Abstract:Mixed cryoglobulinemia (MC) is the most common extrahepatic manifestation of chronic hepatitis C (CHC), with the presence of symptoms in 10-15% of cases. There have been encouraging data regarding immunological and clinical responses in patients treated with the novel combinations of direct-acting antivirals (DAAs), but the role of ribavirin (RBV) in the treatment of MC has not yet been demonstrated. We prospectively enrolled 132 patients affected by MC and CHC, and virological, immunological and clinical resp… Show more
“…11 Our findings revealed significantly higher RF with significantly lower C3 and C4 serum levels among the included HCV-MC in comparison with the controls, with significant improvements in their level following DAAs. In line with our data, Boglione et al 14 and Gragnani et al 37 reported similar findings.…”
Section: Discussionsupporting
confidence: 93%
“…Before the advent of direct-acting antivirals (DAAs), interferon (IFN)-based regimens produced clinical recovery with subsequent improvement of MC as a result of HCV clearance; however, the side effects of IFN may mimic the MC manifestations, and the relapse rate with IFN-based regimens was high. 13 Boglione et al 14 reported a study on the treatment of HCV-MC with IFN-free regimens, with or without ribavirin, and concluded that IFN-free regimens were effective and well tolerated in treating HCV-MC and significantly promoted a decrease in cryoglobulins.…”
Background and aimsHepatitis C virus (HCV) infection is associated with extrahepatic manifestations such as cryoglobulinemia and accounts for up to 90% of all cases of mixed cryoglobulinemia (MC). The present study aimed to evaluate the effect of sofosbuvir–daclatasvir therapy on symptomatic HCV-related MC and sustained virologic response (SVR) achievement.Patients and methodsThis prospective cohort study was carried out on 120 patients with chronic HCV infection, clinically suspected to have MC, but only 63 of whom were positive for cryoglobulins. HCV-MC patients were treated with sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months. The serum cryoglobulins levels, complement 3 (C3), complement 4 (C4) (using ELISA assay kits) and rheumatoid factor (RF) (using immunoturbidimetric assay kit), were measured in the included HCV infected patients (to confirm HCV-MC diagnosis), in addition to quantitave HCV-RNA assays, using real time PCR. All these measurements have been done before stating therapy and 12, 24 weeks post-therapy for assessments of immunological recovery, viral load and SVR.ResultsSignificant increase in the serum cryoglobulin levels and RF with significant decrease in C3 and C4 serum levels were detected in only 63 out of 120 included HCV infected patients, upon whom the study has been completed. They showed significant decrease in their mean cryoglobulin levels from 41.47 µg/mL ±12.32 SD to 5.12 µg/mL ±3.59 SD then to 5.09 µg/mL ±3.02 SD, 12 to 24 weeks post-therapy respectively (p<0.001), with significant decline in RF concentrations and rise in C3 and C4 serum levels approaching the normal values. There were improvements in the presenting HCV-MC clinical manifestations in variable degrees, ranging from 5 (71.42%) in patients with glomerulonephritis to 62 (98.4%) in patients with purpura. Eighty-seven percent of the included patients showed complete response (clinical, virological and immunological recovery) and 13% showed partial response (virological and immunological recovery without clinical improvement of cryoglobulinemia associated manifestations).ConclusionA combined therapy of sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months was associated with a significant decrease in serum cryoglobulin levels and appears as a reasonable treatment option for HCV-associated MC.
“…11 Our findings revealed significantly higher RF with significantly lower C3 and C4 serum levels among the included HCV-MC in comparison with the controls, with significant improvements in their level following DAAs. In line with our data, Boglione et al 14 and Gragnani et al 37 reported similar findings.…”
Section: Discussionsupporting
confidence: 93%
“…Before the advent of direct-acting antivirals (DAAs), interferon (IFN)-based regimens produced clinical recovery with subsequent improvement of MC as a result of HCV clearance; however, the side effects of IFN may mimic the MC manifestations, and the relapse rate with IFN-based regimens was high. 13 Boglione et al 14 reported a study on the treatment of HCV-MC with IFN-free regimens, with or without ribavirin, and concluded that IFN-free regimens were effective and well tolerated in treating HCV-MC and significantly promoted a decrease in cryoglobulins.…”
Background and aimsHepatitis C virus (HCV) infection is associated with extrahepatic manifestations such as cryoglobulinemia and accounts for up to 90% of all cases of mixed cryoglobulinemia (MC). The present study aimed to evaluate the effect of sofosbuvir–daclatasvir therapy on symptomatic HCV-related MC and sustained virologic response (SVR) achievement.Patients and methodsThis prospective cohort study was carried out on 120 patients with chronic HCV infection, clinically suspected to have MC, but only 63 of whom were positive for cryoglobulins. HCV-MC patients were treated with sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months. The serum cryoglobulins levels, complement 3 (C3), complement 4 (C4) (using ELISA assay kits) and rheumatoid factor (RF) (using immunoturbidimetric assay kit), were measured in the included HCV infected patients (to confirm HCV-MC diagnosis), in addition to quantitave HCV-RNA assays, using real time PCR. All these measurements have been done before stating therapy and 12, 24 weeks post-therapy for assessments of immunological recovery, viral load and SVR.ResultsSignificant increase in the serum cryoglobulin levels and RF with significant decrease in C3 and C4 serum levels were detected in only 63 out of 120 included HCV infected patients, upon whom the study has been completed. They showed significant decrease in their mean cryoglobulin levels from 41.47 µg/mL ±12.32 SD to 5.12 µg/mL ±3.59 SD then to 5.09 µg/mL ±3.02 SD, 12 to 24 weeks post-therapy respectively (p<0.001), with significant decline in RF concentrations and rise in C3 and C4 serum levels approaching the normal values. There were improvements in the presenting HCV-MC clinical manifestations in variable degrees, ranging from 5 (71.42%) in patients with glomerulonephritis to 62 (98.4%) in patients with purpura. Eighty-seven percent of the included patients showed complete response (clinical, virological and immunological recovery) and 13% showed partial response (virological and immunological recovery without clinical improvement of cryoglobulinemia associated manifestations).ConclusionA combined therapy of sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months was associated with a significant decrease in serum cryoglobulin levels and appears as a reasonable treatment option for HCV-associated MC.
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