Gilead Will Allow Generic Truvada to Hit US Market Next Year

Get PrEP-ared for generic Truvada in the next year, according to an official document that Gilead, the pharmaceutical company that manufactures the drug, released on their website.

According to a quarterly report filed to the Securities and Exchange Commission, Gilead announced that it reached an agreement to allow a generic version of Truvada to be manufactured in the United States on September 30, 2020.

The document cites generic competition for the two separate components of the pill -- the drugs emtricitabine and tenofovir -- as the reason behind releasing the patent a year early. However, according to the document, only one company, Teva Pharmaceuticals, will be able to manufacture the combination pill generically.

A member of PrEP activist group PrEP4All, Robert Kessler, told Out that Gilead's announcement is "just the first step" in making sure people have access to the drug.

"Gilead is not breaking its patent, but rather allowing one specific manufacturer, Teva, to enter the market in 2020, which does not guarantee it will be a cost-effective alternative," Kessler said. "Further, the issue of PrEP access doesn't stop at the specific cost of the pill. Structural and systemic barriers like racial biases and the burden of quarterly STI testing and lab work also prevent those who are vulnerable from accessing PrEP."

Kessler stressed that PrEP4All's goal is universal access to PrEP and clinical care for those who need it.

In a statement, Aaron S. Lord, a physician and member of PrEP4All, called the decision a "victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers," and cautioned that the fight for widespread PrEP access is not over. Lord specifically pointed to the fact that only Teva will be allowed to manufacture generic PrEP.

"This will do little to reduce price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement," Lord wrote in the statement. "I have to ask, what's to stop them -- other than a desire for profit margins -- from releasing the rights now?"

Activists also claim that Gilead's statement in its filing don't match earlier statements they'd made to shareholders about a timeline for Truvada's patent. In an earnings call with investors in 2017, then-CEO John F. Milligan told investors that they didn't expect generic Truvada to be on the market in the United States until 2021. However, in an email to shareholders announcing the securities filing, Gilead said that it had reached the deal with Teva in 2014, three years before it told investors that Truvada would be available in 2021. Out obtained a copy of the email and verified the statement.

"If this agreement was made in 2014, why did he lie to shareholders?" Lord asked.

Gilead's patent for Truvada as pre-exposure prophylaxis has been under increased scrutiny in past months after a Washington Post story showed that Gilead had made $3 billion off the drug in 2018 alone and that U.S. taxpayers, who paid for the development of the drug, were not seeing any of the benefits. Gilead also recently announced that it would increase the price of Truvada by 4.9 percent in 2019.

In an earlier email to Out, Tim Horn, director of medication access and pricing at NASTAD, a leading public health organization focused on HIV and hepatitis, said, "You'd better believe that Gilead will take price increases while it still has the monopoly. Once generics become available -- and assuming Gilead actually decides to keep Truvada on the market -- it may continue to take annual price increases on the product; it certainly won't drop the price to compete with generic competitors."

The Justice Department began looking into whether Gilead violated the terms of the federal government's patent on Truvada in April. The investigation happened after seven United States senators, prompted by a PrEP4All report on Gilead's profits, sent a letter to health and human services secretary Alex Azar and CDC director Robert Redfield alerting them to the issue. The senators included Bernie Sanders (D-VT), Tammy Duckworth (D-IL), and Tammy Baldwin (D-WI).

"The government should also be willing to enforce its patents and take legal action against companies that appear to be infringing on their patents to prevent multinational companies from reaping billions of dollars in profits without properly compensating the government for its investments," the senators wrote.

Currently, Truvada costs between $1,600 and $2,000 per month, a prohibitive cost that has led to low access to the drug for those who need it. Pre-exposure prophylaxis is a cornerstone of Trump's plan to end the HIV/AIDS epidemic, but Gilead's sticker price would hinder those efforts. In other countries, Truvada is available for as little as $6.50 a month.

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