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Acute hepatitis C: A 24‐week course of pegylated interferon alpha‐2b versus a 12‐week course of pegylated interferon alpha‐2b alone or with ribavirin
Author(s) -
Santantonio Teresa,
Fasano Massimo,
Sagnelli Evangelista,
Tundo Paolo,
Babudieri Sergio,
Fabris Paolo,
Toti Mario,
Perri Giovanni,
Marino Nicoletta,
Pizzigallo Eligio,
Angarano Gioacchino
Publication year - 2014
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.26991
Subject(s) - ribavirin , medicine , pegylated interferon , gastroenterology , alpha interferon , randomized controlled trial , clinical endpoint , hepatitis c , intention to treat analysis , combination therapy , hepatitis c virus , interferon , immunology , virus
Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the 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 (RBV) in AHC patients. One hundred and 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 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6‐month posttreatment follow‐up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real‐time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent‐to‐treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 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%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, 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. (H epatology 2014;59:2101‐2109)