Long-Acting HIV Pre-Exposure Prophylaxis Cabotegravir Approved in China, Endorsed by WHO as Part of Comprehensive Prevention Strategy

China Finance Network, May 14th: Yesterday, GlaxoSmithKline ("GSK") announced that its HIV drug-focused joint venture company, ViiV Healthcare ("ViiV"), had received simultaneous approval from the National Medical Products Administration for Cabotegravir Sodium Tablets and Cabotegravir Injection. These are indicated for pre-exposure prophylaxis (PrEP) against HIV-1 in adults and adolescents (weighing ≥35kg) at risk of infection, to reduce the risk of sexually transmitted HIV-1 infections. Combining safe sexual practices is recommended to achieve optimal HIV-1 PrEP effectiveness.

The U.S. FDA noted in its official press release on December 20, 2021, that it is the first therapy that prevents HIV infection without the need for daily medication.

Pre-exposure prophylaxis (PrEP) is an effective biological prevention method that uses antiviral drugs to prevent HIV infection. As an HIV-1 integrase strand transfer inhibitor (INSTI), the long-acting regimen of cabotegravir requires a minimum of six injections per year for HIV pre-exposure prophylaxis. Users will receive an initial injection of 600mg (3ml) monthly for the first two months, followed by a maintenance injection of 600mg (3ml) every two months. Prior to the first injection, users may choose to take oral cabotegravir sodium tablets for approximately one month (at least 28 days) to assess drug tolerability.

The approval was based on two international Phase IIb/III multicenter, randomized, double-blind, active-controlled studies (HPTN 083 and HPTN 084), which aimed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP) in HIV-1 negative men who have sex with men, transgender women, and cisgender women. Results from the HPTN 083 study showed that participants receiving long-acting injectable cabotegravir had a 68% reduction in the risk of acquiring HIV compared to those on the daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) regimen (12 vs. 39; annual incidence rate: 0.37% vs. 1.22%; HR 0.32 [CI: 0.16, 0.58]). The HPTN 084 study results demonstrated that, compared to the TDF/FTC oral tablet group, the long-acting injectable group experienced a 91% reduction in HIV infection risk (3 vs. 36; annual incidence rate: 0.15% vs. 1.85%; HR 0.09 [CI: 0.04, 0.27]).

"Studies show that the long-acting regimen of cabotegravir significantly reduces the risk of HIV infection in men who have sex with men, transgender women, and cisgender women, with good tolerability. It is superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in preventing HIV infection and helps improve user adherence," said Professor Zhang Fujie, Director of the AIDS Clinical and Research Center at Capital Medical University. The long-acting regimen of cabotegravir has now been recommended by the WHO as part of comprehensive HIV prevention measures.

GSK China General Manager and Vice President Qi Xin stated that the HIV field is one of GSK's global business strategic priorities. The approval of the long-acting regimen of Cabotegravir for HIV pre-exposure prophylaxis (PrEP) provides a new option for people who may benefit from PrEP (PWBP), significantly reducing their preventive medication burden and adding an important tool to help end the HIV epidemic. "In the future, we will continue to introduce more innovative drugs in the HIV field, not only reducing the risk of HIV infection through effective prevention methods but also providing long-acting innovative treatment options for people living with HIV."

AIDS is one of the major public health issues faced globally, with approximately 39 million people currently living with HIV. The UNAIDS has set a goal and commitment to ensure that by 2025, 95% of populations at risk of HIV infection worldwide will have access to effective and comprehensive preventive measures. Therefore, preventing new HIV infections has become a key focus in controlling the spread of AIDS.

In recent years, China has been making every effort to implement various HIV prevention and control measures, placing great emphasis on HIV prevention tasks. Researcher Han Mengjie, the chief expert of HIV/AIDS prevention and control at the Chinese Center for Disease Control and Prevention, pointed out that sexual transmission has become the main route of HIV transmission in China. Heterosexual transmission methods are complex and diverse, while male-to-male homosexual transmission carries a higher risk. "China's HIV prevention and control efforts primarily focus on curbing sexual transmission, while actively promoting pre-exposure prophylaxis (PrEP) pilot programs. Long-acting PrEP drugs will become a powerful new addition to comprehensive intervention strategies."