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Table Of Contents
- What is Truvada?
- How Does it Work?
- What’s the Problem with HIV Treatment Drugs?
- Judge Clears Suit Alleging Gilead HIV Drugs Defectively Designed
- Scientific Findings on Truvada
- Which Other HIV Medications Have Been Linked to These Side Effects?
- Are Truvada Lawsuits Being Filed?
- Truvada Litigation
- AIDS Healthcare Foundation Files Truvada Class Action Lawsuit
- Has There Been a Recall?
- Truvada Lawsuit 2025: Are You Eligible for Compensation?
- How Can Filing a Lawsuit Help Me?
- FAQs
- Get a Free Truvada Lawsuit Evaluation With Our Personal Injury Lawyers
What is Truvada?
As claimed by the manufacturer, Truvada (tenofovir disoproxil fumarate TDF) is one of several pre-exposure prophylaxis medications that are currently used to treat human immunodeficiency virus (HIV) and hepatitis B virus infection [1].
The drug is sometimes considered a safer HIV drug for some people who do not have HIV infection (for example, those who do not always use condoms or who have a sex partner that has HIV infection) to help reduce their chances of getting an HIV infection. Truvada was approved by the U.S. Food and Drug Administration in 2012.
How Does it Work?
Truvada prevents HIV infection by blocking the virus’s ability to replicate inside human cells. Understanding how Truvada works can help individuals make informed decisions about its use and effectiveness in HIV prevention.
Detailed Comparison of TDF vs. TAF Effectiveness
As HIV prevention and treatment continue to evolve, newer formulations of tenofovir have been developed to improve safety while maintaining efficacy.
One such advancement is tenofovir alafenamide (TAF), which provides similar effectiveness to tenofovir disoproxil fumarate (TDF) but with a reduced risk of kidney and bone-related side effects
Understanding the differences between these two drugs can help individuals make informed decisions about their treatment options.
Key Differences Between TDF and TAF Drugs
While both TDF and TAF are effective at preventing HIV, their impact on long-term health differs significantly. TDF has been linked to kidney and bone issues, whereas TAF has been developed to minimize these risks while maintaining strong antiviral protection.
The table below outlines the most important distinctions between the two formulations:
| Feature | TDF (Truvada and Similar Drugs) | TAF (Newer Alternative) |
|---|---|---|
| Efficacy | Highly effective for PrEP and HIV treatment | Similar efficacy in preventing HIV |
| Kidney Impact | Higher risk of kidney damage, including acute kidney injury and Fanconi Syndrome | Lower risk of kidney toxicity due to lower drug accumulation in the blood and kidneys |
| Bone Density | Increased risk of bone loss, osteopenia, and osteoporosis | Less impact on bone mineral density, reducing the likelihood of fractures |
| Drug Concentration in Blood | Higher concentration of tenofovir in the blood | Lower concentration, reducing toxicity risks |
| Overall Safety Profile | Known to cause kidney and bone complications, especially with long-term use | Considered a safer alternative, with fewer kidney and bone side effects |
These differences highlight why many healthcare providers are considering TAF-based medications for patients who need long-term HIV treatment or prevention.
What This Means for Patients?
The choice between TDF and TAF is crucial for individuals who are looking for the safest and most effective HIV treatment.
While TDF-based drugs like Truvada have been widely used for years, their higher risk of kidney and bone complications has led to the development of TAF-based alternatives that offer a better safety profile.
- TDF (found in Truvada and similar drugs) is highly effective for both PrEP and HIV treatment but has been associated with long-term kidney damage and bone loss.
- TAF is designed to be a safer alternative by maintaining effectiveness while reducing risks to the kidneys and bones.
- TAF works at a lower drug concentration in the bloodstream, preventing excess buildup in kidneys and bones, which reduces the likelihood of toxicity.
For individuals who are already experiencing kidney or bone issues, switching to TAF-based medication may be a safer and more sustainable option.
Should You Switch from TDF to TAF?
Given the differences between TDF and TAF, many individuals may wonder whether they should switch to a TAF-based medication. The answer depends on individual health factors, risk level, and long-term treatment goals.
