Gilead HIV Drug Health Risks Were Known Before First TDF-Based Antiretrovirals Hit The Market: Lawsuit

Earlier Gilead antiviral drugs using similar molecular formulations carried black box warnings due to the risks of kidney damage.

Lawsuits continue to be filed over health risks with older Gilead HIV drugs, alleging the manufacturer knew the medications were more dangerous than they needed to be before the first TDF-based medications were introduced, and also knew that it had a safer alternative that was not introduced until patent protection for those first products ran out.

About 40 plaintiffs filed a joint complaint (PDF) against Gilead Sciences, Inc. last month in the U.S. District Court for the Middle District of North Carolina, alleging that they suffered various kidney and bone injuries after taking HIV drugs that contained the compound tenofovir disoproxil fumarate (TDF), including Truvada, Atripla, Viread, Complera and Stribild.

Gilead developed and manufactured each of the medications, and promoted them as safe and effective HIV treatments, while creating an essential monopoly in the U.S. market. 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.

The lawsuit also claims Gilead knew about it’s HIV drug health risks before the drug was placed on the market, but provided false and misleading information to consumers and the medical community.

“Before Gilead’s first TDF product, Viread, received FDA approval in 2001, Gilead knew that two of its other antiviral drugs that are structurally similar to tenofovir caused significant kidney damage,” the lawsuit states, noting that tenofovir is a member of a class of molecules known as acyclic nucleoside phosphonates, like two previous antiviral drugs Gilead manufactured; cidofovir and adefovir. “Cidofovir injection, marketed as Vistide, was Gilead’s first commercial product. When the FDA approved Vistide in 1996, it carried a black box warning stating that renal impairment is the drug’s major toxicity and renal failure resulting in dialysis or contributing to death have occurred with as few as one or two doses of Vistide.”

Rather than introducing the safer HIV drugs, the drug maker decided to sit on the development of the TAF formulations and continued to market the Gilead 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, promoting the new drugs as safer alternatives to the toxic HIV drugs they sold for years knowing they exposed users to serious health risks.

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

The case joins a growing number of similar lawsuits filed by plaintiffs nationwide, who say they were unnecessarily exposed to the Gilead HIV drug health risks, leaving them with permanent injuries. 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.