Atripla Lawsuit in 2024 (Get the Right Attorney)

What is Atripla?

Atripla (generic: efavirenz/tenofovir disoproxil fumarate TDF) is a dangerous drug that treats human immunodeficiency virus (HIV), the infection that causes acquired immunodeficiency syndrome (AIDS). It doesn’t cure HIV or AIDS, but instead may slow the disease’s progress and prolong life. Atripla is manufactured by Gilead Sciences, and was approved by the U.S. Food and Drug Administration (FDA) in July 2006.

What’s the Problem with HIV Medications?

Pending lawsuits allege that the TDF medication tenofovir disoproxil fumarate, the active ingredient in Atripla, contributes to kidney problems and bone demineralization due to compromised bone density, which has led to serious side effects in some patients.

Atripla Side Effects

Health complications linked to Atripla include:

• • Bone injuries
  • Bone mineral loss
  • Bone loss
  • Nervous system problems

• Bone fractures
• Severe bone loss
• Osteopenia
• Osteoporosis
• Acute renal failure
• Declining kidney function
• Kidney damage
• Kidney toxicity
• Chronic kidney disease (CKD)
• Kidney failure (renal failure)
• Liver problems
• Lactic acidosis
• And more

What are TDF Medications?

Atripla is an antiretroviral drug that is marketed as a safer HIV drug that belongs to a group of highly toxic TDF medications known as NRTIs (nucleoside reverse transcriptase inhibitors). NRTI drugs work by blocking a specific enzyme called reverse transcriptase (RT). The RT enzyme helps certain types of cells copy their DNA and replicate themselves through a process called reverse transcription.

Retroviruses such as HIV (human immunodeficiency virus) utilize the RT enzyme in their early stages to duplicate and fuel the progression and expansion of the virus inside the body. TDF drug doesn’t kill the virus so it cannot cure HIV/AIDS.

“Atripla can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, severe skin rash and allergic reactions, mental health problems, and new or worsening kidney problems, including kidney failure,” stated Laura Bachmann, MD, MPH, FIDSA, FACP, Acting Director, Division of STD Prevention, National Center for HIV

However, by blocking the RT enzyme, Atripla is a safer drug by effectively preventing the HIV cells from multiplying. When used in combination with other drugs, TDF can not only stop HIV from growing but reduce the amount of HIV in the system.

TDF was developed and patented by Gilead Sciences Inc. In 2001, the U.S. Food and Drug Administration (FDA) approved TDF for use in the treatment of HIV infection. Atripla was a groundbreaking drug and soon after its release, hundreds of thousands of people living with HIV-1 were using it to manage their condition. If left untreated, HIV can destroy the body’s immune system and be fatal. Viread drastically changed the outlook and prognosis of countless HIV patients.

Unfortunately, the amazing benefits of Atripla came with a fairly heavy price tag. Medical records indicate that TDF is not easily absorbed into the body. As a result, users must take very high doses of the drug for it to have any effect.

According to the National Center for Biotechnology Information, this meant that Atripla had a long list of potential side effects including problems with the kidneys and loss of bone density. Some studies have now confirmed that continued use of Viread can cause acute kidney failure, cancer, and osteoporosis and the incidence rate of these side effects is alarmingly high [1].

Which Other HIV Drugs Contain Tenofovir?

In addition to Atripla, other HIV Medications that contain tenofovir include:

• Complera
• Stribild
• Truvada
• Viread

Has Atripla Been Recalled?

No. Despite the risk of serious side effects from Atripla and tenofovir, no recall has been issued for it or any other HIV medication in its class. However, in Oct. 2018, the U.S. Department of Health and Human Services (DHHS) downgraded Atripla from a “recommended” regimen to an “alternative” regimen for people just beginning antiretroviral therapy (ART).

Chronic Kidney Disease Symptoms

• Decreased urine output, although occasionally urine output remains normal
• Fluid retention, causing swelling in your legs, ankles or feet
• Shortness of breath
• Fatigue
• Confusion
• Nausea
• Weakness
• Irregular heartbeat
• Chest pain or pressure
• Abdominal pain
• Seizures or coma in severe cases

AIDS Healthcare Foundation Files Atripla Class Action Lawsuit Over Kidney Injuries

AIDS Health Foundation (AHF), the largest global AIDS organization, helped file a class action lawsuit against drug companies on behalf of Devin Martinez, Ricardo Wohler, and others who purchased Truvada and other TDF drugs in May 2018.