If you are currently taking Truvada (TDF-based PrEP) or another TDF medication, it’s worth discussing alternative TAF-based options with your healthcare provider, especially if:
- You have a history of kidney disease or reduced kidney function.
- You have osteoporosis or concerns about bone density loss.
- You plan to take HIV medication long-term and want to reduce future health risks.
While TDF-based drugs remain effective, newer TAF-based medications offer a safer alternative with fewer risks.
Always consult your doctor before making any medication changes to ensure the best treatment plan for your specific health needs.
By taking proactive steps, you can protect your long-term health while continuing to benefit from effective HIV prevention or treatment.
Drug Interaction Information
Since Truvada is primarily processed through the kidneys, certain medications can interfere with its effectiveness or increase the risk of side effects.
Medications That Require Caution with Truvada
- NSAIDs (e.g., ibuprofen, naproxen) – May increase kidney strain.
- Other HIV medications – Taking Truvada alongside certain antiretrovirals can lead to higher tenofovir levels, increasing toxicity risks.
- Medications for Hepatitis B – Truvada also treats Hepatitis B, so stopping it abruptly could cause severe flare-ups in people with HBV.
By understanding how Truvada works and following best practices for adherence, individuals can take full advantage of its life-changing benefits while minimizing risks.
What’s the Problem with HIV Treatment Drugs?
According to the Clinicalinfo.HIV.gov research from 2023, Truvada side effects can be [2]:
- Acute or chronic kidney disease – When damage to the kidneys prevents them from filtering blood properly. Anything below 90 GFR (glomerular filtration rate) is abnormal. Truvada‘s “poor bioavailability” keeps the body from efficiently absorbing the drugs. This leads to kidney problems and kidney injuries.
- Kidney failure – occurs when kidney disease is left untreated. Patients would then need a kidney transplant or dialysis to filter waste from their blood. Kidney function failure can be acute or chronic.
- Fanconi Syndrome – Occurs when impaired kidney tubule function affects the urine’s chemical makeup. This includes abnormal protein levels in the urine, called proteinuria. Fanconi Syndrome can lead to kidney damage and bone loss.
- Osteopenia – Medical condition characterized by weakened bone mineral density (including teeth). If left untreated, it could lead to breaks and fractures.
- Osteoporosis – occurs when bones become brittle and fracture easily.
- Osteomalacia – When bones break down more quickly than they can re-form.
Judge Clears Suit Alleging Gilead HIV Drugs Defectively Designed
U.S. District Judge Jon S. Tigar has allowed a lawsuit against Gilead Sciences Inc. to proceed, filed by a group of patients accusing the company of negligence, product liability, and defective drug design.
However, he dismissed allegations that Gilead intentionally hid knowledge that its tenofovir disoproxil fumarate (TDF)-based HIV drugs were “unreasonably and unnecessarily unsafe.”
Despite this, key claims remain in the case, including:
- Design defect – Plaintiffs argue that TDF drugs had a flawed formulation that led to serious health risks.
- Negligence – The lawsuit claims Gilead failed to act responsibly in designing, testing, and warning patients about risks.
- Product liability – Allegations include the failure to ensure patient safety and market a safer alternative (TAF) sooner.
This lawsuit underscores growing concerns over the long-term safety of TDF-containing drugs like Truvada, especially their impact on kidney and bone health.
Scientific Findings on Truvada
Recent research has raised significant concerns about the long-term effects of Truvada, particularly its impact on bone health and kidney function.
Studies have shown measurable declines in bone mineral density and a heightened risk of kidney complications, underscoring the need for closer monitoring and proactive healthcare strategies for individuals on TDF-based medications.
Bone Density Loss Linked to Truvada
One recent study found that patients taking Truvada experienced bone mineral density (BMD) loss of 2-6% within the first two years of treatment.
The study also revealed that:
- This decline is particularly concerning for individuals at risk of osteoporosis or fractures.
- Long-term use may increase the likelihood of developing osteopenia or osteoporosis, requiring additional monitoring and preventive measures.
Given these findings, bone health screenings and calcium/vitamin D supplementation may be necessary for individuals on long-term Truvada therapy.
