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

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 g/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.

Prediction of Response to Pegylated Interferon Plus Ribavirin in Hepatitis C Patients by Il28b Variation and Its Relation to Other Different Predictors.

“…undetectable HCV RNA at week 4, has a high positive predictive value of SVR (Yu ML et al, 2008). Several independent studies have consistently shown that single nucleotide polymorphisms (SNPs) near IL28B, which encodes the type III interferon are strongly associated with the response to treatment of chronic hepatitis C (Ge D et al, 2009).…”

Viral Factors Associated with Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection

“…The extent of reductions in HCV RNA during the initial treatment phase is closely associated with the achievement of SVR [27]. Thus, evaluation of rapid virological response (RVR; reduction of HCV RNA at 4 weeks of therapy) or early virological response (EVR; reduction of HCV RNA at 12 weeks of therapy) has become more important than pretreatment HCV RNA levels [28].…”

Rapid virological response in hepatitis C virus genotype 1 and early ribavirin exposure

“…4,[6][7][8] We have recently reported a RVR rate of 43.5% (87/200) among Taiwanese patients infected with HCV genotype 1 in our randomized trial. 9 The rates of RVR in patients with hepatitis C genotype 1 differ greatly from different areas. Although we applaud the study conducted by Loustaud-Ratti et al, 1 the predictive value of ribavirin exposure at D0 for SVR and the proposed target for ribavirin dose adjustment of minimum AUC0-4h threshold of 1755 g.h/L need further confirmatory studies in different countries.…”