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Abstract Details
Acute hepatitis C: A 24 week-course of Peg-Interferon alpha-2b versus a 12 week-course of Peg-Interferon alpha-2b alone or with ribavirin
Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Perri GD, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Hepatology. 2014 Jan 18. doi: 10.1002/hep.26991. [Epub ahead of print]
Author information
Infectious Diseases, University of Foggia, Italy.
Abstract
Background and aims: Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open randomized multicentre trial aimed to assess efficacy and safety of a 24-week-course of pegylated IFN (Peg-IFN) alpha-2b versus a 12 week-course of Peg-IFN alpha-2b alone or with ribavirin in AHC patients. Methods: One hundred thirty HCV acutely-infected patients who did not spontaneously resolve by week 12 after onset, were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 mcg/kg/week) for 24 or 12 weeks (arm 1, n=44 and arm 2, n=43, respectively), or in combination with ribavirin (10.6 mg/kg/day) for 12 weeks (arm 3, n=43). The primary end-point was undetectable HCV RNA at 6-month post-treatment follow up (SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by Real Time PCR (limit of detection 15 IU/ml) at the central laboratory at baseline, week 4, end of treatment, 6 and 12 months post-treatment. Results: Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, a SVR was achieved in 31/44 (70.5%), 31/43 (72.1%), and 31/43 (72.1%) patients in arms 1, 2, and 3, respectively (p=0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus sustained response rates with per-protocol analysis were 81.6%, 81.6%, 81.6% for patients in arms 1, 2 and 3 respectively. With multivariate analysis, the virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well-tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration.