2021 TDDW
Free Paper Section：HCV
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EFFECTIVENESS OF GLECAPREVIR/PIBRENTASVIR FOR PATIENTS WITH HEPATITIS C AND COMPENSATED CIRRHOSIS IN A REAL-WORLD SETTING IN TAIWAN Pei-Kai Su1, Te-Sheng Chang1,2 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan1 College of Medicine, Chang Gung University, Taoyuan, Taiwan2
台 灣 真 實 環 境 中 Glecaprevir/ Pibrentasvir 對 C 型肝炎和代償性肝 硬化患者的效力 蘇培凱1 張德生1,2 嘉義長庚紀念醫院內科部腸胃肝膽科1 長庚大學醫學院2 Background: Real-world data regarding the effectiveness of glecaprevir/pibrentasvir (GLE/ PIB) for patients with hepatitis C virus (HCV) infection and compensated cirrhosis is limited, especially in the Asian population. Aims: Proving the effectiveness of glecaprevir/ pibrentasvir for patients with hepatitis C and compensated cirrhosis in a real-world setting. Methods: This retrospective cohort study included consecutive patients with chronic HCV infection and compensated cirrhosis treated with GLE/ PIB from August 2018 to January 2021 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The diagnosis of cirrhosis was determined using acoustic radiation force impulse (> 1.98 m/s), fibrosis-4 index (> 6.5) or the presence of clinical, radiological, endoscopic, or laboratory evidence of cirrhosis and/or portal hypertension. Sustained virological response (SVR12) was defined as undetectable HCVRNA 12 weeks after the end of treatment. Adverse events (AEs) were also evaluated. Results: A total of 160 patients with HCV and compensated cirrhosis treated with GLE/PIB were enrolled: 57 for 8 weeks and 103 for 12 weeks. In the per protocol analysis, 95.7% (45/47) of the 8-week group and 100% (99/99) of the 12-week group achieved SVR; in the evaluable population
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analysis, 78.9% (45/57) of the 8-week group and 96.1% (99/103) of the 12-week group achieved SVR. Two patients had no response and did not attain SVR in the 8-week group, one of them had documented poor drug adherence. The AEs were numerically higher in the 12-week group compared to the 8-week group including pruritus (26.2% vs. 12.3%), fatigue (9.7% vs. 3.5%), and dizziness (7.8% vs. 1.8%). Laboratory abnormalities were also more common in the 12-week group. Total bilirubin elevation >3× the upper normal limit (UNL) was observed in 13.6% in the 12-week group and 5.3% in the 8-week group. Patients with alanine transaminase elevation >5× the UNL were very rare in both groups of patients. No AEs resulted in treatment discontinuation. Conclusions: GLE/PIB treatment for 8 weeks is as effective as that for 12 weeks in patients of Taiwanese ethnicity with HCV and compensated cirrhosis.
