Lawsuit Alleges Bone Damage, Kidney Injuries from HIV Drugs

A new lawsuit has been filed against drug manufacturer Gilead on behalf of nearly 30 plaintiffs who allege that side effects of Truvada, Atripla and other HIV medications caused them to suffer severe kidney injuries and bone damage. According to the ongoing tenofovir disoproxil fumarate (TDF) litigation, Gilead could have released a safer and more effective version of the drug (known as tenofovir alafenamide fumarate, or TAF) sooner, to the benefit of HIV patients, but instead put its own bottom line ahead of patients’ health and delayed the development of the newer formulation in order to make more money off the older drugs. Gilead is accused of letting HIV patients continue taking the more dangerous TDF for nearly ten years, when they could have made the decision to accelerate the development of TAF and significantly reduced their risk of suffering kidney and bone disease.

Potential Side Effects of TDF Drugs

Truvada, Atripla, Stribild, Viread and Complera are all HIV drugs sold by Gilead that contain the antiretroviral drug tenofovir disoproxil fumarate (TDF), which has been widely used over the past 20 years to slow the progression of HIV, the virus that causes AIDS. There is no cure for HIV or AIDS, but when the U.S. Food and Drug Administration (FDA) approved Gilead’s TDF treatment in 2001, it quickly became a recommended component of most HIV treatment regimens. Despite TDF being the most commonly prescribed antiretroviral, Truvada and other TDF-based drugs come with considerable warnings about the potential for the medications to cause severe side effects in users. Among the potential side effects associated with TDF-based HIV medications are:

  • Chronic kidney disease
  • Bone deterioration
  • Renal (kidney) failure
  • Dental problems
  • Fanconi syndrome
  • Osteoporosis
  • Bone fractures
  • Osteopenia
  • Tubular dysfunction

Mounting Legal Claims Against Gilead

Gilead faces a growing number of lawsuits involving claims that patients taking Truvada, Atripla and other TDF-based HIV drugs were unnecessarily exposed to serious side effects. This latest lawsuit alleges that patients could have avoided experiencing the severe bone and kidney side effects linked to TDF had Gilead not deliberately withheld the safer version of the drug, tenofovir alafenamide fumarate (TAF). According to the complaint, filed in the U.S. District Court for the Northern District of California on December 5, Gilead knew that the TDF-based drugs were highly toxic and posed a significant risk of bone and kidney injury, yet failed to properly warn users about these side effects. Furthermore, the lawsuit alleges that Gilead knew about the safer version of the HIV medication, yet withheld it from the market in an effort to extend patent protection and maximize profits from the brand-name drugs.

“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.” Only since 2015 has Gilead been promoting a new version of these best-selling HIV drugs that contain TAF, which is less toxic to users and poses a lower risk of side effects. However, legal claims currently pending against Gilead allege that the drug maker knew about this safer alternative to TDF for years and deliberately waited to introduce TAF until its TDF drugs were nearing the end of patent protection.

TAF-Based Treatment Approved by FDA

It was in 2015 that the FDA finally approved Genvoya, the first HIV treatment with TAF, the new and improved formulation of tenofovir, and two additional TAF medications, Descovy and Odefsey, were approved by the FDA the following year. The major difference between the old and new HIV treatments is that TDF has a much higher plasma tenofovir exposure, which is why it poses such a serious risk to users. TAF in Genvoya, on the other hand, is formulated with one-tenth the dose of TDF in Stribild, which results in fewer kidney complications and other related side effects. Now, patients who took Truvada and other TDF drugs for HIV and subsequently developed side effects like chronic kidney disease and bone problems are filing lawsuits against Gilead, alleging that by deliberately delaying the development of the safer and more effective TAF drugs, the drug maker exposed countless HIV patients to devastating side effects that could have been avoided.

Contact a Truvada Injury Attorney Today

If you or someone you know took a TDF drug like Truvada, Stribild or Atripla and subsequently developed a devastating kidney- or bone-related side effect, contact a reputable TDF injury attorney today for legal help. You may have grounds to file a drug injury lawsuit against Gilead in order to pursue financial compensation for your injuries and losses.