Emtricitabine-tenofovir disoproxil fumarate found to be comparable in safety to PrEP.
Research has just squashed any doubts fueling the thought that emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) is not safe as a pre-exposure prophylaxis (PrEP).
The human immunodeficiency virus (HIV) is not the same death sentence of a disease it was in the 1980’s when the first cases were reported. Between better understanding its pathology and developing novel treatments to help patients live longer, there have been a lot of positive strides made over the years.
FTC-TDF received the FDA seal of approval to be used as a PrEP, the fairly new preventive method against HIV, in July 2012. Although the medication has proven to be effective, questions about the safety of this specific treatment have lingered.
Five studies that evaluated PrEP for HIV prevention consisting of a total of 15,490 patients were assessed in September 2015. Two major studies which looked at the safety of aspirin in 61,947 patients were also analyzed. Researchers from the University of California Los Angeles took that information to determine the safety profile of FTC-TDF.
The PrEP studies recruited participants ages 18 and older while the aspirin-focused ones focused on those ages 40 or 45 and older. By evaluating the numbers needed to harm (NNH), the team found that FTC-TDF is favorably comparable to aspirin when it comes to safety.
The NNH for heterosexual couples was 68 for moderate decreased absolute neutrophil count. For men who have sex with men and transgender women, the NNH was 114 for nausea and 96 for unintentional weight loss. The aspirin NNH was 68 for gastrointestinal bleeding, 123 for any gastrointestinal bleeding, 15 for any bleeding problems in men, and 10 for easy bruising in women — remember that the aspirin cohort was larger than the PrEP’s.
“Careful monitoring of renal functioning and bone metabolism is recommended due to FTC-TDF associated effects on kidney function and bone density,” the researchers advised.
So if you ever worried that FTC-TDF isn't actually safe, let the findings published in Open Forum Infectious Diseases put your mind at ease.
“While long-term studies are needed, providers should feel reassured about the safety of short- and medium-term PrEP for HIV infection with FTC-TDF,” the team concluded.