Lawsuit Alleges Side Effects of Atripla, Stribild and Other HIV Drugs Endangered Patients to Increase Gilead Profits

Plaintiffs say kidney and bone injuries could have been avoided if Gilead had marketed its safer formulation to avoid the side effects of Atripla, Stribild and other HIV drugs.

A group of 20 plaintiffs have filed an product liability lawsuit against Gilead, claiming the company endangered the health and safety of individuals suffering from HIV by unnecessarily exposing them to the toxic side effects of Atripla, Stribild and other TDF-based drugs, as part of a scheme intended to maximize the company’s profits before safer, less toxic versions of the drugs were released.

The complaint (PDF) was filed in the Superior Court of California in San Francisco County on September 15, indicating that the plaintiffs suffered various kidney and bone injuries after taking versions of Gilead 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.

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, until its patent protections expired.

Once Gilead started to face the prospect of competition from generic equivalents for Truvada, Atripla, Stribild, Viread and other TDF drugs, it began to introduce and aggressively market 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 side effects from Atripla, Stribild and the other older drugs, including low kidney function, bone demineralization, osteoporosis, and bone fractures.

“Before the FDA approved Viread, Gilead had already discovered a different design for an orally available version of tenofovir that is more potent than TDF, meaning that it can be administered at a significantly lower dose with fewer side effects than TDF,” the lawsuit states. “Unlike TDF, TAF is not converted into tenofovir until it has been absorbed by the cell. As a result, TAF is more efficiently absorbed by the cells HIV targets compared to TDF. This more efficient absorption allows TAF to achieve far greater intracellular concentrations of the activated drug (tenofovir-diphosphate) in target cells than even a dramatically larger dose of TDF, while achieving plasma concentrations of tenofovir that are 90% lower than TDF. The lowered plasma concentrations of tenofovir found with TAF result in reduced toxicity compared to TDF, making TAF safer to use than TDF.”

October 2022 Atripla, Stribild and TDF-Based Drug Lawsuit Update

The complaint filed last month in San Francisco County will join a constantly growing number of similar Atripla lawsuits, Stribild lawsuits, Truvada lawsuits, Viread lawsuits and Complera lawsuits being filed by individuals nationwide, most of which are pending in the California state court system.

Given common questions of fact and law, the litigation is being coordinated in California state court during discovery and a series of early “bellwether” trials will be scheduled to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.

Last year, a federal judge rejected an attempt by Gilead to dismiss a Truvada lawsuit, in a decision that had widespread impact on the litigation. U.S. District Judge Kevin McNulty permitted a case pending in the federal court system to move forward, since the lawsuit alleges that Gilead had new information about the side effects of its HIV drugs, which it did not pass on to federal regulators.

While early trial dates approaching in California state court will not have any binding impact on hundreds of individual plaintiffs involved in the litigation, the outcome will be closely watched and is likely to have a large impact on the value of any Gilead HIV drug settlements that are offered for individuals who suffered bone problems and kidney side effects from Atripla, Stribild and other TDF-based drugs.