Gilead's (GILD) Truvada Approved to Reduce HIV-1 in Adults with High-Risk of Becoming Infected


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The Food and Drug Administration (FDA) has approved the new use of Gilead Sciences' (Nasdaq: GILD) Truvada—to be taken once daily and used in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. (HIV-1 is the most common form of HIV.)

In two large clinical trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection:
  • by 42 percent in a study sponsored by the National Institutes of Health (NIH) of about 2,500 HIV-negative gay and bisexual men and transgender women, and

  • by 75 percent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.
Truvada, produced by Gilead Sciences Inc., is a combination of two antiretroviral medications used to treat HIV—tenofovir disoproxil fumarate and emtricitabine. When Truvada is used as a treatment for HIV rather than a preventive, the patient also takes a third drug, Birnkrant says. Which of the other approved HIV drugs is added depends on the needs of the patient.

Before this medicine is prescribed, Birnkrant says there are several factors that a person and his or her health care professional must consider in weighing the risk versus the benefit:
  • The person must be tested to ensure that he or she is HIV negative.

  • Flu-like symptoms—such as fever or muscle aches—are a red flag because they could indicate the presence of early, acute HIV infection, even if test results are negative. There is a window of four to five weeks with some tests, and up to three months with others, in which the antibodies that indicate HIV infection do not appear in the blood.

  • Safety concerns tied to Truvada have to do with its effect on the bones and kidneys. While effects observed in clinical trials were mild and reversible with discontinuation of the medication, people with a history of bone or kidney ailments should be regularly monitored to ensure their continued health.

  • It is recommended that the person also be tested for hepatitis B because worsening of hepatitis B infections has been reported in those who have both HIV-1 and hepatitis B when treatment with Truvada was stopped.


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