Hepatitis C Viral Kinetic Changes in a Retrospective Cohort Study of Chronic Hepatitis C Virus Egyptian Patients on Pegylated Interferon and Ribavirin Therapy.

Abstract

The aim of this study was to determine the relative importance of the kinetics of antiviral response compared to baseline host and virological factors for predicting treatment outcome. A retrospective analysis of 285 chronic hepatitis C virus (HCV) patients, encompassing genotypes 4 treated with peginterferon alpha-2a and ribavirin, was performed. Baseline characteristics were compared across HCV genotypes and pretreatment factors associated with rapid virological response (RVR) were identified. The relative significance of RVR compared to other baseline factors for predicting sustained virological response was analyzed by multiple logistic regression analysis. Ninety-seven percent of the patients harbored HCV genotype 4a patients. The positive predictive value (PPV) of RVR for end-of-treatment response (ETR) was 88% and of early virological response (EVR) was 85%, which means that achievement of both RVR and EVR is a good positive predictive factor of response. The negative predictive value (NPV) of RVR for ETR was low and equals 26.77%, which means that approximately two-thirds of patients were able to achieve ETR despite not experiencing RVR, which means RVR is a bad negative predictive factor of response. The NPV of EVR for ETR was high and equals 90%, which means that only 10% of patients were able to achieve an ETR despite not experiencing EVR, which explains that EVR is a very good negative predictive factor of response. In univariate logistic regression analysis, which included the following: female gender, alanine aminotransferase, aspartate transaminase, α-fetoprotein, baseline HCV-RNA levels, grade of activity, stage of fibrosis, and positive HCV-RNA, by polymerase chain reaction at week 4, none of the previous factors was a significant independent factor of failure of response to treatment. The current study demonstrated that a viremia at week 4 has a good PPV, but it has a very low NPV. The NPV of EVR was more robust for ETR (90%). EVR is regarded as a robust indicator of treatment outcome, and a 12-week stopping rule for patients is strongly evident.