Kidney Function Decline and Truvada
A large-scale study conducted by researchers at the University of San Francisco examined 10,000 patients and found a direct link between Truvada and kidney complications, including [3]:
- Proteinuria – High levels of protein in urine, indicating kidney damage.
- Rapid decline in kidney function – Accelerated deterioration of renal filtration capacity.
- Chronic Kidney Disease (CKD) – Long-term kidney dysfunction, increasing the risk of kidney failure.
- Kidney failure – A life-threatening condition requiring dialysis or transplantation.
These findings support concerns raised in lawsuits that Gilead was aware of these risks but continued marketing TDF-based drugs without adequate warnings.
Increased Protein Levels in Urine (Proteinuria) in iPrEx Study
The iPrEx study, a major clinical trial on PrEP effectiveness, found no significant differences in markers of kidney damage between treatment arms.
However, in the iPrEx-OLE (open-label extension) study, more concerning data emerged:
- After 24 weeks on PrEP, patients experienced [4]:
- 21% increase in urine α1m levels (a marker of kidney damage)
- 18% increase in proteinuria (95% confidence interval: 8 to 28)
These results suggest that long-term PrEP use with TDF-based medications may lead to gradual kidney damage even in individuals without pre-existing conditions.
Given these findings, patients taking Truvada should undergo routine kidney function tests to monitor for early signs of deterioration, especially if they have pre-existing kidney issues or risk factors such as diabetes or hypertension.
Among the 200 participants included in the cross-sectional iPrEx substudy, the median age was 23 years and 18% of participants were transgender. Persons of black race comprised 11% of participants, whereas Asians and Latinos comprised 27% and 54% of participants, respectively. – Stated the National Center for Biotechnology Information.
Which Other HIV Medications Have Been Linked to These Side Effects?
Truvada and other tenofovir disoproxil fumarate (TDF)-based drugs—including Atripla, Stribild, Complera, and Viread—are widely used for HIV treatment and prevention (PrEP).
While effective, these medications can cause a range of mild to severe side effects that patients should be aware of.
Understanding how these symptoms progress and the key risk factors can help individuals take proactive steps in managing their health while on these medications.
Early Warning Signs and Progression Timeline
Recognizing the early warning signs of side effects can prevent more serious complications from developing.
Mild Symptoms (First Few Weeks)
- Many individuals experience headaches, nausea, diarrhea, dizziness, fatigue, abdominal pain, and weight loss shortly after starting Truvada or similar drugs.
- Some may develop mild upper respiratory infections.
- These symptoms often resolve within the first month as the body adjusts to the medication.
Progression to More Serious Symptoms (Months to Years)
- Kidney problems may develop or worsen, especially in patients with pre-existing conditions.
- Bone density loss (osteopenia, osteoporosis, osteomalacia) can occur gradually, leading to an increased risk of fractures.
- Lactic acidosis, a rare but life-threatening condition, has been reported in post-marketing surveillance, though it was not observed in clinical trials.
Because some side effects take months or years to appear, regular monitoring is essential for early detection and management.
Risk Factors for Developing Complications
While anyone taking Truvada or similar TDF medications can experience side effects, certain individuals are at a higher risk of developing serious complications:
Pre-existing Kidney Conditions
- People with reduced kidney function are at a higher risk of developing renal impairment while on TDF-based drugs.
- These individuals should have their kidney function monitored more frequently.
Liver Disease and Hepatitis B
- Patients with liver disease should be cautious, as Truvada and similar drugs can cause liver toxicity.
- Those with Hepatitis B (HBV) who stop taking Truvada abruptly may experience a severe worsening of their liver disease.
Age and Bone Health
- Older adults naturally experience decreased bone density, making them more prone to osteoporosis and fractures when taking TDF medications.
- Individuals with a family history of osteoporosis should discuss preventative strategies with their doctor.
By identifying these risk factors early, patients can take steps to minimize potential complications while continuing their HIV treatment or prevention regimen.
