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A new analysis indicates that Gilead is working to quickly switch patients taking its older pre-exposure prophylaxix (PrEP) drug Truvada to it’s new medication Descovy, which is reinforcing claims brought in a growing number of HIV drug lawsuits that allege the manufacturer sat on the safer alternative for years to extend patent protection and increase profits.
Truvada is part of a class of HIV treatments that contain the antiretroviral tenofovir disoproxil fumarate (TDF), which was approved in 2004 for the treatment of HIV. It was also the first medication approved for use as a PrEP drug to prevent HIV among individuals at risk of contracting the disease, and has generated billions in profits for Gilead.
Descovy is part of a newer generation of HIV drugs introduced by Gilead in recent years, which are known as tenofovir alafenamide (TAF), and can be taken at much lower doses and still be effective. As a result, users are able to avoid side effects of Truvada and other TDF-based drugs, which increase the risk of serious kidney problems and fractures caused by bone density loss.
Over the past year, a growing number of product liability lawsuits have been filed against Gilead, alleging that it delayed development of TAF-based drugs, waiting to introduce the safer alternative until patent protection was about to expire, avoiding competition from generic versions of Truvada and other TDF drugs. As a result, Gilead now has patent protection for the brand-name HIV treatments until at least 2032.
In a recent report by Jefferies & Company analysts, Michael Yee found that Gilead has already converted about 10% of Truvada prescribers to Descovy in just two months since the newer HIV drug was approved by the FDA for PReP treatment, and is on track to convert about 50% to 60% of all users by the time generic Truvada hits the market next year, avoiding a loss of sales for the drug maker.
Gilead marketing has heavily focused on the safer aspects of Descovy, the analysis indicates. However, critics point out that the drug maker knew about the safer alternative as early as 2004, but held off on pursuing FDA approval for TAF-based drugs until the patent protection for the lucrative TDF-based drugs was nearing expiration.
Individuals who have suffered kidney damage or severe injuries from bone density loss after taking TDF-based drugs now allege they may have avoided the problems if Gilead had not placed its desire for profits before patient safety.