On July 25, 2025, Lenacapavir, the world's first pre exposure preventive drug against HIV that only needs to be administered twice a year, was officially launched in Hainan Boao Lecheng International Medical Tourism Pioneer Zone. This innovative drug with a breakthrough mechanism and long-term protection capability has realized the synchronous accessibility of almost "zero time difference" with the world, provided a new weapon for ending the AIDS epidemic goal, and is expected to further enhance the diversification process of China's HIV prevention and control pattern.

We have reached a real turning point in the journey of HIV prevention and control. Professor Zhang Fujie from Beijing Ditan Hospital affiliated with Capital Medical University introduced that Lenacapavir is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, suitable for pre exposure prophylaxis (PrEP) in adults at risk of HIV-1 infection and adolescents weighing not less than 35 kg to reduce the risk of HIV-1 infection through sexual activity. Recently, Lenacapavir was recommended by the World Health Organization (WHO) for pre exposure prevention of HIV, highlighting its strategic position in the global prevention system.

Concept upgrade: the necessary path from passive treatment to active prevention

Currently, HIV remains a major public health challenge faced globally and in China. HIV attacks the human immune system. Once infected, there is no cure. If you do not receive standard antiviral treatment in time, you may eventually develop AIDS. With the continuous optimization of China's comprehensive prevention and control strategy, significant achievements have been made in HIV prevention and control. For a long time, HIV prevention and control strategies have evolved from mainly "behavioral intervention" to a combination of "behavior+medication". Pre exposure prevention, as an important drug prevention method, has become one of the mainstream comprehensive prevention measures worldwide.

Pre exposure prophylaxis refers to the use of specific antiretroviral drugs by individuals who are not infected with HIV before engaging in HIV prone behavior, in order to prevent HIV infection and provide a "protective wall" for those who may be at risk of HIV infection. This is like pre emptive defense in the human body. Once HIV exposure occurs, drugs can directly intercept and control the virus, preventing infection, "explained Professor Zhang Fujie.

Treatment is a protracted battle against the virus, while prevention is an ambush battle, blocking the virus that has just come into contact with the human body, thereby reducing the risk of infection. Professor Zhang Fujie pointed out that the integration of medical and preventive measures is currently the core principle of infectious disease prevention and control. However, there are some common misconceptions in society, where people always believe that HIV is far away from them and neglect prevention. In fact, the prevention and control of new HIV infections in China still face challenges, and sexual transmission is the main route. In 2024, the number of newly reported infections in China has reached 102000, accounting for 7.8% of the global new infections. Once infected, patients will face the physical and mental burden of lifelong antiviral treatment. Therefore, the fundamental way to end the AIDS epidemic is to focus on prevention and avoid infection through scientific prevention and control.

At present, the development path of HIV vaccines is still long, and pre exposure prevention remains an irreplaceable pillar of prevention and control at this stage. As an effective means to reduce new HIV infection among high-risk groups, pre exposure prevention is listed as one of the important intervention strategies for high-risk groups in the Chinese AIDS Diagnosis and Treatment Guidelines (2024). China's Plan for Combating and Preventing AIDS (2024-2030) also defines the general policy of "prevention first and combination of prevention and treatment", and puts forward the goal of reducing new infections, reducing related deaths, and maintaining a low prevalence level [3]. However, in reality, due to the difficulty of long-term adherence to the daily medication regimen, many people have used it but eventually give up, or even know about it but have never used it, which also poses a challenge to the popularization of PrEP.

Drug Innovation: How can the world's first "twice a year" long-term plan overturn the HIV prevention landscape?

Compared to other approved antiretroviral drugs, Lenacapavir is a truly "long-acting regimen" - administered only twice a year, the drug will be sustained-release in the body to maintain a high antiviral concentration, forming a protective barrier for more than six months. Professor Zhang Fujie metaphorically stated that this is because Lenacapavir can directly bind to the HIV capsid protein subunit, acting like a precise "virus bomb disposal expert", blocking key steps of virus replication, such as preventing virus assembly and release, thereby preventing HIV infection. Our previous drugs were more like 'guarding at the door', while Lenacapavir had sentinels arranged in 'the door, hallway, and living room'. In addition, as an innovative capsid inhibitor, Lenacapavir does not have known cross resistance with other existing drugs, which means that Lenacapavir is equally effective when faced with some existing drug-resistant virus strains.

