Evaluation of cabotegravir plus rilpivirine in routine clinical settings in Japan: A multicentre study of efficacy, safety and biomarker dynamics.

Long-acting cabotegravir plus rilpivirine (CAB+RPV) offers an alternative to daily oral therapy, but real-world data in East Asia remain scarce. This study aims to evaluate the impact of CAB+RPV in people with HIV in Japan, focusing on virological outcomes, treatment continuation and inflammatory markers, providing valuable insight into the use of injectable regimens in clinical practice. This multicentre retrospective study analysed routinely collected data from eight HIV centres in Japan on people with HIV who initiated CAB+RPV before January 2024. Virological, renal, inflammatory and lipid outcomes were assessed using follow-up laboratory data obtained through April 2025. Among 136 participants, over 95% maintained HIV RNA <50 copies/mL, and more than 75% sustained undetectable levels through 14 months. No virological failures occurred. Seven participants (5.1%) discontinued treatment, mostly due to injection site reactions (ISRs). Serum creatinine and cystatin C significantly decreased overall, although a significant change in serum creatinine was not observed in the subgroup switching from a regimen that did not contain a renal tubular transport inhibitor. CD4 and CD8 cell counts declined (median changes: -32 cells/μL, p = 0.0047; -52 cells/μL, p < 0.0001), with no significant change in the CD4/CD8 ratio or CRP. high-density lipoprotein cholesterol (HDL-c) increased significantly (p = 0.0005), while LDL-c and the T-chol/HDL-c ratio remained unchanged. This study provides the first multicentre real-world data on CAB+RPV in Japan, demonstrating high virological outcomes among a significant portion of Japanese people with HIV. The findings suggest that CAB+RPV maintains a favourable safety profile, with no significant effects on chronic inflammation.