Gilead’s TDF Drugs cause Serious Side Effects
(May 15, 2019) Two California men living with HIV filed a personal injury lawsuit last May against Gilead Sciences. The men claim Gilead intentionally delayed the development of a safer version of the HIV medicine called tenofovir. Tenofovir disoproxil fumarate (TDF) – the original form of the drug – is sold under the brand name Viread. It is found in Truvada, Atripla, Stribild, and Complera.
Gilead HIV Drug Kidney & Bone Injuries
The LA Times reported that the lawsuit also claims Gilead hid the risks of the less-safe version of tenofovir while letting people with HIV take the more dangerous medicine which harmed their kidneys and bones.
Related: Truvada Lawsuit
AIDS Healthcare Foundation (AHF), which operates HIV clinics around the world, is funding the two men’s lawsuits. An AHF press release read: “[A] class action lawsuit against Gilead by two other Californians living with HIV who suffered bone and kidney damage from taking TDF was filed on behalf of all persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.”
AHF also filed a previous lawsuit against Gilead over tenofovir. A judge who heard a similar case in 2016 ruled that Gilead did not illegally manipulate the patent system, but an appeal is pending.
What is Tenofovir?
The FDA approved Gilead’s TDF as an HIV med in 2001. The FDA approved TAF in 2015 as part of Gilead’s single-tablet combo pill Genvoya. Since then, TAF has been included in other HIV single-tablet regimens, such as Biktarvy and Descovy
At issue, says the lawsuit, is that Gilead had already begun research on an improved version called tenofovir alafemanide fumarate (TAF). Gilead wrongly withheld that research and delayed the release of TAF. According to the Times, the lawsuit claims, “[B]y holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in 20 years.”
The Times reports that both men named in the lawsuit took the older tenofovir and developed related health issues. Michael Lujano of Los Angeles County took TDF from 2004 to 2015. He developed osteopenia and osteoporosis of the spine, neck and hip. Jonathan C. Gary of San Diego County took TDF for 10 years starting in 2001. In 2010, he was diagnosed with the rare kidney disorder Fanconi syndrome, and last year was also diagnosed with osteopenia and osteoporosis.
“A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the ‘Miracle Drug’ and using other deceptive marketing strategies,” Mr. Lujano said in the AHF press release. “Gilead shelved a far safer drug, TAF, simply to increase its long-term profits. I’m bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety.”
In related news, one recent analysis found that the updated version of tenofovir may not offer any more safety benefits than the first version. Please see the POZ feature: “Is Gilead’s Entire HIV Enterprise Built on a False Promise?”
HIV Drug Lawsuits filed over Tenofovir
Plaintiffs’ attorneys are filing lawsuits for people with HIV who took one or more of Gilead’s tenofovir disoproxil fumarate (TDF) drugs –Truvada, Viread, Atripla, Complera, and Stribild –and then allegedly suffered kidney disease and/or bone density loss.
Nearly 20,000 people with HIV were allegedly diagnosed with kidney disease after taking TDF-based antiretroviral drugs. Studies have also shown TDF drugs may increase the risk of bone fractures. Nearly 6,000 bone breaks are alleged to be linked to the drug compound.
What Gilead Knew and When
Gilead allegedly knew that TDF could cause serious side effects as early as 2001. In 2002, the company allegedly tested a new formula – tenofovir alafenamide fumarate (TAF), later marketed as Genvoya and Odefsey – that achieves the therapeutic effect of TDF but uses a safer, lower dose. Plaintiffs believe the new formula isn’t linked to the same risk of kidney and bone injuries as the earlier version. Lawsuits are being considered for those who took Gilead’s Tenofovir drugs and then developed problems that include:
- Chronic kidney disease (CKD) or declining kidney function
- Acute kidney injury (AKI) or acute renal failure (ARF)
- Fanconi syndrome
- Tubular dysfunction
- Bone fractures