Truvada and other TDF drugs can cause kidney damage and kidney failure. The medical complications that can result can be fatal, and include lactic acidosis. However, Truvada’s warning label downplays the risks. As a result, numerous patients have been unable to make an informed health decision and have suffered some severe injuries from taking Truvada, including:
- Decreased kidney function,
- Kidney damage,
- Kidney failure, also known as renal failure,
- Bone damage from altered phosphate levels, or osteomalacia,
- Hyperkalemia, from the accumulation of potassium in the blood,
- Anemia,
- Lactic acidosis, and
- Heart disease.
Shouse Law Group is bringing Truvada lawsuits on behalf of patients who took the drug and suffered these serious side effects. In this article, we will discuss:
- 1. What is Truvada?
- 2. What is TDF?
- 3. Kidney failure and the medical complications it can cause
- 4. Medical studies show TDF and Truvada cause kidney failure
- 5. Lawsuits over kidney injuries caused by TDF and Truvada
1. What is Truvada?
Truvada is an HIV treatment manufactured by the pharmaceutical company Gilead Sciences, Inc. It was approved for medical use by the U.S. Food and Drug Administration (FDA) in 2004,1 making it one of the first drugs released by Gilead to treat HIV.
Truvada works by stopping HIV cells that have already entered the body from replicating and spreading.
Before Gilead’s line of HIV drugs came out, the only effective HIV treatment could only be administered intravenously. Gilead’s development of a pill-based drug represented a huge development in HIV treatment. However, Truvada and Gilead’s other HIV drugs only treated HIV. It did not cure people who had contracted the disease, and so had to be continually taken by people who were at risk of catching HIV.
Despite these limitations, Truvada and Gilead’s other HIV drugs have been a popular prophylactic choice for people who are in intimate relationships with people who are HIV-positive.
2. What is TDF?
TDF, or tenofovir disoproxil fumarate, is one of the two drugs that make up Truvada. The other drug is emtricitabine.
While Truvada is split between these two drugs, it is TDF that is the central ingredient of HIV treatment. In fact, all of Gilead’s other drugs include TDF as their core component, including the drugs:
- Truvada,
- Complera,
- Atripla,
- Symfi-Lo,
- Viread,
- Cimduo, and
- Stribild.
In addition to being a very powerful drug, though, TDF is also very toxic. Worse, very little of the drug gets absorbed in the body. High doses of TDF are necessary for the drug to be effective at containing HIV cells. Together with TDF’s toxicity levels, the high doses can cause severe side effects, though people who take Truvada are often willing to deal with those side effects so they do not get HIV.
3. Kidney failure and the medical complications it can cause
Kidney damage and kidney failure are two of the severe side effects of Truvada and other HIV drugs that rely on TDF.
Kidney damage is a medical condition that lowers the effectiveness of a patient’s kidneys. When that damage becomes so severe that the kidneys are no longer able to function well enough for a patient to survive without a transplant or dialysis, it becomes kidney failure, or renal failure.
3.1. Symptoms of kidney damage
There are no symptoms of kidney damage in its early stages. However, as the damage gets progressively worse, the following symptoms may begin to appear:
- Fatigue,
- Sleeping problems,
- Muscle cramps,
- Shortness of breath,
- Nausea,
- Vomiting,
- Increased or decreased amounts of urine,
- Confusion,
- Decreased appetite,
- Weight loss, and
- Swelling in the legs, feet, and ankles.
Most instances of kidney damage are discovered only after a urine test. If protein is found in the patient’s urine, it is a strong sign that there is kidney damage. Follow-up ultrasound tests are often used to confirm the diagnosis.
3.2. Symptoms of kidney failure or renal failure
Once the damage reaches the point that the kidneys can no longer function well enough on their own, the following symptoms can appear:
- Potentially dehydrating vomiting or diarrhea,
- Nausea,
- Weight loss,
- Itching,
- Pain in the lower back or the side,
- Muscle cramps,
- Paralyzed muscles,
- Heart arrhythmias,
- Blood in the urine,
- Very little or, more frequently, far more urine than normal,
- Difficulties urinating, and
- Urinating during sleep.
3.3. Medical complications caused by kidney failure
In addition to these symptoms, the failure of one or both kidneys causes a backup in the body’s excretion systems. This can lead to some other very serious medical complications as the rest of the body has to deal with it, including:
- Anemia, as hormones produced by the kidneys decreases, lowering the production of red blood cells,
- Hyperkalemia, as potassium builds up in the bloodstream,
- Polycystic kidney disease, which causes bubbles of fluid to form on the kidneys and liver,
- Osteomalacia, or bone damage from the altered levels of phosphates in the bloodstream, which the kidneys used to be able to filter,
- Fluid buildup as the kidneys are no longer able to excrete the volume of fluid as before, causing high blood pressure, swelling, and forcing fluid into the lungs,
- Lactic acidosis, and
- Heart disease.
While many of these medical conditions are severe or even life-threatening, the bone damage that can be caused by renal failure is especially problematic for people taking TDF drugs. This bone damage, or osteomalacia, can exacerbate the bone density loss that TDF toxicity already causes on a patient’s bone structure.
