Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two

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 have become 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 was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.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 real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.

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Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld.2014.1121.262.rom ◽

2017 ◽

Vol 26 (2) ◽

pp. 171-181 ◽

Cited By ~ 2

Author(s):

Liana Gheorghe ◽

Ioan Sporea ◽

Speranţa Iacob ◽

Roxana Şirli ◽

Anca Trifan ◽

...

Keyword(s):

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

Limit Of Detection ◽

Position Paper ◽

Hcv Infection ◽

Fixed Dose ◽

Diagnostic Tools ◽

End Stage Liver Disease ◽

End Stage

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.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.

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O.143 Monitoring of end-stage liver disease associated with hepatitis C virus (HCV) infection in Scotland: Record-linkage study

Journal of Clinical Virology ◽

10.1016/s1386-6532(06)80137-x ◽

2006 ◽

Vol 36 ◽

pp. S44

Author(s):

S.J. Hutchinson ◽

S.M. Bird ◽

D.J. Goldberg

Keyword(s):

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

Record Linkage ◽

Linkage Study ◽

Hcv Infection ◽

End Stage Liver Disease ◽

End Stage

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Value of Sustained Virologic Response in Patients with Hepatitis C as a Function of Time to Progression of End-Stage Liver Disease

Clinical Drug Investigation ◽

10.1007/s40261-016-0458-z ◽

2016 ◽

Vol 37 (1) ◽

pp. 61-70 ◽

Cited By ~ 5

Author(s):

Thomas Ward ◽

Jason Gordon ◽

Beverley Jones ◽

Hayley Bennett ◽

Samantha Webster ◽

...

Keyword(s):

Liver Disease ◽

Hepatitis C ◽

Sustained Virologic Response ◽

Virologic Response ◽

Time To Progression ◽

End Stage Liver Disease ◽

End Stage

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Survival after liver transplantation for hepatocellular carcinoma in the model for end-stage liver disease and pre-model for end-stage liver disease eras and the independent impact of hepatitis C virus

Liver Transplantation ◽

10.1002/lt.21744 ◽

2009 ◽

Vol 15 (7) ◽

pp. 754-762 ◽

Cited By ~ 20

Author(s):

Paul J. Thuluvath ◽

Anurag Maheshwari ◽

Nimisha P. Thuluvath ◽

Geoffrey C. Nguyen ◽

Dorry L. Segev

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Transplantation ◽

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

End Stage Liver Disease ◽

End Stage

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Sustained Virologic Response of Patients Hospitalized Compared With Those Not Hospitalized During Treatment for Hepatitis C Virus With Direct-Acting Antivirals

Annals of Pharmacotherapy ◽

10.1177/1060028020964117 ◽

2020 ◽

pp. 106002802096411

Author(s):

Anthony J. Gentene ◽

Allison M. Bell ◽

Alicia Pence ◽

Kelly Thomas ◽

Collin Jakubecz ◽

...

Keyword(s):

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

Sustained Virologic Response ◽

Disease Patient ◽

Virologic Response ◽

Great Success ◽

Direct Acting Antivirals ◽

Inpatient Mortality ◽

Direct Acting

Background: Direct-acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) have resulted in great success through high attainment of sustained virologic response (SVR). Risk factors for DAA treatment failure are important to identify because of worsened outcomes with failure and high treatment cost. Objective: We sought to identify whether hospitalization during treatment affects SVR. The primary outcome was the difference in SVR at 12 weeks after treatment Methods: This multicenter, single health system retrospective cohort review compared achievement of SVR between patients hospitalized during DAA treatment for HCV with those not hospitalized during treatment. Results: Patients in the hospitalized cohort (n = 94) had more severe disease at baseline than nonhospitalized patients (n = 167) as indicated through higher Model for End-Stage Liver Disease (MELD) scores, Fibrosis-4 scores, and imaging-suggested or biopsy-confirmed cirrhosis. Patients hospitalized during treatment had lower SVR rates compared with those not hospitalized (87.2% vs 95.2%; P = 0.043) but failed to reach significance when inpatient mortality was excluded on secondary analysis (91.1% vs 95.2%; P = 0.195). Patients who were hospitalized and did not achieve SVR had higher MELD scores, were more likely to have intensive care unit stay, and had longer hospital stay compared with those who achieved SVR. Of 94 patients, 93 provided home supply of DAAs during hospitalization. Conclusion and Relevance: Patients hospitalized during DAA treatment for HCV had reduced rates of SVR. This reduced SVR rate may be driven by inpatient mortality and severity of liver disease. Patient education to bring home supply of medication for use during admission is an effective intervention.

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