The side effects of Truvada and TDF are several potentially life-threatening complications, including decreased bone density, lactic acidosis, and renal failure. These side effects have led to hundreds of Truvada lawsuits against Gilead Sciences, Inc., the maker of Truvada and other TDF-based HIV drugs. Those lawsuits seek compensation for losses caused by the side effects of TDF, including:
- Medical expenses,
- Pain and suffering,
- Lost wages and other professional problems, and
- Loss of consortium for the victim’s loved ones.
- 1. What are Truvada and TDF?
- 2. Side effects of Truvada and TDF
- 3. TDF and Truvada lawsuits
1. What are Truvada and TDF?
Truvada is a pill-based drug that works as a prophylactic treatment for HIV. Truvada is manufactured by Gilead Sciences, Inc. By preventing HIV cells from multiplying, it works as a treatment for HIV. However, the drug does not kill those HIV cells, it is not a cure for the disease. Instead, Truvada has to be taken for as long as someone is at risk of developing HIV or AIDS.
TDF, or tenofovir disoproxil fumarate, is one of the major components of Truvada and many other HIV pills produced by Gilead. TDF is also found in:
- Symfi-Lo, and
All but one of these other drugs mix TDF with other drugs that complement the effect TDF has on HIV cells. Only Viread is solely comprised of TDF.
TDF has been around since the 1980s, but was not feasible for HIV treatment because it had to be taken intravenously. It was only when Gilead bought the rights to TDF and modified the drug so it could be taken orally in pill form that it started getting used to prevent HIV from spreading.
Gilead has used TDF in its prophylactic HIV treatments since 2001 when it got approved by the U.S. Food and Drug Administration (FDA) for its inaugural HIV drug, Viread.1
2. Side effects of Truvada and TDF
Truvada, and all of Gilead’s other TDF-based HIV pills, can cause a handful of common side effects, including:
- Skin rashes,
- Discolored skin,
- Breathing troubles,
- Muscle pain,
- Fatigue and weakness,
- Stomach and abdominal pain,
- Nightmares, and
The people taking Truvada often consider these minor side effects to be worth it for the protection from the spread of HIV that it affords. However, there are also several far more severe side effects that have been linked to Truvada and TDF. These are:
- A decrease in bone density,2
- Kidney damage,3 and
- Lactic acidosis.4
Each of these side effects can be severe or even fatal. They can also cause a host of other medical complications that drastically impair a victim’s quality of life.5
2.1. Decrease in bone density
One of the serious side effects of Truvada and other TDF drugs is a decrease in bone density.6 In some cases, this decrease can be severe enough to amount to osteoporosis. One result of this decrease is a sharply heightened risk of suffering a broken bone.
The negative impact that TDF could have on a patient’s bone density was clear even in early randomized clinical studies.7 Those clinical studies compared TDF-based HIV drugs with stavudine, an existing HIV drug marketed under the name Zerit, and found that TDF lowered spinal bone densities by 2.2% over three years, while Zerit only caused a 1.0% decrease.8
The true extent of the decrease in bone density, however, did not become apparent until Gilead released its new line of HIV drugs that replaced TDF with tenofovir alafenamide fumarate, or TAF. At that point, Gilead no longer wanted to cover up TDF’s serious side effects, and actually wanted to trump them up as reasons for patients to switch over to its new drugs. One of those studies found a decrease in bone density as high as 3.8% after only 48 weeks.9
The decrease in bone density that is caused by TDF drugs like Truvada is especially problematic because the people taking them are already likely to suffer bone density problems caused by their HIV infection. One study estimated that up to 9 in 10 HIV-positive people suffer from bone mineral densities that are low enough to be diagnosed as osteoporosis.10 This strong probability is almost certainly behind the increased risk that HIV-positive people face for bone fractures, which one study says is 60% higher than for people who do not have HIV.11 With the additional bone density problems caused by TDF drugs, HIV-positive people who take Truvada can have even high rates of broken bones.
Adding to the evidence that TDF drugs like Truvada decrease bone density is a medical study that found bone density actually increases once people stop taking Truvada, returning to their baseline levels within a year.12
2.2. Kidney damage
A potentially more fatal side effect of Truvada and other TDF drugs is the toll that TDF takes on a patient’s kidney function. The kidney damage can become so bad that it leads to kidney failure, also known as renal failure, and all of its attendant complications.
The kidney damage caused by TDF-based HIV drugs like Truvada was also known early on. The standardized clinical trial that compared TDF with the drug stavudine stated that the “renal safety profile was similar” between the two drugs, making TDF a significant threat to a patient’s kidneys.13 One meta-analysis found 11 other medical studies that all found people taking TDF-based HIV drugs suffered a “significantly greater loss of kidney function over the course of treatment” than study participants in the control groups.14
This kidney damage from TDF drugs accumulates over time, as kidney function declines and the kidneys struggle to continue to process and expel TDF. As the damage grows, it can reach a stage of renal failure, where the kidneys stop functioning, entirely.
