TY  - JOUR
A1  - Huss, André M.
A1  - Halbgebauer, Steffen
A1  - Öckl, Patrick
A1  - Trebst, Corinna
A1  - Spreer, Annette
A1  - Borisow, Nadja
A1  - Harrer, Andrea
A1  - Brecht, Isabel
A1  - Balint, Bettina
A1  - Stich, Oliver
A1  - Schlegel, Sabine
A1  - Retzlaff, Nele
A1  - Winkelmann, Alexander
A1  - Roesler, Romy
A1  - Lauda, Florian
A1  - Yildiz, Özlem
A1  - Voß, Elke
A1  - Muche, Rainer
A1  - Rauer, Sebastian
A1  - Bergh, Florian Then
A1  - Otto, Markus
A1  - Paul, Friedemann
A1  - Wildemann, Brigitte
A1  - Kraus, Jörg
A1  - Ruprecht, Klemens
A1  - Stangel, Martin
A1  - Buttmann, Mathias
A1  - Zettl, Uwe K.
A1  - Tumani, Hayrettin
T1  - Importance of cerebrospinal fluid analysis in the era of McDonald 2010 criteria: a German-Austrian retrospective multicenter study in patients with a clinically isolated syndrome
JF  - Journal of Neurology
N2  - The majority of patients presenting with a first clinical symptom suggestive of multiple sclerosis (MS) do not fulfill the MRI criteria for dissemination in space and time according to the 2010 revision of the McDonald diagnostic criteria for MS and are thus classified as clinically isolated syndrome (CIS). To re-evaluate the utility of cerebrospinal fluid (CSF) analysis in the context of the revised McDonald criteria from 2010, we conducted a retrospective multicenter study aimed at determining the prevalence and predictive value of oligoclonal IgG bands (OCBs) in patients with CIS. Patients were recruited from ten specialized MS centers in Germany and Austria. We collected data from 406 patients; at disease onset, 44/406 (11 %) fulfilled the McDonald 2010 criteria for MS. Intrathecal IgG OCBs were detected in 310/362 (86 %) of CIS patients. Those patients were twice as likely to convert to MS according to McDonald 2010 criteria as OCB-negative individuals (hazard ratio = 2.1, p = 0.0014) and in a shorter time period of 25 months (95 % CI 21-34) compared to 47 months in OCB-negative individuals (95 % CI 36-85). In patients without brain lesions at first attack and presence of intrathecal OCBs (30/44), conversion rate to MS was 60 % (18/30), whereas it was only 21 % (3/14) in those without OCBs. Our data confirm that in patients with CIS the risk of conversion to MS substantially increases if OCBs are present at onset. CSF analysis definitely helps to evaluate the prognosis in patients who do not have MS according to the revised McDonald criteria.
KW  - multiple sklerosis
KW  - MRI criteria
KW  - conversion
KW  - MS
KW  - CSF
KW  - biomarker
KW  - OCB
Y1  - 2016
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-186619
VL  - 263
IS  - 12
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  -