Gilead Knew HIV Drug Compound TDF Was Toxic to Kidneys and Bones, Lawsuit Alleges

Lawsuit indicates Gilead sat on safer drug formulations until it completely cashed in on the older, more dangerous TDF-based HIV drugs.

Nearly 30 plaintiffs have joined together to file an HIV drug lawsuit against Gilead, claiming the pharmaceutical company intentionally sold toxic drugs to patients in order to maximize profits, even though there were safer alternatives available.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on October 22, by a group of plaintiffs who indicate they suffered various kidney injuries and bone damage after using different HIV medications with the antiretroviral compound tenofovir disoproxil fumarate (TDF), which includes the blockbuster drugs Truvada, Atripla, Stribild and Viread.

Gilead developed manufactured each of the medications, promoting them as safe and effective for years, while developing an essential monopoly over HIV treatments. However, plaintiffs allege the TDF-based medications were more toxic than they had to be, since Gilead was already aware of a safer alternative, using the HIV drug compound tenofovir alafenamide fumarate (TAF), which could be taken at lower doses and be equally as effective.

Rather than introducing the safer HIV drugs, Gilead decided to sit on the development and continued to market the TDF drugs for years. However, once it started to face competition from generic equivalents for Truvada, Atripla, Stribild, Viread and other TDF drugs, Gilead introduced and began aggressively marketing versions of the medications with the HIV drug compound TAF.

“Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones. Gilead knew that two of its other antiviral drugs with structures similar to tenofovir, cidofovir and adefovir dipivoxil, had been highly nephrotoxic (i.e., toxic to kidneys) and that preclinical data for TDF showed that it could cause significant kidney and bone damage,” the lawsuit states. “Once Gilead’s first TDF product, Viread, was on the market, Gilead did not want to hurt TDF sales by admitting that its TDF-based products are unreasonably and unnecessarily unsafe.”

As a result of the apparent decision to place profits before consumer safety, plaintiffs allege they suffered various injuries from side effects from the TDF HIV drugs, including low kidney function, bone demineralization, osteoporosis, and bone fractures.

In addition to withholding the safer drugs, plaintiffs also allege that Gilead failed to provide adequate warnings to doctors and patients about the risks of linked to kidney, bone and liver damage. The lawsuit presents claims of strict product liability, design defect, failure to warn, negligence, gross negligence, fraud by omission, breach of warranty and violation of several states’ consumer protection laws.

Gilead began selling TAF-based HIV drugs in 2015, as sales of TDF drugs began to erode due to generic equivalents. It has since introduced a number of similar medications with the TAF compound, including Descovy, Genvoya and others, which it now actively promotes as safer than TDF-based versions of the older drugs they sold for years.

Plaintiffs indicate the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided.

The case joins a growing number of similar lawsuits filed by plaintiffs nationwide, who say they suffered Gilead HIV drug side effects. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past two years.