TY  - JOUR
A1  - Heidrich, Benjamin
A1  - Wiegand, Steffen B.
A1  - Buggisch, Peter
A1  - Hinrichsen, Holger
A1  - Link, Ralph
A1  - Möller, Bernd
A1  - Böker, Klaus H. W.
A1  - Teuber, Gerlinde
A1  - Klinker, Hartwig
A1  - Zehnter, Elmar
A1  - Naumann, Uwe
A1  - Busch, Heiner W.
A1  - Maasoumy, Benjamin
A1  - Baum, Undine
A1  - Hardtke, Svenja
A1  - Manns, Michael P.
A1  - Wedemeyer, Heiner
A1  - Petersen, Jörg
A1  - Cornberg, Markus
T1  - Treatment of Naive Patients with Chronic Hepatitis C Genotypes 2 and 3 with Pegylated Interferon Alpha and Ribavirin in a Real World Setting: Relevance for the New Era of DAA
JF  - PLOS ONE
N2  - Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin. However, treatment with sofosbuvir-based regimens is 10-20 times more expensive compared to pegylated interferon alfa and ribavirin (PegIFN/RBV). It has to be discussed if PegIFN/RBV is still an option for easy to treat patients. We assessed the treatment of patients with chronic hepatitis C genotypes 2/3 with PegIFN/RBV in a real world setting according to the latest German guidelines. Overall, 1006 patients were recruited into a prospective patient registry with 959 having started treatment. The intention-to-treat analysis showed poor SVR (GT2 61%, GT3 47%) while patients with adherence had excellent SVR in the per protocol analysis (GT2 96%, GT3 90%). According to guidelines, 283 patients were candidates for shorter treatment duration, namely a treatment of 16 weeks (baseline HCV-RNA <800.000 IU/mL, no cirrhosis and RVR). However, 65% of these easy to treat patients have been treated longer than recommended that resulted in higher costs but not higher SVR rates. In conclusion, treatment with PegIFN/RBV in a real world setting can be highly effective yet similar effective than PegIFN +/- sofosbuvir/RBV in well-selected naive G2/3 patients. Full adherence to guidelines could be further improved, because it would be important in the new era with DAA, especially to safe resources.
KW  - peginterferon alpha-2B
KW  - HCV genotype-2
KW  - sofosbuvir
KW  - infection
KW  - epidemology
Y1  - 2014
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-115149
SN  - 1932-6203
VL  - 9
IS  - 10
ER  - 
TY  - JOUR
A1  - Heidrich, Benjamin
A1  - Cordes, Hans-Jörg
A1  - Klinker, Hartwig
A1  - Möller, Bernd
A1  - Naumann, Uwe
A1  - Rössle, Martin
A1  - Kraus, Michael R.
A1  - Böker, Klaus H.
A1  - Roggel, Christoph
A1  - Schuchmann, Marcus
A1  - Stoehr, Albrecht
A1  - Trein, Andreas
A1  - Hardtke, Svenja
A1  - Gonnermann, Andrea
A1  - Koch, Armin
A1  - Wedemeyer, Heiner
A1  - Manns, Michael P.
A1  - Cornberg, Markus
T1  - Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial): A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial
JF  - PLoS ONE
N2  - Although sofosbuvir has been approved for patients with genotypes 2/3 (G2/3), many parts of the world still consider pegylated Interferon alpha (P) and ribavirin (R) as standard of care for G2/3. Patients with rapid virological response (RVR) show response rates >80%. However, SVR (sustained virological response) in non-RVR patients is not satisfactory. Longer treatment duration may be required but evidence from prospective trials are lacking. A total of 1006 chronic HCV genotype 2/3 patients treated with P/R were recruited into a German HepNet multicenter screening registry. Of those, only 226 patients were still HCV RNA positive at week 4 (non-RVR). Non-RVR patients with ongoing response after 24 weeks P-2b/R qualified for OPTEX, a randomized trial investigating treatment extension of additional 24 weeks (total 48 weeks, Group A) or additional 12 weeks (total 36 weeks, group B) of 1.5 \(\mu\)g/kg P-2b and 800-1400 mg R. Due to the low number of patients without RVR, the number of 150 anticipated study patients was not met and only 99 non-RVR patients (n=50 Group A, n=49 Group B) could be enrolled into the OPTEX trial. Baseline factors did not differ between groups. Sixteen patients had G2 and 83 patients G3. Based on the ITT (intention-to-treat) analysis, 68% [55%; 81%] in Group A and 57% [43%; 71%] in Group B achieved SVR (p=0.31). The primary endpoint of better SVR rates in Group A compared to a historical control group (SVR 70%) was not met. In conclusion, approximately 23% of G2/3 patients did not achieve RVR in a real world setting. However, subsequent recruitment in a treatment-extension study was difficult. Prolonged therapy beyond 24 weeks did not result in higher SVR compared to a historical control group.
KW  - chronic hepatitis C
KW  - peginterferon alpha-2b
KW  - infection
KW  - sofosbuvir
KW  - therapy
KW  - HCV genotype 2
Y1  - 2015
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-151811
VL  - 10
IS  - 6
ER  -