(Reuters) – U.S. regulators have delayed until mid-September a decision on whether to approve Gilead Sciences’ HIV pill Truvada for preventing the infection, citing the need to review the company’s risk mitigation plan, Gilead said on Friday.
An advisory panel to the Food and Drug Administration last month recommended that the agency approve Truvada as a treatment for preventing HIV infection among people at risk for contracting AIDS, including homosexual and bisexual men.
Opponents of the move have argued that the drug has shown to be only partially effective in preventing transmission of the virus and protection is dependent on taking a pill every day – a regimen which healthy people may not adhere to.
During the advisory panel last month, members expressed concern about prospective FDA guidelines that call for education and training for prescribing physicians but avoid basic restrictions on the availability of the treatment.
Some said drug recipients should be required to undergo regular HIV screening to prevent them from becoming HIV positive while taking the treatment and unknowingly passing drug-resistant HIV strains to their sexual partners.
Truvada combines Gilead’s HIV drugs Emtriva, also known as emtricitabine, with Viread, or tenofovir. It already has FDA approval to treat people infected with HIV.
Studies showed Truvada to be more than 90% effective at preventing HIV infection among test subjects who took the drug as prescribed, but only 44% effective among test populations with intermittent use.
“Our earlier survey of high-volume HIV specialists indicated that difficulties related to cost, resistance, and compliance will make broad uptake of Truvada PrEP challenging, which in totality suggests limited commercial impact in the prevention setting,” UBS analyst Matthew Roden said in a research note.
The term “PrEP” is shorthand for pre-exposure prophylaxis.
The AIDS Healthcare Foundation estimated the cost of Truvada at $14,000 a year.
The new deadline for a decision from the FDA is Sept. 14. If approved, Truvada would be the first drug for use as a preventive treatment for HIV in the United States.