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 was 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
- 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 infection can take Truvada for PrEP.
Truvada for PrEP was the first drug approved for 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 simultaneously every day, and those who use it must also undergo testing for HIV every three months.
Despite this, other safe sex practices must also be used 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.
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 had 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 drug use can lead to long-term kidney and bone damage. Further, TDF, one of Truvada’s main ingredients, is toxic.
Notable side effects of Truvada include:
- 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 severe, the kidneys no longer work properly. Those diagnosed with kidney failure will need either a kidney transplant or dialysis, or they will die. Kidney failure is also an end-stage renal disease (ESRD) or renal failure.
- 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 increase osteoporosis risk.
- 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, osteoporosis patients risk broken bones from bending over, coughing, or falling.
- Tooth loss: Teeth are similar to bones but are harder and cannot regrow if 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 now, 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 in improving the quality of life in patients.
- August 2, 2004: The FDA approves the new drug, now officially known as Truvada, for treating 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 overstate 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: The FDA approved a new Gilead drug, Genvoya. 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 the FDA has approved Truvada for PrEP for use in those ages 15-17 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 continued to sell Truvada anyways.
The company is now selling safer TAF-based drugs, but 2018 lawsuits claim that Gilead 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 might be able to receive compensation.