Monitoring Requirements and Recommended Tests
Routine medical tests can help detect issues before they become serious, ensuring that individuals using Truvada or similar medications remain in optimal health.
| Test | Purpose |
|---|---|
| Kidney Function Tests (eGFR, Creatinine Clearance) | Measure how well the kidneys are filtering waste. |
| Urine Tests | Check for proteinuria, an early sign of kidney damage (Fanconi Syndrome). |
| Bone Density Scans (DEXA Scan) | Assess bone mineral density, especially for long-term users. |
| Liver Enzyme Tests (ALT, AST, Bilirubin Levels) | Detect potential liver damage or toxicity. |
Regular screening helps ensure that any potential side effects are identified and managed early, preventing long-term complications.
Prevention Strategies While on Truvada and Similar Medications
While Truvada and other TDF-based drugs can cause side effects, there are steps individuals can take to minimize these risks and maintain overall health:
-
Stay Hydrated: Drinking plenty of water supports kidney function and may help reduce the risk of renal impairment.
-
Support Bone Health: Consume calcium- and vitamin D-rich foods to maintain bone strength and engage in weight-bearing exercises to prevent bone density loss.
-
Limit Alcohol and NSAID Use: Excessive alcohol intake can worsen liver function, especially for those at risk, also avoid NSAIDs (e.g., ibuprofen, naproxen) unless prescribed, as they can strain the kidneys.
-
Attend Regular Medical Check-ups: Follow-up appointments help detect side effects before they become serious, ensuring long-term health.
By understanding early warning signs, key risk factors, and proper medical monitoring, individuals can stay proactive about their health while using these medications.
Are Truvada Lawsuits Being Filed?
Only a qualified attorney can determine whether you are eligible to file a dangerous drug lawsuit against Gilead Sciences Inc., the maker of Truvada, which is why we are currently offering free case evaluations.
Simply fill out the confidential evaluation form below to contact our law firm now to see if you qualify for Truvada Lawsuit Settlements.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect.
In the case of a Truvada Lawsuit, our attorneys suspect that patients may be able to take legal action in light of claims that Gilead failed to adequately warn consumers about the risk of kidney disease and bone loss.
Truvada Litigation
Truvada lawsuits have been consolidated in the Northern District of California in multidistrict litigation (MDL). This is where similar lawsuits are consolidated to speed up litigation and a settlement.
The Truvada Lawsuit MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881. Currently, the first Bellwether trial is scheduled for June 2022.
Failure to Warn and Defective Design Claims
The bulk of the lawsuits deal with the claim that Gilead Sciences knew that Truvada carried serious design defects that caused severe side effects. Gilead also failed adequately to warn doctors or patients of those risks in its disclaimers.
The lawsuits claim that Gilead knew that the drug TDF was very toxic in the prescribed doses. The company even sought a safer version of it right after TDF was approved by the FDA in 2001. Nevertheless, Gilead continued to tout TDF and Truvada as “risk-free.”
The FDA reprimanded Gilead in 2002 and 2003 for false claims that TDF did not put a patient’s bone density or kidneys in jeopardy. Truvada continued to be marketed as a safe drug to maximize profits. This happened despite a growing body of scientific evidence to the contrary.
Claims that Gilead Withheld a Safer Drug
Lawsuits against Gilead Sciences allege that the company deliberately withheld a safer alternative to its tenofovir disoproxil fumarate (TDF)-based HIV medications.
This alternative, tenofovir alafenamide (TAF), was shown to be less toxic and more effective at lower doses.
- Higher Absorption, Lower Toxicity: Studies conducted before Truvada’s approval in 2004 found that TAF was absorbed more efficiently by the body, requiring a much lower dosage than TDF.
- Early Risk Warnings: These same studies also confirmed that TDF carried a much greater risk of kidney damage and bone density loss compared to TAF.
Despite this knowledge, Gilead chose not to release TAF at the time, raising concerns about whether financial motivations played a role in delaying its introduction.
Patent Protections and Market Control Over TDF
At the time of Truvada’s release in 2004, Gilead held a patent on TDF, meaning it would have years of exclusivity before generic competitors could enter the market.
- TDF Was Highly Profitable: Because TDF-based drugs were the dominant HIV treatment at the time, Gilead was able to set high prices per dose.
