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Gilead Sciences Inc. was hit with another lawsuit on January 15, 2020, in Miami Federal Court. The company along with Johnson & Johnson, Japan Tobacco Inc., and Bristol-Myers Squibb Co. were sued because of claims of an HIV prevention therapies drug market conspiracy.
The suit states that Gilead extended patent protection for their drugs, as well as hindered entry of generic competitors, and charged very expensive prices for the drugs. Prior to that, numerous lawsuits have been filed against Gilead claiming that Truvada causes kidney damage and bone injuries, including bone loss and fractures.
TDF stands for tenofovir disoproxil fumarate, and is an ingredient in Truvada (TDF/FTC). Gilead Sciences created two medications that are both used to treat HIV-1 infected patients and were also later both approved for pre-exposure prophylaxis (PrEP) in adults and pediatric patients. Truvada was first approved in 2002 by the FDA, and later in 2012 approved for PrEP.
Years later in 2016, Descovy (TAF/FTC) was approved for HIV-1treatment, and also for PrEP in 2019. In an FDA press announcement, Jeffrey Murray M.D., M.P.H., Deputy Director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research stated, “PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection.”
In a recent online article of Annals of Internal Medicine; Gilead claimed that Descovy is both safer and more effective than Truvada. However, this statement is only supported by data from the DISCOVER trial, which is detailed on the Gilead Press Release.
Researchers are concerned because the drug was evaluated using a different patient population than Truvada. On an online AJMC article, the authors wrote, “It would be a clinical leap of faith to use TAF/FTC instead of TDF/FTC in other populations.”
If its manufacturer claim that Descovy is better in efficacy and safety is true; then why is Truvada still on the market? Interestingly, Gilead’s recent claim that Descovy is superior to Truvada comes shortly after the numerous Truvada lawsuits. In addition, Gilead’s patent on Truvada is expiring soon; where Descovy does not expire until 2022.
What does the FDA say? According to an online article in AJMC, The FDA removed the risk evaluation and mitigation strategy requirements and its generics as pre-exposure prophylaxis.
The reasoning behind this was that most healthcare professionals and at-risk individuals can find this information on the CDC. This supports the US government’s 2019 launch of, “Ending the HIV epidemic initiative”, which is described on the CDC website.
This initiative aims at reducing the incidence of 90% within 10 years. At the President’s request, $291 million in the FY 2020 HHS budget was funded.
What about current users of Truvada? Hundreds of thousands of patients are currently taking Truvada. Recent claims would mean that all these patients would benefit from switching to Descovy. It appears that Gilead Sciences will do whatever it takes to monopolize the market.
Elena Borrelli is a certified physician assistant, or PA, with 18 years of experience in health care. She has worked 11 years as a PA in diverse clinical settings, including surgery, trauma, primary care, women’s health and quality management. Over the years, she has authored several publications and lectured on various health care-related topics.