title: [Hepatitis C: diagnosis, anti-viral therapy, after-care. Hungarian consensus guideline].
abstract: Approximately 70,000 people are infected with hepatitis C virus in Hungary, and more than half of them are not aware of their infection. From the point of infected individuals early recognition and effective treatment of related liver injury may prevent consequent advanced liver diseases and complications (liver cirrhosis, liver failure and liver cancer) and can increase work productivity and life expectancy. Furthermore, these could from prevent further spread of the virus as well as reduce substantially long term financial burden of related morbidity, as a socioeconomic aspect. Pegylated interferon + ribavirin dual therapy, which is available in Hungary since 2003, can clear the virus in 40-45% of previously not treated (naïve), and in 5-21% of previous treatment-failure patients. Addition of a direct acting first generation protease inhibitor drug (boceprevir or telaprevir) to the dual therapy increases the chance of sustained viral response to 63-75% and 59-66%, respectively. These two protease inhibitors are available and financed for a segment of Hungarian patients since May 2013. Between 2013 and February 2015, other direct acting antivirals and interferon-free combination therapies have been registered for the treatment of chronic hepatitis C with a potential efficacy over 90% and typically with a short duration of 8-12 weeks. Indication of therapy includes exclusion of contraindications to the drugs and demonstration of viral replication with consequent liver injury, i.e., inflammation and/or fibrosis in the liver. Non-invasive methods (elastography and biochemical methods) are accepted and preferred for staging liver damage (fibrosis). For initiation of treatment accurate and timely molecular biology tests are mandatory. Eligibility for treatment is a subject of individual central medical review. Due to budget limitations therapy is covered only for a proportion of patients by the National Health Insurance Fund. Priority is given to those with urgent need based on a Hungarian Priority Index system reflecting primarily the stage of liver disease, and considering also additional factors, i.e., activity and progression of liver disease, predictive factors of treatment and other special issues. Approved treatments are restricted to the most cost-effective combinations based on the cost per sustained viral response value in different patient categories with consensus between professional organizations, National Health Insurance Fund and patient organizations. More expensive therapies might be available upon co-financing by the patient or a third party. Interferon-free treatments and shorter therapy durations preferred as much as financially feasible. A separate budget is allocated to cover interferon-free treatments for the most-in-need interferon ineligible/intolerant patients, and for those who have no more interferon-based therapy option.
authors.affiliation: Somogy Megyei Kaposi Mór Oktató Kórház Belgyógyászati Osztály Kaposvár Tallián Gy. u. 20-32. 7400 Pécsi Tudományegyetem, Általános Orvostudományi Kar I. Belgyógyászati Klinika Pécs.
authors.forename: Béla
authors.initials: B
authors.lastname: Hunyady
authors.affiliation: Semmelweis Egyetem, Általános Orvostudományi Kar Transzplantációs és Sebészeti Klinika Budapest.
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Gerlei
authors.affiliation: Szent György Egyetemi Oktató Kórház I. Belgyógyászat és Molekuláris Diagnosztikai Laboratórium Székesfehérvár.
authors.forename: Judit
authors.initials: J
authors.lastname: Gervain
authors.affiliation: Szent János Kórház és Észak-budai Egyesített Kórházak Hepatológiai Szakrendelés Budapest.
authors.forename: Gábor
authors.initials: G
authors.lastname: Horváth
authors.affiliation: Semmelweis Egyetem, Általános Orvostudományi Kar II. Belgyógyászati Klinika Budapest.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Lengyel
authors.affiliation: Pécsi Tudományegyetem, Általános Orvostudományi Kar I. Belgyógyászati Klinika Pécs.
authors.forename: Alajos
authors.initials: A
authors.lastname: Pár
authors.affiliation: MH Egészségügyi Központ Honvédkórház I. Belgyógyászati Osztály Budapest.
authors.forename: László
authors.initials: L
authors.lastname: Rókusz
authors.affiliation: Semmelweis Egyetem, Általános Orvostudományi Kar I. Belgyógyászati Klinika Budapest.
authors.forename: Ferenc
authors.initials: F
authors.lastname: Szalay
authors.affiliation: Egyesített Szent István és Szent László Kórház Budapest.
authors.forename: László
authors.initials: L
authors.lastname: Telegdy
authors.affiliation: Debreceni Egyetem, Általános Orvostudományi Kar, Orvos- és Egészségtudományi Centrum Belgyógyászati Intézet Debrecen.
authors.forename: István
authors.initials: I
authors.lastname: Tornai
authors.affiliation: Semmelweis Egyetem, Általános Orvostudományi Kar II. Belgyógyászati Klinika Budapest.
authors.forename: Klára
authors.initials: K
authors.lastname: Werling
authors.affiliation: Egyesített Szent István és Szent László Kórház Budapest.
authors.forename: Mihály
authors.initials: M
authors.lastname: Makara
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D032921:Consensus; D018450:Disease Progression; D004334:Drug Administration Schedule; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D006526:Hepatitis C / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy* / Q000191:economics / Q000534:rehabilitation; D006801:Humans; D006814:Hungary; D019458:Insurance Coverage; D007348:Insurance, Health; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008103:Liver Cirrhosis / Q000517:prevention & control / Q000821:virology; D017093:Liver Failure / Q000517:prevention & control / Q000821:virology; D008113:Liver Neoplasms / Q000517:prevention & control / Q000821:virology; D009842:Oligopeptides / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives; D011480:Protease Inhibitors / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012042:Registries; D012254:Ribavirin / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D011480:Protease Inhibitors; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: asunaprevir; boceprevir; daclatasvir; dasabuvir; direct acting antiviral drug; direkt ható antivirális szer; genotype; genotípus; hepatitis C virus; hepatitis C-vírus; hepatocellular cancer; interferon; ledipasvir; liver cirrhosis; májrák; májzsugor; ombitasvir; paritaprevir; pegilált interferon; pegylated interferon; polimerase-inhibitor; polimerázgátló; protease-inhibitor; proteázgátló; ribavirin; ritonavir; simeprevir; sofosbuvir; telaprevir; viral hepatitis; vírushepatitis