Generic of Gilead’s HIV pre-exposure drug coming to market in 2020
A generic version of Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) will hit the market in 2020, a year earlier than expected.
Truvada is used for HIV pre-exposure prophylaxis (PrEP), and is a once-daily prescription medicine that can help reduce the risk of getting HIV-1 through sex.
According to Gilead’s quarterly report, which was issued yesterday, May 8, the generic version stems from a settlement agreement with Teva and will be released in the US on September 30, 2020.
Truvada is the only drug approved in the US for PrEP use. When taken consistently, PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92%, according to the Centers for Disease Control and Prevention (CDC).
Filter Magazine, which first reported the news, said that it had reviewed an email from Douglas Brooks, Gilead’s executive director of community engagement, which told investors that the anticipated relinquishment of its exclusive patent on Truvada was set for a year earlier than anticipated.
In the email, Brooks emphasised that this change is not in response “to current discussions with the US government to broaden access to Truvada for PrEP for vulnerable populations and support the federal plan to end the HIV epidemic”.
In recent years, activists launched a “break the patent” campaign, which is designed to make Truvada more accessible and affordable.
“While Gilead’s announcement that generic Truvada will be made available in the United States a year early is a victory for the LGBTQ+ community, for HIV activists, and for US taxpayers, this should only be the beginning,” said PrEP4All, the activists behind the campaign.
However, the activists did state that this still leaves Gilead with exclusive rights for another 15 months and Teva as the only generic maker in the US market.
The release added: “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 … what’s to stop them–other than a desire for profit margins–from releasing the rights now?”
Gilead’s rights to Truvada hit the headlines in March this year, after the Washington Post reported that US taxpayers had almost fully funded CDC work to develop Truvada.
In April, Democratic presidential candidate Bernie Sanders and six other senators joined the #BreakThePatent campaign.
They requested that the CDC and Health and Human Services (HHS) detail what steps the government has taken to ensure government patents on emtricitabine and tenofovir (the two main components of the drug) are not being infringed by Gilead.
The US Department of Justice then launched an investigation into “the facts about the strength of the government patent”, according to the Washington Post.
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