ROMANIAN SGH* CORNER
Position Paper on Treatment of Hepatitis C in Romania, 2017.
Liana Gheorghe1, Ioan Sporea2, Speranţa Iacob1, Roxana Şirli2, Anca Trifan3, Daniela Dobru4, Mircea Diculescu1, Carol Stanciu3, Oliviu Pascu5, Monica Acalovschi5, Ciprian Brisc6, Cristina Cijevschi3, Cristian Gheorghe1, Zeno Spârchez5, Ion Rogoveanu7, Dan Dumitrascu8
1) Center for Digestive Diseases and Liver Transplantation, Fundeni Clinical Institute, Carol Davila University of Medicine and Pharmacy, Bucharest; 2) Dept. of Gastroenterology and Hepatology, Victor Babeș University of Medicine and Pharmacy, Timișoara; 3) Institute of Gastroenterology and Hepatology, Grigore T. Popa University of Medicine and Pharmacy, Iasi;
4) Gastroenterology Department, University of Medicine and Pharmacy, Târgu Mureș; 5) Prof. Dr. Octavian Fodor Regional Institute of Gastroenterology and Hepatology, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca;
6) Gastroenterology Department, Faculty of Medicine and Pharmacy, Oradea;
7) Gastroenterology Department, University of Medicine and Pharmacy, Craiova;
8) 2nd Medical Clinic, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Background & Aims: Hepatitis C Virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments became available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.
Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention has been created. These items were discussed and rated. Decisions were taken by consensus.
Recommendations: We present here the first of the two parts of our Society’s recommendations for chronic HCV infection treatment. An agreement was reached regarding the diagnostic tools, the assessment of severity and the up-dated therapy schedules.
Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to the real-life conditions in this country.
Key words: Hepatitis C Virus – Guideline – Diagnosis – Treatment – Direct Antiviral Agents – National Strategy – Viral hepatitis C.
Abbreviations: DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESLD: End-stage liver disease; ESRD: End-stage renal disease; eGFR: Estimated glomerular filtration rate; EASL: European Association for the Study of the Liver; EMA: European Medicines Agency; FDA: US Food and Drug Administration; FDC: Fixed-dose combination; GT: Genotype; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; LLD: Lower limit of detection; MELD score: Mayo-Clinic End-Stage Liver Disease score; ANMDM: National Agency of Medicines and Medical Devices; PPIs: Proton pump inhibitors; PWID: People who inject drugs; RCT: Randomized controlled trial; RDT: Rapid diagnostic test; RAS: Resistance-associated substitution; SRGH: Romanian Society of Gastroenterology and Hepatology; SAE: serious adverse events; SPC: Summary of Product Characteristics; SVR: Sustained virologic response.