An advocacy group concerned about the costs and possible health problems related to a drug being considered to help stop the spread of HIV infection to healthy people has asked U.S. regulators to delay or deny approval.
Los Angeles-based AIDS Healthcare Foundation (AHF) has petitioned the Food and Drug Administration on the grounds that studies have shown that the pill, Truvada, made by Gilead Sciences, is only partially effective in preventing transmission. The drug is already used to treat people who have human immunodeficiency virus.
AHF said Truvada's efficacy was affected by trial participants not faithfully taking Truvada.
"Any approach that relies on adherence for people who don't have a disease is going to fail," AHF President Michael Weinstein said at a press conference on Thursday.
Officials at Gilead did not immediately respond to a request for comment.
A decision by the FDA, which granted an expedited review of the company's application, is expected by June 15.
AHF estimates the cost of Truvada for preventing transmission of HIV at $14,000 a year.
Gilead is seeking permission for Truvada to be used as a form of "pre-exposure prophylaxis," often shortened to PrEP.
"People who take PrEP even haphazardly will consider themselves protected" and could well let up on other safe-sex measures, such as condoms, said AHF General Counsel Tom Myers.
Truvada consists of Gilead's HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir. The AHF said it is associated with kidney problems and that use of Truvada by healthy people could cause them to become resistant to the drug, complicating treatment if they contract HIV.
"Expanding the use of antiretrovirals to include pre-exposure prophylaxis will increase the risk of resistance, which is already a serious problem," British medical journal Lancet said in an editorial last year. "HIV is a rapidly evolving virus and development of resistance creates the need for ever-changing regimens of drugs in various classes."
An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention. (Reporting By Deena Beasley)