Treatment and outcome of genotype 4 chronic hepatitis C patients with pegylated interferon α-2b and ribavirin in a German real-life-setting

S Mauss; E Zehnter; MP Manns; G Teuber; T Dahhan; U Meyer; K Dach; M Bilzer; G Tossing; D Hueppe

doi:10.1055/s-0030-1269729

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

Treatment and outcome of genotype 4 chronic hepatitis C patients with pegylated interferon α-2b and ribavirin in a German real-life-setting

S Mauss ¹, E Zehnter ², MP Manns ³, G Teuber ⁴, T Dahhan ⁵, U Meyer ⁶, K Dach ⁷, M Bilzer ⁸, G Tossing ⁸, D Hueppe ⁹

¹Medical Group Practice, Düsseldorf
²Gastroenterologic Practice, Dortmund, dr.elmar-zehnter-dortmund@t-online.de
³Medical High School, Hannover
⁴Johann Wolfgang Goethe University Frankfurt, Frankfurt
⁵Medical Practice, Backnang
⁶Medical Practice, Berlin
⁷FGK Clinical Research GmbH, München
⁸Essex Pharam GmbH, München
⁹Medical Group Practice, Herne

Abstract

Aims: Pegylated interferon (PEG-IFN) α and ribavirin (RBV) are the standard of care for hepatitis C treatment. The efficacy and safety of PEG-IFNα-2b and RBV was observed within a large German real life surveillance study.

Methods: Between 9/2003 and 5/2009, a total of 279 sites (71 sites with single and dual genotype 4 patients) have treated a total of 4061 patients. 121 patients (2.9%) were infected with genotype 4. Patients with dual genotypes (genotype 4/1, 4/2, or 4/3) were excluded for the purpose of this evaluation (3/121 patients) and only patients with genotype 4 monoinfection were analyzed.

Results: The 118 genotype 4 patients had a mean age of 40.9 years and 58.5% (n=69) were male. The majority of patients were German (46.6%, n=55), followed by Egyptian (12.7%, n=15), Italian (6.8%, n=8), Turkish (5.1%, n=6), and Ethiopian (4.2%, n=5). Cirrhosis was present in 4 patients (3.4%) and 11 patients (9.3%) were receiving opiate-substitution therapy. A HBV- or HIV-coinfection was present in 7 patients (5.9%). Of the 77 genotype 4 patients evaluable for response after 24 weeks of follow-up (9 patients were lost to follow up or prematurely discontinued, 32 patients were not evaluable), 39 patients (33.1%) experienced sustained virologic response (SVR: HCV-RNA-negativity at end of therapy and after 24 weeks of follow-up), while 25 patients (21.2%) were primary non-responders; 13 patients (11.0%) relapsed after HCV-negativity at the end of therapy (Table 1).

*Table 1:* Disease status in patients with single genotype 4 after 24 weeks of follow-up after end of therapy: evaluable patients
n=number of patients, SVR=sustained virologic response
Status after 24 weeks of follow-up	n	(%)
SVR	39	(33.1)
Relapse	13	(11.0)
Non-response	25	(21.2)
Lost to follow-up/premature discontinuation	9	(7.6)
Not evaluable	8	(6.8)
Not documented	24	(20.3)
Total	118	(100)

Normalization of ALT was seen in 46 (39.0%) of the patients at follow-up. Of these, 38 patients (82.6%) had SVR, 4 patients (8.7%) relapsed, 3 patients (6.5%) were non-responders, and 1 patient (2.2%) was lost to follow-up.

Conclusion: In the difficult-to-treat genotype 4 patients treated in a real life setting, PEG-IFNα-2b and RBV treatment lead to encouraging rates of SVR.