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
T2  - 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
UR  - https://opus.bibliothek.uni-wuerzburg.de/frontdoor/index/index/docId/15181
UR  - https://nbn-resolving.org/urn:nbn:de:bvb:20-opus-151811
VL  - 10
IS  - 6
ER  -