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

Abstract

Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.