Gilead's Truvada® Becomes China's First Approved HIV Pre-Exposure Prophylaxis (PrEP) Medication

GileadGilead Sciences announced today,Shufatai® (Truvada) has been approved by the National Medical Products Administration of China for use in pre-exposure prophylaxis (PrEP), in combination with safer sex practices, to reduce the risk of acquiring HIV-1 through high-risk sexual behavior in adults and adolescents weighing at least 35 kg.

It is reported that PrEP is an HIV prevention strategy. For pre-exposure prophylaxis, one tablet of Truvada® should be taken daily in conjunction with safe sexual practices. Prior to using Truvada® for pre-exposure prophylaxis, individuals must test negative for HIV-1.

Truvada® was first approved by the U.S. FDA in 2004 for use in combination with other antiretroviral agents to treat HIV infection in adults and children aged 12 years and older. In July 2012, the FDA further approved once-daily oral Truvada® for HIV pre-exposure prophylaxis (PrEP) in adults.

Truvada® is the first drug approved for use in individuals who are HIV-negative but at risk of HIV infection, including those who may have sexual contact with HIV-positive partners. Clinical study results show that Truvada® can reduce the incidence rate among sexual partners of HIV-positive individuals by 75%, marking a groundbreaking milestone in HIV prevention. According to FiercePharma data, Truvada generated $2.64 billion in revenue in the United States in 2019.

In China, the drug was approved for import in December 2012, but its approved indication was limited to: use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older. It is only now that Truvada® has been approved in China for pre-exposure prophylaxis (PrEP), becoming the first drug approved in the country for HIV PrEP in HIV-uninfected individuals.

According to data released by the National Health Commission of China in November 2019, a total of 131,000 new HIV cases were reported nationwide from January to October 2019. Among these newly reported cases, sexual transmission was the primary route of infection. In addition to practicing safe sex and using condoms correctly, the World Health Organization (WHO) recommends providing pre-exposure prophylaxis (PrEP) to populations at high risk of HIV, thereby establishing a comprehensive set of HIV prevention measures.

Luo Yongqing, Vice President of Gilead Sciences and General Manager of its China region, stated, “With the approval of the PrEP indication for Truvada®, Gilead’s innovative medicines will be able to provide solutions for a broader population at high risk of HIV as well as those living with HIV, helping to meet diverse needs ranging from pre-exposure prophylaxis to HIV treatment. We are committed to working with the government and healthcare institutions to contribute to the continuous improvement of public health in China.”

As a company focused on the research and development of antiviral drugs, Gilead has currently launched four innovative HIV medications in China, including Descovy (emtricitabine and tenofovir alafenamide), Truvada (emtricitabine and tenofovir disoproxil fumarate), Stribild (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate), and Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), which was launched in 2019. These products cover comprehensive solutions ranging from post-exposure prophylaxis (PEP) to single-tablet regimen (STR) treatments.

This article is sourced from EO Intelligence, an original piece by author Qi Yeqing. For reprints or collaborations, please click here.Reprint Notice, Unauthorized reposting will be subject to legal action.