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Gilead Sciences, makers of HIV prevention drug Truvada, have announced that a generic version will be available as early as September 2020.
Truvada, also called PrEP, is a daily pill that prevents those who take the drug from transmitting to their partner.
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“Gilead reached an agreement with Teva Pharmaceuticals in 2014 to allow the early launch of a generic version of Truvada into the market in 2020, a year earlier than required,” says Douglas Brooks, Gilead’s executive director for community engagement, in an email to advocacy group PrEP4All.
The announcement was also noted on page 35 of a Gilead SEC filing released Wednesday, and comes amid pressure from HIV activists to make the drug more affordable.
A month’s supply for Truvada can run a patient $1,600 to $2,000 in the US, while other countries get it for as low as $70. During President Donald Trump’s most recent State of the Union Address, he announced his “Ending the HIV Epidemic” plan, which relies heavily on Truvada to curb global transmission, but activists said the costs were too high for the drug to make a significant impact.
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Back in 2017, then-Gilead CEO John Milligan projected a generic version of the drug to hit the market in 2021, but pressure from the #BreakThePatent campaign seems to have spurred Gilead to save face by making good on the promise a little sooner.
Activists with the PrEP4All Collaboration call this “a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers.”
However, Dr. Aaron S. Lord of PrEP4All expresses some concern over relying on just one drug manufacturer, Israel-based Teva Pharmaceuticals, to supply the generic PrEP pill.
“This will do little to reduce the price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement,” he asks. “I have to ask, what’s to stop them — other than a desire for profit margins — from releasing the rights now?”
Recently, an investigation by Global Health Justice Partnership at Yale University revealed that development and testing of Truvada was funded almost entirely by the Centers for Disease Control and Prevention, so the US government ought to have control over the patent — not Gilead. Later, The Washington Post reported that the Justice Department and Gilead were still negotiating over the Truvada patent.
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In a recent email obtained by NBC News, Gildead’s senior director for community engagement Douglas Brooks tells his “colleagues” that Teva will launch their “generic fixed-dose combinations of emtricitabine and TDF … on September 30, 2020.”
He goes on to clarify that this move is unrelated to the President’s “Ending the HIV Epidemic” plan.
“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 writes. “Those discussions are ongoing.”
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