After years of raking in billions of dollars from its Tenofovir Disoproxil Fumarate (TDF) drug monopoly, Gilead Sciences will have to face competition from the first wave of generic TDF drugs which were recently launched by Israeli drug manufacturer Teva Pharmaceuticals. On October 2, 2020, Teva announced the launch and pricing of long-awaited generic versions of HIV-1 treatment drugs Truvada and Atripla.
What are TDF Drugs?
Truvada is one of the most frequently prescribed drugs providing treatment for the symptoms of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immune Deficiency Syndrome). Tenofovir Disoproxil Fumarate (TDF) is the active ingredient for a class of antiretroviral drugs known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs) commonly used to treat HIV. The drugs stop HIV from multiplying by blocking an enzyme in the body called Reverse Transcriptase. TDF drugs are prescribed in combination with other medications to help improve the quality of life for those living with HIV. All five of the TDF drugs on the market today are produced by Gilead Sciences.
Truvada, which is a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine, was approved by the U.S. Food and Drug Administration in 2004 for HIV treatment and for Pre-Exposure Prophylaxis or PrEP in 2012. Although tenofovir disoproxil Fumarate (TDF) is already off patient, the patient for emtricitabine is not set to expire until September 2021.
Despite its 99% effectiveness level, the high cost of Truvada has limited wider access to PrEP treatment, according to recent study by the Centers for Disease Control and Prevention (CDC). The CDC estimates more than 1 million people in the U.S. are at substantial risk for HIV and should be using PrEP treatment. However, only around one third of gay and bisexual men are using the preventative treatment. Gilead critics attribute low usage to the prohibitively high cost of treatment.
Will Generics Bring Pricing Relief?
In early 2019, Gilead reached an agreement with Teva Pharmaceuticals to grant an exclusive right for Teva to sell a generic version of Truvada in the U.S. a year ahead of the patent expiration date. Teva’s exclusive agreement ends after just six months. After expiration, other companies will have access to the U.S. market. Generic versions of Truvada are readily available in other countries at a cost of only $25 per month.
Teva reported the generic version of Truvada is expected to be available through retailers and wholesalers at a wholesale acquisition cost (WAC) of $48.51 per tablet. The generic version of Atripla will be available through retailers and wholesalers at a WAC of $78.86 per tablet.
Truvada Linked to Bone and Kidney Problems
Due to its high toxicity levels, Truvada has been linked to serious side effects such kidney damage and kidney failure, bone deterioration, decreased bone density, osteoporosis due to high toxicity of the medication. Lawsuits have been filed claiming that Gilead failed to adequately warn patients of these risks and suppressed a safer version of the medication for over a decade to maximize profits.
Kidney Problems
- Acute kidney injuries
- Chronic kidney disease
- Renal failure
- Kidney failure
- Related nephritic injuries
Bone density Issues
- Bone fractures
- Osteoporosis
- Osteopenia
- Osteomalacia
- Related orthopedic injuries
Allegations that Gilead Sciences Put Profits Over Patients
Lawsuits filed by patients with HIV allege that Gilead suppressed a safer version of the drug with far less toxicity in order to maximize profits by extending the sales of the initial TDF drug. In the late 1990s when Gilead was developing treatments for HIV, their own lab tests proved TAF (Tenofovir Alafenamide) was a safer alternative because it released fewer toxins into the body and therefore placed less strain on the kidneys to filter out the waste.
The strain of expelling Truvada’s high toxicity level can lead to kidney damage and kidney failure. Rather than seeking FDA approval for the safer TAF option, Gilead sought and was granted approval in 2001 for the TDF based medication, Viread.
Despite the knowledge of a safer alternative drug, Gilead did not release TAF based medications until just a few years ago. Their decision put may patients who were already suffering with HIV at greater risk of developing kidney problems and bone density issues. The decision also rewarded drug manufacturer with billions of dollars in additional revenue as the out-of-pocket cost for many consumers reached an astronomical $2,000 per month.
If your firm is considering joining the fight against Gilead and Truvada, Case Works can help get your cases proven up and ready to file. The Truvada Team at Case Works is expertly trained to evaluate medical records and work with clients to maximize the value of their claim.
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