By: MIRIAM E. TUCKER, Family Practice News Digital Network
The US FDA has approved the use of the tablet Truvada to prevent HIV infection in people at high risk.
Truvada – a combination of emtricitabine and tenofovir – has already been in use since 2004 as a part of the treatment of HIV infection.
This is the first ever use for uninfected individuals, along with safer sex practices, to reduce the risk of acquiring HIV infection among high-risk adults.
Studied in men who have sex with men (MSM) and also in heterosexual, serodiscordant couples, the new indication also allows for use in other adults who are deemed to be at high risk: including those who have sex with people known to be HIV infected (who are not necessarily regular partners) and those who do not routinely use condoms.
The requirement is for testing and documentation of a negative HIV test prior to prescribing for prophylaxis and will be contraindicated in people who have flu-like symptoms, because that could indicate the presence of early acute but as yet undetected, or undetectable, HIV infection.
Testing for hepatitis B is also recommended, because worsening of hepatitis B has been reported in individuals with both HIV and hepatitis B when Truvada treatment was stopped.
The approval comes with a risk evaluation and mitigation strategy (REMS) to inform prescribers and potential users of the importance of daily use of the medication, regular HIV testing, and other infection risk-reducing measures.
In the large placebo-controlled Pre-Exposure Prophylaxis Initiative (iPrEx), and PartnersPrEP trials, Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively; when used in combination with other preventive strategies, such as safer sex practices, counseling, and regular testing.
Truvada alone should not be used to prevent HIV infection.