Efficacy of Peginterferon plus Ribavirin in patients receiving Opioid substitution therapy – final results of the Austrian Peghope-study

M Gschwantler; H Laferl; W Vogel; W Korak; S Moser; H Hofer; B Bauer; M Schleicher; B Bognar; M Bischof; R Stauber; A Maieron; P Ferenci

doi:10.1055/s-0035-1551740

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

Efficacy of Peginterferon plus Ribavirin in patients receiving Opioid substitution therapy – final results of the Austrian Peghope-study

M Gschwantler ¹, H Laferl ², W Vogel ³, W Korak ⁴, S Moser ¹, H Hofer ⁵, B Bauer ⁶, M Schleicher ¹, B Bognar ⁷, M Bischof ⁸, R Stauber ⁹, A Maieron ¹⁰, P Ferenci ⁵

¹Wilhelminenspital, Department of Internal Medicine IV, Vienna, Austria
²Kaiser-Franz-Josef-Spital, Department of Internal Medicine IV, Vienna, Austria
³Department of Medicine II, Gastroenterology and Hepatology, Medical University of Innsbruck, Innsbruck, Austria
⁴Department of Internal Medicine I, Klinikum Klagenfurt, Klagenfurt, Austria
⁵Department of Internal Medicine III, Medical University Vienna, Vienna, Austria
⁶Department of Internal Medicine, LKH Hörgas, Hörgas, Austria
⁷Gesundheitszentrum Wien-Mitte, Vienna, Austria
⁸Rudolfstiftung, Department of Internal Medicine IV, Vienna, Austria
⁹Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
¹⁰Division of Gastroenterology and Hepatology, Internal Medicine IV, Elisabeth Hospital Linz, Linz, Austria

Abstract

Background: Patients included in an official opioid substitution program represent an important subgroup of patients with chronic hepatitis C. Treatment of these patients with peginterferon plus ribavirin has yielded conflicting results. However, interferon-based regimens are still deemed standard of care in many parts of the world due to high costs of new direct acting antivirals.

Patients and Methods: This prospective, multicenter, observational, non-interventional trial (clinicaltrials.gov identifier, NCT01416610) included treatment-naïve patients with chronic hepatitis C undergoing opioid maintenance therapy. Treatment consisted of peginterferon alpha-2a (PEGASYS®, 180 mikrog/week) plus ribavirin (COPEGUS®, 1000/1200 mg/d in genotype (GT) 1/4, 800 mg/d in GT 2/3) for 24 – 72 weeks, according to GT and viral response [1].

Results: The ITT-population comprised 88 patients (m/f: 64/22, mean age ± SD: 34.6 ± 8.5 years, GT 1: 28, GT2: 1, GT3: 55, GT4: 3, missing: 1, median baseline HCV-RNA: 2.6 × 10⁵ IU/ml). Mean duration of therapy was 6.0 ± 2.8 months. Treatment was discontinued earlier than planned in 41/88 patients (47%), mainly because of poor adherence; lack of efficacy was the reason for early discontinuation of therapy only in 4/88 patients (5%). At the end of treatment 65/88 patients (74%) were PCR-negative. During follow-up, 15 patients relapsed. Only 44/88 patients (50%) could be evaluated 24 weeks after the end of treatment. SVR24 was documented in 39/88 patients (44%), including 10/28 patients with GT1 (36%), 1/1 with GT2 (100%), 28/55 with GT3 (51%) and 0/3 with GT4 (0%).

Conclusions: Despite of favorable prognostic factors like young age and a high proportion of GT3, SVR-rates were low in this cohort of patients receiving opioid substitution therapy, the main reason being poor adherence. However, in those patients completing treatment, the SVR-rate was high.

[1] Ferenci P et al. Gastroenterology 2010; 138(2): 503 – 512.

This study was sponsored by Roche Austria