FDA Eliminates REMS for HIV Drug Truvada and its Generics

Regulatory NewsRegulatory News | 02 July 2019 |  By 

The US Food and Drug Administration (FDA) announced late Monday that it would eliminate the risk evaluation and mitigation strategy (REMS) for Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and its four approved generics, which reduce the risk of sexually acquired HIV.

As part of the 2012 FDA approval of Truvada for HIV pre-exposure prophylaxis (PrEP), in combination with safe sex practices, the agency required manufacturers to provide training materials for health care professionals and educational information for consumers because of the risk of developing a resistant strain of HIV (HIV-1 variants) when starting PrEP or continuing its use in a patient who has undiagnosed HIV-1 infection.

Debra Birnkrant, director of FDA’s Division of Antiviral Products, said in a statement: “We have also reinforced to health care professionals and at-risk individuals that before starting PrEP with Truvada, or emtricitabine/tenofovir disoproxil fumarate, and during its use, health care professionals should routinely screen patients for HIV, at least once every three months. This screening diminishes the risk of individuals with undiagnosed HIV infection developing a resistant strain of HIV while using PrEP.”

As far as why the agency decided to remove the REMS, Birnkrant said that after seven years on the market, FDA has evidence showing that the vast majority of health care professionals and at-risk individuals “are aware of these risks and prevention methods, and educational materials and treatment guidelines are readily available from the U.S. Centers for Disease Control and Prevention [CDC].” 

The FDA action to remove the REMS follows Gilead’s decision last month to donate to CDC up to 2.4 million bottles of Truvada annually for uninsured Americans at risk for HIV. The donation, which extends to 2030, will transition to Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets), if it is approved by FDA for use as PrEP, Gilead said.

Gilead CEO Daniel O’Day’s also testified before the House Oversight Committee last month on his company’s pricing practices related to Truvada. And the committee last week sent further questions to O’Day on the company’s decision to raise the price of Truvada from an average wholesale price of about $1,300 in 2012 to more than $2,000 in 2019, in addition to questions about Truvada patents.

Meanwhile, the US Department of Health and Human Services established an initiative earlier this year, with an aim to reduce new HIV infections by 75% in the next five years and by 90% in the next 10 years, possibly averting more than 250,000 HIV infections.

FDA In Brief


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