This California lawsuit is separate from the individual personal injury lawsuits filed by people who suffered injuries from TDF, but it deals with similar issues.

According to the complaint, Gilead Sciences misrepresented TDF’s safety profile as early as 2001. The FDA even reprimanded Gilead Sciences 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 Sciences in the class action include:

• Failing to disclose that tenofovir disoproxil fumarate TDF had a significant risk for toxicity, bone loss, and kidney damage
• Failed to warn consumers of the kidney, bone risks and minor trauma in all patients, not just those with preexisting kidney and bone density loss
• Gilead Sciences misrepresented the risks and benefits of its TDF drugs to sell them

Atripla Statistics and Facts

As stated by the NCBI, the majority of studies did not find a significantly higher risk of proteinuria, Atripla, or end-stage renal disease (ESRD) requiring dialysis in HIV patients treated with tenofovir compared to those receiving other antiretroviral drugs [2].

This is somewhat expected since CKD is a severe, irreversible manifestation of kidney toxicity that may take many years to develop. CKD may be asymptomatic until GFR is <30 mL/min/1.73 m². Thus, there is a real chance that nephrotoxicity might be overlooked, as serum creatinine may not rise above the upper limit of normal until GFR is <60 mL/min/1.73 m².

According to the NCBI, patients should be trained to collect 24-hour urine specimens for the calculation of creatinine clearance, since estimating glomerular filtration rate (GFR) based on serum creatinine using the Modification of Diet in Renal Disease (MDRD) or Cockcroft-Gault formulas may underestimate the degree of renal dysfunction in cases where muscle mass is lower than the standard for their age and sex, as is often the case with HIV-infected individuals [3].

Some observational cohort studies describing low rates of renal dysfunction with tenofovir use were of short duration. A recent meta-analysis of 13 studies (>5767 patients) reported a significantly faster loss of kidney function (−5.4 mL/min) in patients receiving tenofovir compared with control subjects (mean difference between groups in GFR loss estimated by the Cockroft-Gault formula: 3.9 mL/min; 95% confidence interval (CI), 2.1–5.7 mL/min).

As claimed by the NCBI, a crucial piece of information was missing: the time frame over which the 3.9 mL/min of renal function was lost. Clinical trials reported a significantly smaller degree of renal function loss compared to observational studies, with a mean decrease in estimated glomerular filtration rate (eGFR) of 1.5 versus 5.45 mL/min, respectively [4].

Similar results, albeit nonsignificant due to the smaller number of studies, were observed when GFR was estimated by the MDRD formula. In this regard, mean rates of eGFR loss as severe as −14.7 mL/min in less than 1 year (48 weeks) were reported in patients treated with tenofovir plus ritonavir-boosted protease inhibitor regimes and this was significantly greater than that in patients treated with tenofovir plus nonnucleoside reverse transcriptase inhibitor regimes or regimes without tenofovir (−4.5 mL/min).

According to the NCBI, declines in GFR averaging 7–10 mL/min/year have been reported in subjects treated with tenofovir [5]. This is not a modest rate of eGFR decline. This rate of decline is observed in diabetic or Fabry nephropathies and if maintained over time it will lead to ESRD in 10 years.

As a reminder the age-related estimated loss of GFR is −1 mL/min/year. Slower rates of decline in eGFR were observed in clinical trials of selected populations and unselected cohorts. However, some of the estimates reporting lower rates of GFR loss are not reliable due to a high rate of missing values during follow-up, which might have been biased by the loss of patients with nephrotoxicity.

For example, in a safety data analysis from France, Germany, and Italy values for serum creatinine were available at baseline for 2790 patients, but follow-up data were available only for 1704 patients: nearly 40% of patients lacked follow-up creatinine values.

Can I File a Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against Gilead Sciences, the maker of Atripla, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

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 Atripla, our attorneys suspect that patients may be able to take legal action in light of claims that Gilead Sciences failed to adequately warn doctors and patients about the risk of kidney damage and bone problems.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of HIV drugs, you may be entitled to collect legal 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 manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.

See all related dangerous drug lawsuits our attorneys covered so far.

Get a Free Atripla Lawsuit Evaluation With Our 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 Atripla lawsuits. We are handling individual litigation nationwide and currently accepting new kidney injuries and bone fracture cases in all 50 states.

Free Atripla Lawsuit Evaluation: Again, if you were harmed by the side effects of Atripla, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit for medical bills and pain and suffering, and we can help.

References:

1. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/37/whats-new-in-the-guidelines
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/#B11
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/#B44
5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/#B21
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119412/#B10