title: Simple Predictive Model for Identifying Patients with Chronic Hepatitis C and Hepatitis C Virus Genotype 4 Infection with a High Probability of Sustained Virologic Response with Peginterferon Alfa-2a/Ribavirin: Pooled Analysis of Data from Two Large, International Cohort Studies.
abstract: Wherever access to direct-acting antiviral agents is restricted, dual peginterferon/ribavirin (PegIFN/RBV) therapy remains an option for treatment of hepatitis C virus (HCV) genotype 4 (GT4) infection, which predominates in the Middle East and Sub-Saharan Africa. Our goal was to develop a baseline scoring system to identify GT4-infected patients with a low or high probability of achieving a sustained virologic response (SVR) with PegIFN alfa-2a/RBV using data from two large cohort studies.
  
  
  
  Associations between baseline characteristics and SVR were explored by generalized additive models and multiple logistic regression analysis to develop a predictive model, which was then checked by bootstrapping. The score comprised four factors with points assigned thus: age ≤40, 3 points; >40 but ≤55, 2 points; alanine aminotransferase ≤1 or >3× the upper limit of normal, 1 point; no cirrhosis, 1 point; HCV RNA <50,000 IU/mL, 2 points; 50,000 to <400,000 IU/mL, 1 point. The values for a given patient are summed to produce a score from 0 to 7 where higher scores indicate higher chances of SVR.
  
  
  
  Among the 459 patients, 28 (6%), 50 (11%), 92 (20%), 121 (26%), 103 (22%), and 65 (14%) patients had scores of 0-1, 2, 3, 4, 5, and 6-7, respectively, with respective SVR rates of 11%, 28%, 50%, 57%, 63%, and 83%. Relapse rates decreased with increasing prediction score (80%, 39%, 15%, 19%, 5%, and 7%, respectively). SVR rates were consistently higher in Caucasian than Black patients and in patients with a rapid virologic response HCV RNA <50 IU/mL at week 4); however, the trend toward higher SVR rates with increasing score remained apparent in each subgroup.
  
  
  
  In conclusion, a simple scoring system can be used to identify GT4-infected patients with a high probability of achieving an SVR with PegIFN alfa-2a/RBV.
  
  
  
  F. Hoffmann-La Roche Ltd.
authors: Centre de Recherche sur l'Inflammation (CRI), INSERM UMR 1149, Service d'Hépatologie, Université Paris Diderot, AP-HP Hôpital Beaujon, Clichy, 100 Bd du Général Leclerc, 92110, Clichy, France. tarik.asselah@aphp.fr.
authors: Tarik
authors: T
authors: Asselah
authors: Endemic Medicine Department, Cairo University, Cairo, Egypt.
authors: Gamal
authors: G
authors: Esmat
authors: Liver Disease Research Center, King Saud University, Riyadh, Saudi Arabia.|Gastroenterology Unit, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia.
authors: Faisal M
authors: FM
authors: Sanai
authors: 4th Department of Internal Medicine, Hippokration General Hospital, Αristotle University of Thessaloniki Medical School, Thessaloniki, Greece.
authors: Ioannis
authors: I
authors: Goulis
authors: PROMETRIS GmbH, Mannheim, Germany.
authors: Diethelm
authors: D
authors: Messinger
authors: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors: Georgios
authors: G
authors: Bakalos
authors: National Liver Institute, Shebeen El Kom, Egypt.
authors: Imam
authors: I
authors: Waked
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005006:Ethnicity; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy / Q000208:ethnology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D008962:Models, Theoretical; D017063:Outcome Assessment, Health Care; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D012254:Ribavirin / Q000627:therapeutic use*; D000072230:Sustained Virologic Response
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: Access to treatment; Genotype 4; HCV; Hepatology; Infectious diseases; Peginterferon alfa; Predictors; Ribavirin; Sustained virologic response