Truvada

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Manufacturer 

 

Gilead Sciences                   $80.47 Billion

 

FDA Approval 

 

Truvada                                  NDA 21-752                                      August 2, 2004
Viread                                     NDA 21-356                                     October 26, 2001
Atripla                                     NDA 21-937                                     July 12, 2006
Stribild                                    NDA 203100                                    August 27, 2012
Complera                               NDA 202123                                    August 10, 2011

Generics

Truvada (September 2020), Viread (December 2017), Atripla (September 2020), Stribild (N/A), Complera (N/A)

 

MDL Information 

 

MDL 2881 – Northern District of California (California JCCP 5043)

Background

In 1997, Gilead modifies the intravenous drug tenofovir to create tenofovir disoproxil fumrate (TDF), which can be given as a pill.  According to Gilead’s annual reports, they have generated $36.2 billion in sales on Truvada since 2004.

 

Treatment / Use

 
Tenofovir is an antiviral drug that is approved for the treatment of HIV infection.  It is able to reduce the amount of HIV in the blood, help prevent or reverse damage to the immune system and reduce the risk of AIDS-related illnesses.
 
 
In July 2012, the FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

Injuries / Complications / Concerns

 
In 2018, two California men filed suit against Gilead Sciences, saying that they were harmed when the drug company intentionally delayed development of a safer version of a crucial HIV medicine so that it could continue to profit from its lucrative monopoly.
 
 
The lawsuit claims, the Foster City company decided to hide tenofovir’s risks while earning billions of dollars as it became one of the world’s most prescribed medicines for HIV.  The lawsuit says that HIV patients suffered from as many as 10 years of “additional accumulated kidney and bone toxicity” while using the drug while the company kept the safer version on a shelf in its lab.
 
 
Viread, Truvada, Atripla, Stribild and Complera are tenofovir dispoproxil fumerate (TDF) drugs.  The lawsuit says that Gilead knew when Viread was approved in 2001 that it would have to be given in high doses, which meant it could damage the kidneys and bones.  Yet, the company failed to adequately disclose those dangers in the medicine’s label.
 
 
At the time of the drug’s approval, Gilead scientists were already working to reduce the adverse effects.  In April 2001, the scientists published research on a different chemical version of the medicine called tenofovir alafenamide fumerate (TAF).
That animal study showed TAF had a thousand-fold greater activity against HIV than the original medicine invented in Europe, raising the possibility that it would have far less toxicity.
 
 
Gilead then paid doctors across the country to give TAF to patients in small clinical trials. The positive results of those studies were not published for years — secrecy that the lawsuits filed in 2018 were “an act of extreme malice.”
 
Instead, in October 2004, Gilead abruptly announced that it was ending research on TAF after an “internal business review.” And it continued to pour money into selling the older drug, which was bringing in billions of dollars each year.
 
 
The company also continued to quietly apply for new patents on TAF — the drug it had said it would no longer be developing.
 
More than six years after that 2004 announcement, with the older drug’s patent running out, an executive told investors about “an interesting new molecule” the company had added to its research plans. That drug was TAF. The company then began publishing the results of the earlier studies.
In November 2015, the FDA approved TAF in a combination pill with three other medicines. The drug was called Genvoya.
 
 
Other new pills also containing TAF include Odefsey and Descovy.
 
The company’s sales force is now urging doctors to switch their patients to the new drugs to reduce possible harm to their kidneys and bones.
 
 
The legal actions, prepared by Rutherford Law attorney Michelle M. Rutherford and in-house counsel for AHF, were filed in Superior Court of the State of California for the County of Los Angeles, [Case No. BC702302, Personal Injury Claims; and Case No. BC 705063, Class Action Status], and each demands a jury trial.  AHF is funding the litigation and providing pro bono counsel and will not receive any financial recovery from the lawsuit in excess of its actual costs.
 
 
Injuries associated with Truvada and other Gilead TDF drug brands include: chronic kidney disease, severe renal deficiency, fatal renal insufficiency, end stage renal disease, loss of bone density, bone loss, bone breaks or fractures, bone necrosis, tooth loss attributed to bone density disorder, Fanconi Syndrome (disorder of kidney tubes), osteomalacia (softening of the bones).

