The AIDS Healthcare Foundation (AHF) is claiming that the recent campaign by Gilead Sciences Inc. to obtain approval by the FDA for Truvada as PrEP (pre-exposure prophylaxis) has led to a "black market" for the drug in Florida. FDA-approval for use of Truvada-Gilead's blockbuster HIV/AIDS treatment drug-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.
The State of Florida Agency for Health Care Administration (AHCA) recently sent out an alert to Florida health care providers and pharmacies notifying them of stricter requirements for incoming pharmacy claims for HIV/AIDS medications. AHCA informed AHF that the change is in response to an increase in demand for Truvada for use as a prevention pill by HIV-negative individuals and the fraudulent prescriptions that are appearing as a result.
AHCA's notice stated: "Effective August 12, 2011, all incoming pharmacy claims for HIV/AIDS related anti-retroviral medications will require specific HIV/AIDS diagnosis codes in the medical claims history. Recipients who are being treated for Hepatitis B with a medication in this class will need to have the appropriate Hep B diagnosis code in the medical claims history. An appropriate diagnosis code must be found within the past 365 days of the date of the pharmacy claim submission. HIV/AIDS-related anti-retroviral medications generally remain included on the preferred drug list by statutory exemption. However, the Agency has an obligation to ensure appropriate utilization of medications. Therefore, pharmacy claims for recipients who lack the appropriate HIV/AIDS and/or Hepatitis B diagnosis code(s) in the medical claims file will deny at point-of-sale. Providers are advised to update recipient diagnoses codes when billing for office visits or other related services." "The fact that a 'black market' has cropped up in response to Gilead's campaign to obtain FDA approval for Truvada shows what a dangerous game Gilead is playing," said Michael Weinstein, President of AIDS Healthcare Foundation. "The increased demand that has been created by Gilead's reckless push to have Truvada approved prematurely for this new use is only a preview of what is to come. If the company succeeds, Gilead will have free reign to market Truvada to HIV-negative individuals. This will open up a demand for the drug that will inevitably create an even bigger 'black market,' ultimately resulting in increased infections, viral resistance and a huge step backwards in efforts to fight the epidemic." The campaign for FDA approval of Truvada as an HIV prevention pill has ramped up since the iPrEx study. The study of 2,499 HIV-negative high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection in MSMs by 44%.
Subsequent studies since have shown the drug to be even less effective than in the iPrEx study, due largely to poor adherence.
Recently, 618 doctors and advocates sent or signed letters to the FDA and to Gilead detailing a number of concerns raised by the iPrex study. Ultimately, the doctors were concerned that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections.
Additional concerns raised about the possible FDA approval of Truvada as PrEP include the fact that: PrEP is only partially effective at preventing the spread of HIV; the iPrEx trial demonstrated limited efficacy despite ideal study conditions that cannot be replicated in the real world; taking PrEP after becoming infected with HIV increases the risk of developing drug resistance, and; the use of PrEP carries significant risk of unsafe behavior that has not been thoroughly examined in any trial.
AHF has been spearheading a campaign against the premature FDA-approval of Truvada as PrEP under the name "There is no magic pill."