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The Tenofovir lawsuits claim Gilead Sciences was aware its hepatitis B drug Tenofovir Disoproxil Fumarate (TDF) put patients at risk for unnecessary kidney disease and bone injuries. Yet, the company made the decision not to remove TDF from the market and sale a safer alternative.
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Plaintiffs claim Gilead Sciences minimized the risks of kidney disease and bone injuries from the use of Tenofovir Disoproxil Fumarate (TDF) and had available a safer drug to treat hepatitis B, known as Tenofovir Alafenamide Fumarate (TAF), but withheld it from the market for almost 10 years. Gilead Sciences allegedly withheld TAF in order to maximize the patent and lifecycle of TDF. By doing so, plaintiffs say Gilead exposed patients unnecessarily to the risk of kidney disease and osteoporosis.
TDF and TAF are similar drugs and are derived from the same source. They can have the same side effects. However, TAF can be taken at a much smaller dose than TDF and still provide the same therapeutic effect. It is thus less toxic than TDF and patients are less likely to suffer serious side effects.
Tenofovir lawsuits allege Gilead knew of TAF’s greater safety and efficacy but intentionally delayed approval of the drug by the FDA until the patent on TDF was about to expire. Gilead did this in order to continue profiting from TDF for as long as the patent could be held, and then get a new patent issued on TAF.
TIn addition to kidney disease and bone injuries, the most common side effects of Tenofovir are:
More serious side effects include lactic acidosis and hepatomegaly (enlargement of the liver).
Kidney damage due to long-term Tenofovir use can take several forms. Among these are reductions in renal function, or a rare condition known as Fanconi Syndrome, in which substances such as glucose, which are normally absorbed into the bloodstream, are passed in the urine instead.
Tenofovir disoproxil fumarate (TDF) is a medication used as a treatment for hepatitis B and for the prevention and treatment of HIV/AIDS in patients who are at risk due to exposure. Although it can be used as monotherapy, it’s often prescribed in conjunction with other retroviral medications.
TDF is used with:
TDF is what is known as a “prodrug.” Although prodrugs do have therapeutic effects, they are biologically inert or inactive until ingested by the patient. Once taken, the patient’s own metabolism activates the substance as gut flora in the digestive tract breaks it down, essentially turning it into a medication.
TDF was originally patented in 1996 and provided FDA approval for the treatment of HIV in 2001. TDF is used primarily to treat HIV or to prevent it from becoming full-blown AIDS. It is not a cure but when given in combination with other medications it can slow the progression of the disease and extend a patient’s life expectancy.
In 2008, the FDA approved TDF for the treatment of chronic hepatitis B.
Tenofovir is part of a class of molecules known as “nucleotide analog reverse-transcriptase inhibitors” (NtARTIs). The active compound in tenofovir is rendered inert by a molecular “side chain” or a group of chemicals that are attached to the core of the TDF molecule itself. Once the medication enters the gastrointestinal tract, this molecular side chain is dissolved, releasing a low dose of tenofovir and enabling it to reach the therapeutic site.
Once tenofovir comes into contact with the retrovirus, it inserts itself into the DNA chain, where it prevents the action of transcriptase, the substance that enables DNA to replicate itself. This in turn stops the transcription process, making the virus unable to reproduce.
As of July 21, 2021, there have been no large groups of mass tort settlements involving Tenofovir Disoproxil Fumarate and the potential unnecessary risks of kidney disease and bone injuries. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
Gilead Sciences has faced years of allegations that it sidelined its safer, next-gen HIV drugs to reap as much revenue as possible from the older generation before the new meds hit. And a federal judge has allowed one set of those allegations—filed by 140 patients from 31 states—to proceed. To read more, click Fierce Pharma
The lawsuit — and a similar case that seeks class-action status — says that Gilead executives knew as early as 2000 that the company’s scientists had developed a less toxic form of its HIV medicine tenofovir that was less harmful to patients’ kidneys and bones. But instead of continuing to develop the safer alternative, the lawsuit claims, the Foster City company decided to hide tenofovir’s risks while earning billions of dollars as it became one of the world’s most prescribed medicines for HIV. To read more, click Los Angeles Times.
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