{"title":"Changes in renal function in patients with chronic hepatitis C treated with sofosbuvir-velpatasvir","authors":"Pei-Kai Su, Te-Sheng Chang, Shui-Yi Tung, Kuo-Liang Wei, Chien-Heng Shen, Yung-Yu Hsieh, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Chen, Chih-Wei Yen, Huang-Wei Xu, Wei-Ling Tung, Kao-Chi Chang","doi":"10.1002/aid2.13336","DOIUrl":null,"url":null,"abstract":"<p>Direct-acting antivirals (DAAs) have become an effective first-line treatment for chronic hepatitis C (CHC), and the fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL) is one of the most important pangenotypic DAA regimen according to present treatment guideline. The association between SOF-based regimens and renal toxicity remains controversial. A total of 953 patients including 130 with estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m<sup>2</sup> and 823 with eGFR > 60 mL/min/1.73m<sup>2</sup> receiving SOF/VEL therapy for 12 weeks were enrolled in this study. The eGFR was assessed at baseline, end of treatment (EOT), and 12 weeks after completion of the therapy (end of follow-up, EOF). The eGFR in patients with eGFR ≤ 60 mL/min/1.73m<sup>2</sup> increased from baseline (47.89 ± 10.25 mL/min/1.73m<sup>2</sup>) to EOT (51.65 ± 15.92; <i>P</i> < .001) and EOF (51.51 ± 14.46 mL/min/1.73m<sup>2</sup>; <i>P</i> < .05). The eGFR in patients with eGFR > 60 mL/min/1.73m<sup>2</sup> at baseline (91.52 ± 22.06 mL/min/1.73m<sup>2</sup>) was lower at EOT (90.37 ± 22.3; <i>P</i> < .05), with no difference between EOT and EOF (<i>P</i> = .06). Multivariable analysis showed that a higher serum albumin level was associated with a lower risk of eGFR decrease at EOT, and the patients with baseline eGFR > 60 mL/min/1.73m<sup>2</sup> were associated with a higher risk of eGFR decrease at EOF. The rates of sustained virologic response 12 weeks after treatment cessation (SVR12) were 99.2% in per-protocol analysis, and the most common adverse events were fatigue (4.7%), abdominal discomfort (4.5%), and skin itching (3.7%). In conclusion, renal function improved after the SOF/VEL treatment in patients with CHC and chronic kidney disease. Thus, SOF/VEL was safe, effective, and tolerable in these patients.</p>","PeriodicalId":7278,"journal":{"name":"Advances in Digestive Medicine","volume":"10 3","pages":"150-158"},"PeriodicalIF":0.3000,"publicationDate":"2022-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/aid2.13336","citationCount":"3","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Digestive Medicine","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/aid2.13336","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 3
Abstract
Direct-acting antivirals (DAAs) have become an effective first-line treatment for chronic hepatitis C (CHC), and the fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL) is one of the most important pangenotypic DAA regimen according to present treatment guideline. The association between SOF-based regimens and renal toxicity remains controversial. A total of 953 patients including 130 with estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 and 823 with eGFR > 60 mL/min/1.73m2 receiving SOF/VEL therapy for 12 weeks were enrolled in this study. The eGFR was assessed at baseline, end of treatment (EOT), and 12 weeks after completion of the therapy (end of follow-up, EOF). The eGFR in patients with eGFR ≤ 60 mL/min/1.73m2 increased from baseline (47.89 ± 10.25 mL/min/1.73m2) to EOT (51.65 ± 15.92; P < .001) and EOF (51.51 ± 14.46 mL/min/1.73m2; P < .05). The eGFR in patients with eGFR > 60 mL/min/1.73m2 at baseline (91.52 ± 22.06 mL/min/1.73m2) was lower at EOT (90.37 ± 22.3; P < .05), with no difference between EOT and EOF (P = .06). Multivariable analysis showed that a higher serum albumin level was associated with a lower risk of eGFR decrease at EOT, and the patients with baseline eGFR > 60 mL/min/1.73m2 were associated with a higher risk of eGFR decrease at EOF. The rates of sustained virologic response 12 weeks after treatment cessation (SVR12) were 99.2% in per-protocol analysis, and the most common adverse events were fatigue (4.7%), abdominal discomfort (4.5%), and skin itching (3.7%). In conclusion, renal function improved after the SOF/VEL treatment in patients with CHC and chronic kidney disease. Thus, SOF/VEL was safe, effective, and tolerable in these patients.
期刊介绍:
Advances in Digestive Medicine is the official peer-reviewed journal of GEST, DEST and TASL. Missions of AIDM are to enhance the quality of patient care, to promote researches in gastroenterology, endoscopy and hepatology related fields, and to develop platforms for digestive science. Specific areas of interest are included, but not limited to: • Acid-related disease • Small intestinal disease • Digestive cancer • Diagnostic & therapeutic endoscopy • Enteral nutrition • Innovation in endoscopic technology • Functional GI • Hepatitis • GI images • Liver cirrhosis • Gut hormone • NASH • Helicobacter pylori • Cancer screening • IBD • Laparoscopic surgery • Infectious disease of digestive tract • Genetics and metabolic disorder • Microbiota • Regenerative medicine • Pancreaticobiliary disease • Guideline & consensus.