by Mike Andrew -
SGN Staff Writer
A panel of medical experts recommended on May 10 that the FDA approve Truvada as a PrEP drug - one that can be taken by HIV-negative patients to prevent HIV infection.
The FDA's Antiviral Drugs Advisory Committee voted 19-3 in favor of prescribing Truvada for the highest risk group - HIV-negative men who have sex with multiple male partners.
The FDA is expected to make a final decision by June 15.
Truvada, manufactured by Gilead Sciences, is currently approved as an antiretroviral medication, to control HIV in patients who are HIV-positive.
Because Truvada is already on the market as an antiretroviral, some doctors have prescribed it as a preventive measure. But FDA approval would allow Gilead to market the drug explicitly for that purpose.
According to U.S. Centers for Disease Control and Prevention estimates, some 1.2 million people in the U.S. are living with HIV, and there are about 50,000 new cases each year.
Gilead projects that the target group of healthy people who would be eligible to take Truvada as a PrEP drug is in the tens of thousands. The cost of a PrEP program using Truvada is estimated at $14,000 per year.
Researchers first reported that Truvada could prevent people from contracting HIV in 2010.
The three-year iPrEx study found that daily doses cut the risk of infection in healthy Gay and Bisexual men by 44%, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was HIV-positive and the other was not.
The FDA panel's decision sparked debate among medical professionals and HIV/AIDS activists, with some calling it a 'watershed' moment in the fight against AIDS and others urging the FDA to 'slow down.'
'This brings us closer to a watershed for global HIV prevention efforts,' said Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition, after the vote.
'If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people,' said Ronald Johnson, vice president of AIDS United.
'I fear that men will take the drug inconsistently, have a false sense of security, and increase risky behavior,' said AIDS Healthcare Foundation spokesperson Joey Terrill.
'We need to slow down. I care too much about my community not to speak my concerns.'
Critics of the panel's decision fear Truvada might become a 'party drug' that at-risk individuals would take only when they expected to have sex. Intermittent use of the drug, medical experts said, would not only decrease its effectiveness dramatically, but might contribute to the emergence of drug-resistant strains of HIV.
'Truvada needs to be taken every day, 100% of the time, and my experience as a registered nurse tells me that won't happen,' Karen Haughey, R.N., told the FDA panel.
'In my eight years, not one patient that I've cared for has been 100% adherent.'
Others worried that at-risk individuals might abandon condoms, which are considered a very effective method of preventing HIV infection, for a less effective drug.
AIDS activist Elizabeth Nash told the FDA panel she thought that 44% effectiveness was too low for an intervention that was intended to be preventive.
'It's hard to think of other preventive measures such as birth control or vaccines where 44% relative efficacy is deemed effective,' she said.
Is Truvada right for me?
Local health care providers were cautiously optimistic about the prospects of a new PrEP drug.
Acknowledging that 'PrEP is a complicated option for people,' and that 'it's not a great option for everyone,' Gay City Executive Director Fred Swanson observed that 'the research is pretty clear that it can prevent new infection.'
Gay City has provided HIV testing, counseling, and prevention programs in Seattle since 1995.
A successful PrEP regimen 'first requires access to the medication and then requires a person to actually take the pills as prescribed,' Swanson told SGN.
'[W]e're supportive of the forward momentum on PrEP and hope that more research is done on long-term side effects, access issues, and ways to support people who have chosen this option. While it may not be right for everyone, it could make a huge difference in the lives of people for whom it is a good option.'
Dr. Matt Golden, Director of the Seattle-King County Public Health HIV/STD program, told SGN, 'Look, to have more options is a good thing. Whether this will actually result in fewer infections is not clear.'
Golden agreed with Swanson that 'for some people [Truvada] is probably a good option.'
When asked for what population it would be a desirable option, Golden answered, 'Mostly men who have sex with men - those at high risk - but those who will reliably take the meds every day.'
'The relatively low efficacy - 44% effective - in the iPrEx study is at least partially due to poor adherence to the once-a-day regimen,' he added.
Golden said one important piece of PrEP therapy is being left out of the current controversy.
'If we're going to use these drugs in this way,' he told SGN, 'we need to have the infrastructure to support people in using them as prescribed. We need providers who are committed to counseling, to education, to follow-up - who aren't just going to write a prescription and then that's the end of it.
'This is not in place at present, but it could be put in place,' he added.
'The other big question,' Golden continued, 'is whether insurance will pay for it. Right now it looks like insurance companies will pay, but there's only a small number of people using [Truvada] in this way. If we see large numbers of people asking for the drug, will they still be committed?'
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