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Gilead TDF HIV Drugs

Gilead Sciences manufactures Viread, Truvada and other HIV medications based on the antiviral tenofovir disoproxil fumarate (TDF) which may have serious and toxic side effects affecting the bones and kidneys. Gilead was accused of withholding safer medications based on a similar drug tenofovir alafenamide fumarate (TAF) HIV medications to maximize profits.

Gilead Sciences is the leading manufacturer of HIV drugs around the globe, holding about 80% of the HIV drug market. They manufacture tenofovir disoproxil fumarate based (TDF-based) antiretroviral drugs including:

TDF Drugs

Brand Contains medications
Viread tenofovir disoproxil fumarate 
Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Complera emtricitabine, rilpivirine, and tenofovir disoproxil fumarate
Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Truvada emtricitabine and tenofovir disoproxil fumarate

Thousands of people who were already living with Human Immunodeficiency Virus (HIV) may have experienced kidney and bone injuries after taking TDF drugs, when safer drugs may have been available.

Gilead Sciences is facing lawsuits claiming that they withheld a newer type of drug, tenofovir alafenamide fumarate based (TAF-based) drugs from the market in favor of continuing to make higher profits.

Safer TAF Gilead Drug May Have Been Delayed

Gilead owns about 80% of the antiretroviral drug market, used to treat HIV diseases. TDF drugs have been very profitable for Gilead, encompassing the greatest portion of their earnings and making combined $11 billion annual revenue.

TDF-based drugs were introduced to the U.S. market in 2001, when the U.S. Food and Drug Administration (FDA) approved Viread. After 2001 approval of Viread, Gilead began development of another type of HIV drug, tenofovir alafenamide fumarate (TAF), which proved to be less toxic. Despite improved safety, and proof of efficacy which was established as early as 2002, the company slowed development in 2004 to allow for continued marketing of the more dangerous TNF drugs.

Since that time, Gilead has also brought combination TDF drugs Truvada, Atripla, Complera, and Stribild to market. TAF drugs, safer and equally effective, could be administered at about one-tenth the dose with decreased toxicity but TAF drugs were not introduced until years later, in 2015 when Genvoya was introduced.

Since 2015, additional TAF combinations have been introduced including:

TAF Drugs

Brand Contains medications
Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Odefsey emtricitabine, rilpivirine, and tenofovir alafenamide
Descovy  emtricitabine and tenofovir alafenamide
Biktarvy bictegravir, emtricitabine, and tenofovir alafenamide 
Symtuza darunavir, cobicistat, emtricitabine, and tenofovir alafenamide

It appears that Gilead delayed introducing TAF drugs until a short time before TDF’s patent expired in 2018, when the company would lose exclusivity and face generic competition. Before that occurred however, the price of TDF drugs was increased, which forced some patients to the newer medications and eliminated the advantages of generic competition.

Gilead Raised Prices on Older Drugs Before Releasing New Medications

Reportedly, shortly after introduction of the first TAF drugs, Odefsey and Genvoya, Gilead Sciences raised prices for the corresponding TDF drugs, making the switch to TAF drugs even more desirable for insurance companies. Prices for a month’s supply of certain drugs were raised by 7%, which for HIV medication can mean prices would go up by hundreds or even thousands of dollars.

The timing of price increases and the impending patent expiration was suspicious and alarming to people in the HIV community and medical community at large, unfortunately HIV patients do not have much choice and must take the life-saving medications.

Many people have felt that Gilead’s actions in both market delays and price increases were improper and unethical, if not illegal.

Increased Toxicity Exposure Due to Market Delays

Many people have felt that Gilead’s actions in both market delays and price increases were improper and unethical, if not illegal.

Because of the market delays and patients being unable to receive otentially safer drugs, more people may have experienced serious complications including:

Kidney Injuries:

  • High serum creatinine (SCr) or abnormal glomerular filtration rate (GFR)
  • Abnormal protein levels in the urine
  • Impaired kidney function requiring medication adjustments
  • Chronic Kidney Disease (CKD) or Chronic Renal Failure (CRF)
  • Acute Kidney Injury (AKI) or Acute Renal Failure (ARF)
  • Tubular dysfunction
  • Fanconi’s syndrome
  • Hospitalization
  • Death due to renal failure

Bone Injuries:

  • Osteoporosis
  • Osteopenia
  • Bone density loss
  • Demineralization
  • Bone fracture due to weakening or demineralization

Gilead HIV Drugs Lawsuit

Gilead Sciences is facing numerous lawsuits filed by patients who took TDF-based drugs and were harmed. Patients who experienced bone fracture or kidney injury may qualify for compensation for medical costs, lost wages, pain and suffering or other damages and should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

Sources:

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