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Moving Forward on FDA Review of HIV Prevention Drugs

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David Ernesto Munar, president and CEO of the AIDS Foundation of Chicago, writes in The Huffington Post about the efforts by several AIDS advocacy organizations to encourage the Food and Drug Administration (FDA) to expedite its review of a medication that prevents HIV infection. Truvada, manufactured by Gilead Sciences, has emerged as a promising drug for a new HIV prevention strategy called pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM).

Mr. Munar writes:

"We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men. Delaying FDA review of PrEP for gay and bi men is bad health policy that could result in many preventable new HIV-infections."

Although the preliminary evidence supporting the use of Truvada is highly encouraging, some AIDS advocates have been critical of PrEP. Over the last year, the AIDS Healthcare Foundation (AHF) has launched a media campaign against FDA review of Truvada for use as a PrEP drug. AHF contends, "Truvada lacks effectiveness in preventing the transmission of HIV. A rate of 44 percent preventive effectiveness is much too low to merit FDA approval." AHF also claims, "prevention using [PrEP] has not been shown to be as effective as condom-use in [MSM]." Additionally, AHF is concerned about adherence to PrEP: "How likely are uninfected men to take pills every day for the rest of their lives to prevent a possible HIV infection?"

AHF's media campaign against FDA review of PrEP is myopic, blinded by its determination to derail a promising new medication. AHF's concerns regarding Truvada's effectiveness are subject to interpretation and inexcusably fail to mention certain encouraging data.

In a landmark study published in The New England Journal of Medicine, daily and consistent use of PrEP prevented new HIV infections by 92 percent compared to placebo in MSM. All trial participants received a comprehensive package of monthly prevention services including risk-reduction counseling and condoms. Given the higher rate of HIV infection in the placebo arm, the data demonstrates the difficulty in averting new HIV infections in MSM by traditional prevention interventions alone such as condoms. Concerns over medication adherence are legitimate as is with any new drug. However, given the newly-established benefits of Truvada, it could actually motivate patients to adhere to the prescribed regimen better than in a randomized control trial where patients do not know if they are taking the active drug over placebo.

Despite the encouraging data on Truvada, the FDA approval process must address the issue of pharmacological safety, including the emergence of HIV drug resistance. The results of upcoming PrEP studies, including one by the National Institutes of Health, will address these important concerns.

The health care community needs every available tool to prevent new HIV infections. It may very well be that PrEP for MSM is not the most effective broad scale public health intervention, as AHF claims, but nevertheless stymieing the FDA review process is not a productive agenda. FDA review/approval would ensure appropriate use by physicians and patients as well as mitigate the ambiguities of "off-label" use.

As Mr. Munar writes:

"FDA's approval of PrEP is imperative. The drugs used in PrEP were approved for treatment years ago, but FDA approval of their use for prevention -- in any population -- is essential to promoting equitable access, appropriate use and insurance reimbursement."

AIDS activists must aspire for responsible advocacy. I encourage AHF to adopt a more pragmatic strategy regarding FDA review of PrEP. AHF should follow the lead of other AIDS organizations and support the FDA inquiry into the safety, efficacy and applicability of PrEP without obstructing the review process. Let the data speak for itself.

Anand Reddi is at the University of Colorado School of Medicine and served on the board of directors of the AIDS Healthcare Foundation from 2009 to 2011.

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