4. Medical studies show TDF and Truvada cause kidney failure
There are plenty of studies that suggest Truvada and other TDF-based HIV drugs cause kidney damage and, eventually, kidney failure.2
When Gilead Sciences, Inc. was first exploring TDF as a drug to treat HIV, it conducted clinical trials that compared it to the existing HIV treatment, stavudine. This old HIV treatment was known for causing kidney problems, and its warning label told doctors not to prescribe it to anyone with impaired kidney function.3 The TDF trials determined that there was little difference between the two drugs on the kidneys, suggesting that Truvada and TDF would also pose a threat of causing kidney damage and failure.4
Numerous medical studies followed suit.
Several cohort studies found an increased risk of kidney problems with people who took TDF, compared to those who did not.5 Another observational cohort study estimated that people who took TDF-based HIV drugs like Truvada suffered nephrotoxicity, or a poisoning of the kidneys that was bad enough to stop HIV treatment, at the increased rate of 1% per year.6
As early as 2010, one meta-analysis looked at the then-existing medical literature surrounding TDF drugs and HIV treatment, and found a widespread agreement that TDF drugs caused kidney damage and kidney failure. Even though many studies were published after this meta-analysis, it still noted 11 studies, totaling 5,767 participants, that reported a significantly greater loss of kidney function in people taking TDF drugs compared to the control group.7
Subsequent studies continued to indicate that Truvada and other TDF drugs caused kidney damage and failure. One covered 10,841 HIV-positive individuals in San Francisco – nearly double the size of all of the 11 studies covered in the earlier meta-analysis. This San Francisco monitored the participants’ urine for protein, a strong indication of early kidney damage. Even after controlling for environmental factors, age, and health, it found that there was a 34% increased chance of developing kidney damage for every year a patient was taking TDF. There was also a 33% increase for developing chronic kidney disease, and an 11% increase for a sudden and steep decline in kidney function.8
5. Lawsuits over kidney injuries caused by TDF and Truvada
Injuries caused by kidney damage and kidney failure created by Truvada and other TDF drugs have led to hundreds of lawsuits being filed against Gilead Sciences, Inc. These lawsuits claim that Gilead failed to warn people of the risks of taking their HIV treatments, and also claim that Gilead withheld its safer alternatives of the drugs – those based on TAF, rather than TDF – for years to pad its bottom line.
These TDF lawsuits have not just been filed over injuries suffered when victims have taken Truvada. There are also hundreds of:
There are even dozens of Genvoya lawsuits, for kidney damage allegedly caused by one of Gilead’s supposedly safer TAF drugs.
All of these lawsuits seek compensation for:
- Pain and suffering,
- Medical expenses,
- Professional ramifications of a long and arduous recovery, and
- Loss of companionship.
They also demand punitive damages be assessed against Gilead for its egregiously careless behavior.
Because all of these lawsuits involve similar victims with similar injuries that were sustained through the same course of conduct, they are presently being consolidated into an MDL (multidistrict litigation) out of the Northern District of California (federal court). An MDL is where similar lawsuits are consolidated to speed up litigation and a settlement. The Truvada MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.
Legal References:
- FDA – Approval Letter for Truvada (August 2, 2004).>
- See generally, Ustianowski A, Arends JE, “Tenofovir: What We Have Learnt After 7.5 Million Person-Years of Use,” Infectious Diseases and Therapy 4(2):145-57 (June 2, 2015).>
- Zerit Warning Label.>
- Gallant JE, et al., “Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial,” Journal of the American Medical Association 292(2):191-201 (July 14, 2004).>
- See e.g., Buchacz K, Young B, Baker RK, Moorman A, Chmiel JS, Wood KC, Brooks JT, “Renal function in patients receiving tenofovir with ritonavir/lopinavir or ritonavir/atazanavir in the HIV Outpatient Study (HOPS) cohort,” Journal of Acquired Immune Deficiency Syndromes 43(5):626-8 (December 15, 2006), Gallant JE, Parish MA, Keruly JC, Moore RD, “Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment,” Clinical Infectious Diseases 40(8):1194-8 (April 15, 2005).>
- Fux CA, Simcock M, Wolbers M, et al., “Tenofovir use is associated with a reduction in calculated glomerular filtration rates in the Swiss HIV Cohort Study,” Antiviral Therapy 12(8):1165-73 (2007).>
- Cooper RD, Wiebe N, Smith N, Keiser P, Naicker S, Tonelli M, “Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients,” Clinical Infectious Diseases 51(5):496-505 (September 1, 2010).>
- Scherzer R, Estrella M, Li Y, Choi AI, Deeks SG, Grunfeld C, Shlipak MG, “Association of tenofovir exposure with kidney disease risk in HIV infection,” AIDS 26(7):867-75 (April 24, 2012) and Steve Tokar, “Tenofovir, Leading HIV Medication, Linked with Risk of Kidney Damage,” University of California – San Francisco News Report (February 10, 2012).>