GSK Launches Long-Acting HIV PrEP Drug Apretude (Cabotegravir Injection) in China, Requiring Only Six Injections Annually

China Finance Network January 10th — GSK announced today the official launch of its long-acting HIV pre-exposure prophylaxis (PrEP) drug, Apretude (cabotegravir injection), for use in adults and adolescents (weighing ≥35kg) at risk of HIV infection to reduce the risk of sexually transmitted HIV-1 infection. Combined with safe sexual practices, it achieves better HIV-1 PrEP effectiveness.

As of January 2025, the long-acting regimen of Cabotegravir is the first and only long-acting injectable approved by the National Medical Products Administration (NMPA) in China for HIV pre-exposure prophylaxis (PrEP). As an HIV-1 integrase strand transfer inhibitor (INSTI), the Cabotegravir long-acting regimen requires a minimum of six injections per year to achieve HIV pre-exposure prophylaxis. Users will receive an initial injection of 600mg (3ml) once a month for the first two months, followed by a maintenance injection of 600mg (3ml) every two months.

Helen Yu, Vice President of GSK and General Manager of China, stated that the successful commercial launch of the long-acting Cabotegravir regimen in China marks another key milestone in GSK's continuous innovation in the field of HIV prevention and treatment. "We believe that this long-acting pre-exposure prophylaxis regimen will bring more options and benefits for the prevention of HIV among at-risk populations in China and will have a significant impact on ending the HIV epidemic."

Previously approved based on two international Phase IIb/III multicenter, randomized, double-blind, active-controlled studies (HPTN 083 and HPTN 084). The results of the HPTN 083 study showed that, compared with the daily oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) regimen, the risk of HIV infection in participants receiving long-acting injectable Cabotegravir was reduced by 68% (12 vs 39; annual incidence rate: 0.37% vs 1.22%; HR 0.32 [CI: 0.16, 0.58]). The results of the HPTN 084 study showed that, compared with the TDF/FTC oral tablet group, the risk of HIV infection in the long-acting injectable group was reduced by 91% (3 vs 36; annual incidence rate: 0.15% vs 1.85%; HR 0.09 [CI: 0.04, 0.27]).

Zhang Fu-Jie, Director of the AIDS Clinical Research Center at Capital Medical University, introduced that in terms of preventing HIV infection, the long-acting regimen of Cabotegravir has demonstrated superior efficacy compared to daily oral TDF/FTC tablets in clinical studies. Additionally, with an administration method requiring only one injection every two months, it offers a novel pre-exposure prophylaxis option and experience for individuals at risk of HIV infection. This helps alleviate medication anxiety and social discrimination associated with oral pre-exposure prophylaxis, significantly improving their quality of life, enhancing adherence, and increasing persistence.

According to the "China Plan for Containment and Prevention of AIDS (2024-2030)," China's HIV prevention and control efforts have achieved remarkable results. Current HIV prevention work must adhere to the principle of prioritizing prevention while integrating prevention and treatment. Therefore, implementing comprehensive HIV intervention measures and preventing new HIV infections have become key directions in China's AIDS prevention efforts. Pre-exposure prophylaxis (PrEP), as an effective method to reduce the risk of HIV infection among high-risk populations, is an essential component of the comprehensive HIV intervention strategy. Authoritative guidelines recommend that individuals with ongoing HIV exposure risk should be advised to use pre-exposure prophylaxis.

Sun Xinhua, Chairman of the China Foundation for the Prevention of STD and AIDS, stated that AIDS prevention and control is not only a significant task concerning individual health and life safety but also a key cornerstone for building a robust public health system and promoting social harmony and stability. "In addressing the challenges in China's HIV prevention work, on one hand, we need to enhance public awareness of pre-exposure prophylaxis (PrEP); on the other hand, we must actively promote the standardized implementation of PrEP measures to provide more accessible and sustainable preventive service options for people at risk of HIV infection. A safe and highly effective long-acting PrEP solution will become a powerful addition to reducing new HIV infections, controlling the spread of AIDS, and further advancing China’s AIDS prevention and treatment efforts."