Truvada

Truvada is the only drug for HIV prevention approved by the Food and Drug Administration (FDA). Truvada can also be used as a treatment for those already infected with the virus. Although drugmaker Gilead charges up to $1,758 for a month’s prescription of Truvada, the drug has been linked to serious kidney and bone damage in recent years through lawsuits.

What Is Truvada?

Truvada is a medicine made up of tenofovir disoproxil fumarate (TDF) and emtricitabine. These two compounds are available by prescription in a single pill.

Truvada has two uses as of 2019. First, the drug helps prevent HIV from worsening in those already infected. Second, Truvada is used as a form of pre-exposure prophylaxis (PrEP), or prevention, in those at risk of contracting the virus.

The pharmaceutical company Gilead began selling Truvada as a treatment for HIV in 2004 after approval from the FDA. In 2012, the FDA approved Truvada for PrEP.

Since Truvada has been sold, it has been hailed as a lifesaver for those with HIV. However, lawsuits filed in 2018 claim that Truvada causes deadly side effects.

Truvada may cause: 

  • Acute kidney injury
  • Chronic kidney disease (CKD)
  • End-stage renal disease (kidney failure)
  • Renal impairment
  • Bone density loss
  • Broken or fractured bones
  • Osteoporosis
  • Tooth loss

Truvada can also be hard to afford. In the U.S., the yearly cost of a Truvada prescription equals approximately $21,096, according to the Gilead website.

Today, those who took Truvada and developed bone or kidney problems can file a lawsuit against Gilead. Through a lawsuit, these victims may receive financial compensation to help cover the cost of treating their illnesses and other expenses.

Who Can Take Truvada?

While AIDS and HIV cannot be cured, companies like Gilead offer Truvada as a way to keep HIV from progressing. However, not everyone with HIV can safely use Truvada. Consult your doctor for the best treatment option for you.

Truvada for PrEP

Those who may be at risk of developing HIV and want to prevent an infection can take Truvada for PrEP.

Truvada for PrEP was the first drug approved as an HIV prevention by the FDA. It is still in use as of 2019. However, Truvada for PrEP cannot be used by those already infected with the virus.

A report from WCMH-TV in Columbus, Ohio states that Truvada is 94% effective at preventing HIV infection.

It must be taken at the same time every day, and those who use it must also undergo testing for HIV every three months.

Despite this, other safe sex practices must be used as well when taking Truvada. The drug itself is not enough to protect against HIV infection.

In addition, the Washington Post noted that in the U.S., 80% of people who could benefit from Truvada for PrEP are not taking it. U.S. lawmakers have claimed this is due to the drug’s high cost.

Truvada Cost

When Truvada first hit the market in 2004, it cost $800 a month, according to the Washington Post. Since that time, the cost has increased dramatically.

According to the Gilead website, as of 2019 it costs approximately $1,758 for a month’s supply of Truvada in the U.S. However, a generic version of Truvada in Australia costs less than $100 a year, according to a 2019 report by WCMH-TV.

Further, the New York Times stated that Gilead has sued U.S. competitors who tried to sell generic versions of Truvada.

Truvada Cost & Government Involvement

The cost of Truvada has concerned U.S. lawmakers and activists. In May 2019, the U.S. House Committee on Oversight and Reform held a hearing about Gilead and the costs of Truvada for PrEP.

As part of this hearing, the CEO of Gilead claimed the high price tag of Truvada helped the company fund AIDS research.

Though this may be true, the company has spent just $6 Billion on AIDS research since 2000. Gilead has earned over $36 Billion since Truvada was introduced in 2004.

Adding to the controversy is that the Centers for Disease Control and Prevention (CDC) owns the patents to Truvada, meaning tests to determine Truvada’s safety were done using public funds.

Yet, according to the Washington Post, the U.S. government does not enforce these patents as of 2019, allowing Gilead to set its own prices for Truvada without paying back to the U.S. government.

Truvada Side Effects

Other than the costs associated with Truvada, recent legal actions claim that prolonged use of the drug can lead to long-term kidney and bone damage. Further, TDF, one of Truvada’s main ingredients, has been shown to be toxic.

