Did You Use Complera & Develop Serious Bone Or Kidney Side Effects?

If you have used Complera or another tenofovir-based HIV medication (Viread, Atripla, Stribild, or Truvada), and you are now suffering from any of these problems as a side effect of taking the medication, you may be eligible for compensation for your injuries.

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complera side effects

Complera Bone Side Effect

  • Osteoporosis
  • Osteopenia
  • Decreased bone mineral density
  • Bone fractures
  • Tooth decay or tooth loss
  • Hypophosphatemia
complera side effects

Complera Kidney Side Effects

 

  • Kidney failure
  • Acute renal failure
  • Declining kidney function
  • Acute kidney injury
  • Fanconi Syndrome

Complera Side Effect Patients Forced Into Dialysis

 

Patients have reported serious kidney and urinary disorders ranging from renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis, nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, and polyuria after using the drug Complera.

 

With continued use, some patients have developed severe kidney problems where none had existed before or where there had been a prior history of only mild renal impairment. As a result, some of these patients have been forced to undergo intrusive and expensive dialysis treatments as a result.

 

Complera is a combination of 3 drugs used as a complete treatment regimen against HIV infection in adults and children over 35 kg with no antiretroviral treatment history and meeting other requirements determined by a healthcare professional.

 

The drug is composed of emtricitabine, rilpivirine, and TDF in fixed dosages of 200 mg emtricitabine, 27.5 mg rilpivirine, and 300 mg TDF. The standard dose is 1 tablet taken once per day. In combination the drugs block an HIV enzyme, which can prevent HIV from multiplying and reduce the total amount of HIV in the body.

 

Since the dosages are not alterable and kidney-related side effects can be substantial, Complera is not recommended for patients with already moderate to severe renal impairment.

 

It is recommended that after initiation of Complera use, patients have HIV-1 RNA and regimen tolerability monitored to determine the potential for virologic failure or rebound.

Complera Lawsuit

Patients taking Complera or another TDF medication for the treatment or prevention of HIV allege that they have experienced serious bone and kidney issues following their use of the medication, and that the drug manufacturer Gilead Sciences understated the side effects and withheld a more effective and less harmful drug in order to increase corporate profits.

The FDA Warned Gilead about Complera

Gilead was contacted by the FDA in writing on two separate occasions (once in 2002 and once in 2003) referencing incidents in which the company’s sales representatives violated the law by giving doctors and patients false or misleading information about side effects that did not accurately reflect the side effect statements listed on the drug label.

The first letter referred to incidents at a 2001 medical conference where Gilead’s representatives referred to these drugs as having “no toxicities” and being “extremely safe.” The then CEO of Gilead was quoted calling TDF a “miracle drug.”

The second letter took the rare action of requiring Gilead to retrain its sales staff due to “significant health and public safety concerns” over repeated false or misleading statements.

Along with other evidence, advocates are using these warnings to show that Gilead was aware and conspired to purposefully overstate the safety and effectiveness of its TDF medications.

Gilead Allegedly Conceals A New Less Toxic HIV Drug

Lawsuits have been filed by affected patients and their advocates in response to what they have alleged to be false or misleading statements made by Gilead about Complera. Plaintiffs in the lawsuits argue that Gilead understated the possible bone and kidney side effects for patients with no history of complications.

The lawsuits being filed also allege a sinister conspiracy undertaken at the highest levels of Gilead Sciences. Allegedly, to maximize profits and increase the value and life of their exclusive patent, Gilead chose to withhold a safer alternative drug that had been developed and tested even before the more dangerous drug had been brought to market.

The safer alternative is a different form of the tenofovir compound called Tenofovir Alafenamide Fumarate (TAF). Animal studies and human trials conducted using the TAF compound seemed to show that TAF could be administered in much smaller doses than TDF, therefore decreasing the likelihood that the drug might cause toxicity.

Then, after an “internal business review” in 2004, the TAF drug was suddenly and unceremoniously shelved with the company later noting that the risk profiles of the two drugs were too similar to inspire further development of TAF.

Patents & Profits Over Patients & People

What has many advocates pointing to as evidence of a concerted conspiracy is the timing of Gilead’s actions.

Drug patents give the manufacturer the exclusive right to synthesize, develop, and market those drugs for a period of 20 years.

Since TAF had been developed so shortly after TDF, some people say that Gilead saw this as a threat to the profitability of the drug they had just worked so hard to develop. If they were to introduce a better, safer, and more effective drug so soon, they would not be able to profit from the continued use of the TDF drugs such as Complera.

Suddenly in 2014 – just a few years before their patent on the TDF drugs was set to expire and open the market to generic competition – Gilead begins applying for a patent for TAF, advertising it as a “new” and “novel” and “safer” drug.

But it wasn’t “new” or “novel.” It was the same drug they had developed in their own laboratory back in the early 2000s.

And now that they had introduced a “new” and “safer” drug to replace TDF, there would be no generic competition to challenge Gilead – effectively extending their monopoly for another 20 years over the antiretroviral market.

Was it on purpose? Was it all part of a sinister Big Pharma scheme to increase profits at the expense of vulnerable patients?

The courts will decide those issues as litigation takes place and all of the appropriate evidence is able to be examined and affected individuals are able to make their voices heard.

How Can I Get a Complera Lawyer to Help File a Lawsuit Against Gilead?

If you or someone you know took one of Gilead’s TDF medications (Truvada, Viread, Stribild, Complera, or Atripla) and experienced bone or kidney problems as a result of taking the drug, it is important that your voice be heard.

Contact an attorney with experience fighting for HIV patients against greedy corporate giants. Call for a free Truvada case evaluation today and find out what you can do to fight back.

complera lawsuit

How Could I Benefit from Filing a Complera Lawsuit?

