TDF Toxicity

  • TDF Toxicity.

Tenofovir Disoproxil Fumarate (TDF) is an orally administered prodrug of tenofovir. Tenofovir is similar to Adefovir, which is used for the treatment of HIV and chronic hepatitis B virus infections. 

Gilead Sciences Inc. originally developed it under the brand name Viread, tenofovir disoproxil fumarate, or TDF. Gilead sells five different TDF brand name drugs in the United States, and the drug also comes in generic form.

  • Viread

  • Truvada

  • Atripla

  • Complera

  • Stribild

FDA Approval:

The U.S. FDA on October 26, 2001, approved Tenofovir disoproxil for the treatment of HIV, and on August 11, 2008, for the treatment of chronic hepatitis B.

Gilead Sciences, Inc.'s Truvada for the treatment of HIV-1 infection in adults was approved by the FDA on August 2, 2004.

The FDA approved Truvada for reducing the risk of sexually-acquired HIV infection in adults on July 16th, 2012.

The FDA expands approval for reducing the risk of HIV infection in adolescents on May 15, 2018.

In 2001, the first documented instance of kidney toxicity over the usage of TDF occurred in the United States, which was the same year the drug hit the market. The instance was reported by Willem D.F. Venter and the coauthors of a 2018 study in Southern African Journal of HIV Medicine. The patient suffered acute kidney injury (AKI), Fanconi syndrome, and nephrogenic diabetes insipidus.

AIDS Health Foundation (AHF), the largest global AIDS organization, sued Gilead in 2016, following which the TDF litigation began. The company was accused of manipulating the patent system by withholding from patients a more potent, less toxic drug called TAF.

Severe side effects:

High blood lactate

Enlarged liver

Serious Alleged Injuries may include:

  • Acute kidney injury or Acute renal failure
  • Chronic kidney disease or declining kidney function
  • Fanconi Syndrome
  • Kidney tubular dysfunction
  • Osteopenia
  • Osteoporosis
  • Bone Fractures

FDA Safety Warnings:

2012: The FDA expanded the boxed warning to alert health care professionals that PrEP use of Truvada is only for “individuals who are confirmed to be HIV-negative before prescribing the drug and at least every three months during use.” They strongly recommended stopping the use in patients “with unknown or positive HIV status.”

Legal Updates:

Defendants: 

Gilead Sciences Inc.

Defendant Law Firm:

Debra E. Pole, Joshua Anderson, Alycia A. Degen, Daniel A. Spira, Adriane Peralta, Anna Tutundjian,  and Inn-Young Park of Sidley Austin LLP.

Timothy F. Daniels and Carlos A. Benach of Irwin Fritchie Urquhart & Moore LLC.

Allegations: Allegations include the manufacturer failed to warn about their tenofovir disoproxil fumarate HIV medication Truvada, Viread, Atripla, Complera, and Stribild led to kidney problems and bone loss.

Lawsuit Status:

The lawsuits are consolidated under MDL-2881, IN RE: Tenofovir Disoproxil Fumarate Products Liability Litigation, filed on December 19, 2018, in the Judicial Panel on Multidistrict Litigation.

MDL Status: Active and on appeal.

Important Verdicts & Settlements: Currently, there are no settlements made.

Evidence:

  • Usage in Pharmacy Records
  • Duration of Usage
  • Indication of usage in Medical Records

Medical Record Review and claim validation of TDF Toxicity case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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