A generic version of Truvada, the only drug approved to prevent HIV infection, will be available in September 2020, NBC News reports. 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.”<doc-sep>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. RELATED | The Justice Department Is Looking Into Gilead’s PrEP Profits<doc-sep>
Gilead Sciences announced Wednesday that a generic version of Truvada will be available in September 2020, one year earlier than expected. Truvada is the pill used for HIV pre-exposure prophylaxis, or PrEP. When taken daily, Truvada prevents HIV transmission. "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," wrote Douglas Brooks, Gilead's executive director for community engagement, in an email shared with NBC News by the advocacy group PrEP4All. The information about generic Truvada is also disclosed on page 35 of a Gilead SEC filing released Wednesday morning. While a month’s supply of generic Truvada is available in countries around the world for as little as $70, in the United States a month’s supply sells for $1,600 to $2,000, and activists have mounted a pressure campaign to force Gilead to make the drug more widely available in order to curb the global HIV epidemic. President Donald Trump’s “Ending the HIV Epidemic” plan, announced at this year’s State of the Union address, will rely heavily on Truvada in order to stem the spread of the virus. But Truvada’s high price threatened to make the plan extremely expensive, activists said. Previously, in a phone call with investors in the second quarter of 2017, then-Gilead CEO John Milligan said, "We don't expect generic Truvada in the United States until 2021." Activists who have been pushing Gilead to #BreakThePatent hailed the news Wednesday, calling it “a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers," but also tamped down expectations. In a statement from the PrEP4All Collaboration, Dr. Aaron S. Lord said allowing just one generic manufacturer, Israel-based Teva Pharmaceuticals, to make generic PrEP “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.” “What’s to stop them — other from a desire for profit margins — from releasing the rights now?” Lord asked. PrEP4All had recently publicized news that Gilead’s development and testing of Truvada as PrEP was almost entirely funded by the U.S. government and therefore the CDC, not Gilead, controls the patent for PrEP. That information was first publicized by the Global Health Justice Partnership at Yale University, which wrote "based on our preliminary review, CDC’s Patents for PrEP appear to be valid and enforceable." The news that the Justice Department and Gilead were negotiating over the Truvada patent issue was first reported by The Washington Post. An email addressed to “Colleagues” sent Wednesday morning by Douglas Brooks, Gilead’s senior director for community engagement, said, “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.” "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," Brooks wrote. "Those discussions are ongoing." Gilead did not immediately respond to a request for comment. FOLLOW NBC OUT ON TWITTER, FACEBOOK & INSTAGRAM