title: Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients.
abstract: Major changes have emerged during the last few years in the therapy of chronic HCV. Several direct acting antiviral agents have been developed showing potent activity with higher rates of sustained virological response, even in difficult-to-treat patients. This study explores real life experience concerning efficacy, safety and possible predictors of response for the first cohort of Egyptian patients with chronic HCV genotype IV treated with Sofosbuvir/Simprevir combination therapy.
  
  
  
  This real life study recruited the first (6211) chronic HCV genotype IV Egyptian patients, who received antiviral therapy in viral hepatitis specialized treatment centres affiliated to the National committee for control of viral hepatitis. All enrolled patients received 12 weeks course of daily combination of sofosbuvir (400 mg) and simeprevir (150 mg). Patients were closely monitored for treatment safety and efficacy.
  
  
  
  Overall sustained virological response 12 rate was 94.0% while the end of treatment response rate was 97.6%. sustained virological response 12 rates in easy and difficult-to-treat groups were 96% and 93% respectively. Univariate and multivariate logistic regression analysis revealed significant association of low albumin (<3.5), cirrhosis and Fib-4 score (>3.25) with treatment failure. Fatal adverse events occurred in 23/6211 cases (0.37%) due to liver cell failure adverse events or SAEs leading to treatment discontinuation occurred in 97 patients (1.6%).
  
  
  
  Sofosbuvir/Simeprevir combination is an effective and well tolerated regimen for patients with chronic HCV genotype IV.
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Rasha
authors.initials: R
authors.lastname: Eletreby
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Wafaa
authors.initials: W
authors.lastname: Elakel
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Said
authors.affiliation: Endemic Medicine Department, Helwan University, Cairo, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: El Kassas
authors.affiliation: National Hepatology & Tropical Medicine Research Institute, Cairo, Egypt.
authors.forename: Sameh
authors.initials: S
authors.lastname: Seif
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Tamer
authors.initials: T
authors.lastname: Elbaz
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Maissa
authors.initials: M
authors.lastname: El Raziky
authors.affiliation: Tropical Medicine Department, Alexandria University, Alexandria, Egypt.
authors.forename: Siham
authors.initials: S
authors.lastname: Abdel Rehim
authors.affiliation: Tropical Medicine Department, El Azhar University, Cairo, Egypt.
authors.forename: Samy
authors.initials: S
authors.lastname: Zaky
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Rabab
authors.initials: R
authors.lastname: Fouad
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Hadeel
authors.identifier: 0000-0002-9058-9888
authors.initials: H
authors.lastname: Gamal Eldeen
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Abdo
authors.affiliation: Cairo Fatemic Hospital, Cairo, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Korany
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Ayman
authors.initials: A
authors.lastname: Yosry
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Magdy
authors.initials: M
authors.lastname: El Serafy
authors.affiliation: Pediatric Hepatology, Ain Shams University, Cairo, Egypt.
authors.forename: Manal Hamdy
authors.initials: MH
authors.lastname: El-Sayed
authors.affiliation: Internal Medicine Department, Ain Shams University, Cairo, Egypt.
authors.forename: Yehia
authors.initials: Y
authors.lastname: ElShazly
authors.affiliation: National liver institute, Shebeen El Kom, Menoufia, Egypt.
authors.forename: Imam
authors.initials: I
authors.lastname: Waked
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Wahid
authors.initials: W
authors.lastname: Doss
authors.affiliation: Hepatology & Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors.forename: Gamal
authors.initials: G
authors.lastname: Esmat
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004534:Egypt / Q000453:epidemiology; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012720:Severity of Illness Index; D000069616:Simeprevir / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use*; D000072230:Sustained Virologic Response; D017211:Treatment Failure; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000069616:Simeprevir; D000069474:Sofosbuvir
keywords: HCV genotype IV; Sofosbuvir/Simeprevir; efficacy; safety