New AHF ad campaign warns preventive use of Gilead AIDS drug Truvada is premature

The USA-based AIDS Healthcare Foundation (AHF) this week unveiled a new print ad that lays out data on the use of Gilead Sciences’ (Nasdaq: GILD) blockbuster HIV treatment drug Truvada (tenofovir and emtricitabine), as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the US Food and Drug Administration for this new use of the drug, which last year generated sales of $2.6 billion for the drugmaker.

The information detailed in the “Gilead’s Truvada as Prevention - Just the Facts” ad illuminates the reasons why it is premature for the FDA 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. 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.

The push for FDA approval of PrEP has increased since late last year when the results of the iPrEx study were released (The Pharma Letter November 24, 2010). 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, says AHF, 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 Gilead Sciences urging a halt to pursuit of FDA approval for use of 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.