'Miracle drug' for HIV or dangerous hype?By Charlene Muhammad -National Correspondent- | Last updated: Jan 23, 2012 - 11:41:10 AM
Anti-HIV pill will cause confusion, not prevention, warn worried advocates
She knew exactly what drug they were talking about. She also felt fears about the danger of misinformation about a proposed drug, Once Daily Truvada, were coming true.
Truvada, a combination of drugs used to treat HIV/IADS, is manufactured by Gilead Sciences and currently used to treat people infected with HIV at a cost of $13,000 per year.
Its maker has asked the U.S. Food and Drug Administration to approve combining the individual drugs into a single pill—Once Daily Truvada—and allowing use of the pill to prevent HIV in people who are not infected.
There are too many unanswered questions about using Once Daily Truvada for prevention, said Ms. Davis, an assistant professor in the College of Medicine and College of Science and Health at Charles R. Drew University of Medicine and Science in Los Angeles.
Truvada was approved by the FDA in 2004 for use in combination with other medicines to treat HIV infection in adults, said Cara Miller, a spokesperson for Gilead Sciences. Although Truvada is not the only drug regime that has been studied for prevention use, “it is the only drug that has been submitted to the FDA for consideration for a PrEP indication,” she told The Final Call in an e-mail statement. PrEP stands for drugs used to prevent HIV.
Black AIDS experts worry about how the one-pill approach will affect Blacks, if hundreds of thousands of HIV-negative people take the medication. They say its side effects could be dangerous for people who aren’t sick. They also fear funding could be taken from treating those who are infected and used in an unproven and dangerous prevention scheme.
Advocates concede a few targeted Centers for Disease Control studies showed some positives, but how the drug would impact vulnerable people and the general population is unknown.
Gilead’s first Once Daily Truvada trial, in concert with the CDC, was among 2,500 high-risk HIV-negative, adult men who have sex with men, in the U.S., Africa, Asia, and South America. The drug reduced risk of acquiring HIV overall by 44 percent and by 73 percent among those who took the pill consistently (at least 90 percent of the days), according to a company news release.
Another CDC study of heterosexual women in three African countries using the daily pill was ended because women given the drug became infected at the same rate as women who weren’t, Ms. Davis said. Drug effectiveness rates must be 90 percent or greater for drugs to be cleared for use in general U.S. populations, she added.
“There are multiple concerns. Number one, who’s going to pay for it? Number two, you will have groups of people who think, because they’re on this pill and it has this protective factor, that they don’t have to practice safer sex anymore ... Because they’re on this medication, they’ll have this false sense of security,” Ms. Davis said.
Several ongoing studies will reveal more about Once Daily Truvada, including its impact on different populations and whether it really needs to be taken every day, every other day, or just right around the time one is exposed to HIV, said Jennifer Sayles, Office of AIDS medical director for the Los Angeles County Department of Public Health.
“We really don’t have any answers to those questions at this point in time. But when people are considering prescribing PrEP for a really high risk person, the only thing that has been shown to be effective is Truvada, that particular medication, and in men who have sex with men.
“So there just really isn’t data for anything else and that’s important to remember,” Ms. Sayles told The Final Call.
Ms. Sayles said the drug costs so much money, it could create disparities because so many people would not be able to afford it. Even with insurance, the drug would be out of reach for many people, she said.
There were approximately 50,000 new HIV infections in the U.S. each year between 2006 and 2009, a number that was relatively stable, according to the Centers for Disease Control.
The CDC believes daily Truvada could help with the HIV/AIDS crisis in the U.S., but more testing is needed.
Jennifer Hovarth, a CDC spokesperson, said until there is widespread testing of men and women in the United States, there are serious unknowns about whether daily Truvada can prevent HIV here.
Whether the pill could help curb the HIV/AIDS epidemic in the U.S. also depends on answers to questions like who would have access to daily Truvada, would patients take the pill properly and how would the pill be used with other prevention methods, she explained.
“With limited resources to combat the HIV epidemic, we do need to carefully consider how we can most effectively reduce the human and economic toll of HIV and we have a moral imperative to treat those who are already ill and to also prevent new infections,” Ms. Hovarth said.
There are people who still need treatment but treatment alone won’t reduce the epidemic, she argued.
Tony Wafford, national health and wellness director for the National Action Network, has heard the questions about One Daily Truvada.
He is sure of one thing: People should not mistake it for a miracle drug.
Though some people are supporting it, the CDC is not supporting it as a first-line defense against HIV, he pointed out.
“If a person takes (Once Daily Truvada) everyday very diligently, they are 60-70 percent less likely to be infected or infect somebody else ... The scary part to me is, it is being perceived that something magical will happen but there’s not enough data, and the people who are at greatest risk can’t even afford it,” Mr. Wafford told The Final Call.
“My biggest argument and what we can’t get around is medication is never going to replace morality ... We’ve got to come to some hard terms about how we should behave and govern ourselves with each other,” Mr. Wafford continued.
The lack of information Blacks have about daily Truvada comes from the absence of Black experts in discussions, Mr. Wafford added.
“Most of these decisions are made above most of our pay grades and made before they get to even our most prominent medical representatives,” he said.
Mr. Wafford feels the motive for pushing the single pill is money, especially for insurance companies that will underwrite treatments.
“They can make a ton but what we can’t lose sight of is it ain’t new. Folks been talking about it a long time and my concern is it enabling people to engage in high risk activity that they normally wouldn’t or to continue their risky behavior,” he said.