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Essential Efforts for Japanese Leadership in Ending the Global HIV/AIDS Epidemic

Human immunodeficiency virus (HIV) continues to claim many lives worldwide. Despite advances in treatment, the spread of HIV infections persists. At the “11th NIKKEI FT Communicable Diseases Conference,” held on October 22-23, 2024 in Tokyo, organized by Nikkei Inc., the Japan subsidiary of U.S.-based Gilead Sciences hosted a special session. The session highlighted critical initiatives for combating the HIV epidemic, including the importance of early diagnosis and treatment and the efficacy of pre-exposure prophylaxis (PrEP). The latest scientific findings were presented to advance public health efforts in this area.

Obtaining knowledge to End the HIV Epidemic

Challenges in Early Diagnosis and Treatment

Dr. Junko TANUMA

Dr. Junko TANUMA, MD, PhD
Professor, Department of Infectious Diseases, School of Medicine
Professor, Department of Global Health and Infectious Diseases, Graduate School of Public Health
International University of Health and Welfare

With the support of Gilead Sciences, the Boston Consulting Group has compiled a report on AIDS countermeasures in nine developed countries, including Japan. According to the report, 1.3 million people are newly infected with HIV annually, with a global total of 39 million people living with HIV.

To end the epidemic, three key strategies have been highlighted: (1) introducing pre-exposure PrEP (Pre-Exposure Prophylaxis), which involves the preventive use of anti-HIV medication by individuals who are not yet infected; (2) encouraging early diagnosis and treatment to lower viral loads to undetectable levels, thereby preventing transmission to others; and (3) addressing stigma and discrimination to create a supportive environment.

In Japan, delays in testing and diagnosis remain significant issues. Addressing these issues requires promoting diverse testing methods, enhancing accessibility, and bolstering public awareness initiatives.

Early treatment is another major challenge. The World Health Organization (WHO) recommends starting treatment within one week of diagnosis. However, in Japan, it can take more than two months. This delay is partly due to the requirement for laboratory test results taken at least four weeks after diagnosis to obtain a physical disability certificate, which is necessary to access subsidized medical care under the public assistance system. Some individuals have even foregone treatment altogether due to difficulties in obtaining the required certificate.

In Japan, base hospitals are well-established, with excellent treatment outcomes. Such efforts should also be directed towards early diagnosis and treatment and the widespread utilization of PrEP.

No Prevention Without Testing

Prof. Shuzo MATSUSHITA, MD, PhD

Prof. Shuzo MATSUSHITA, MD, PhD
Professor; Joint Research Center
for Human Retrovirus Infection, Division of Clinical Retrovirology, Kumamoto University

In Japan, limited testing opportunities prevent early diagnosis, with around 30% of new cases being identified only after the onset of AIDS. Regional variations exist approximately 18% in Tokyo and 21% in Osaka. However, outside these cities, the national average rises to approximately 38%. Regions with active support organizations tend to achieve earlier diagnoses.

Infectious disease control in Japan is primarily carried out through public health centers.

Only about 30% of cases are detected through testing conducted by public health centers. During the COVID-19 pandemic, testing opportunities were reduced by half, leading to an estimated 100 undiagnosed infections annually. To address this issue, the current testing system, primarily reliant on public health centers, should be reevaluated. A more diverse range of testing options should be introduced, such as clinic-based testing, mail-in testing, and self-testing.

The impact of PrEP is profound. In some overseas cities, aggressive governmental promotion has markedly reduced the number of new infections.

The promotion of PrEP requires the involvement of medical institutions. Primary care clinics should take part in performing tests, providing ongoing monitoring, and offering continuous support. The community also plays a significant role. A large number of individuals may be interested in PrEP, and efforts to popularize it must be undertaken with a firm commitment.

Prevention is impossible without testing. Mechanisms for early diagnosis and treatment should be urgently established, while mental support and psychological research are needed for individuals who, despite recognizing their high risk, remain reluctant to undergo testing.

Initiating Revisions to the HIV Prevention Guidelines

Manabu SUMI, MD, MPH, PhD

Manabu SUMI, MD, MPH, PhD
Director-General
Department of Infectious Disease Prevention and Control
Ministry of Health, Labour and Welfare

Discussions have started in Japan regarding the revision of the “HIV Prevention Guidelines,” which outline the direction of national measures against HIV infection.

The guidelines suggest prominently placing “Respect for Human Rights” at the beginning. During the meeting of the “Subcommittee on AIDS and Sexually Transmitted Infections” held in June, the main topics of discussion included establishing targets to end the HIV epidemic, enhancing medical and testing systems, and exploring the use of PrEP.

