Gilead Sciences has agreed to pay $40m to more than 2 600 patients who developed kidney and bone diseases while taking its anti-HIV drug Truvada, to settle allegations that the company had already discovered a safer alternative drug but delayed its development and launch for years to extend the profitable life of Truvada.
Gilead dominates the world market in HIV pre-exposure prophylaxis (PrEP) with its drug Descovy, based on the molecule tenofovir alafenamide fumarate (TAF). It previously led the market with Truvada, based on the earlier molecule tenofovir disoproxil fumarate (TDF).
PrEP drugs based on TDF have saved millions of lives worldwide, and Truvada is still sold in generic form, but side effects include renal damage and loss of bone density, reports The BMJ.
In 2002, the patients alleged, Gilead discovered the new tenofovir molecule, TAF, was effective at much lower doses and likely to cause fewer of these side effects. But the company’s patent on Truvada still had 18 years to run.
The plaintiffs allege Gilead deliberately delayed the newer, safer version of the drug while knowing Truvada caused health damage – just so that it could reap more profits from TDF.
Poz reports that Gilead eventually resumed work on TAF, which received FDA approval in 2015.
In a statement earlier this month, Gilead said it had “entered into this agreement to avoid the cost and distraction of litigating these cases, and in no way is this settlement an admission of liability or wrongdoing… Gilead expects the settlement will resolve the claims of the overwhelming majority of plaintiffs in the TDF litigation”.
“However, there may be some plaintiffs in the federal TDF litigation who do not elect to participate in the settlement and there are others who are not part of this agreement. As to those plaintiffs, Gilead will continue to vigorously defend itself…and has never stopped working to improve the lives of people with HIV. The evidence shows the long-term safety of TAF was unknown and impossible to predict in October 2004 when Gilead stopped TAF development in favour of further developing TDF medications. Today, both TDF- and TAF-containing medicines are approved by the FDA, are recommended in the US Department of Health & Human Services HIV treatment guidelines, and successfully help treat and prevent HIV in millions of people.”
The settlement was reached after a district judge refused to dismiss the case last year, noted the San Francisco Chronicle at the time.
The newspaper added that although Gilead insists it did nothing wrong, the fact that the company is willing to pay about $15 000 to each plaintiff means the drugmaker knew it was legally vulnerable.
POZ article – Drugmaker Gilead to Pay $40M to People With HIV in Lawsuit Settlement (Open access)
See more from MedicalBrief archives:
Gilead, Teva cleared in generic HIV medicines lawsuit
Gilead wins billion-dollar patent lawsuit against US Government
US Health department sues Gilead Sciences over Truvada patent rights
‘Malicious’ Gilead vs US in mega HIV drug patent trial
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