Information on the Topic of Paragard

 

U.S. Sues Gilead, Claiming it Owns HIV PrEP Patent (11-7-2019)

https://www.nbcnews.com/feature/nbc-out/u-s-sues-gilead-claiming-it-owns-hiv-prep-patent-n1078346

 

Gilead Gets 2nd HIV Drug Approved for PrEP, but its Own Truvada may be Hard to Dethrone (10-4-2019)

https://medcitynews.com/2019/10/gilead-gets-2nd-hiv-drug-approved-for-prep-but-its-own-truvada-may-be-hard-to-dethrone/?rf=1

 

Single Dose Truvada Study (8-28-2019)

https://clinicaltrials.gov/ct2/show/NCT03719053

 

An HIV Treatment Cost Taxpayers Millions. The Government Patented it. But a Pharma Giant is Making Billions (3-26-2019)

https://www.washingtonpost.com/business/economy/pharma-giant-profits-from-hiv-treatment-funded-by-taxpayers-and-patented-by-the-government/2019/03/26/cee5afb4-40fc-11e9-9361-301ffb5bd5e6_story.html

Gilead Sciences Announces Fourth Quarter and Full Year 2018 Financial Results

(2-4-2019)

https://www.gilead.com/news-and-press/press-room/press-releases/2019/2/gilead-sciences-announces-fourth-quarter-and-full-year-2018-financial-results

 

Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study. (9-2018)

https://www.ncbi.nlm.nih.gov/pubmed/29623648

 

An Overview of Tenofovir and Renal Disease for the HIV-Treating clinician (7-17-2018)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6111387/

 

New Lawsuits Against Gilead Over Its HIV Med Tenofovir (5-10-2018)

https://www.poz.com/article/new-lawsuits-gilead-hiv-med-tenofovir

 

Patients Sue Gilead, Saying Drug Company Intentionally Delayed Safer HIV Medicine (5-9-2018)

https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html

HIV Patients Say Gilead Suppressed Safer Drug to Preserve Profits (5-9-2018)

https://www.kqed.org/futureofyou/441435/hiv-patients-say-gilead-suppressed-safer-drug-to-preserve-profits

 

HIV/AIDS Historical Time Line 2010 – 2017 (1-8-2018)

https://www.fda.gov/patients/hiv-timeline-and-history-approvals/hivaids-historical-time-line-2010-2017

 

Tenofovir and Bone Health (5-1-2017)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4844450/

 

A History of Gilead’s Biggest HIV Drug (5-29-2016)

https://www.latimes.com/business/la-fi-gilead-timeline-20160527-snap-story.html

 

Tenofovir Linked with Acute Kidney Injury in HIV-Infected Patients (11-6-2015)

https://www.sciencedaily.com/releases/2015/11/151106133104.htm

 

Modest Bone Loss Seen in Young Men Taking Truvada for Pre-Exposure Prophylaxis (10-22-2015)

https://www.aidsmap.com/news/oct-2015/modest-bone-loss-seen-young-men-taking-truvada-pre-exposure-prophylaxis

A Chronic Kidney Disease Risk Score to Determine Tenofovir Safety in a Prospective Cohort of HIV-Positive Male Veterans (6-1-2014)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4188545/

 

Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men (3-10-2014)

https://clinicaltrials.gov/ct2/show/NCT00131677

 

Tenofovir Effect on the Kidneys of HIV-Infected Patients: A Double-Edged Sword? (10-2013)

https://jasn.asnjournals.org/content/24/10/1519

 

Truvada Prescribing Information (6-2013)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf

 

FDA Drug Approval Package – Stribild (8-27-2012)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000TOC.cfm

FDA Approves First Drug for Reducing the Risk of Sexually Acquired HIV Infection (7-16-2012)

https://aidsinfo.nih.gov/news/1254/fda-approves-first-drug-for-reducing-the-risk-of-sexually-acquired-hiv-infection

 

FDA Drug Approval Package – Complera (8-10-2011)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202123_compleratm_toc.cfm

 

Tenofovir Nephrotoxicity: 2011 Update (6-7-2011)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/

 

Conference Reports for NATAP – The Kidney at CROI (2-27-2011)

http://www.natap.org/2011/CROI/croi_54.htm

 

Tenofovir-Induced Kidney Disease: An Acquired Renal Tubular Mitochondriopathy (12-1-2010)

https://www.kidney-international.org/article/S0085-2538(15)54446-3/abstract

 

Tenofovir-Associated Bone Density Loss (2-2-2010)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2817787/

FDA Drug Approval Package – Atripla (7-12-2006)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021937TOC2.cfm

 

FDA Drug Approval Package – Truvada (8-2-2004)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_TruvadaTOC.cfm

 

Acute Renal Failure Associated with Tenofovir Treatment in a Patient with Acquired Immunodeficiency Syndrome (8-1-2003)

https://academic.oup.com/cid/article/37/3/e41/440391

 

FDA Drug Approval Package – Viread (10-26-2001)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm