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Interleukin-28B (rs12979860) gene variation and treatment outcome after peginterferon plus ribavirin therapy in patients with genotype 1 of hepatitis C virus.

ABSTRACT: BACKGROUND:The success of treatment of chronic hepatitis C (CHC) with pegylated interferon-? (PEG-IFN-?) and ribavirin (RBV) is affected by several host, viral, and treatment factors. This study was designed to describe the association of interleukin (IL) 28B genotypes for rs12979860 with sustained virologic response (SVR) in patients with genotype 1 CHC infection treated with PEG-IFN ?-2 and RBV. MATERIALS AND METHODS:Interleukin-28B genotype in 100 studied patients was detected by tagman real-time polymerase chain reaction. Before treatment blood samples were obtained, then patients were treated for 48-week with a combination therapy using of the PEG-IFN ?-2 and RBV. SVR evaluated 6 months after stopping therapy, and was defined as undetectable plasma hepatitis C virus-RNA. RESULTS:Among studied patients, 65% were IL-28B CT, 27% CC, and 8% TT. In all studied patients, SVR was 58.3%, relapse 15.6%, and null virological response 26.1%. SVR rates were 76.9% in IL-28B-CC, 56.4% in IL-28B-CT, and 12.5% in IL-28B-TT patients. Relapse rates were 7.7% in IL-28B-CC, 12.9% in IL-28B-CT, and 62.5% in IL-28B-TT patients. There was a significant difference between response to treatment in patients IL-28B-CC, CT, and TT (P = 0.003). IL-28B genotype CC, (odds ratio = 0.053, 95% confidence interval; 0.005-0.54, P = 0.03), was the independent predicting factor. CONCLUSION:Interleukin-28B was an important predictor of CHC treatment outcome with Peg-IFN-? and RBV. IL-28B-CC seems to be more important than IL-28B-CT/TT in predicting positive treatment response.

SUBMITTER: Kalantari H

PROVIDER: S-EPMC4310080 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Interleukin-28B (rs12979860) gene variation and treatment outcome after peginterferon plus ribavirin therapy in patients with genotype 1 of hepatitis C virus.

Kalantari Hamid H Tavakoli Tahmine T Bagherpour Bahram B Honarmand Shahram S

Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences 20141101 11

<h4>Background</h4>The success of treatment of chronic hepatitis C (CHC) with pegylated interferon-α (PEG-IFN-α) and ribavirin (RBV) is affected by several host, viral, and treatment factors. This study was designed to describe the association of interleukin (IL) 28B genotypes for rs12979860 with sustained virologic response (SVR) in patients with genotype 1 CHC infection treated with PEG-IFN α-2 and RBV.<h4>Materials and methods</h4>Interleukin-28B genotype in 100 studied patients was detected ...[more]

PMID: 25657752

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Project description:BackgroundRandomized clinical trials (RCTs) of interventions for the hepatitis C virus have historically used sustained virological response (SVR) at 24 weeks after treatment (SVR24) as the key effect measure. However, recent RCTs investigating the efficacy of new direct acting agents (DAAs) have used SVR at 12 weeks after treatment (SVR12). While there is evidence to suggest SVR24 and SVR12 are similar in patients receiving new DAAs, this is unlikely to be true for patients receiving backbone peginterferon-ribavirin control treatment. Establishing the difference between SVR12 and SVR24 for patients receiving peginterferon-ribavirin treatment is therefore necessary to avoid biased interpretations of the benefits of newer DAAs.MethodsWe searched the MEDLINE®, Embase™, and Cochrane CENTRAL for RCTs with a peginterferon-ribavirin arm that used SVR24 and/or SVR12. As no RCTs reported on both, we pooled SVR12 and SVR24 proportions using conventional meta-analysis. Proportions were pooled separately for peginterferon alpha-2a and alpha-2b. Further, a Bayesian meta-regression model was employed to estimate the difference between SVR12 and SVR24.ResultsThirty-five RCTs including a peginterferon arm were identified. Twenty-four trials included a peginterferon alpha-2a plus ribavirin arms, of which 20 reported SVR24 and five reported SVR12. Seventeen trials included a peginterferon alpha-2b plus ribavirin arm, of which 16 reported SVR24 and one reported SVR12. Using Bayesian meta-regression, the pooled SVR12 was 6% higher than SVR24 with peginterferon alpha-2a (53% versus 47%) and 5% higher with peginterferon alpha-2b (45% versus 40%) and 95% credible intervals (CrIs) were only marginally overlapping. The meta-regression also demonstrated a marginally significant relative risk of 1.13 (95% CrI 0.99-1.26) of SVR12 versus SVR24. The conventional pairwise meta-analyses were consistent with these findings.ConclusionConsidering the relatively large difference observed between SVR12 and SVR24, it seems reasonable to insist that future clinical trials report both to allow for complete transparency and clarity in their interpretation.

Project description:AIM:To evaluate addition of boceprevir to peginterferon/ribavirin (PR) in Russian patients with chronic hepatitis C virus (HCV). METHODS:Treatment-naive (TN) and treatment-experienced (TE) patients (who had failed prior treatment with PR for ? 12 wk) with chronic HCV genotype 1 infection were enrolled in this placebo-controlled, double-blind study. All patients initially received PR for 4 wk. Patients randomized to control treatment then received PR for an additional 44 wk. TN patients randomized to triple therapy received boceprevir (800 mg three times daily) plus PR for 24 wk and then further therapy according to treatment week 8 (TW8) HCV RNA levels. TE patients received boceprevir plus PR for 32 wk and then further therapy according to TW8 HCV RNA levels. Treatment was discontinued for TN patients with detectable HCV RNA at TW24 and TE patients with detectable HCV RNA at TW12 because of futility. The primary efficacy end point was sustained virologic response (SVR) defined as undetectable HCV RNA 24 wk after completing all study therapy. RESULTS:SVR was 74.8% in the boceprevir plus PR arm compared with 46.2% in the control arm, with a stratification-adjusted treatment difference of 29.2% (95%CI: 16.4-41.5; P < 0.0001). Rates of SVR were higher in the boceprevir arm in both TN and TE patient groups (TN 78.4% vs 56.3%; TE 69.4% vs 30.0%). Within TE patients, the rates of SVR were higher with boceprevir plus PR compared with PR, regardless of treatment failure type (null responder, partial responder, and relapser). Most patients receiving boceprevir plus PR in both TN (86%) and TE (71%) populations were eligible for reduced treatment duration. Anemia was increased in patients receiving boceprevir plus PR vs PR alone (47.2% vs 24.4%); there was a corresponding increase in ribavirin dose reduction and erythropoietin use. Among patients receiving boceprevir plus PR, SVR rates were similar in patients with anemia (< 10 g/dL) and those without anemia (71.2% vs 77.4%). CONCLUSION:Regulatory approval has been obtained for boceprevir plus PR in Russian patients with HCV genotype 1 infection based on the results of this study.

Dataset Information

Interleukin-28B (rs12979860) gene variation and treatment outcome after peginterferon plus ribavirin therapy in patients with genotype 1 of hepatitis C virus.

Publications

Interleukin-28B (rs12979860) gene variation and treatment outcome after peginterferon plus ribavirin therapy in patients with genotype 1 of hepatitis C virus.

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