TDF (Viread) HIV Medications

Viread, Atripla, Truvada and other antiviral medications based on tenofovir disoproxil fumarate (TDF) are used to treat HIV and Hepatitis B infection but may have resulted in serious bone and kidney injuries in people who took them. Gilead Sciences, TDF manufacturer has been accused of delaying introduction of newer, safer drugs containing tenofovir alafenamide fumarate (TAF) in order to maximize profits.

Quick Summary
TDF (Viread) HIV Medications

Gilead Sciences accounts for about 80% of the HIV antiviral market sales. Their success has been based on an antiviral medication tenofovir disoproxil fumarate (TDF) which was approved in 2001, under the brand name, Viread and was later introduced in combination with other products under brand names Atripla, Truvada, Stribild and Complera.

TDF is a member of the nucleoside reverse transcriptase inhibitors (NRTIs) group of antiviral medications which works by blocking an enzyme needed for viral reproduction. It is used to treat human immunodeficiency virus (HIV) infections to prevent multiplication and spread of the HIV organism which attacks the body’s immune system.

TDF Side Effects

TDF may cause severe side effects involving the kidney and bones which may result in serious or permanent injury or may be life-threatening. Kidney and bone side effects of TDF may include:

  • Acute kidney failure
  • Chronic kidney disease
  • Fanconi syndrome
  • Tubular acidosis
  • Osteoporosis
  • Osteopenia
  • Bone fractures

Gilead has been accused of delaying development of safer medications that contain a similar drug tenofovir alafenamide fumarate (TAF) in order to maximize profits from TDF medications, placing patients at increased risk of toxic effects. Gilead is facing hundreds of TDF HIV medication lawsuits for kidney and bone injuries.

Gilead Sciences is the largest manufacturer of antiviral medications used to treat HIV infections in the U.S. and around the world. Gilead’s line of HIV drugs has included Viread and other medications based on tenofovir disoproxil fumarate (TDF) and has accounted for about 80% of the HIV antiviral drug market.

Viread, containing TDF, was approved in 2001 for the treatment of HIV infection in adults. Its use was expanded in 2008 to include chronic hepatitis B infection and in 2012, for HIV infection in children. Gilead also introduced a number of combination products containing TDF and other antiviral medications including Truvada which is used as pre-exposure prophylaxis (PrEP) therapy to prevent HIV infection in people who may be exposed to HIV, including sexual partners of HIV positive individuals.

Tenofovir disoproxil fumarate is a member of the nucleoside reverse transcriptase inhibitors (NRTIs) group of antiviral medications which works by blocking an enzyme needed for viral reproduction. It is used to treat human immunodeficiency virus (HIV) infections to prevent multiplication and spread of the HIV organism which attacks the body’s immune system.

In severe cases, advanced HIV disease results in acquired immunodeficiency disease syndrome (AIDS) in which the immune system is so compromised, that it is no longer able to defend he body against infections. HIV infection cannot be cured but it may be controlled so that it does not worsen to develop AIDS or spread to other non-infected people.

TDF has been used alone and in combination with other medications to fight HIV and hepatitis B infection but has a low bioavailability and requires high doses to be absorbed and used by the body. Because of the high doses required to maintain effectiveness, TDF may result in serious toxicity and may particularly cause kidney and bone injuries in some users.

TDF medications include:

  • Viread (tenofovir disoproxil fumarate)
  • Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate)
  • Truvada (emtricitabine and tenofovir disoproxil fumarate)
  • Stribild (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate)
  • Complera (emtricitabine, rilpivirine, and tenofovir disoproxil fumarate)

TDF Side Effects

All medications cause side effects, most of which are mild to moderate and will go away with time. Other side effects may be more serious or even, life-threatening.

Common side effects include:

  • Diarrhea
  • Nausea and Vomiting
  • Fatigue
  • Headache
  • Dizziness
  • Depression
  • Insomnia or Abnormal dreams
  • Rash
  • Upper respiratory tract infections
  • Nasopharyngitis or Sinusitis

More severe side effects which may be serious or result in permanent injury may include:

  • Chronic kidney disease
  • Acute kidney failure
  • Fanconi syndrome
  • Tubular acidosis
  • Osteopenia
  • Osteoporosis
  • Bone fractures

In some cases, TDF containing medications may increase the risk for acute exacerbation of hepatitis B virus in patients who stop taking the medication.

Safer TAF Medications

Gilead Sciences has been accused of withholding safer medications in order to maximize profits. When the first TDF medication, Viread, was introduced, Gilead research scientists were already at work developing a next generation form of TDF, tenofovir alafenamide fumarate (TAF) which was showing promise as a safer and more effective alternative. As a marketing and development decision, the company introduced a number of combination drugs from the TDF line but reportedly suppressed news of research studies of the newer molecule.

In 2004, the company went so far as to announce they were halting research on TAF but continued to apply for new patents, indicating research and development was ongoing. This allowed Gilead to continue to market the more toxic, TDF-based drugs until the patent exclusivity was close to running out.

Once patent expiration was close, newer TAF drugs were introduced and the company did a second marketing maneuver which has been criticized. Gilead increased the price of the old TDF drugs so that physicians would be encouraged to immediately switch patients over to newer formulations before generic medications became available.

The FDA approved the first of the TAF medications in November 2015 as “Genvoya”, a TAF combination with three other antiviral ingredients. Current TAF combinations include:

  • Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)
  • Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide)
  • Descovy (emtricitabine and tenofovir alafenamide)
  • Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
  • Vemlidy (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)

The patent for TDF expired in 2018 and some of the TDF products have become available as generic medications while Gilead has continued to sell more medications in the HIV drug market.

Gilead TDF Warnings and Lawsuits

Shortly after the introduction of Viread, Gilead was accused of making a number of misleading statements about the effectiveness and safety of TDF antivirals. In 2002, the FDA sent a warning letter instructing the company to stop making misleading and illegal claims after representatives were accused of claiming the drug had “no toxicities”, was “extremely safe”, “extremely well-tolerated” and was a “miracle drug”.

Another letter was sent in 2003 requiring that the company conduct retraining of its sales staff and provide more accurate information about the TDF drugs including information about side effects after representatives had been heard claiming Viread was “more potent” and “safer” and had “fewer side effects” than other medications.

In 2016, Gilead was sued by the AIDS Health Foundation (AHF) on behalf of several patients who the organization claimed may have taken more toxic TDF medications for most of a decade when TAF drugs should have been made available. AHF accused Gilead of putting profits above patient’s health and though these first cases were dismissed, the company has been subject to hundreds of additional lawsuits which have not been dismissed.

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