Objective: To report the results of a pilot study using rituximab combined with Peg-Interferon (IFN)α2b-ribavirin in severe refractory hepatitis C virus (HCV) related mixed cryoglobulinemia (MC) vasculitis.
Methods: Sixteen consecutive patients with severe HCV-MC vasculitis which were resistant (n=11) or relapser (n=5) to a previous combination therapy with standard (n=10) or Peg-IFNα2b (n=6) plus ribavirin were included. They were treated with rituximab (375mg/m² intravenously weekly for 4 weeks) combined with Peg-IFNα2b (1.5µg/kg/week subcutaneously) plus ribavirin (600-1,200 mg/day orally) for 12 months.
Results: Fifteen patients (93.7%) showed clinical improvement, 10 of whom (62.5%) were clinical complete responders (CR). HCV RNA and serum cryoglobulin became undetectable in all the clinical CR. Peripheral blood B cell depletion was achieved in all patients (CD19+ cells 111 ± 32/mm3 at baseline vs 2 ± 2/mm3 after the fourth infusion of rituximab) with reconstitution starting at the end of antiviral therapy. Compared with clinical CR, the partial or non responders had a 3.6 times longer duration of vasculitis prior to therapy and a lower rate of early virologic response. Treatment was well tolerated with no infectious complications. After a mean follow-up of 19.4 ± 3.6 months, two patients experienced clinical relapse associated with simultaneous reappearance of HCV RNA and cryoglobulin and an increase in the number of B-cells.
Conclusion: Rituximab combined with Peg-IFNα2b-ribavirin represents a safe and effective therapeutic option in severe refractory HCV-MC vasculitis.
- Hepatitis C
- antiviral therapy
- mixed cryoglobulinemia,