If successful, you may be able to recover compensation for:

Medical

Bills

Current and future

Lost wages

Pain

Suffering

Funeral

Expenses

complera side effects

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a California based biotechnology and pharmaceutical giant which researches, develops, and markets several popular drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza.

 With a market capitalization of over $86 billion and 2018 revenue of over $22 billion, Gilead is a major player in the pharmaceutical industry. It has been estimated that Gilead owns upward of 80% of the antiretroviral drug market, and that sales of these drugs account for approximately $11 billion per year.

About Complera

Complera contains 3 different medications: emtricitabine, rilpivirine, and tenofovir (TDF).

 

Complera can be used alone or with other HIV medications to help contain and control HIV infection. The drug helps to lower the amount of HIV present in the body which allows the immune system to work more effectively. This decreases the chance of getting HIV-related complications and improves the quality of life for many patients.

 

About TDF & Complera

TDF or Tenofovir Disoproxil Fumarate helps to treat HIV and can also be used as an oral prophylactic. TDF has also been approved by the FDA for the treatment of chronic hepatitis B in adults and children over the age of 12.

TDF works to block a critical HIV enzyme which prevents the virus from continuing to replicate.

 

 

19,414

Serious cases

Have been reported relating to one of the 5 TDF drugs released by Gilead (such as Complera), with 697 new cases being reported in the first quarter of 2019,
according to the FDA Adverse Event Reporting System (FAERS).

14,669

Serious cases

Including death are reported of March 31, 2019, and cases that have led to death are reported at 1 244.

860 or 4.4%

Acute Kidney Injury

Acute kidney injury made. Keep in mind that these are only the cases that have been reported to the FDA Adverse Event Reporting System. It is likely that there are many other cases which have not yet been reported.

Alleged Bone & Kidney Side Effects Resulting From Complera

complera kidney

Complera Kidney Injuries such as:

  • Declining kidney function
    Kidney functions are impaired making patients susceptible to heart and arterial problems
  • Acute kidney injury
    An abrupt reduction in the ability of the kidneys to filter waste products
  • Acute renal failure
    A rapid decline in kidney function with accumulation of waste products in the blood
  • Fanconi Syndrome
    Inadequate reabsorption in the proximal renal tubules of the kidneys
  • Complera Kidney failure
    kidneys lose the ability to filter waste from the bloodstream
complera side effects

Bone Injuries such as:

  • Osteoporosis
    A medical condition in which bones become fragile and brittle from the loss of tissue.
  • Decreased bone mineral density
    A decrease in the amount of bone mineral in bone tissue
  • Osteopenia
    A reduction in bone mass less severe than osteoporosis
  • Bone fractures
    Includes both partial and complete bone fractures due to unusual bone fragility
  • Tooth decay or loss
    Loss or decay of teeth
  • Low phosphate levels (hypophosphatemia)
    Loss or decay of teeth
complera lawyer

According to animal toxicology studies conducted by Gilead prior to FDA approval of TDF, bones and kidneys were shown to be the target organs for toxicity, and bone toxicities were shown to include osteomalacia and decreases in bone mineral density.

Clinical studies and adverse event reports from 2001 and 2002 record several cases of severe renal deficiencies and toxicity in patients whose histories did not include any prior kidney problems. A 2003 report details fatal renal insufficiency in a patient with a history of only mild renal impairment.

It is asserted that Gilead knew about the potential seriousness of TDF side effects and engaged in a deceptive campaign to understate these side effects. All of this is alleged to have happened after Gilead developed and tested TAF and showed it to be a more effective and safer alternative. Withholding the TAF formula may have then caused untold needless suffering for an already vulnerable patient population.

Frequently Asked Questions About Complera

What Is TDF?

TDF or Tenofovir Disoproxil Fumarate is a compound used alone or in combination with other drugs to treat HIV-infected patients. It has also been approved by the FDA for use as an oral prophylactic for preventing infection and transmission of HIV in high-risk populations.

Is TDF In Complera?

Yes. TDF is an active ingredient in Complera.

How Do I Know If My Side Effects Resulted From Complera Use?

If you took any of Gilead’s TDF medications including Truvada, Viread, Stribild, Atripla, or Complera and afterwards you developed bone or kidney problems where none had existed before, you might have a product liability case against Gilead.

Talk to your doctor about your side effects and medical history.

For a free case evaluation and consultation, call our law firm today. We pride ourselves on representing patients against greedy corporations who put the value of money over peoples’ lives.

What Should I Do If I (Or Someone I Know) Has Been Affected By Complera?

Contact a qualified patient advocate attorney to help you understand what you’ll need and how strong of a case you might have. You may call our firm for a free case evaluation and consultation.

Isn’t Complera Approved By The FDA?

Yes. But FDA approval doesn’t mean “completely safe.” There are many instances in which drug side effects are found to be more pronounced years after FDA approval.

What Is A Product Liability Claim?

Product liability claims rest on the idea that a product manufacturer has a duty to warn about the possible dangers from the regular use of a product. It appears Gilead failed to properly warn of these dangers. This failure resulted in injury and death related to the use of Gilead’s products. By this logic, we assert that Gilead is liable for the damage caused by their products.

What Is Necessary To Succeed In A Product Liability Claim?

You must be able to show that the defective product (Truvada, Viread, Atripla, Stribild, or Complera) is the cause of your injuries or complications, and that you sustained compensatory damages such as medical bills, lost wages, pain and suffering, funeral expenses, or other related costs.

Should I Stop Taking Complera?

No. Do not stop taking any medications without first contacting your healthcare provider. This is very important as stopping certain medications without supervision can be seriously detrimental to your health and possibly even fatal.

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