Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan

• Published in: BMC gastroenterology Vol. 21; no. 1; pp. 1 - 259
• Main Authors: Huang, Yu-Ting, Hsieh, Yung-Yu, Chen, Wei-Ming, Tung, Shui-Yi, Wei, Kuo-Liang, Shen, Chen-Heng, Chang, Kao-Chi, Lu, Chung-Kuang, Yen, Chih-Wei, Lu, Sheng-Nan, Hung, Chao-Hung, Chang, Te-Sheng
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 12.06.2021; BioMed Central; BMC
• Subjects: Adverse events; Alanine; Alanine transaminase; Antiviral drugs; Bilirubin; Cirrhosis; Clinical medicine; Diabetes; Drug dosages; Drug therapy; FDA approval; Fibrosis; Gastroenterology; Genotype & phenotype; Hepatitis; Hepatitis C; Infections; Liver cirrhosis; Liver diseases; Patient outcomes; Patients; Population studies; Pruritus; Public health; RNA polymerase; Sofosbuvir/velpatasvir; Sustained virologic response; Transaminase; Taiwan; Asia
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-021-01837-y

Abstract Introduction Real-world data regarding the impact of hepatic fibrosis on the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) treatment is limited in the Asian population. Methods We analyzed data for all 823 patients with hepatitis C virus treated with SOF/VEL from June 2019 to September 2020 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The degree of fibrosis was determined using the fibrosis-4 (FIB-4) index, with advanced fibrosis or cirrhosis defined as a FIB-4 score of > 3.25. The primary treatment outcome was the rate of sustained virologic response 12 weeks after treatment cessation (SVR). Adverse events (AEs) were also evaluated. Results SVR rates did not significantly differ ( p  > 0.05) between patients with FIB-4 scores of ≤ 3.25 and those with scores of > 3.25. In the per protocol analysis, 99.2% (593/598) of the FIB-4 ≤ 3.25 group and 100% (172/172) of the FIB-4 > 3.25 group achieved SVR; in the evaluable population analysis, 93.4% (593/635) of the FIB-4 ≤ 3.25 group and 91.5% (172/188) of the FIB-4 > 3.25 group achieved SVR. Five patients with FIB-4 scores of ≤ 3.25 did not attain SVR: two relapsed and three had no response. The most common AEs were comparable ( p  > 0.05) for the FIB-4 ≤ 3.25 group and the FIB-4 > 3.25 group and included abdominal discomfort (4.4% vs. 5.9%), fatigue (4.1% vs. 5.9%), and skin itching (3.6% vs. 3.2%). Laboratory abnormalities were more common in the FIB-4 > 3.25 group ( p  < 0.001). Six patients with FIB-4 scores of > 3.25 had total bilirubin elevation > 3 × the upper normal limit (UNL). Alanine transaminase elevation > 5 × the UNL was observed in two patients with FIB-4 scores of ≤ 3.25 and one patient with a FIB-4 score of > 3.25. No AEs resulted in treatment discontinuation. Conclusions SOF/VEL treatment is well tolerated and achieves high SVR rates for patients of Taiwanese ethnicity with HCV, regardless of cirrhosis status.