AHF branded Gilead’s latest pricing action a shameless move by what one expert called “perhaps the most ethically challenged drug company,” in the drug pricing documentary, “Your Money or Your Life.”
In October 2017, as patent expiration loomed for Gilead, AHF called on Gilead to reduce the price of its tenofovir-based drug regimens—including Truvada—by as much as 90%.
The California drug company has made billions off of sales of its tenofovir-based drugs since the FDA first approved Gilead’s tenofovir disoproxil fumarate (TDF), branded as Viread, on October 26, 2001. That patent expired on December 15, 2017, with the patent on a pediatric version of the drug set to expire in early 2018. All the while Gilead simultaneously sought to ‘evergreen’ and manipulate the patent extension process.
“It is nothing short of grotesque that Gilead raised the price of Truvada by 6.9% despite the fact that it is now off patent and generic,” said Michael Weinstein, President of AIDS Healthcare Foundation. “This is a lifesaving HIV/AIDS treatment that they have already made billions off of and they are now trying to squeeze the well dry. Also, if Gilead is truly committed to providing and enhancing access to Truvada for use as pre-exposure prophylaxis or PrEP to prevent HIV acquisition by uninfected individuals, it is unconscionable for them to also charge this steep price on a now generic medicine. We call on other AIDS and community groups nationwide to join us in calling on Gilead to reduce its pricing, and also loudly renew our October call on Gilead to reduce the price of its tenofovir-based drug regimens—including Truvada—by 90% as well as on other combination therapies using tenofovir that Gilead makes in partnership with companies like BMS and Janssen.”
Since FDA approval of the drug in 2001, the TDF formulation of tenofovir has become a cornerstone of other big money Gilead combination HIV/AIDS treatment therapies beyond Viread, including:
In February 2016, AHF filed a lawsuit against Gilead over its manipulation of the patent system in order to derail competition to its HIV medicines. As reported at the time by Ed Silverman on the health news service, STAT, “At issue is tenofovir, or TDF, which is a cornerstone of the combination HIV treatments that Gilead sells. The patent on the TDF compound expires in December 2017 and Gilead hopes to replace it with a modified version known as TAF. The patent on TAF doesn’t expire until May 2022, and the prospect of nearly five more years of sales without generic competition is extremely valuable.”
He also noted, “There is another important difference between the two compounds — TAF is more potent and causes fewer side effects, notably bone damage and kidney toxicity.”
In 2014, in anticipation of Viread’s upcoming patent expiration, Gilead pulled a much more efficacious 30mg lower dose version of Viread off its development shelf and instead began the evergreening process by filing its first New Drug Application (NDA) for the modified Viread molecule, tenofovir alafenamide, or TAF (later branded Vemlidy).
It should be noted that Teva, an Israeli multinational pharmaceutical company and generic drug manufacturer, is allowed to begin production of a generic version of Viread as of December 15, 2017, resulting from its litigation against Gilead. Truvada, which contains the older version of Viread combined with a second Gilead drug called Emtriva, can also go generic as of December 2017.
What is most telling about Gilead’s corporate conscience—or lack thereof—is that after many years of incredible successes, this newer TAF version of Viread, which has a significantly better adverse event profile (particularly regarding renal side effects that impact African Americans much more) was reportedly left on the shelf post-development by Gilead Sciences for years. The reason for doing so is obvious: to maximize profits via the evergreening process by waiting until just the right time to begin filing new drug applications for all previously approved combination therapies. This effectively extends patent life of Gilead’s drug portfolio and greatly enhances the profit margins for Gilead.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 855,000 individuals in 39 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.