The HIV medication Truvada will come off patent a year early in the United States and will be available to patients and providers as a generic starting in 2020, according to Gilead Sciences.
In its quarterly report to the Securities and Exchange Commission, Gilead said it had reached an agreement to allow Teva Pharmaceuticals to launch generic versions of Truvada (emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) and Atripla (FTC/TDF/efavirenz) on Sept. 30, 2020.
FTC/TDF treats HIV and has been approved in the U.S. since 2012 as pre-exposure prophylaxis (PrEP) for HIV prevention. The FDA approved Teva’s generic version of FTC/TDF in 2017.
PrEP can reduce the risk for HIV infection by up to 92% when taken consistently, according to the CDC, but uptake has been slow and cost has been an issue.
A generic version of Truvada will be available in 2020.
Source: Adobe Stock.
According to the PrEP4All Collaboration, a group of activists seeking wider access to the HIV prevention medication, Gilead charges between $1,600 and $2,000 for a 1-month supply of FTC/TDF. A Teva spokesperson did not immediately respond to a question asking how much it would charge.
“The news that a generic version of Truvada — the only medication currently approved for PrEP — will be available in 2020 rather than 2021 is welcome, but we are unlikely to see a dramatic drop in the price until there is meaningful competition and options for PrEP since one generic manufacturer will have exclusive rights for a period of time,” W. David Hardy, MD, chair of the HIV Medicine Association, told Infectious Disease News.
“More immediate actions also are needed to significantly reduce the price and associated medical costs of PrEP, in addition to investments in provider education and capacity building in medically underserved urban and rural areas — particularly in the southern region of the country,” Hardy said.
The Trump administration has made increasing the use of PrEP a focal point of its 10-year plan to end the HIV epidemic in the U.S. – by Gerard Gallagher
Gilead Sciences. Form 10-Q. http://investors.gilead.com/static-files/0ff8d741-b9eb-4162-bcb4-f16094d37254. Accessed May 9, 2019.
PrEP4All. Official statement responding to Gilead Sciences’ announcement that it will allow Teva to manufacture a generic version of Truvada. https://breakthepatent.org/official-statement-responding-to-gilead-sciences-announcement-that-it-will-be-release-its-patent-on-truvada-a-year-early/. Accessed May 9, 2019.
Disclosures: Hardy reports receiving clinical research funding to his institution from Amgen, Gilead Sciences, Janssen, Merck and ViiV/GlaxoSmithKline, and serving as an advisor or on an advisory board for Gilead, Merck, ViiV/GlaxoSmithKline, CSL Behring (Calimmune) and Enochian.