PrEP approved to prevent HIV in Japan

Japan’s health ministry has approved the prescription of tenofovir disoproxil (TDF) and emtricitabine (FTC), sold by Gilead Sciences under the brand name Truvada, as PrEP for the prevention of HIV.

Whilst TDF/FTC has been available in Japan for the treatment of HIV since 2005 the country has lagged behind other nations in approving the use as pre-exposure prophylaxis (PrEP). The United States, for example, started its PrEP rollout in 2012.

Petitions were submitted by the Japanese Society for AIDS Research in 2018 and 2021, but were ultimately unsuccessful. In 2023 Japan’s health ministry finally decided to start the approval process, requesting Gilead Sciences put in the appropriate applications.

In a press release regarding the approval, Kennet Brysting, President of Gilead Sciences Japan, stated:

“Our goal is to reduce new infections to zero and end the HIV epidemic in Japan and around the world. Ending the HIV epidemic requires effective use and widespread adoption of PrEP.”
“The approval of this drug for PrEP is an important milestone. We will continue to work with regulators,
healthcare professionals, relevant organisations and the community to end the HIV epidemic in Japan.”

Japan joins 144 other countries around the world that have followed the World Health Organisation (WHO) guidance to provide PrEP to all people at “substantial” risk of acquiring HIV.

A representative from Japan’s health ministry confirmed the approval of TDF/FTC for preventing HIV but chose not to comment on whether the drug would be eligible for health insurance coverage.

The approval of TDF/FTC as PrEP in Japan follows the recent news that Gilead Sciences’ twice-yearly lenacapavir injections were up to 100% effective at preventing HIV acquisition in cisgender women.