2.3. Lactic acidosis
One of the worst complications of renal failure is lactic acidosis.
Lactic acidosis is caused by poorly functioning or damaged kidneys. Kidneys regulate the amount of lactic acid in the bloodstream. When kidney function declines, lactate can build up in the blood. Because it is acidic, the accumulation of lactate can slowly lower the pH level of the blood. Early on in this process, the condition is known as hyperlactatemia. The symptoms of hyperlactatemia do not betray the severity of the underlying problem:
- Abdominal pain,
- Vomiting, and
As the blood becomes more acidic, hyperlactatemia can become full-blown lactic acidosis. This condition can come with a host of medical complications, including:
- Cardiac arrhythmia, and
- Organ failure.
There are indications that Truvada or other HIV treatments that use TDF can independently cause lactic acidosis or hyperlactatemia without deteriorating the kidneys, first.15 One study found that these drugs blocked the production of both HIV cells as well as DNA cells. Blocking the latter could lead to the development of lactic acidosis.16
One cohort study estimated that 8-21% of people developed hyperlactatemia while on TDF drugs, while 1-2% developed severe lactic acidosis.17
While people taking TDF-based HIV drugs like Truvada rarely develop lactic acidosis, the condition is fatal around half of the time.18 It usually begins to develop within the first 20 months of taking Truvada or other TDF-based drugs.19
3. TDF and Truvada lawsuits
The side effects of Truvada and other TDF-based HIV treatments have led to hundreds of lawsuits against Gilead Sciences, Inc. These lawsuits claim that Gilead failed to warn doctors and patients of the risks of taking their drug by not mentioning the severe side effects on the TDF drug’s warning label, even though the company knew the risks existed. The lawsuits also claim that Gilead had developed a safer alternative to TDF but did not release it in order to maximize their period of market protection from generic versions of the drug.
The lawsuits seek punitive damages as well as compensation for:
- Medical expenses,
- Pain and suffering,
- Lost wages, and
- Loss of consortium.
In addition to Truvada lawsuits, many other Gilead’s HIV drugs have spawned their own litigation. There are:
At first, most of these lawsuits were being filed individually by victims. There is also a class-action lawsuit of victims who live in California.20 And presently, there is an 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.
- FDA Approval Letter for TDF.
- Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky, “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (2010).
- Willem D.F. Venter, June Fabian, and Charles Feldman, “An overview of tenofovir and renal disease for the HIV-treating clinician,” South African Journal of HIV Medicine 19(1):817 (2018).
- Pablo Rivas, Jorge Polo, Miguel de Górgolas, Manuel L Fernández Guerrero, “Drug points: Fatal lactic acidosis associated with tenofovir,” British Medical Journal 327:711 (2003).
- 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).
- See generally, Grigsby IF, Pham L, Mansky LM, Gopalakrishnan R, Mansky KC, “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (February 2, 2010) and Grant PM, Cotter AG, “Tenofovir and bone health,” Current Opinion in HIV and AIDS 11(3):326-32 (May 2016).
- 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 note 7.
- Mills A, et al., “Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study,” Journal of Acquired Immune Deficiency Syndromes 69(4):439-45 (August 1, 2015).
- Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA, “Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen,” Journal of Acquired Immune Deficiency Syndromes 51(5):554-61 (August 15, 2009).
- Shiau S, Broun EC, Arpadi SM, Yin MT, “Incident fractures in HIV-infected individuals: a systematic review and meta-analysis,” AIDS 27(12):1949-57 (July 31, 2013).
- Glidden DV, et al., “Recovery of Bone Mineral Density Following Discontinuation of Tenofovir-Based HIV Pre-Exposure Prophylaxis,” Journal of Acquired Immune Deficiency Syndromes 76(2):177-82 (October 1, 2017).
- See note 7.
- 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).
- See Murphy MD, O’Hearn M, Chou S, “Fatal lactic acidosis and acute renal failure after addition of tenofovir to an antiretroviral regimen containing didanosine,” Clinical Infectious Diseases 36(8):1082-5 (April 15, 2003).
- Kakuda TN, “Pharmacology of nucleoside and nucleotide reverse transcriptase inhibitor-induced mitochondrial toxicity,” Clinical Therapeutics 22(6):685-708 (June 2000).
- Boubaker K, et al., “Hyperlactatemia and antiretroviral therapy: the Swiss HIV Cohort Study,” Clinical Infectious Diseases 33(11):1931-7 (December 1, 2001).
- Falcó V, et al., “Severe nucleoside-associated lactic acidosis in human immunodeficiency virus-infected patients: report of 12 cases and review of the literature,” Clinical Infectious Diseases 34(6):838-46 (March 15, 2002).
- See note 18.
- Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).