Notable side effects of Truvada include:

Kidney Injuries

  • Acute Kidney Injury (AKI): According to the National Kidney Foundation, AKI occurs when kidneys are damaged or fail completely. This causes waste to build up in a person’s blood, leading to urinary problems, confusion, and seizures — or coma in some cases. AKI sets in relatively quickly, typically in just a few days or even hours.
  • Chronic Kidney Disease (CKD): CKD occurs as the kidneys slowly lose their function over time. This causes nausea, a loss of appetite, shortness of breath, and blood pressure issues. The Mayo Clinic notes that CKD may not be apparent until it is severe.
  • Kidney Failure: When CKD becomes very severe, the kidneys no longer work properly. Those diagnosed with kidney failure will need to have either a kidney transplant or dialysis or else they will die. Kidney failure is also known as end-stage renal disease (ESRD) or renal failure.

Bone Injuries

  • Low bone density: Low bone density occurs when the body cannot make new bone tissue fast enough. This can make bones more likely to break and fracture and increases the risk of osteoporosis.
  • Osteoporosis: Osteoporosis is an extreme form of bone loss. By this point, the bones have become so brittle that basic activities can cause them to break. According to the Mayo Clinic, those with osteoporosis risk broken bones from bending over, coughing, or falling.
  • Tooth loss: Teeth are similar to bones, but they are harder and cannot regrow if they are damaged. In a lawsuit filed in May 2018, one man claimed he lost 17 teeth after taking Gilead drugs for a decade.

Sadly, when Truvada was first sold, doctors and consumers may not have been properly warned about these health problems.

For example, a November 2018 lawsuit claims that Truvada’s initial advertisements warned only about kidney damage in those with pre-existing kidney conditions. Documents filed state that Gilead knew anyone who used Truvada could be at risk of kidney damage.

Truvada FDA Approval Timeline

Though Truvada has been approved twice by the FDA, it has also faced controversy.

  • March 15, 2004: Gilead submits a new drug application to the FDA. Though unnamed at this time, the proposed drug combines Viread (TDF) and another drug known as Emtriva (emtricitabine) into one pill for a new HIV treatment. This combination of TDF and emtricitabine will become known as Truvada.
  • May 17, 2004: The FDA gives Gilead’s new drug priority review status, meaning that the agency considers it to be a high priority on improving the quality of life in patients.
  • August 2, 2004: The FDA approves the new drug, now officially known as Truvada, for the treatment of HIV infection. The approval comes more than a month ahead of the September 12 deadline. Truvada becomes the fourth Gilead HIV drug approved by the FDA since 2001.
  • March 26, 2010: The FDA warns Gilead that its print ads for Truvada are misleading. The agency claims the ads downplay the risks of Truvada and overstates its effectiveness. In 2002 and 2003, Gilead received similar warnings about downplaying the risks of Viread, another HIV treatment drug the company produced.
  • July 16, 2012: Truvada for PrEP receives approval from the FDA. Though FDA commissioner Margaret Hamburg calls the approval an “important milestone in the fight against HIV,” Truvada for PrEP does not come without controversy. A 2012 report from Time magazine states that some health experts worried the drug could make people believe they could not get HIV at all, leading to risky behavior.
  • November 5, 2015: A new Gilead drug, Genvoya, is approved by the FDA. Genvoya uses tenofovir alafenamide (TAF), a safer alternative to TDF. Though Genvoya is approved, Truvada continues to be sold.
  • May 15, 2018: Gilead announces that Truvada for PrEP has been approved by the FDA for use in those ages 15-17 in an effort to protect adolescents from HIV.

Truvada Legal Action

While Truvada was once thought to be a cornerstone in the fight against HIV, it may put consumers in danger of kidney and bone damage. Even worse, Gilead had access to safer alternatives but continues to sell Truvada anyways.

Safer TAF-based drugs are now being sold by the company, but 2018 lawsuits claim that Gilead actually had the TAF formula available as far back as 2000. Despite this, Gilead made and sold drugs like Truvada and downplayed the health risks.

In May 2019, Gilead announced that it would donate supplies of Truvada to help up to 200,000 people each year through 2030. The company did not say that it would lower its prices in the U.S., which have only increased since the drug was introduced.

If you used Truvada or other Gilead HIV drugs and developed bone or kidney damage, you may be able to receive compensation through a Truvada lawsuit.

To learn more, get a free case review today.

Author:HIV Drug Justice Editorial Team
HIV Drug Justice Editorial Team

HIV Drug Justice educates people about the risks of HIV drugs, which can cause kidney failure and bone damage. Our site is managed by the HIV Drug Justice Editorial Team, a group of concerned writers, editors, journalists, and illustrators. Our team helps readers understand what medical and legal options are available if they used dangerous HIV drugs and developed serious health problems as a result.

