https://scholars.lib.ntu.edu.tw/handle/123456789/551073
標題: | Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan | 作者: | CHEN-HUA LIU CHUN-JEN LIU TUNG-HUNG SU HUNG-CHIH YANG CHUN-MING HONG TAI-CHUNG TSENG PEI-JER CHEN DING-SHINN CHEN JIA-HORNG KAO |
公開日期: | 2018 | 出版社: | Public Library of Science | 卷: | 13 | 期: | 12 | 來源出版物: | PLoS ONE | 摘要: | Background The real-world data for the effectiveness and safety of sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with hepatitis C virus genotype 1 (HCV-1) infection remain limited in Taiwan. Methods A total of 273 chronic HCV-1 patients receiving 8, 12, or 24 weeks of SOF/LDV with or without RBV were enrolled. The sustained virologic response rate at week 12 off-therapy (SVR 12 ) by evaluable population (EP) and per-protocol population (PP) were assessed for effectiveness. The treatment discontinuation rate due to adverse events (AEs) and serious AE rate were assessed for safety. Baseline patient characteristics and on-treatment HCV viral kinetics associated with SVR 12 were analyzed. Results The SVR 12 rates by EP and PP analyses were 96.7% (95% confidence interval [CI]: 93.9%-98.3%) and 97.5% (95% CI: 94.8%-98.8%), respectively. The rates of treatment discontinuation due to AE and serious AE were 0.4% and 4.4%, respectively. Seven patients with true virologic failure were relapsers. In 2 patients who were lost-to follow-up, one expired at treatment week 3 due to pneumonia which was considered not related to treatment, and one declined follow-up at off-therapy week 4. The SVR 12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. Conclusions SOF/LDV with or without RBV for 8–24 weeks is well tolerated and achieves a high SVR 12 rate in patients with HCV-1 infection in Taiwan. ? 2018 Liu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85058917724&doi=10.1371%2fjournal.pone.0209299&partnerID=40&md5=fe6eeaba34cb7c666f34f6db5f9cf426 https://scholars.lib.ntu.edu.tw/handle/123456789/551073 |
ISSN: | 1932-6203 | DOI: | 10.1371/journal.pone.0209299 | SDG/關鍵字: | alanine aminotransferase; bilirubin; hemoglobin; ledipasvir plus sofosbuvir; ribavirin; robatrol; antivirus agent; benzimidazole derivative; fluorene derivative; ledipasvir, sofosbuvir drug combination; ribavirin; uridine phosphate; adult; aged; Article; bacterial peritonitis; Child Pugh score; chronic hepatitis C; clinical assessment; clinical feature; clinical protocol; controlled study; drug efficacy; drug safety; drug screening; drug tolerability; drug withdrawal; duodenal ulcer bleeding; estimated glomerular filtration rate; fatigue; female; follow up; headache; Hepatitis C virus genotype 1; herpes zoster; human; insomnia; leukocyte count; liver cell carcinoma; major clinical study; male; nausea; platelet count; pneumonia; population research; recurrence risk; retrospective study; side effect; stomach varices bleeding; sustained virologic response; Taiwan; treatment duration; treatment outcome; analogs and derivatives; chronic hepatitis C; combination drug therapy; drug administration; genetics; genotype; Hepacivirus; middle aged; safety; very elderly; virology; Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Drug Administration Schedule; Drug Therapy, Combination; Female; Fluorenes; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Male; Middle Aged; Retrospective Studies; Ribavirin; Safety; Sustained Virologic Response; Taiwan; Treatment Outcome; Uridine Monophosphate |
顯示於: | 醫學系 |
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