- Patents Delayed Generic Competition: With patent protection in place, there was no immediate financial incentive for Gilead to introduce a safer alternative like TAF.
Rather than prioritizing patient safety, lawsuits claim that Gilead stopped researching TAF in 2004 and instead focused on maximizing profits from TDF-based drugs.
Gilead’s Sudden Shift to TAF After TDF’s Patent Expiry
By 2010, Gilead’s exclusive TDF patent was nearing expiration, meaning the company would soon face competition from generic drug manufacturers.
Around this time, Gilead suddenly announced the discovery of a “new” breakthrough in HIV treatment – TAF.
- Reviving Old Research: Gilead began unveiling studies on TAF, many of which had been conducted years earlier but were previously unpublished.
- Marketing TAF as a Safer Option: The company promoted TAF-based drugs such as Genvoya, Odefsey, and Descovy, highlighting their lower risks of kidney and bone damage.
- Encouraging Patients to Switch: Patients taking older TDF-based medications were urged to switch to TAF-based alternatives, despite the fact that Gilead had known about TAF’s advantages for over a decade.
This timeline raised serious ethical concerns, leading to allegations that Gilead deliberately delayed the release of TAF in order to maximize profits from TDF for as long as possible.
Patient Risks and Lawsuit Allegations
Because Gilead allegedly withheld a safer alternative, HIV patients were exposed to severe health risks for nearly a decade.
The lawsuits argue that patients unnecessarily suffered from:
- Osteoporosis and Bone Fractures: Many patients developed bone density issues and suffered fractures due to long-term TDF use.
- Kidney Damage and Renal Failure: TDF’s impact on the kidneys led to cases of chronic kidney disease and, in some cases, complete kidney failure.
- Lactic Acidosis: A rare but life-threatening buildup of lactic acid in the blood was linked to TDF use.
The lawsuits claim that Gilead prioritized corporate profits over patient safety, delaying the introduction of a safer medication (TAF) for business reasons rather than scientific or regulatory concerns.
As these lawsuits progress, they aim to hold Gilead accountable for withholding a safer treatment option and demand compensation for the harm suffered by affected patients.
AIDS Healthcare Foundation Files Truvada Class Action Lawsuit
AIDS Health Foundation (AHF), the largest global AIDS organization, helped file the class action lawsuit on behalf of Devin Martinez, Ricardo Wohler, and others who purchased Truvada and other TDF drugs in May 2018.
This California class action lawsuit is separate from the individual injury lawsuits filed by people who suffered injuries from TDF, but it deals with similar issues.
According to the complaint, Gilead misrepresented TDF’s safety profile as early as 2001. The FDA even reprimanded Gilead in 2002 and 2003 for claiming the drug had no toxicities and would not cause bone or kidney damage, but the company continued to downplay the risks.
Allegations against Gilead in the class action include:
- Failing to disclose that TDF had a significant risk for toxicity and bone and kidney damage
- Failed to warn of the kidney and bone risks in all patients, not just those with preexisting kidney and bone problems
- Gilead misrepresented the risks and benefits of its TDF drugs to sell them
Has There Been a Recall?
Truvada is still available and has yet to be taken off the market. Despite the evidence linking the drug to several serious injuries, the FDA has not mandated a recall of the product.
If you are currently taking Truvada, talk to your doctor about other treatment options. Before stopping use, consult with your doctor to make sure that it is safe.
Truvada Lawsuit 2025: Are You Eligible for Compensation?
If you or a loved one suffered kidney damage, bone loss, or other serious health issues after taking Truvada or another TDF-based HIV drug, you may be eligible for a Truvada lawsuit in 2025.
Lawsuits against Gilead Sciences claim the company withheld a safer alternative (TAF) and failed to warn patients about the risks.
Use this decision guide to determine your eligibility, gather evidence, and take action before it’s too late.
1. Do You Qualify for Legal Action?
You may qualify for a Truvada lawsuit in 2025 if:
- You took Truvada, Atripla, Complera, Stribild, or Viread for HIV treatment or prevention (PrEP).
- You developed serious kidney conditions.
