Abstract
BackgroundThe efficacy and safety of direct-acting antiviral agents (DAAs) were evaluated in a cohort of prospectively enrolled patients with hepatitis C virus (HCV)-related mixed cryoglobulinaemia (MC), an immune complex-mediated vasculitis of small and medium vessels in which the pathogenetic role of HCV has been clearly established.MethodsTwenty-two patients received DAAs. Clinical and laboratory features were recorded at baseline, every 4 weeks until the end of treatment (EoT), and 12 weeks afterwards. Primary efficacy endpoints were (a) sustained virological response 12 weeks after therapy completion (SVR12), (b) regression of symptomatology (clinical response) and (c) cryoglobulin disappearance or cryocrit reduction ≥50% (immunological response). Complete response (CR) was defined as the occurrence of all three primary endpoints; partial response (PR) was defined as the occurrence of SVR12, with or without either immunological or clinical response; and no response was defined as missing the achievement of all three endpoints.ResultsAll patients reached SVR12. Compared with basal values, mean cryocrit values were significantly decreased at EoT and SVR12. A significant reduction of alanine transaminase and a parallel increase of complement component C4 levels were also detected. Rheumatoid factor activity was significantly reduced at EoT but not at SVR12. At SVR12, a CR was established in 14 patients (63.7%) and a PR in 8 patients (36.3%). In one patient with small lymphocytic lymphoma, the tumour progressed despite viral clearance. Mild adverse events were recorded in nine patients (40.9%).ConclusionsThe response rates induced by the use of DAAs in patients with MC were remarkably higher than those previously achieved with pegylated interferon-α/ribavirin, with or without rituximab. A much longer follow-up is desirable to achieve useful information in terms of persistent viral clearance and clinical response.
Highlights
The efficacy and safety of direct-acting antiviral agents (DAAs) were evaluated in a cohort of prospectively enrolled patients with hepatitis C virus (HCV)-related mixed cryoglobulinaemia (MC), an immune complex-mediated vasculitis of small and medium vessels in which the pathogenetic role of HCV has been clearly established
We report the results of our single-centre, prospective study of a cohort of patients with MC whose main features can be summarised as follows: (a) unresponsiveness to or relapse after the previous standard-of-care treatment consisting of Pegylated interferon (pIFN)-α + RBV combination, or previously untreated patients; (b) the assignment to receive variable combinations of DAAs according to the guidelines of the Italian Medicines Agency (AIFA) eligibility criteria; and (c) a post-treatment evaluation at weeks 12 and 24, with a prolonged follow-up until 12 months in some cases
Comparing these results with those of our previous study in which we assessed the response to pIFN-α + RBV + RTX combination therapy [19], we found that the all-oral therapeutic approach was significantly better in terms of Complete response (CR) achievement (p = 0.0008 and p =0.030 at end of treatment (EoT) and SVR12, respectively) (Table 3)
Summary
The efficacy and safety of direct-acting antiviral agents (DAAs) were evaluated in a cohort of prospectively enrolled patients with hepatitis C virus (HCV)-related mixed cryoglobulinaemia (MC), an immune complex-mediated vasculitis of small and medium vessels in which the pathogenetic role of HCV has been clearly established. Hepatitis C virus (HCV) is a major cause of chronic liver disease that can potentially progress to cirrhosis and hepatocellular carcinoma (HCC) [1,2,3]. It has been estimated that about 130 million to 150 million people worldwide have HCV infection and that HCV causes about 500,000 deaths each year [4]. In addition to liver damage, HCV infection is associated with several extrahepatic disorders [5]; among them, the striking association between HCV. In our experience, compared with patients with chronic HCV infection without cryoglobulinaemia, HCV-positive patients with MC exhibit a lower rate of liver fibrosis and a lower cumulative probability of developing cirrhosis and HCC, but a more frequent occurrence of renal failure, neurologic impairment and B-cell non-Hodgkin lymphoma (B-NHL). The 15-year survival rates in these groups have been found to be roughly similar [11]
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