Impact of Disability Certificate Requirements on Antiretroviral Initiation in HIV Care in Japan: A Retrospective Study

Objective: In Japan, antiretroviral therapy (ART) for individuals living with human immunodeficiency virus (HIV) is financially supported through the Physical Disability Certification System for Immunological Impairment. However, certification requires multiple laboratory assessments after diagnosis, possibly delaying ART initiation. This study examined the impact of these eligibility requirements on ART initiation using real-world clinical data. Design: Single-center retrospective cohort study. Setting: Nagoya Medical Center, Japan. Subjects, participants: A total of 568 patients who attended their first consultation between 2015 and 2019 were included. Of these, 434 were ART-naive, and 134 had already initiated ART at the first visit. Main outcome measures: ART initiation rate, time to treatment initiation, factors associated with treatment delay, and utilization of the Physical Disability Certificate system. Results: Among the 434 untreated patients, the median time to ART initiation was 42 days. Seven patients (1.6%) did not meet the Grade 4 certification requirements and remained untreated. Overall, 13 of the 568 patients (2.3%) were affected by the certification system, including those importing ART from overseas or using alternative financial support mechanisms. Non-Japanese nationality, lack of health insurance, unstable employment, and low CD4 cell counts were significantly associated with failure to initiate treatment. Among the 134 previously treated patients, 108 (80.5%) had obtained a Physical Disability Certificate. Conclusions: Although relatively few patients were affected, certification requirements may delay ART initiation among socioeconomically vulnerable populations. Further multi-center and cost-effectiveness studies are needed to improve compatibility between long-term financial support systems and rapid ART initiation strategies after diagnosis.