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A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis.

ABSTRACT: OBJECTIVE:To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis. METHODS:We conducted a single-center, open-label, randomized controlled trial of rituximab (375 mg/ m(2) /week for 4 weeks) compared to the best available therapy (maintenance or increase in immunosuppressive therapy) for HCV-associated cryoglobulinemic vasculitis in patients in whom antiviral therapy had failed to induce remission. The primary end point was disease remission at 6 months from study entry. RESULTS:A total of 24 patients were enrolled (12 in each treatment group). Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, as compared with 1 patient in the control group (8%), a result that met the criterion for stopping the study (P < 0.001). The median duration of remission for rituximab-treated patients who reached the primary end point was 7 months. No adverse effects of rituximab on HCV plasma viremia or on hepatic transaminase levels were observed. CONCLUSION:Rituximab was a well-tolerated and effective treatment in patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission.

SUBMITTER: Sneller MC

PROVIDER: S-EPMC3243106 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis.

Sneller Michael C MC Hu Zonghui Z Langford Carol A CA

Arthritis and rheumatism 20120301 3

<h4>Objective</h4>To perform a randomized controlled trial of rituximab in patients with hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis.<h4>Methods</h4>We conducted a single-center, open-label, randomized controlled trial of rituximab (375 mg/ m(2) /week for 4 weeks) compared to the best available therapy (maintenance or increase in immunosuppressive therapy) for HCV-associated cryoglobulinemic vasculitis in patients in whom antiviral therapy had failed to induce remission. ...[more]

PMID: 22147444

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Project description:Hepatitis C virus (HCV) infection recurs in liver recipients who are viremic at transplantation. We conducted a randomized, controlled trial to test the efficacy and safety of pretransplant pegylated interferon alpha-2b plus ribavirin (Peg-IFN-?2b/RBV) for prevention of post-transplant HCV recurrence. Enrollees had HCV and were listed for liver transplantation, with either potential living donors or Model for End-Stage Liver Disease upgrade for hepatocellular carcinoma. Patients with HCV genotypes (G) 1/4/6 (n = 44/2/1) were randomized 2:1 to treatment (n = 31) or untreated control (n = 16); HCV G2/3 (n=32) were assigned to treatment. Overall, 59 were treated and 20 were not. Peg-IFN-?2b, starting at 0.75 ?g/kg/week, and RBV, starting at 600 mg/day, were escalated as tolerated. Patients assigned to treatment versus control had similar baseline characteristics. Combined virologic response (CVR) included pretransplant sustained virologic response and post-transplant virologic response (pTVR), defined as undetectable HCV RNA 12 weeks after end of treatment or transplant, respectively. In intent-to-treat analyses, 12 (19%) assigned to treatment and 1 (6%) assigned to control achieved CVR (P = 0.29); per-protocol values were 13 (22%) and 0 (0%) (P = 0.03). Among treated G1/4/6 patients, 23 of 30 received transplant, of whom 22% had pTVR; among treated G2/3 patients 21 of 29 received transplant, of whom 29% had pTVR. pTVR was 0%, 18%, and 50% in patients treated for <8, 8-16, and >16 weeks, respectively (P = 0.01). Serious adverse events (SAEs) occurred with similar frequency in treated versus untreated patients (68% versus 55%; P = 0.30), but the number of SAEs per patient was higher in the treated group (2.7 versus 1.3; P = 0.003).Pretransplant treatment with Peg-IFN-?2b/RBV prevents post-transplant recurrence of HCV in selected patients. Efficacy is higher with >16 weeks of treatment, but treatment is associated with increased risk of potentially serious complications.

Dataset Information

A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis.

Publications

A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis.

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