Gilead’s Truvada becomes first China-approved drug to prevent HIV-1
China’s National Medical Products Administration (NMPA) has awarded approval to Gilead’s Truvada in a pre-exposure prophylaxis (PrEP) indication to prevent sexually acquired HIV-1 infection when used in combination with safe sex practices, it has emerged.
The therapy was evaluated in a study of 2,499 HIV-seronegative men and transgender women who have sex with men, and in a second study of 4,758 HIV-1 serodiscordant heterosexual couples, with 2,834 patients receiving Truvada overall. From these samples, it was found that use of Truvada led to “significantly lower” rates of new HIV-1 seroconversions compared to placebo. The efficacy of the therapy was also linked closely to patient adherence.
“The approval of Truvada for PrEP addresses an area of significant unmet need in the field of HIV prevention medicine in China. It provides a new prevention option with a demonstrated safety and efficacy profile,” explained Professor Zhang Fujie, Director of Clinical and Research Center of Infectious Diseases at Beijing Ditan Hospital, Capital Medical University. “Truvada for PrEP could play an important role in our response to the HIV epidemic and may help reduce the number of new HIV infections in China.”
While Truvada had already secured approval in China for the treatment of HIV-1 infection in patients at least 12 years old, this latest approval makes it the first therapy available in the country to pre-emptively prevent infection with the virus.
It was stipulated that potential patients must test negative for HIV-1 immediately before starting treatment with Truvada.
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