TDF HIV Anti-Viral Drug Lawsuit

Gilead has been accused of misrepresenting the safety of its TDF (tenofovir disoproxil fumarate) HIV anti-viral drugs, including Truvada, Viread, Atripla, Complera, and Stribild.

TDF HIV anti-viral drug lawsuits also allege that the drug maker intentionally delayed the launch of a safer version of tenofovir for years in order to protect its valuable TDF patents, thus allowing thousands of patients to take medications that could harm their bones and kidneys.

Contact a Lawyer to Learn More About Filing a TDF Lawsuit

The nationwide law firm of Bernstein Liebhard LLP is currently investigating TDF HIV anti-viral drug lawsuits involving the following kidney injuries:

  • Chronic Kidney Disease (CKD)
  • Acute Kidney Injury or Acute Renal Failure
  • Fanconi’s syndrome
  • Tubular dysfunction

Our attorneys are also investigating claims on behalf of TDF users who suffered complications associated with bone demineralization, such as:

  • Osteopenia
  • Osteoporosis
  • Bone fracture

If you or someone you love experienced any of these injuries and complications while using a TDF medication to treat HIV or chronic hepatitis B, or as pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV, please contact our office at (888) 994-5118 for a free, no-obligation and confidential review of your case.

What are TDF HIV Anti-Viral Drugs?

TDF HIV anti-viral drugs belong to a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs reduce the amount of virus in the body and prevent its replication by blocking an enzyme called reverse transcriptase.

The U.S. Food & Drug Administration approved the first TDF medication – Viread (tenofovir disoproxil fumarate) –  for the treatment of HIV in October 2001. Gilead received FDA clearance to market Viread as a treatment for chronic hepatitis B on August 11, 2008.

The company has since obtained approval to market several TDF combination drugs, including:

  • Truvada (emtricitabine/tenofovir disoproxil fumarate)
  • Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
  • Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate)
  • Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)

In 2012, Truvada became the first TDF drug approved by the FDA for PrEP.

TDF Lawsuits Accuse Gilead of Downplaying Side Effects, Delaying Safer Tenofovir Version

In May 2018, two California men filed a personal injury lawsuit against Gilead, accusing the drug maker of downplaying the potential for serious kidney injuries and bone demineralization when taking TDF medications.

Among other things, the TDF HIV anti-viral drug lawsuit notes that the FDA has sent two warnings letters to Gilead over its marketing practices:

  • An FDA warning letter issued in 2002 asserted that Gilead salespeople had falsely stated that TDF had ‘no toxicities’ was ‘benign’ and was ‘extremely safe.’
  • In a 2003 letter, the FDA took the uncommon step of requiring Gilead to retrain its sales representatives to provide accurate information regarding the significant side effects associated with TDF.

The plaintiffs also claim that Gilead intentionally shelved a safer version of tenofovir – tenofovir alafenamide or TAF – in 2004 in order to protect its valuable TDF patents, which weren’t due to expire for over a decade.

“… studies showed that TAF was far less toxic and confirmed that TDF’s low absorption, high dosage, and potential bone and renal toxicity were real risks,” the lawsuit states. “But, Gilead did not publish this research, did not conduct clinical trials of TAF, did not change its prescribing information, and did not instruct its sales representatives to begin informing doctors that the toxicities associated with TDF could be eliminated with a new, better drug.”

A class action lawsuit filed the same month also accuses Gilead of delaying the development of TAF solely in the interest of its bottom line.

“After learning that TAF had a higher absorption rate and largely avoided the bone and kidney toxicity associated with TDF, Gilead shelved its development of TAF and instead kept HIV infected patients and their doctors in the dark about the true risks associated with TDF, along with the solution to those risks, for over a decade,” the complaint asserts.  “In 2014, as Gilead’s patent on TDF approached its expiration and Gilead faced a sharp decrease in profits that would result from competition entering the market for TDF-containing drugs, Gilead decided to release the results of the TAF studies it began conducting in 2001.”

The FDA finally approved TAF as part of a combination drug called Genvoya in November 2015 and has since approved several other TAF drugs, including Biktarvy and Descovy.

Obtain a Free TDF Lawsuit Review

You may be eligible to file your own TDF HIV anti-viral drug lawsuit if you or a loved one developed kidney problems or complications associated with bone demineralization while taking Truvada, Viread, Atripla, Complera, and Stribild.

To learn more, please contact our office at (888) 994-5118 to arrange for your free consultation.

  1. FDA (N.D.) “Viread: Highlights of Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022577lbl.pdf
  2. FDA (2018) “HIV/AIDS Historical Time Line 2000 – 2010” https://www.fda.gov/forpatients/illness/hivaids/history/ucm151081.htm
  3. National Institutes of Health (2012) “FDA approves first drug for reducing the risk of sexually acquired HIV infection https://aidsinfo.nih.gov/news/1254/fda-approves-first-drug-for-reducing-the-risk-of-sexually-acquired-hiv-infection
  4. Los Angeles Times (2018) “A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner.” http://www.latimes.com/business/la-fi-gilead-20160529-snap-story.html
  5. Superior Court of the State of California for the County of Los Angeles (2018) “Case No. BC702302, Personal Injury Claims” and “Case No. BC 705063, Class Action Status”
Last Modified: May 30, 2018

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