Challenges in Early Diagnosis and Treatment

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
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
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
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.

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