Extended Treatment Duration for Hepatitis C Virus Type 1: Comparing 48 Versus 72 Weeks of Peginterferon-Alfa-2a Plus Ribavirin

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 130; no. 4; pp. 1086 - 1097
• Main Authors: Berg, Thomas, von Wagner, Michael, Nasser, Samer, Sarrazin, Christoph, Heintges, Tobias, Gerlach, Tilman, Buggisch, Peter, Goeser, Tobias, Rasenack, Jens, Pape, Gerd R., Schmidt, Wolfgang E., Kallinowski, Birgit, Klinker, Hartwig, Spengler, Ulrich, Martus, Peter, Alshuth, Ulrich, Zeuzem, Stefan
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-04-2006
• Subjects: Adult; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Drug Administration Schedule; Drug Therapy, Combination; Hepacivirus - classification; Hepacivirus - genetics; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Middle Aged; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Recombinant Proteins; Recurrence; Ribavirin - administration & dosage; Ribavirin - adverse effects; Ribavirin - therapeutic use; RNA, Viral - blood; Treatment Outcome; Viremia - drug therapy; EVR; OR; GGT; CI; PCR; SVR; BMI; PEG–IFN
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2006.02.015

Background & Aims: The treatment of patients infected with hepatitis C virus (HCV) type 1 remains a challenge necessitating innovative strategies to improve treatment outcome. The extension of treatment duration beyond 48 weeks is one possible strategy to address this problem. Methods: The efficacy and safety of 48 weeks (group A, N = 230) vs 72 weeks (group B, N = 225) of treatment with pegylated–interferon-alfa-2a (180 μg/wk) plus ribavirin (800 mg/day) were studied in treatment-naive patients with HCV type 1 infection. On-treatment and sustained virologic response (SVR) 24 weeks after stopping treatment was assessed by qualitative reverse-transcription polymerase chain reaction (sensitivity 50 IU/mL). Results: Overall, no significant differences could be observed in the treatment outcome between both groups. End-of-treatment and SVR rates in groups A and B were 71% vs 63% and 53% vs 54%, respectively. Patients with undetectable HCV-RNA levels already at weeks 4 and 12 had excellent SVR rates ranging from 76% to 84% regardless of treatment group, whereas patients shown to be still HCV-RNA positive at week 12 achieved significantly higher SVR rates when treated for 72 instead of 48 weeks (29% vs 17%, P = .040). A particular benefit from extended treatment duration was seen in patients with low-level viremia (<6000 IU/mL) at week 12. The frequency and intensity of adverse events was similar between the 2 groups. Conclusions: Extended treatment duration generally is not recommended in HCV type 1 infection and should be reserved only for patients with slow virologic response defined as HCV-RNA positive at week 12 but negative at week 24.