stop using them because of a false sense of protection from taking PrEP.
• Condoms work - Prevention using Truvada has not been shown to be as effective as condom-use.

AHF supports continued research on HIV prevention, but opposes quick fixes that run the risk of contributing to the spread of HIV and drug-resistant viruses. Our community must consider these issues if we are going to offer up hundreds of thousands of gay men for this totally misguided experiment.

Please join AHF in expressing concern about this ineffective HIV prevention approach, by sending the e-letter below to Chairman and CEO of Gilead Sciences, Inc. John C. Martin.

Let your voice be heard!

Sincerely,
AIDS Healthcare Foundation

__________________________________________________________________________________________

John C. Martin, Chairman and CEO
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404

Dear Mr. Martin,

I am concerned about possible approval by the U.S. Food & Drug Administration (FDA) of Gilead Sciences, Inc.'s drug Truvada as a pre-exposure prophylaxis (PrEP) to prevent HIV transmission.

The results of a recent study using Truvada as PrEP, involving 2,500 gay men and showing a 44% effectiveness rate in preventing HIV are insufficient to support FDA approval of Truvada as an HIV prevention tool for gay men for numerous reasons.

First and foremost, the drug lacks effectiveness in preventing the transmission of HIV. A rate of 44% preventive effectiveness is much too low to merit FDA approval. If we were talking about protecting the general population with a treatment that was only 44% effective, would we be celebrating?

Secondly, at this time, real-world information is lacking. The 44% who were shown to have received a benefit from Truvada during the study were intensively counseled monthly and tested frequently for sexual infections. This is in no way representative of the real world.

I am deeply concerned about the possibility of increased risk that could come with the use of Truvada as PrEP. How likely are uninfected men to take pills every day for the rest of their lives to prevent a possible HIV infection? The consequences of patients who take Truvada haphazardly are that they will become infected, develop drug resistance, and spread drug-resistant virus to others. This is a very serious matter that could significantly set back efforts to fight the epidemic.

There is the very real potential that there will be a decrease in condom usage due to a false sense of protection from taking PrEP. If patients are taking a drug that they believe will prevent them from becoming HIV-positive, they may be more lax in their use of condoms. There may be men who are currently using condoms 100% of the time who will stop using them. Prevention using Truvada has not been shown to be as effective as condom-use.

Finally, there is the question of who will be for this $35-a-day pill. Currently, there are more than 6,450 low-income Americans who are living with HIV/AIDS who are on waiting lists to receive lifesaving medications from state AIDS programs because funding is lacking.

I join AIDS Healthcare Foundation in supporting continued research on HIV prevention, but opposing quick fixes that run the risk of contributing to the spread of HIV and drug-resistant viruses. Our community must consider these issues if we are going to offer up hundreds of thousands of gay men for this totally misguided experiment.

Please halt any further pursuit of FDA approval for Truvada as PrEP until further study is completed.

Sincerely,

(name of letter sender)

__________________________________________________________________________________________

Separately, during the recent Conference on Retroviruses and Opportunistic Infections (CROI), a widely followed medical conference attended by many HIV/HIDS medical providers and researchers, Bloomberg News released a news article headlined, "Gilead's $35 HIV Prevention Pill Fails to Win Doctor Support." The Feb. 28^th article noted, "…doctors say they're wary about giving healthy people a $12,000-a-year medicine that has side effects including nausea and kidney damage, and may not be used as regularly as needed. They also say they're not often asked to make the drug available for that use." The article noted that Gilead nevertheless, "plans to file for U.S. approval as a preventative in the first half of 2011, said Chief Executive Officer John C. Martin in the company's Jan. 25 earnings call."

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.