Gilead Launches China's First HIV PrEP Drug and Introduces Four Innovative Anti-HIV Medicines

In the recently concluded 2020 national medical insurance negotiations, Biktarvy, a flagship product of U.S. pharmaceutical giant Gilead Sciences (hereinafter referred to as “Gilead”), failed to secure inclusion. Previously, four new drugs from Gilead had successfully entered the National Reimbursement Drug List through negotiations at the end of 2019.

Just before the release of the national medical insurance negotiation results, Gilead announced on December 26 that Truvada (emtricitabine and tenofovir disoproxil fumarate tablets) had officially launched in China as the first and currently only approved medication for HIV pre-exposure prophylaxis (PrEP), filling the gap in the domestic landscape where there were previously no pharmaceutical options for HIV prevention.

Truvada is a medication used for the prevention and treatment of HIV/AIDS, first approved by the U.S. FDA in 2004. In China, although the drug was approved for import as early as 2012, 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 was not until August this year that Truvada received approval for a second indication in China, namely “for pre-exposure prophylaxis (PrEP) against HIV when combined with safer sex practices,” becoming the first preventive medication approved for use in HIV-uninfected individuals in the country.

“Since commencing commercial operations in China in 2017, Gilead has introduced multiple globally innovative HIV treatment regimens to the Chinese market and continuously improved drug accessibility to help more people living with HIV return to normal lives.” On December 26, Dr. Jacopo Andreose, Global Senior Vice President, Head of Intercontinental Markets, and General Manager of Greater China at Gilead Sciences, told The Times Weekly reporter, “Today, the world’s first medication for HIV pre-exposure prophylaxis (PrEP) has also been launched in China. In the future, we will continue to contribute our efforts in the field of HIV prevention and treatment.”

Pre-Exposure Prophylaxis Is Key

As of the end of October 2020, China reported 1.045 million existing cases of HIV infection, remaining at a low prevalence level.

With the continuous emergence of new antiretroviral therapies in recent years, HIV/AIDS has transformed from a fatal epidemic into a preventable and manageable chronic disease, significantly reducing mortality rates among infected individuals. However, the number of new infections continues to rise, making the prevention of new HIV infections a key strategy in controlling the spread of AIDS.

Currently, there is no vaccine available worldwide for the prevention of AIDS. Condoms and post-exposure prophylaxis (PEP) are widely promoted as effective measures to prevent HIV infection. In recent years, international attention on pre-exposure prophylaxis (PrEP) has been increasing.

“The key to HIV prevention and control still lies in pre-exposure prophylaxis.” On December 26, Professor Wang Ning from the Chinese Center for Disease Control and Prevention pointed out to Times Weekly reporter that pre-exposure prophylaxis refers to a method of preventing HIV infection by taking specific antiviral medications before engaging in behaviors that pose a risk of HIV transmission among individuals who are not yet infected with the virus.

“PrEP is effective when used correctly and can significantly reduce the risk of HIV infection through sexual transmission. With good adherence, the efficacy of pre-exposure prophylaxis in preventing HIV infection can exceed 90%,” stated Wang Ning.

As the first drug approved in China for pre-exposure prophylaxis (PrEP) against HIV in uninfected individuals, Truvada fills the current gap in domestic HIV prevention where no pharmaceutical options were previously available. However, PrEP is not a vaccine and does not induce the production of HIV antibodies; therefore, it demands a high level of adherence to the medication regimen.

Four New Anti-HIV Drugs Rapidly Enter China

As one of the top ten global pharmaceutical giants and a world leader in anti-HIV therapies, Gilead Sciences focuses on antiviral fields such as HIV/AIDS, hepatitis B, and hepatitis C, as well as oncology and respiratory diseases.

As more patients with chronic hepatitis C are cured, HIV medications have surpassed hepatitis C drugs to become Gilead’s largest product line. Financial report data shows that in the first three quarters of 2020, Gilead achieved total product sales revenue of $17.027 billion, a year-on-year increase of 4%. Among this, HIV drugs contributed $12.681 billion in sales, a year-on-year increase of 7%, accounting for as high as 74.48% of the total pharmaceutical sales revenue.

For Gilead Sciences, China represents a key future growth market beyond its established markets in Europe and the United States. Although Gilead only commenced commercial operations in China in 2017, it has introduced eight innovative drugs to the Chinese market, four of which were successfully included in the National Reimbursement Drug List through negotiations by the end of 2019.

Currently, all four of Gilead’s innovative HIV medicines have entered the Chinese market, achieving simultaneous availability with global launches. These four new anti-HIV drugs include Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide), Descovy (emtricitabine/tenofovir alafenamide), Truvada (emtricitabine/tenofovir disoproxil fumarate), and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which was launched earlier this year. Together, they provide a comprehensive portfolio covering pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and single-tablet regimen (STR) therapy. Notably, Biktarvy was approved in China only about one year after its approval in the United States.

To improve the accessibility of new medicines, the pricing of Genvoya, Descovy, and Truvada in the Chinese market is lower than that in European and American markets. Taking Genvoya, a single-tablet regimen, as an example, its price in the United States is approximately USD 3,000 per bottle (30 tablets), whereas its launch price in China was around RMB 2,980 per bottle (30 tablets), which amounts to less than 15% of the U.S. price.

In the national medical insurance negotiations at the end of 2019, Genvoya was included in the National Reimbursement Drug List at a price of RMB 1,290 per bottle (30 tablets), representing a price reduction of 56.71%. After medical insurance reimbursement, patients’ out-of-pocket expenses were reduced to only RMB 258–387, significantly lowering the cost of treatment.

However, besides Descovy, the other three anti-AIDS drugs—Descovy, Truvada, and Biktarvy—are currently not included in the national medical insurance. Among them, Biktarvy is the smallest triple-combination single-tablet regimen based on integrase inhibitors available today, with global sales reaching $3.297 billion in the first half of 2020.

(Editor:Wang Xing）

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