GSK (GlaxoSmithKline PLC.) announced today its long-acting HIV pre-exposure prophylaxis drug, Apretude.®(Cabotegravir Injection) Officially Launched for HIV-1 Pre-Exposure Prophylaxis (PrEP) in Adults and Adolescents (Weight ≥35kg) at Risk of Infection, to Reduce the Risk of Sexually Transmitted HIV-1 Infection, Combined with Safe Sexual Practices for Better HIV-1 PrEP Outcomes.
As of January 2025, the long-acting regimen of Cabotegravir is the first and only long-acting injectable approved by the China National Medical Products Administration 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.1
GSKVice President, General Manager of China, Yu Huiming"This successful commercial launch of the long-acting Cabotegravir regimen in China marks another key milestone in GSK's ongoing innovation in the field of HIV prevention and treatment. We believe that this long-acting pre-exposure prophylaxis regimen will offer more choices and benefits for HIV risk populations in China and make a significant impact on ending the AIDS 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]).2、3、4、5
Zhang Fujie, Director of the AIDS Clinical Research Center at Capital Medical UniversitySaid: "In the prevention of HIV infection, the long-acting regimen of cabotegravir has shown superior results to daily oral TDF/FTC tablets in clinical studies. At the same time, the dosing method of injection once every two months also provides an innovative pre-exposure prophylaxis option and experience for people at risk of HIV infection, which helps alleviate medication anxiety and social discrimination caused by oral pre-exposure prophylaxis regimens, significantly improving their quality of life and increasing medication adherence and 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 a 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) is an effective means of reducing the risk of HIV infection among high-risk populations.6、7, which is an important part of the comprehensive HIV intervention strategy. Authoritative guidelines recommend that people who are continuously at risk of HIV exposure should be recommended to use pre-exposure prophylaxis.8。
Sun Xinhua, Chairman of the China Foundation for Prevention of STD and AIDS"It is noted that the prevention and treatment of AIDS is not only a significant task related to individual health and life safety, but also a key cornerstone for building a robust public health system and promoting social harmony and stability. Facing the challenges in China's HIV prevention work, on one hand, we need to enhance the public’s correct understanding of pre-exposure prophylaxis (PrEP); on the other hand, we also need to actively promote the standardized implementation of PrEP measures to provide more convenient and sustainable preventive service options for populations at risk of HIV infection. Safe and highly effective long-acting PrEP solutions will become a powerful supplement in reducing new HIV infections, controlling the spread of AIDS, and advancing China's AIDS prevention and treatment efforts."
About Aipute®(Cabotegravir Injection)
Cabotegravir Long-Acting Injection for HIV Pre-Exposure Prophylaxis is an Integrase Strand Transfer Inhibitor (INSTI) that suppresses HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (CD4+ T cells). This step is crucial in the HIV replication cycle and is also the reason why HIV becomes a chronic condition.
Cabotegravir requires a minimum of six injections per year for pre-exposure prophylaxis of HIV. 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 tablets for approximately one month (at least 28 days) to assess drug tolerability.
About GSK
GlaxoSmithKline (GSK) is a global biopharmaceutical company with the mission to "unite science, technology, and talent to push boundaries and overcome diseases together." For more information, please visit gsk.com.
1. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PREP) IN UNDIAGNOSED HIV-1 INFECTION
2. Delaney-Moretlwe S, Hughes J, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet 2022;399(10337):1779-1789. DOI: 10.1016/S0140-6736(22)00538-4
3. Clinical Trials.gov - Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed August 2023.
4. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. The New England Journal of Medicine 2021;385:595-608. DOI: 10.1056/NEJMoa2101016
5. Clinical Trials.gov - Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. Available at https://clinicaltrials.gov/ct2/show/NCT02720094. Last accessed August 2023.
6. UNAIDS. In Danger: UNAIDS Global AIDS Update 2022 [Z].2022.
7. WHO. Guidelines on long-acting injectable cabotegravir for hiv prevention [Z]. 2022.
8. CDC. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States (2021 Update) - Clinical Practice Guideline.