We need to clarify a key concept that Lenacapavir is a long-acting HIV preventive drug, not a prophylactic vaccine. Professor Zhang Fujie stated that there is currently no effective vaccine available, and long-acting preventive drugs do not stimulate the body's own immune system to produce antibodies like vaccines do. Instead, by placing drugs in the body in advance that can maintain a specific concentration for a long time, they can prevent the invasion of viruses and prevent diseases during the subsequent protection period.

Lenacapavir not only has a unique mechanism of action, but has also demonstrated protective efficacy beyond previous studies in multiple clinical trials. The top medical journal, The New England Journal of Medicine, published two global Phase III clinical studies, PURPOSSE 1 and PURPOSSE 2, covering different genders and risk populations. The research conclusions are consistent, showing that under the "two doses a year" regimen, more than 99.9% of subjects continue to test negative for HIV, demonstrating its excellent effectiveness and becoming one of the most effective prevention programs at present. Therefore, Lenacapavir has been selected as the top scientific breakthrough of 2024 by the journal Science.

For high-risk populations, the advantage of Lenacapavir lies not only in its effectiveness, but also in significantly reducing the psychological burden caused by frequent medication, avoiding privacy risks caused by drug exposure, and preventing prevention failure due to missed or discontinued doses. It is particularly suitable for people who are concerned about their medication behavior being discovered by family, partners, or colleagues, or who have difficulty adhering to daily medication due to unstable daily routines, providing them with a long-lasting and privacy preserving protective option.  

Collaborative Progress: Multiple Solutions Build a Strong HIV Protection Network

The core measures to prevent HIV infection include avoiding high-risk behaviors of HIV infection and taking timely medical interventions. From the popularization of daily oral medication to the introduction of long-term plans, China is building a multi-level and comprehensive HIV prevention and control network. The mainstream prevention plan, such as daily oral PrEP medication, provides reliable protection for high-risk populations. Currently, China has approved the use of Dapagliflozin ® And Shu Fatai ® With the launch of Lenacapavir in Boao, Hainan, two daily oral PrEP drugs will provide a more convenient and efficient prevention option for those in need.

However, currently the awareness and usage rates of PrEP in China are at a relatively low level, and many high-risk populations still face practical obstacles such as poor information access, concerns about medication privacy, and social bias. Even though there are drugs available, there are still many people who "know but hesitate, want to use but give up". As an innovative long-acting preventive drug, Lenacapavir can greatly alleviate these real-life anxieties, improve medication convenience, and enable high-risk populations to hardly change their lifestyle, while also benefiting privacy protection. Nowadays, with diversified pre exposure prevention options, everyone can find a suitable pre exposure prevention plan based on their own needs and under the guidance of a doctor.

Preventing and controlling HIV cannot be achieved solely with one drug, it requires the combination of multiple prevention methods. Professor Zhang Fujie reminds that pre exposure drug prevention, as part of the comprehensive HIV prevention strategy, should be combined with safer sexual behavior, including the use of condoms, to reduce the risk of HIV infection through sexual activity. Lenacapavir, as an efficient "biological shield," can significantly reduce the risk of HIV infection, while condoms are an indispensable "physical barrier" that can prevent multiple sexually transmitted infections such as HIV, syphilis, gonorrhea, etc. When used in combination, it can provide more comprehensive protection.

Nowadays, innovative drugs are constantly being introduced and applied, and the key challenge in the future is how to improve their awareness, acceptance, and usage rates. This requires public awareness enhancement, deepening clinical education, medical insurance policy support, and community mobilization to work together, all of which are indispensable. Professor Zhang Fujie pointed out that having multiple sexual partners, unprotected sex, and sharing needles/syringes in daily life may increase the risk of HIV infection. In addition to these traditional behavioral interventions, innovative drug prevention methods also provide a new option for preventing HIV/AIDS. Both the general population and high-risk individuals should raise their awareness of HIV/AIDS prevention, and individuals should make good use of innovative drugs according to their own needs, in order to achieve more comprehensive, scientific, and adaptive health protection. With the accumulation of more and more innovative drug research and clinical evidence, it is believed that the global HIV prevention and treatment work will enter a new stage.

reference material

[1] National epidemic situation of AIDS and sexually transmitted diseases in December 2024 [J]. AIDS and sexually transmitted diseases in China, 2025, 31 (03): 225

[2] UNAIDS GLOBAL AIDS UPDATE 2025

[3] Notice of the General Office of the State Council on Printing and Distributing China's Plan to Stop and Prevent AIDS (2024-2030) _ document of the State Council _ Chinese government website