Efficacy and safety of sofosbuvir plus simeprevir therapy in Egyptian patients with chronic hepatitis C: A real-world experience

Theodor Bilharz Research Institute

Bibliographic Information

Authors: El-Khayat H.R.; Fouad Y.M.; Maher M.; El-Amin H.; Muhammed H.

Journal: Gut

Publisher: BMJ Publishing Group

Publication Date: 10 August 2016

Volume / Issue: Volume 66 / Issue 11

Pages: 2008–2012

ISSN: 175749

DOI: 10.1136/gutjnl-2016-312012

Scopus: View on Scopus

PubMed: 27511197

Document Type: Article

Authors and Affiliations

El-Khayat H.R., Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, Egypt; Fouad Y.M., Gastroenterology and Endemic Medicine Department, Minia University, Minia, 19111, Egypt; Maher M., Gastroenterology and Endemic Medicine Department, Ain Shams University, Cairo, Egypt; El-Amin H., Internal Medicine Department, Assuit University, Assuit, Egypt; Muhammed H., Gastroenterology and Endemic Medicine, Endemic Medicine Department, Minia University, Minia, Egypt

Abstract

Background Simeprevir plus sofosbuvir (SIM/SOF) regimen was recommended by professional guidelines for certain patients with HCV genotype 1 infection and there is lack of data about this regimen in patients with genotype 4 infection. Aim To evaluate the efficacy and safety of this regimen in Egyptian patients with chronic HCV genotype 4 infection in the real world. Methods Multicentre observational study included 583 patients with HCV genotype 4 infection who began 12â €..weeks of treatment with SIM plus SOF. Demographic, clinical and virological data as well as adverse outcomes were collected. Treatment naïve patients were 342 (59%) of all included patients, 45% of patients had severe fibrosis (F3 and F4) while 55% had mild fibrosis (F1 and F2) and the primary outcome was sustained virological response (SVR). Results The overall SVR rate was 95.7% (558 out of 583 patients). In total, SVR12 in naïve patients with mild fibrosis score (F1 and F2) was achieved in 98.9% (94/95) for F1 and 98.1% (105/107) for F2, while naïve patients with severe fibrosis (F3 and F4) achieved SVR of 97.7% (86/88) for F3 and (42/52) 80.8% for F4. SVR in patients with previous interferon treatment achieved in 100% (45/45) for patients with F1 and 98.7% (74/75) for F2. While 94.7% (72/76) in experienced patients with F3; and 88.9% (40/45) for F4 achieved SVR12. Notable side effects included rash in 21 patients, photosensitivity in 18 patients, pruritus in 44 patients and hyperbilirubinemia in 42 patients. Conclusions A 12-week regimen of simeprevir/sofosbuvir was efficacious and well tolerated by treatment-naïve and treatment-experienced patients with chronic HCV genotype 4. © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-And-licensing/.

Keywords

CHRONIC HEPATITIS; CIRRHOSIS; HCV; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Drug Administration Schedule; Drug Therapy, Combination; Egypt; Female; Follow-Up Studies; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Male; Middle Aged; Simeprevir; Sofosbuvir; Treatment Outcome; Young Adult; interferon; antivirus agent; Article; chronic hepatitis C; cohort analysis; demography; disease severity; drug efficacy; drug safety; Egyptian; gastrointestinal hemorrhage; hepatic encephalopathy; Hepatitis C virus genotype 1; Hepatitis C virus genotype 4; human; hyperbilirubinemia; liver fibrosis; major clinical study; multicenter study; observational study; photosensitivity; priority journal; pruritus; rash; scoring system; side effect; sustained virologic response; thrombocytopenia; treatment duration; clinical trial; combination drug therapy; drug administration; follow up; genetics; very elderly; virology

Citation Information

Scopus Citations: 25

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