FDA Approves Drug to Prevent HIV Infection
The US Food and Drug Administration (FDA) todayapproved tenofovir disoproxil fumarate/emtricitabine (Truvada, Gilead) to reduce the risk for HIV infection in uninfected individuals at high risk of catching the virus, possibly through sexual activity. This antiretroviral agent is now the first drug approved for prophylactic use.
Patients prescribed tenofovir disoproxil fumarate/emtricitabine for preexposure prophylaxis (PrEP) are to take the drug daily as part of a comprehensive HIV prevention strategy, which includes safe sex practices, risk reduction counseling, and regular HIV testing.
The drug is only for approved for individuals who are confirmed as HIV-negative both before taking the drug and at least every 3 months afterward. The antiretroviral is contraindicated for individuals with positive or unknown HIV status.
Before taking the drug, individuals should be counseled on several key points:
The drug should not become a substitute for a condom, but rather, an adjunct to condom use and other preventive measures.
The antiretroviral must be taken daily, because its effectiveness strongly correlates to adherence. In addition, intermittent use might spur on the development of Truvada-resistant HIV.
Monitoring a patient's HIV status after the start of PrEP is crucial because if a patient subsequently becomes infected, he or she should switch from the stand-alone antiretroviral to the combination of antiretrovirals for treating — as opposed to preventing — HIV infection.
The most common side effects with Truvada use included diarrhea, nausea, abdominal pain, headache, and weight loss.
Link:
FDA website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
