On Monday, July 16, the Food and Drug Administration (FDA) announced approval of the use of Truvada to help prevent HIV infection in uninfected, high-risk people.
According to Dr. Debra Birnkrant, the director of the division of antiviral products at the FDA’s Center for Drug Evaluation and Research, the pill is taken daily for pre-exposure prophylaxis, or PReP, in combination with safer sex practices, to reduce the risk of sexually acquired HIV infection in at-risk adults.Truvada is the first drug approved for PReP in combination with safer sex practices to reduce the risk of sexually acquired HIV infection.
Birnkrant stresses that Truvada alone should not be used to prevent HIV infection. Studies have shown that condom use increased in people using Truvada while the rate of other sexually transmitted diseases either remained stable or also decreased.
Truvada is on track to help achieve the federal government’s National HIV/AIDS Strategy goal of reducing the number of new infections in the United States by 25 percent by 2015.
Truvada has been available since 2004 to treat those already infected with HIV. However, experts were skeptical and believed there were potential drawbacks to the medication. Truvada is combined of tenofovir (Viread) and emtricitabine (Emtrvia) – two HIV-fighting drugs. Although doctors can already prescribe the mediation to people trying to avoid HIV infection, some critics believe that it’s too early to officially allow it to be promoted for that use.
Truvada works to combat HIV from replicating in the body’s cells. Dr. Kenneth Mayer, an AIDS specialist and medical research director of the Fenway Institute at Fenway Health in Boston explained that in someone who is not yet infected but is exposed to HIV, the drug may prevent the virus from reproducing even if it has already invaded cells.
Side effects of Truvada can include gastrointestinal, bone and kidney problems. The FDA approval comes with a REMS (Risk Evaluation and Mitigation Strategy) plan, which includes regular testing, health care professional education, risk-mitigating measures, voluntary training and education for potential prescribers and a medication guide and safety brochure.
For those wanting to try Truvada, they should be tested for hepatitis B and should be aware that the drug is costly, with prices in the United States ranging from $26 a day, or $10,000 a year.
BY DENNY PATTERSON