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HIV drug effective, but barriers stop general usage
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For the large, uncountable population in the United States at high risk to contract HIV, scientific innovations in the drug world seem promising. Although these improvements may one day help prevent the spread of HIV, in the short term, the populations that most need the help face the most obstacles to getting it.
The Food and Drug Administration on Monday approved a drug called Truvada to prevent HIV infection. The FDA's endorsement of the drug means it may be used more commonly for high-risk individuals likely to contract HIV. But it will be difficult for those groups to get the drug because of its high price and insurance issues -- not to mention behavioral barriers.
"It's a step forward, not a perfect solution," said John Mellors, a UPMC infectious disease physician who recommended to the FDA that it consider Truvada for prevention. Dr. Mellors and other health care professionals said doctors should prescribe the drug along with advice to use condoms and get tested regularly. But he said Truvada is a necessary new tool in the prevention arsenal: "Condoms have only gotten us so far. The fact is that people don't use them all the time."
In Pittsburgh, certain sub-populations have disproportionately high infection rates, said Guillermo Cole, spokesman for the Allegheny County Health Department. African-Americans accounted for nearly half of infected people in 2010, but are 13 percent of the population. And gay men made up 74 percent of cases between 2000 and 2010. They are less than 10 percent of the population, estimated multiple HIV/AIDS experts.
Truvada, which is actually two pills taken together, has been on the market for HIV treatment since 2004. Like all drugs, Truvada has been used "off label" by physicians, which means doctors can prescribe it for uses that the FDA hasn't explicitly recommended. It's a trusted regimen for treatment. And the results for prevention are promising: A clinical study found the drug was more than 90 percent effective in preventing HIV in both homosexual male populations and in partnerships where one person was infected and the other was not.
But getting this cocktail of prevention efforts -- including the drug, condoms, and information about the disease -- to the populations that need it may be easier said than done.
Mary Gallagher, the manager of the Ryan White HIV Clinic at Allegheny General Hospital, said her staff has not yet decided how to talk about Truvada with patients at risk for contracting HIV. Side effects are a concern: Kidney problems arise rarely but are serious, Dr. Mellors said.
And then there's the cost.
Amy Flood, a spokeswoman for Gilead Sciences, which makes Truvada, said the estimated cost of the drug for both treatment and prevention is $13,900 a year.
"We don't know if there are situations where insurance companies will pay for this," Ms. Gallagher said. She added that most insurance companies cover medications that HIV-positive patients need. But such high prevention costs are new.
For patients who depend on federal assistance -- like much of the high-risk population -- things get tougher. The Ryan White legislation that funds Ms. Gallagher's clinic and the Special Pharmaceutical Benefits Program won't give funds to patients who do not already have HIV. Gilead runs an assistance program for treatment that enrolls 10,000 patients; an estimated 1 million people in the United States have HIV. Ms. Flood said she did not know how many people the program would be able to fund for prevention.
"As drugs become older and older, the price generally goes down," said Benjamin Skinker, a family practice doctor at UPMC Shadyside. "If we can go just another decade, I think we're going to see some improvement on that."
Another barrier is the routine, said Chuck Christen, executive director of the Pittsburgh AIDS Task Force. The pills must be taken once a day, every day. He cited other high-risk populations: the homeless, mentally ill, intravenous drug users and alcohol abusers. Even if they get the medicine, Mr. Christen said, without behavioral changes they may not take it regularly.
"Chronically, severely mentally ill folks may not be making healthy choices about a lot of different things," he said. "Are those individuals going to be thinking and making choices about their use of prevention?"
A drug like Truvada doesn't have a place in most people's daily lives, said Dr. Skinker. He said he sees some high-risk patients and would discuss their options with them, but he said it's impractical to try to immunize an entire population when many people not engaging in risky behavior have low risks of HIV infection.
Yet despite innovations in testing, treatment and prevention methods, limiting the spread of HIV in the highest-risk populations continues to come up against the familiar walls of behavior, lack of infrastructure, stigma, and ignorance -- not to mention the money.
Myron Cohen, an AIDS researcher since the disease emerged 30 years ago, did one of the studies initially suggesting that Truvada could help with prevention. He said in the beginning HIV was "uniformly fatal," but today, people live with the disease. Still, he said "the Holy Grail" of HIV prevention is a vaccine that can reach the entire population.
"Nothing precludes our absolute commitment to getting an HIV vaccine," he said. "Even if it takes 1,000 years."
First Published July 18, 2012 12:00 am
