There are two medical milestones to applaud in the detection and prevention of the decades-long HIV epidemic now that the U.S. Food and Drug Administration has approved Truvada.
The revolutionary in-home test kit came early in July, giving those in doubt and at risk of the virus the ability to test themselves discreetly. Then Monday, the FDA approved Truvada, the first pill to reduce the risk of HIV infection after sexual exposure, but this isn’t a foolproof – or cheap – way to avoid the virus.
It has been approved and used for treating patients with HIV since 2004, but two large clinical trials have shown the drug can also be used to prevent the virus. The first was for “men who have sex with men” and, when taken as prescribed, the risk of infection was reduced by 42 percent. The second involved heterosexual couples with one infected partner and the risk dropped to 75 percent with the regular use of condoms.
Truvada is not a vaccine that prevents HIV, nor is it a cure. Those prescribed it are advised not to see it as a license to practice unsafe sex but many fear that’s what some will do. The FDA approval comes with a plan that includes regular testing every three months and education about how it works, when it should be taken, and what the risks are.
Manufacturer Gilead Sciences estimates that the annual cost of the medication for the patient will be about $13,900. Since the drug costs more than some cars, the approval of its preventative qualities gives insurance companies the ability and opportunity to cover those who are not diagnosed with HIV. Many major insurance companies, such as Blue Cross Blue Shield, should seriously consider covering the drug. Smaller companies like Harvard Pilgrim Health Care immediately responded to the approval of Truvada by adding it to the list of HIV treatments already covered, reducing the cost to about $25 or $30 a month for the patient, or $360 a year.
There are dissenters. The AIDS Healthcare Foundation, the nation’s largest education and advocacy group, tore the FDA apart. Foundation president Michael Weinstein called the decision a “catastrophe” in the fight against HIV according to the Los Angeles Times. He’s concerned the drug won’t be used properly and that the FDA doesn’t have enough information to release it to the public.
Still, most health officials and advocacy groups praise the decision, saying it can save lives. James Loduca, vice president of public affairs at the San Francisco AIDS foundation, says the approval of Truvada as a preventative medication is a “watershed moment” in the long battle against HIV.
One pill isn’t going to eradicate HIV overnight, but any new treatments or methods that could work need to be tried. The infection rate – and death rate – remain high.
Condoms are still needed, as is more widespread education about HIV. Still, something as simple as a daily pill could drastically change the statistics and the way we look at HIV.
Pictured above: Dr. Lisa Sterman holds Truvada pills at her office in San Francisco. The pill, already used to treat people with HIV, just received FDA approval to help prevent the virus from infecting healthy people. (May 10, 2012, photo credit: AP)
@ Newsday — Long Island, N.Y.