- You suffered bone density loss or related complications
- You were not warned about the risks, or your doctor was not informed of safer alternatives (e.g., TAF-based drugs like Descovy).
If you meet any of these conditions, you may have a strong case against Gilead Sciences for failing to disclose the risks of TDF medications.
2. What Evidence Do You Need?
To support your claim, you’ll need to collect medical records, prescriptions, and any documented side effects.
Key evidence includes:
Medical Evidence
- Doctor’s records confirming you were prescribed Truvada or another TDF-based drug.
- Lab results showing kidney issues (elevated creatinine, proteinuria, decreased eGFR).
- Bone scans indicating osteopenia or osteoporosis.
- Hospital or emergency records if you suffered fractures or kidney-related hospitalizations.
Prescription History
- Pharmacy records showing Truvada or other TDF drug prescriptions.
- Duration of use (how long you were taking the medication).
Personal Records
- Journal entries tracking symptoms and side effects.
- Communication with doctors regarding your concerns about kidney or bone health.
3. When Should You See a Doctor?
Even if you haven’t been diagnosed with kidney or bone problems, schedule a medical evaluation if you took Truvada and experience:
⚠️ Signs of Kidney Damage
- Unexplained fatigue
- Swelling in legs or feet
- Dark urine or frequent urination
- Nausea and loss of appetite
⚠️ Signs of Bone Loss
- Frequent fractures or broken bones
- Back pain
- Stooped posture
A doctor’s diagnosis can serve as crucial evidence for your claim.
4. Next Steps to Take
Step 1: Gather Your Medical and Prescription Records.
Request copies of your medical history, lab tests, and pharmacy records to document your Truvada use and any related health problems.
Step 2: Consult a Doctor for an Evaluation.
A medical assessment can confirm kidney disease or bone density loss, strengthening your case.
Step 3: Contact a Truvada Lawsuit Attorney.
An experienced lawyer will:
- Review your case for free
- Determine your eligibility for compensation
- Handle legal filings and negotiations
Step 4: Preserve Your Rights.
- Do NOT sign settlements without consulting an attorney.
- Document your symptoms and side effects.
- Stay informed on lawsuit deadlines and updates.
Thousands of lawsuits have already been filed against Gilead Sciences for withholding safer alternatives and failing to warn users about serious health risks.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of Truvada, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering.
Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.
FAQs
What should I do if I suspect Truvada caused my health issues?
If you suspect Truvada caused your health issues, consult with your healthcare provider, gather medical records, document your symptoms, and consult with a lawyer to evaluate your case and discuss potential legal action.
Can ongoing medical expenses be covered in a Truvada lawsuit settlement?
Yes, ongoing medical expenses can be included in a Truvada lawsuit settlement. Compensation may cover current and future medical treatments related to kidney damage or bone density loss caused by Truvada.
Can a Truvada lawsuit settlement include compensation for pain and suffering?
Yes, a Truvada lawsuit settlement can include compensation for pain and suffering. This non-economic damage compensates for the physical and emotional distress caused by health issues related to Truvada use.
What is the process for joining a Truvada class action lawsuit?
To join a Truvada class action lawsuit, contact a lawyer handling the case. They will evaluate your situation, gather necessary documentation, and include you in the collective legal action if your case meets the eligibility criteria.
Related Article: What is a Design Defect?
See all related dangerous drugs lawsuits our lawyers covered so far.
Get a Free Truvada Lawsuit Evaluation With Our Personal Injury Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Truvada lawsuits. We are handling individual litigation nationwide and currently accepting new kidney injury and bone fracture cases in all 50 states.
Free Case Evaluation: Again, if you suffered bone loss or another injury after taking Truvada or other dangerous drugs, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and a Truvada Lawsuit Attorney can help.
References:
- https://www.cdc.gov/hiv/pdf/prep_gl_patient_factsheet_truvada_english.pdf
- https://clinicalinfo.hiv.gov/en/drugs/emtricitabine-tenofovir-disoproxil-fumarate/patient
- https://www.ucsf.edu/news/2012/09/98692/study-underscores-truvadas-potency-preventing-transmission-hiv
- https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
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