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
Articolo
Data di Pubblicazione:
2014
Citazione:
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 / Santantonio, T.; Fasano, M.; Sagnelli, E.; Tundo, P.; Babudieri, S.; Fabris, P.; Toti, M.; Di Perri, G.; Marino, N.; Pizzigallo, E.; Angarano, G.; Pastore, G.; Guastadisegni, A.; Volpe, A.; Stano, F.; Tommasi, D.; Maci, A.; Resta, F.; Loperfido, P.; Esposito, R.; Borghi, V.; Fontana, T.; Francavilla, R.; Mazzola, M.; Pipoli, A.; Stanzione, M.; Amoroso, P.; Lettieri, G.; Messina, V.; Antonucci, G.; Rosati, S.; Giacometti, A.; Costa, C.; De Stefano, C. B.; Cariti, G.; Tositti, G.; Piera Riccardi, M.; Verucchi, G.; Francisci, D.; Petrelli, E.; Stoppini, L.; Raimondo, G.; Squadrito, G.; Caccamo, G.; Antonino, P.; Monica, B.; Lazzarin, A.; Morsica, G.; Mian, P.; Pristerà, R.. - In: HEPATOLOGY. - ISSN 0270-9139. - 59:6(2014), pp. 2101-2109. [10.1002/hep.26991]
Abstract:
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.
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.
Tipologia CRIS:
1.1 Articolo in rivista
Elenco autori:
Santantonio, T.; Fasano, M.; Sagnelli, E.; Tundo, P.; Babudieri, S.; Fabris, P.; Toti, M.; Di Perri, G.; Marino, N.; Pizzigallo, E.; Angarano, G.; Pastore, G.; Guastadisegni, A.; Volpe, A.; Stano, F.; Tommasi, D.; Maci, A.; Resta, F.; Loperfido, P.; Esposito, R.; Borghi, V.; Fontana, T.; Francavilla, R.; Mazzola, M.; Pipoli, A.; Stanzione, M.; Amoroso, P.; Lettieri, G.; Messina, V.; Antonucci, G.; Rosati, S.; Giacometti, A.; Costa, C.; De Stefano, C. B.; Cariti, G.; Tositti, G.; Piera Riccardi, M.; Verucchi, G.; Francisci, D.; Petrelli, E.; Stoppini, L.; Raimondo, G.; Squadrito, G.; Caccamo, G.; Antonino, P.; Monica, B.; Lazzarin, A.; Morsica, G.; Mian, P.; Pristerà, R.
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