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Nearly 30 plaintiffs have joined in a lawsuit recently filed against Gilead, alleging that side effects of Truvada, Atripla and other HIV drugs caused them to suffer severe bone damage and kidney injuries, indicating that the problems may have been avoided if the drug maker had used a safer alternative design.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on December 5, indicating that Gilead knew that HIV drugs containing the antiretroviral tenofovir disoproxil fumarate (“TDF”) were highly toxic to the bones and kidneys, yet failed to adequately warn about the risks and withheld safer versions, known as tenofovir alafenamide fumarate (“TAF”), which are just as effective as much lower doses.
Plaintiffs were users of various TDF-based HIV drugs sold by Gilead, including Truvada, Atripla, Viread, Complera and Stribild, which have been top-selling products over the past two decades, and are widely used to slow the progression of HIV and allow individuals with the disease to lead health lives.
“Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones,” the lawsuit states. “Gilead also knew that the relatively high dose of TDF created a greater risk of toxic effects, and that bone and kidney toxicities were even more likely to be seen with long-term use of TDF for the treatment of a virus that, for the foreseeable future, has no cure.”
More recently, Gilead has been promoting a newer version of the HIV drugs, which contains TAF, which is less toxic and causes fewer side effects. However, plaintiffs indicate that Gilead was aware of this safer alternative years ago, yet stop development in 2014, as part of a coordinated effort to extend patent protection and maximize profits that can be generated from brand-name versions of the drugs.
It was not until TDF drugs were all nearing the end of patent protection, and would be facing generic competition, that Gilead began introducing TAF drugs in 2015.
The case joins a growing number of HIV drug lawsuits filed against Gilead nationwide, involving claims that users may have avoided a diagnosis of chronic kidney diease, renal failure, bone deterioration, dental problems and other side effects.