Ad attacks Gilead over delayed TAF release

A new print advertisement accuses Gilead Sciences of putting profits over the health of patients by stalling the development of a safer formulation of its antiviral HIV drug tenofovir.

The advertisement by AIDS Healthcare Foundation (AHF) comes on the heels of a critical story in the Los Angeles Times about Gilead’s decision to stop research on tenofovir alafenamide (TAF) in 2004 despite evidence that it was less toxic to kidneys and bones than the older form of the compound, tenofovir disoproxil fumarate (TDF).

AHF sued Gilead earlier this year, saying the company purposefully delayed clinical trials of TAF in a “complex, anticompetitive scheme” to extend their patents and keep generics out of the market. AHF wrote in the lawsuit that Gilead prevented access to lifesaving treatments and caused direct harm to the nonprofit organization, which said it spent millions of dollars on the company’s drugs in 2015 alone.

The new ad, which AHF said will run in LGBT publications throughout June, singles out the use of tenofovir in pre-exposure prophylaxis, or PrEP, for HIV prevention.

The ad is titled “Gilead Scandal: Gay men, we don’t care about your kidneys and bones — only the money!” It alleges that Gilead, with the help of the CDC, is promoting “the older, more toxic” TDF to HIV-negative men for PrEP. It says Gilead “never bothered to seek approval” for TAF because waiting until the last moment meant the company’s patents would be extended another 20 years.

Gilead has denied that the decision to halt trials of TAF in 2004 had anything to do with patent expiration dates. In a statement, the company said its decision to focus on other areas of research and development was based on feedback from medical and advocacy groups.

Gilead said it prioritized the development of TAF in 2010 because, according to the statement, “the unmet needs of patients had changed — particularly as people were now living longer with HIV and remaining on [ART] for greater periods of time.”

In a statement, Whitney Engeran-Cordova, senior director of public health for AHF, said the foundation is targeting LGBT news outlets and particularly the gay community with its ad because TDF is the only form of tenofovir available in Truvada (emtricitabine/TDF, Gilead Sciences), the PrEP drug promoted by Gilead for use in patients who are HIV-negative.

“Gilead does not currently make or market TAF as a standalone medication,” Engeran-Cordova said. “It has not been tested or approved by the FDA as a standalone, so unfortunately — and deliberately — the only form of tenofovir patients on PrEP can get is TDF, the older, more toxic form found in Truvada.”

In response to AHF’s recent lawsuit, Gilead said it believes its patents on TAF and cobicistat are “valid and enforceable.” – by Gerard Gallagher

Reference:

AIDS Healthcare Foundation. Gilead scandal: Gay men, we don’t care about your kidneys and bones — only the money! 2016. http://www.aidshealth.org/wp-content/uploads/2016/06/Gilead-Scandal-Frontiers4.pdf. Accessed June 10, 2016.