Abstract

BackgroundVirological response to peginterferon + ribavirin (P+R) at week 4 can predict sustained virological response (SVR). While patients with rapid virological response (RVR) do not require triple therapy, patients with a decline <1log10 IU/ml HCVRNA (D1L) should have treatment discontinued due to low SVR rate.AimTo develop a tool to predict first 4 weeks’ viral response in patients with hepatitis C genotype 1&4 treated with P+R.MethodsIn this prospective and multicenter study, HCV mono-infected (n=538) and HCV/HIV co-infected (n=186) patients were included. To develop and validate a prognostic tool to detect RVR and D1L, we segregated the patients as an estimation cohort (to construct the model) and a validation cohort (to validate the model).ResultsD1L was reached in 509 (80.2%) and RVR in 148 (22.5%) patients. Multivariate analyses demonstrated that HIV co-infection, Forns’ index, LVL, IL28B-CC and Genotype-1 were independently related to RVR as well as D1L. Diagnostic accuracy (AUROC) for D1L was: 0.81 (95%CI: 0.76 — 0.86) in the estimation cohort and 0.71 (95%CI: 0.62 — 0.79) in the validation cohort; RVR prediction: AUROC 0.83 (95%CI: 0.78 — 0.88) in the estimation cohort and 0.82 (95%CI: 0.76 — 0.88) in the validation cohort. Cost-analysis of standard 48-week treatment indicated a saving of 30.3% if the prognostic tool is implemented.ConclusionsThe combination of genetic (IL28B polymorphism) and viral genotype together with viral load, HIV co-infection and fibrosis stage defined a tool able to predict RVR and D1L at week 4. Using this tool would be a cost-saving strategy compared to universal triple therapy for hepatitis C.

Highlights

  • Hepatitis C virus (HCV) infection affects up to 150 million people worldwide, and is a major cause of liver cirrhosis and hepatocellular carcinoma

  • To develop and validate a prognostic tool to detect rapid virological response (RVR) and decline

  • Multivariate analyses demonstrated that HIV co-infection, Forns’ index, LVL, IL28B-CC and Genotype-1 were independently related to RVR as well as D1L

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Summary

Introduction

Hepatitis C virus (HCV) infection affects up to 150 million people worldwide, and is a major cause of liver cirrhosis and hepatocellular carcinoma. A decline at week 4 of treatment of 1 log HCV-RNA (D1L) may be used in scheduling patients to receive protease inhibitor-based triple therapy [2]. IL28B correlates with a faster 1st and 2nd phase decline in viral load during treatment, and a more rapid virological response (RVR) rate [5]. Metabolic factors such as insulin resistance (measured as the HOMA index) and fibrosis were strongly related to SVR [6]. In patients receiving boceprevir-based triple therapy, virological response at week 4 following double P+R therapy could predict SVR; patients without D1L at week 4 showing a very low SVR rate (around 13%) despite protease inhibitor being added [7]. While patients with rapid virological response (RVR) do not require triple therapy, patients with a decline

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