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Yu ML, Dai CY, Huang JF, Chiu CF, Yang YH, Hou NJ, et al. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 2008;47:1884-1893

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Hepatology (Impact Factor: 11.19). 06/2008; 47(6):1884-93. DOI: 10.1002/hep.22319
Source: PubMed

ABSTRACT Recommended treatment for hepatitis C virus genotype 1 (HCV-1) patients is peginterferon plus ribavirin for 48 weeks. We assessed whether treatment duration of 24 weeks is as effective as standard treatment in HCV-1 patients with a rapid virological response (RVR; seronegative for hepatitis C virus [HCV] RNA at 4 weeks). Two hundred HCV-1 patients were randomized (1:1) to either 24 or 48 weeks of peginterferon-alpha-2a (180 microg/week) and ribavirin (1000-1200 mg/day) with a 24-week follow-up. The primary endpoint was a sustained virological response (SVR; seronegative for HCV RNA at 24-week follow-up). Overall, the 48-week arm had a significantly higher SVR rate (79%) than the 24-week arm (59%, P = 0.002). For 87 (43.5%) patients with an RVR, the 24-week arm had a lower SVR rate [88.9%; 95% confidence interval (CI): 80%-98%] than the 48-week arm (100%, P = 0.056). For 52 patients with low baseline viremia (<400,000 IU/mL) and an RVR, the 24-week arm had rates (CI) of relapse and SVR of 3.6% (-3%-11%) and 96.4% (89%-103%), respectively, which were comparable to those of the 48-week arm (0% and 100%) with difference (CI) of 3.6% (-7.2%-6.6%) and -3.6% (-14.3% to -0.6%), respectively. Multivariate analysis in all patients showed that RVR was the strongest independent factor associated with an SVR, followed by treatment duration, mean weight-based exposure of ribavirin, and baseline viral load. CONCLUSION: HCV-1 patients derive a significantly better SVR from 48 weeks versus 24 weeks of peginterferon/ribavirin even if they attain an RVR. Both 24 and 48 weeks of therapy can achieve high SVR rates (>96%) in HCV-1 patients with low viral loads and an RVR.

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Available from: Ming-Lung Yu, Aug 24, 2015
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    • "For treatment of HCV genotype 2, the duration of combination therapy has been extended to raise the sustained virological response rate in patients who do not show a rapid virological response (serum HCV RNA disappearance after 4 weeks of therapy) [Sato et al., 2012], while several trials to shorten the treatment duration have been carried out in patients who had favorable host and viral characteristics and who achieved rapid virological response with combination therapy [Toyoda et al., 2009]. The aim of shortening the duration of therapy is mainly to reduce the expense and the adverse effects of treatment [Yu et al., 2008; Berg et al., 2009]. The results of some randomized, controlled studies suggested that patients with HCV genotype 2 who achieved rapid virological response had a very high, sustained virological response rate after 12 or 16 weeks of Peg- IFN-plus-ribavirin combination therapy [Mangia et al., 2005; von Wagner et al., 2005]. "
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