Developed by Gilead Pharmaceuticals, Truvada is used for HIV pre-exposure prophylaxis, or PrEP, and when taken daily can keep HIV-negative people from contracting the virus. The new generic version will come from a settlement agreement Gilead struck in 2014 with the Israeli-based company, Teva Pharmaceuticals. The generic version was supposed to arrive in 2021, but Gilead announced the new 2020 date in an SEC filing released today, May 8th.
Gilead’s director for community engagement, Douglas Brooks, also sent a letter to “Colleagues” Wednesday that read, “Pursuant to a settlement agreement reached in 2014 … Teva will be able to launch generic fixed-dose combinations of emtricitabine and TDF … on September 30, 2020.”
Brooks also acknowledged President Donald Trump’s plan to make Truvada the cornerstone of a campaign to end HIV, as well as an ongoing dispute between Gilead and the Center for Disease Control over who actually owns the rights to the drug. “This agreement is not related to current discussions with the U.S. government to broaden access to Truvada for PrEP for vulnerable populations and support the federal plan to end the HIV epidemic,” he said.
Truvada was introduced in 2012 and, though it faced initial criticism from public health leaders and the LGBTQ community, attitudes towards the drug shifted as it proved to be a relatively success tool in HIV prevention. However, some studies showed that the populations most at risk of HIV infection were unable to access the drug. Truvada was also notoriously expensive in the United States: While a month’s supply could cost as little as $70 in some parts of the world, in the U.S. it could cost between $1,600 and $2,000.
In recent years, activists have mounted a “break the patent” campaign designed to make Truvada more accessible and affordable. The PrEP4All Collaboration released a statement Wednesday celebrating the news of the generic version, though they did so with plenty of caution. The group noted that Gilead will not only retain the rights to Truvada for another 15 months, but having one generic version “will do little to reduce the price in a way that will increase access.”
The statement, written by Dr. Aaron S. Lord, continued, “PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement. I have to ask, what’s to stop them — other than a desire for profit margins — from releasing the rights now?”
PrEP4All also highlighted the ongoing dispute between Gilead and the CDC. In March, the Global Health Justice Partnership at Yale University revealed that the U.S. government provided most of the funding for Truvada, meaning the CDC could actually own the rights.
“The CDC must use the billions of dollars that the American people overpaid to create a national HIV prevention program, aimed at breaking down structural and systemic barriers that prevent the most at-risk communities from accessing the medication,” PrEP4All said. “Additionally, the CDC must use its significant leverage to ensure that generic Truvada is available at a price affordable to everyone in this country.”