Although PrEP has been reported to have potent preventive effects, its effectiveness depends heavily on patient adherence. Potential concerns, including a rise in other sexually transmitted infections (STIs) and the development of drug-resistant viruses, must also be considered. Regarding the anti-HIV medication approved in August, the Ministry of Health, Labour and Welfare is conducting scientific research to assess both the safety of PrEP and its effects on non-HIV STIs.

A Japanese study on PrEP targeting non-HIV-infected men who have sex with men reported very high rates of infection prevention, retention in care, and patient adherence. Establishing an environment that ensures the appropriate use of PrEP is essential.

Currently, 25 research projects related to HIV are being conducted under the Ministry of Health, Labour and Welfare’s scientific research initiatives, and 23 projects under the AIDS Countermeasure Practical Application Research Program. The prevention guidelines will be revised based on the results of these studies. New innovations should be appropriately incorporated.

Development of Long-Acting Drugs

Masayuki OMOTE, PhD

Masayuki OMOTE, PhD
Executive Director, Clinical Development Japan, Gilead Sciences KK

U.S.-based Gilead Sciences has developed long-acting drugs for inhibiting the capsid protein that encapsulates the RNA of the HIV virus, thereby marking a significant advancement in HIV treatment. This drug, which took 16 years to develop, inhibits viral replication at multiple stages, and is available in two forms: oral tablets and injectable formulations. A single subcutaneous injection provides antiviral effects for about six months. The drug was first approved in 2022 in Western countries and in 2023 in Japan.

To promote the efforts for prevention, it is crucial to encourage HIV-infected individuals to take antiretroviral drugs to prevent transmission to their partners, while also promoting the use of PrEP for uninfected individuals to reduce the risk of HIV infection. In August 2024, one of Gilead’s antiretroviral drugs became the first PrEP medication to receive regulatory approval in Japan.

Clinical trials of long-acting drugs for prevention have demonstrated promising outcomes. Long-acting PrEP, which provides highly effective prevention with just one subcutaneous injection every six months, shows significant potential. To advance this approach, Gilead intends to engage in further discussions with the Ministry of Health, Labour, and Welfare, as well as with community organizations.

Achieving a complete cure for HIV depends on the challenge of eliminating latent infected cells. Gilead’s approach focuses on reactivating dormant HIV through immune-modulating agents, targeting and reducing latent infected cells with broadly neutralizing antibodies, and eliminating residual infected cells with therapeutic vaccines. Although the journey toward a cure is complex, Gilead remains steadfast in its research efforts to bring an end to the global HIV epidemic.

Mr. Omote’s presentation materials

Created based on Mr. Omote’s presentation materials, which refer to documents from the Joint United Nations Programme on HIV/AIDS (UNAIDS).

Question and Answer (Q&A)

Need of Multidimensional Approaches

Dr. Hiroaki MITSUYA, MD, PhD

Moderator
Dr. Hiroaki MITSUYA, MD, PhD
Director; Research Institute
National Center for Global Health and Medicine

Mitsuya: I am a trained hematologist and have conducted research on immunodeficiency diseases. This led me to contribute to the development of the first AIDS treatment. Over the past 40 years, remarkable advancements have been made in HIV therapies. However, significant challenges persist in the effort to end the HIV epidemic.

For example, in Japan, many people cannot start treatment immediately after being diagnosed. According to the report by the Boston Consulting Group, which Dr. Tanuma mentioned earlier, 73% of people diagnosed as HIV-positive in 2021 were categorized as “late presenters,” meaning they had not yet been prescribed antiretroviral drugs. Such cases not only harm the individuals affected but also risk further spreading the infection.

Tanuma: Although the percentage appears to have risen over the years, the absolute number of cases may not have significantly changed. As I mentioned in my earlier presentation, individuals whose viral load falls below the numerical thresholds established by the government often face difficulties in obtaining a disability certificate. This poses a significant obstacle to starting treatment at an early stage.

Mitsuya: During the COVID-19 pandemic, there was a decline not only in cancer screening rates but also in consultations and tests related to AIDS. Public awareness remains insufficient and needs to be improved. It is essential for the government to actively leverage media and other channels to effectively disseminate information.

The approval of HIV medications for PrEP in Japan marks an important advance in prevention efforts. However, unlike the United States, where PrEP-related costs are provided free of charge, Japan faces the challenge of integrating these medications into the healthcare system and ensuring coverage by insurance.

Sumi: In Japan, the Health Insurance Act primarily addresses diseases and injuries, excluding preventive measures, such as vaccines, and childbirth from coverage. Although specific solutions for these gaps are yet to be determined, it is crucial to explore comprehensive approaches to tackle these challenges. This includes strategies for early treatment, disability policies, and the adoption of innovative measures.

Mitsuya: This session has highlighted the complexity of challenges involved in ending the HIV epidemic. Tackling these obstacles demands a comprehensive, multidimensional approach.

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