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Background: Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. Objective: To evaluate use of peginterferon-[alpha]2a plus ribavirin to re-treat nonresponders to peginterferon-[alpha]2b plus ribavirin. Design: Randomized, parallel-group trial conducted between September 2003 and February 2007. Patients and researchers were not blinded to intervention assignment. Random assignment was centralized, computer-generated, and stratified by geographic region, hepatitis C virus (HCV) genotype, and histologic diagnosis. Setting: 106 international centers. Patients: 950 nonresponders to 12 of more weeks of therapy with peginterferon-[alpha]2b plus ribavirin. Intervention: Peginterferon-[alpha]2a, 360 [micro]g/wk, for 12 weeks, then 180 [micro]g/wk to complete 72 weeks (group A) of 48 weeks (group B), of peginterferon-[alpha]2a, 180/[micro]g/wk for 72 weeks (group C) or 48 weeks (group D). All patients received ribavirin, 1000 or 1200 mg/d. Measurements: Sustained virologic response (SVR), defined as undetectable ( Results: The SVR rates in groups A (n = 317), B (n = 156), C (n = 156), and D (n = 313) were 16%, 7%, 14%, and 9%, respectively (relative risk [RR] for group A vs. group D [the primary comparison], 1.80 [95% Cl, 1.17 to 2.77]; P = 0.006). Extended treatment duration increased SVR rates (16% for 72 weeks [groups A and C] vs. 8% for 48 weeks [groups B and D]; RR, 2.00 [CI, 1.32 to 3.02]; P< 0.001). Complete viral suppression (HCV RNA level Limitation: Nonresponders to peginterferon-[alpha]2a plus ribavirin were not evaluated. Conclusion: Re-treating nonresponders to therapy with peginterferon-[alpha]2b plus ribavirin for 72 weeks significantly increases SVR rates compared with re-treating them for 48 weeks. The overall SVR rate was low, but patients who ate most likely to respond to re-treatment can be identified at week 12. Primary Funding Source: Roche.

Background: An association between monoclonal gammopathies and chronic liver diseases has been reported. Objective: To determine the prevalence of monoclonal gammopathies in patients with chronic hepatitis C virus (HCV) infection and the possible association of monoclonal gammopathies with HCV genotypes. Design: Prospective study. Setting: Departments of internal medicine and hematology at two university hospitals in Italy. Patients: 239 HCV-positive and 98 HCV-negative patients with chronic liver diseases were recruited consecutively. Measurements: Clinical data were gathered, liver histologic examination was done, serum immunoglobulin and cryoglobulin levels were measured, and immunoelectrophoresis was done for monoclonal component detection. Patients with monoclonal gammopathy had serum HCV RNA measured and HCV genotype determined by polymerase chain reaction and had histologic examination of bone marrow. Results: Monoclonal band was detected in 11% of HCV-positive patients and in 1% of HCV-negative patients (P = 0.004). The prevalence of HCV genotype 2a/c was higher in patients with monoclonal gammopathies than in those without (50% compared with 18%; P = 0.009). Conclusion: The prevalence of monoclonal gammopathies in patients with HCV-related chronic liver disease is striking and is often associated with genotype 2a/c infection., Some people infected with the hepatitis C virus (HCV) have a monoclonal gammopathy and it appears to be caused by a specific strain of the virus. Monoclonal gammopathy is caused by a proliferation of B cells, which are the immune cells that produce antibodies. Researchers tested 239 HCV-positive people and 98 HCV-negative people for monoclonal gammopathy. Eleven percent of the HCV-positive people had the disease compared to 1% of those who were HCV-negative. Half of those with the disease were infected with the 2a/c viral strain compared ot 18% without the disease.