Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: A randomized trial

✍ Scribed by Ming-Lung Yu; Chia-Yen Dai; Jee-Fu Huang; Chang-Fu Chiu; Yi-Hsin C. Yang; Nai-Jen Hou; Li-Po Lee; Ming-Yen Hsieh; Zu-Yau Lin; Shinn-Cherng Chen; Ming-Yuh Hsieh; Liang-Yen Wang; Wen-Yu Chang; Wan-Long Chuang

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 310 KB
• Volume: 47
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.22319

✦ Synopsis

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.