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Real‐world use, effectiveness and safety of anti‐viral treatment in chronic hepatitis C genotype 3 infection
Author(s) -
Cornberg M.,
Petersen J.,
Schober A.,
Mauss S.,
Böker K. H. W.,
Link R.,
Günther R.,
Serfert Y.,
PfeifferVornkahl H.,
Manns M. P.,
Sarrazin C.,
Hüppe D.,
Berg T.,
Niederau C.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13925
Subject(s) - medicine , hepatitis c , guideline , adverse effect , chronic hepatitis , cirrhosis , immunology , pathology , virus
Summary Background Treatment of chronic hepatitis C genotype 3 ( GT 3) is more challenging compared with other genotypes. Since 2014, several new treatment regimens have been approved but sometimes based on limited data. Aim To validate the use, effectiveness and safety of anti‐viral treatment in chronic hepatitis C genotype 3 infection under real‐word conditions. Methods The German Hepatitis C‐Registry is a large national non‐interventional real‐world study for patients with chronic hepatitis C. A total of 1322 GT 3 patients were enrolled (211 untreated and 1111 treated patients). Results Between February 2014 and September 2015, five different treatment strategies have been used (Peg IFN + RBV , Peg IFN + RBV + SOF , SOF + RBV , DCV + SOF ± RBV , LDV / SOF ± RBV ). Treatment uptake and use of treatment concepts changed markedly and rapidly during the study influenced by new approvals, guideline recommendations, and label updates. Peg IFN ‐based therapies constantly declined while DCV ‐based therapies increased with one interruption after the approval of LDV / SOF , which was frequently used until new guidelines recommended not using this combination for GT 3. Per‐protocol SVR ranged from 80.9% in the Peg IFN + RBV group to 96.1% in Peg IFN + RBV + SOF treated patients. Treatment‐experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF + RBV but a high SVR of 90–95% for DCV + SOF ± RBV . The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens. Conclusions Real‐world data can validate the effectiveness and safety for treatment regimens that had previously been approved with limited data, in particular for specific subgroups of patients. The present study demonstrates how rapid new scientific data, new treatment guidelines, new drug approvals and label changes are implemented into routine clinical practice today.