ArticleAdvances in therapy2026
Real-World Safety and Effectiveness of Cabotegravir in People Living with HIV: Interim Report of a Post-marketing Surveillance in Japan.
Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionCabotegravir (CAB) is an integrase strand transfer inhibitor and the first long-acting injectable antiretroviral agent for human immunodeficiency virus (HIV), administered with rilpivirine. Because approval in Japan relied largely on overseas and international collaborative trials, domestic real-world evidence remains limited. This study evaluated the real-world safety and effectiveness of CAB in people living with HIV (PLHIV) in Japan.
methodsThis interim analysis (June 27, 2022 and June 17, 2025) was part of an ongoing post-marketing surveillance of Japanese PLHIV treated with CAB at institutions participating in the HIV-related Drugs Cooperative Survey. Safety was assessed by the incidence of adverse drug reactions (ADRs). Associations between ADR incidence and background characteristics were examined using Fisher's exact and χ
resultsA total of 121 and 117 participants were included in the safety and efficacy analysis sets, respectively; most were aged over 20 years, and over 96% were male participants. Overall, 76 ADRs were reported in 45 participants (37.19%). The most frequent ADRs were injection site pain and musculoskeletal pain (12.40% each). Four serious ADRs that were not explicitly deemed unrelated to CAB by the reporting physicians occurred in 4 participants: hepatitis B reactivation, monkeypox, syphilis, and type 2 diabetes mellitus. Stratification analyses by participant characteristics revealed high ADR incidences among participants aged ≥ 30 to < 40 years (p = 0.038), without allergy (p = 0.016), and with comorbidities (p = 0.045). HIV RNA copies remained suppressed and CD4
conclusionThis interim analysis indicates that CAB therapy is safe, with no new safety signals, and effective, as demonstrated by sustained virological suppression and stable CD4
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