LOS ANGELES (July 16, 2015) — On the third anniversary of the FDA approval of the use of the HIV anti-retroviral medication, Truvada (tenofovir DF + emtricitabine), for pre-exposure prophylaxis (PrEP), AIDS Healthcare Foundation (AHF) renewed its call for the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) to reevaluate PrEP over concerns about patient adherence, the efficacy and overall wisdom of deploying PrEP as a wide-scale public health prevention strategy. In July 2014, the CDC recommended that 500,000 high-risk Americans go on PrEP—many in high-risk populations that PrEP studies often showed had the most difficulty adhering to the regimen.
The FDA approved Gilead’s Supplemental New Drug application (SNDa) for use of its AIDS treatment Truvada for HIV prevention on July 16, 2012, after hosting an initial public hearing in May 2012 during which the FDA panel—including more than a dozen physicians—considered approving the medication’s new use without even requiring a baseline negative HIV test in individuals starting on PrEP.
“Right now 70% of the 1.2 million HIV-positive people in the United States are either not in care or do not have their viral load under control. Should we abandon our efforts to ensure the millions of Americans currently living with HIV get the care they need?” said AHF President Michael Weinstein. “The real call to action should be to direct the needed resources and attention towards identifying the thousands of people who are infected with HIV and yet are unaware of their status and in connecting HIV-positive people to proper medical care and treatment to suppress the virus and prevent new infections. Despite the hype, it seems that PrEP has not really caught on with providers or patients. We have to question these government agencies wisdom of the mass administration of PrEP.”
Although the FDA approved Truvada for PrEP three years ago, the following facts remain:
- PrEP has been available for three years, but the number of prescriptions in the United States is incredibly low. According to one report, the number of prescriptions in the United States is under 6,000. Even if the number is tripled, the number of published prescriptions is still a fraction of the 500,000 recommended by the CDC.
- There are nearly 20 million new STDs every year in the United States. PrEP will not prevent any of them, including the new cases of ocular syphilis.
- Despite the hype, many medical providers have concerns about prescribing PrEP. According to an April 2015 survey of HIV doctors by the American Academy of HIV Medicine (AAHIVM), the vast majority was worried about patient adherence to this once-a-day pill.
- At $1,500 for a one-month supply, PrEP is an expensive drug. Condoms on the other hand cost just a few cents and prevent far more than just HIV.