Peginterferon Alfa-2a/Ribavirin for 48 or 72 Weeks in Hepatitis C Genotypes 1 and 4 Patients With Slow Virologic Response
Received 9 August 2009; accepted 21 October 2009. published online 11 November 2009.
Background & Aims
This randomized multicenter trial evaluated individualization of treatment duration with peginterferon alfa-2a 180 μg/wk plus ribavirin 1000/1200 mg/day in patients with chronic hepatitis C genotype 1/4 based on the rapidity of virologic response (VR).
Methods
Patients with a rapid VR (RVR; undetectable hepatitis C virus [HCV]-RNA level (<50 IU/mL at week 4) were treated for 24 weeks, those with an early VR (EVR; no RVR but undetectable HCV-RNA level or ≥2-log10 decrease at week 12) were randomized to 48 (group A) or 72 weeks of treatment (group B; peginterferon alfa-2a was reduced to 135 μg/wk after week 48). Patients without an EVR continued treatment until week 72 if they had undetectable HCV-RNA levels at week 24. The primary end point was relapse; sustained VR (SVR; undetectable HCV-RNA level after 24 weeks of follow-up evaluation) was a secondary end point.
Results
Of 551 genotype 1/4 patients starting treatment, 289 were randomized to group A (N = 139) or group B (N = 150). The relapse rate was 33.6% in group A (95% confidence interval [CI], 24.8%–43.4%) and 18.5% in group B (95% CI, 11.9%–27.6%; P = .0115 vs group A) and the SVR rate was 51.1% (95% CI, 42.5%–59.6%) and 58.6% (95% CI, 50.3%–66.6%; P > .1), respectively. The overall SVR rate was 50.4% (278 of 551; 95% CI, 46.2%–54.7%), including 115 of 150 patients with an RVR treated for 24 weeks and 4 of 78 patients without an EVR.
Conclusions
Extending therapy with peginterferon alfa-2a/ribavirin to 72 weeks decreases the probability of relapse in patients with an EVR. If they can be maintained on extended-duration therapy, SVR rates also may improve.
##Universitätsklinik für Innere Medizin III, AKH Wien, Vienna, Austria
Reprint requests Address requests for reprints to: Professor Dr Peter Ferenci, Universitätsklinik für Innere Medizin III, AKH Wien, Waehringer Guertel 18-20, A 1090 Wien, Austria. fax: (43) 1-40400-4735
Conflicts of interest These authors disclose the following: Peter Ferenci serves on advisory boards, is a speaker and investigator for, and also has received research grants from F. Hoffmann-La Roche; Michael Gschwantler, Wolfgang Vogel, Petra Steindl-Munda, and Rudolf Stauber serve as a speaker for F. Hoffmann-La Roche; and Karin Löschenberger is an employee of F. Hoffmann-La Roche. The remaining authors disclose no conflicts.
Funding This study was made possible by an unrestricted grant by Roche Austria. Roche Austria had no role in the study design; in the collection, analysis, and interpretation of data; and in the decision to submit the report for publication. The Main Association (Hauptverband) of the Austrian Health Insurers paid for the study medication.
ABSTRACT
Peginterferon Alfa-2a/Ribavirin for 48 or 72 Weeks in Hepatitis C Genotypes 1 and 4 Patients With Slow Virologic Response