Truvada for PrEP Bone Fracture Risk Limited, Only High Risk Patients Should Be Concerned: Study

A new study suggests that side effects of Truvada for PrEP may result in bone decline among young, otherwise healthy individuals taking the treatment for prevention of HIV, but researchers indicate that the bone fracture resulting from those declines is minor, and should probably only concern those already at risk for bone problems due to other factors.

Researchers from the University of California, San Francisco looked at the bone fracture risk from the HIV drug Truvada, among young people who were taking it as a pre-exposure prophylaxis (PrEP). The findings in a June issue of the medical journal AIDS Research and Human Retroviruses.

The study looked at data from an open-label project involving men who have sex with men, as well as transgender women from South Africa, Thailand, Peru, Brazil and the U.S. Participants underwent bone and metabolic examinations of the hip and lumbar spine from June 2011 through December 2013. The study ultimately involved 290 subjects.

Researchers noted that previous studies had suggested Truvada for PrEP had resulted in declines of bone mineral density of up to five percent. However, this study’s results, which focused on younger, healthier subjects with a median age of 31, showed a decline of only about one percent.

The study did note that high adherence to the daily Truvada regimen was associated with more statistically significant declines in bone mineral density (BMD).

“We found a monotonic dose–response relationship between (Truvada) pill-taking and toxicity,” the researchers concluded. “For those planning prolonged daily PrEP use who are at high risk of fracture, alternate PrEP strategies such as TFV alafenamide-based PrEP could be considered once available.”

Truvada Toxicty Concerns

Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved in 2004 for the treatment of HIV, and is also used as a PrEP HIV drug to prevent the spread of the disease among individuals at risk of contracting the infection. The HIV drug has generated billions in profits for Gilead, although the company now faces claims that it has withheld safer alternatives to increase profits.

The findings come amid growing concerns over Gilead’s stewardship of Truvada and other similar HIV medications that contain the antiviral tenofovir disoproxil fumarate (TDF), which has been used in a series of “cocktail” drugs introduced by the drug maker over the past few decades, including Viread, Truvada, Atripla, Complera and Stribild.

Gilead now faces a growing number of individual HIV drug lawsuits, alleging that side effects of the drugs caused serious kidney problems and bone fractures. Plaintiffs allege that the drug maker knew that an alternative design, involving tenofovir alafenamide fumarate (TAF), would allow delivery of the toxic drug at much lower doses, yet sat on the product for years to exhaust sales of TDF drugs during patent protection. It was not until Truvada and other TDF drugs were about to face competition from generic equivalents that Gilead resumed development of TAF drugs in 2015.

Several groups of plaintiffs have also filed  class action lawsuits over Truvada and other HIV drugs, alleging that Gilead and some other drug makers purposefully price-fixed Truvada and similar tenofovir disoproxil fumarate (TDF) medications in the United States.