FDA Panel Recommends Approval of Drug for HIV Prevention

An FDA advisory panel has recommended Truvada as a pre-exposure prophylaxis for people at risk of contracting HIV.

An FDA advisory panel has recommended Truvada as a pre-exposure prophylaxis for people at risk of contracting HIV.

An advisory panel voted yesterday 19 to 2 (with 1 abstaining) in support of Truvada (emtricitabine/tenofovir disoproxil fumarate) as pre-exposure prophylaxis (PrEP) for HIV-negative partners in serodiscordant couples, and 12 to 8 (with 2 abstaining) for PrEP use in other individuals at risk for acquiring HIV through sexual activity, according to a Gilead press release. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of June 15, 2012.

Truvada is already approved by the FDA for the treatment of HIV infection, but not for its prevention—and this proposed indication is proving to be extremely controversial.

Some advocacy groups argue the drug would encourage risky behavior and its approval would undermine other prevention methods such as condom use. The AIDS Healthcare Foundation is urging the FDA to reject the drug application, and have spearheaded a campaign called No Magic Pills (http://www.nomagicpills.org/) to protest the endorsement.

The group has also cited concerns about the side effects of Truvada on otherwise healthy people, the estimated drug costs of approximately $14,000 per year, and the fact that there is no way to ensure adherence. The group believes that if healthy people taking the drug do not stay adherent, there would be little or no preventive effect, and individuals could be at higher risk for contracting the virus. If the individual were to contract the virus, drug resistance and drug-resistant strains of HIV could develop.

The AIDS Healthcare Foundation also contends that if Truvada is approved as a preventive tool, individuals taking the drug should be required to undergo regular HIV testing to ensure its efficacy as a prophylactic. “This irresponsible step by the FDA to move forward with approval of the use of Truvada as an HIV prevention pill without even requiring regular HIV testing will surely go down in the annals of FDA history as one of its most shameful moments,” said Michael Weinstein, president of AIDS Healthcare Foundation.

Lastly, The AIDS Healthcare Foundation is concerned that the trials submitted by Gilead in support of the new indication do not contain strong enough evidence of efficacy and are also not reflective of real-life situations. The iPrex Trial showed a 44% effectiveness rate in preventing HIV transmission, which the group believes is too low, and patients in the trial received regular counseling and testing.

Despite the criticism voiced by some AIDS activists, there are other groups that support the agency’s decision to approve Gilead’s application. Sixteen advocacy groups have written to the FDA in support of the use of Truvada as a PrEP, including AVAC, The National Minority AIDS Council, and AIDS Foundation of Chicago. These groups note that the Partners PrEP trial reduced HIV infections by 73%, and argue that this and other studies demonstrate that PrEP is safe, with minimal side effects and no significant risk of drug resistance.

AVAC’s website dedicated to the cause, www.prepwatch.com, points out that the effectiveness of Truvada as a PrEP depends greatly on individuals’ adherence to the PrEP regimen, and when used as prescribed, could be a life saving intervention for many men and women. In written comments to the FDA, AVAC pointed out that the use of PrEP would give healthy individuals a means to protect their health. “When men or women lack control over sexual relationships or knowledge of a partner’s HIV status, where they are in HIV serodiscordant relationships (including relationships where they wish to conceive), or when they are unable to use standard prevention, including OTC male and female condom devices, correctly or consistently, daily oral PrEP with TDF/FTC can provide additional protection from acquiring HIV.”

The groups in support of the use of PrEP agree that the launch of this type of drug has to be monitored closely to ensure appropriate use. “There needs to be an FDA requirement to Gilead about a REMS as part of any approval,” Mitchell Warren, executive director at AVAC, told Pharmalot. “And as part of approval, the FDA can insist on post-marketing surveillance and registers, which can’t be done when usage is off-label.”