Last modified: September 17, 2019

View 20 References
  1. American Kidney Fund. (n.d.). Kidney Failure (ESRD) Causes, Symptoms, & Treatments. Retrieved from http://www.kidneyfund.org/kidney-disease/kidney-failure/

  2. Bacome, T. (2019, August 29). Maker of Truvada facing billion dollar lawsuit over patent. Retrieved from https://www.nbc4i.com/news/maker-of-truvada-facing-billion-dollar-lawsuit-over-patent/

  3. Food and Drug Administration. (2006). Truvada. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021752s005lbl.pdf

  4. Food and Drug Administration. (2012, July). Truvada for PrEP Fact Sheet: Ensuring Safe and Proper Use. Retrieved from https://www.fda.gov/media/83586/download

  5. Gilead Sciences. (2004, March 15). Gilead Submits Applications to U.S. and European Regulatory Authorities for Fixed Dose Co-Formulation of Viread and Emtriva. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2004/3/gilead-submits-applications-to-us-and-european-regulatory-authorities-for-fixed-dose-coformulation-of-viread-and-emtriva

  6. Gilead Sciences. (2004, August 2). U.S. FDA Approves Gilead’s Truvada, a One-Tablet, Once-a-Day Fixed-Dose Co-Formulation of Viread and Emtriva as Part of HIV Combination Therapy. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2004/8/us-fda-approves-gileads-truvada-a-onetablet-onceaday-fixeddose-coformulation-of-viread-and-emtriva-as-part-of-hiv-combination-therapy

  7. Gilead Sciences. (2012, July 16). Press Releases. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2012/7/us-food-and-drug-administration-approves-gileads-truvada-for-reducing-the-risk-of-acquiring-hiv

  8. Gilead Sciences. (2018, May 15). U.S. Food and Drug Administration Approves Expanded Indication for Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents. Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2018/5/us-food-and-drug-administration-approves-expanded-indication-for-truvada-emtricitabine-and-tenofovir-disoproxil-fumarate-for-reducing-the-risk-of-

  9. Holley, et al. v. Gilead Sciences Inc. (N.D. Cal. 2018)

  10. House Committee on Oversight and Reform. (2019, May 15). Committee to Hold Hearing on Gilead’s Exorbitant Price for HIV Prevention Drug. Retrieved from https://oversight.house.gov/news/press-releases/committee-to-hold-hearing-on-gilead-s-exorbitant-price-for-hiv-prevention-drug

  11. Madison, A. (2018, May 16). AHF files two lawsuits against Gilead. Retrieved from https://www.ebar.com/news/news//260009

  12. Mayo Clinic. (2019, August 15). Chronic kidney disease. Retrieved from https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

  13. Mayo Clinic. (2019, June 19). Osteoporosis. Retrieved from https://www.mayoclinic.org/diseases-conditions/osteoporosis/symptoms-causes/syc-20351968

  14. Mcneil, D. G. (2019, May 10). Gilead Will Donate Truvada to U.S. for H.I.V. Prevention. Retrieved from https://www.nytimes.com/2019/05/09/health/gilead-truvada-hiv-aids.html

  15. National Kidney Foundation. (2017, February 3). Acute Kidney Injury (AKI). Retrieved from https://www.kidney.org/atoz/content/AcuteKidneyInjury

  16. Park, A. (2012, July 17). Truvada: 5 Things to Know About the First Drug to Prevent HIV. Retrieved from http://healthland.time.com/2012/07/17/truvada-5-things-to-know-about-the-first-drug-to-prevent-hiv/

  17. Rowland, C. (2019, May 16). Gilead CEO insists federal government patent for HIV prevention pill Truvada is invalid. Retrieved from https://www.washingtonpost.com/business/economy/gilead-ceo-insists-federal-government-patent-for-hiv-prevention-pill-truvada-is-invalid/2019/05/16/7c0a79b6-77e1-11e9-b3f5-5673edf2d127_story.html

  18. U.S. Department of Health and Human Services. (2018, October 25). Cost Considerations and Antiretroviral Therapy Limitations to Treatment Safety and Efficacy Adult and Adolescent ARV. Retrieved from https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/459/cost-considerations-and-antiretroviral-therapy

  19. U.S. National Library of Medicine. (2019, July 17). Bone Density. Retrieved from https://medlineplus.gov/bonedensity.html

  20. Venter, W. D. F., Fabian, J., & Feldman, C. (2018, July 17). An overview of tenofovir and renal disease for the HIV-treating clinician. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6111387/