FDA approves HIV-prevention drug
  • Wed, 07/18/2012 - 1:45pm

Adults who do not have HIV but are at high risk of infection are now able to take an FDA-approved medication to decrease the risk of the virus being sexually transmitted.

According to WebMD, “Human immunodeficiency virus, or HIV, is the virus that causes acquired immune deficiency syndrome (AIDS). The virus weakens a person's ability to fight infections and cancer.”

Truvada approval

Monday, the FDA approved Truvada, a drug that reduces the risk of sexually transmitted HIV-1 in people who are at a higher threat of acquiring the infection. The FDA advises that this drug be used with safe sex practices.

According to the FDA, studies showed the drug reduced the risk of HIV:

  • by 42 percent in a National Institutes of Health study of about 2,500 HIV-negative homosexual and bisexual men and transgender women, and
  • by 75 percent in a University of Washington study of about 4,800 heterosexual couples in which one partner was HIV-positive and the other was HIV-negative.

Risk Evaluation and Mitigation Strategy

The FDA approved Truvada with a Risk Evaluation and Mitigation Strategy (REMS) in order to best inform prescribers and health professionals about the drug. 

According to the FDA, REMS goals are:

  • to help health care professionals and possible users of Truvada to be aware of the need to take the medication at a routine time each day;
  • to convey the significance of frequent HIV testing; and
  • the need to practice safe sex while taking the drug to decrease the risk of HIV infection.

A voluntary program will provide prescribers, health professionals and possible Truvada users with medication and safety guides regarding proper use, risks, and important information.

Factors that need to be considered prior to taking Truvada

Patients and their health care professionals must consider a myriad of risk factors prior to Truvada being prescribed. According to the FDA:

  • patients must be tested to ensure that they are not HIV-positive;
  • flu-like symptoms are a red flag because they could be signs of early HIV infection, even if test results are negative (antibodies that show HIV infection do not appear in the blood immediately);
  • there are safety concerns regarding Truvada’s effect on the bones and kidneys. While results in studies were mild and reversible by ceasing taking the drug, patients with a history of bone or kidney problems should undergo regular monitoring; and
  • patients should also be tested for hepatitis B. Infections of hepatitis B have been identified in patients who have both HIV-1 and hepatitis B infections when no longer using Truvada.

 

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About the Contributor

Kaitlin Gill
Cleveland
I report on news regarding product safety concerns for individuals and families.

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