HCV leads to chronic hepatitis (CHC) and mixed cryoglobulinemia (MC). MC is observed in the majority of HCV pts, but is clinically evident (MC syndrome, MCS) in a minority of cases. Antiviral therapy is the first therapeutic option for both CHC and MCS. In previous reports, generally based on retrospective analyses and/or limited populations, no difference was observed in MC/MCS virological response. This is an elusive condition (the diagnosis is not well standardized and the MC impossible to determine in stored samples), and the possibility that some MC/MCS pts were included in the negative control group cannot be ruled out. In this study, we prospectively analyzed MC/MCS data and virological response of a large population of HCV pts treated with anti-HCV SoC (Peg-IFN+RBV). Pts were consecutively recruited from July 2003 to July 2010. Results: 424 pts were enrolled. These included: 121 pts with MCS (HCV+MCS), 132 with MC without MCS (HCV+MC) and 158 without MCS nor MC (HCV). 13 patients (3.1%) resulted of uncertain classification. HCV+MCS group was associated with older age (p=0.0151), more severe liver disease (p=0.02), female sex (p<0.00005) and re-treatment (p=0.0168) in the univariate analysis. No differences were observed in viral genotype distribution, pre-treatment viral load, IL28B allele distribution. No significant differences were observed for both RVR and EVR. However, when SVR was considered, a statistically significant difference was observed between HCV+MCS vs. HCV patients (p=0.012) and also HCV+MC vs HCV (p=0.045). The logistic regression analysis showed that HCV+MCS was an independent risk factor of non-response (O.R. 2.48; CI 1.24-6.3; p=0.013). Conclusions: This study strongly suggests that MCS represents a negative prognostic factor of response to anti-HCV SoC. This does not appear related to a modified early viral kinetics. It may be hypothesized that the higher prevalence of persisting infection in lymphatic reservoirs, previously shown in MCS+ vs. MCS- patients, plays a role.
Mixed cryoglobulinemia syndrome is a negative prognostic factor in the standard of care (Peg-IFN+ribavirin) anti-HCV therapy
GRAGNANI, LAURA;
2012-01-01
Abstract
HCV leads to chronic hepatitis (CHC) and mixed cryoglobulinemia (MC). MC is observed in the majority of HCV pts, but is clinically evident (MC syndrome, MCS) in a minority of cases. Antiviral therapy is the first therapeutic option for both CHC and MCS. In previous reports, generally based on retrospective analyses and/or limited populations, no difference was observed in MC/MCS virological response. This is an elusive condition (the diagnosis is not well standardized and the MC impossible to determine in stored samples), and the possibility that some MC/MCS pts were included in the negative control group cannot be ruled out. In this study, we prospectively analyzed MC/MCS data and virological response of a large population of HCV pts treated with anti-HCV SoC (Peg-IFN+RBV). Pts were consecutively recruited from July 2003 to July 2010. Results: 424 pts were enrolled. These included: 121 pts with MCS (HCV+MCS), 132 with MC without MCS (HCV+MC) and 158 without MCS nor MC (HCV). 13 patients (3.1%) resulted of uncertain classification. HCV+MCS group was associated with older age (p=0.0151), more severe liver disease (p=0.02), female sex (p<0.00005) and re-treatment (p=0.0168) in the univariate analysis. No differences were observed in viral genotype distribution, pre-treatment viral load, IL28B allele distribution. No significant differences were observed for both RVR and EVR. However, when SVR was considered, a statistically significant difference was observed between HCV+MCS vs. HCV patients (p=0.012) and also HCV+MC vs HCV (p=0.045). The logistic regression analysis showed that HCV+MCS was an independent risk factor of non-response (O.R. 2.48; CI 1.24-6.3; p=0.013). Conclusions: This study strongly suggests that MCS represents a negative prognostic factor of response to anti-HCV SoC. This does not appear related to a modified early viral kinetics. It may be hypothesized that the higher prevalence of persisting infection in lymphatic reservoirs, previously shown in MCS+ vs. MCS- patients, plays a role.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
