A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients.
Nevens, F.; Van Vlierberghe, H.; D'Heygere, F.et al.
2010 • In Acta Gastro-Enterologica Belgica, 73, p. 223-228
[en] Background/Aims : A large multicenter trial to compare the
efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination
with ribavirin, in chronic hepatitis C patients. Efficacy data
for prior relapsers are reported because treatment recommendations
for this patient population are not well defined.
Patients and methods : This study was a multicenter, prospective,
randomized clinical trial. The primary efficacy endpoint was sustained
virologic response in naïve patients (n = 348) and relapsers
(n = 95).
Results : Sustained virologic response rates were similar in naïve
patients and relapsers, both for non-pegylated and pegylated interferon
(respectively 27 and 26% and 54 and 43%). Pegylated interferon
given for 48 weeks did not improved the relapse rate : 15.9
and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated
interferon, naïve vs relapsers respectively. Stepwise logistic regression
analysis revealed a significant association between slow
response (detectable HCV RNA at week 12 and undetectable at
week 24) and relapse in patients with an end-of-treatment response
(55% versus 13% respectively ; p = 0.02 ; odds ratio = 6.07).
Conclusions : This trial confirms the value of using peginter -
feron alfa-2a in both naïve and relapsed patients and provides
support for a more tailored approach to treatment for relapsers
and particulary for patients with a slow viral response. (Acta
gastro enterol. belg., 2010, 73, 223-228).
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Nevens, F.
Van Vlierberghe, H.
D'Heygere, F.
Delwaide, Jean ; Université de Liège - ULiège > Gastro-Entérologie-Hépatologie
Adler, M.
Henrion, J.
Lenaerts, A.
Hendlisz, A.
Michielsen, P.
Bastens, B.
Brenard, R.
Laureys, A.
Language :
English
Title :
A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients.
HADZIYANNIS S. J., SETTE H. JR., MORGAN T.R., BALAN V., DIAGO M., MARCELLIN P., RAMADORI G., BODENHEIMER H. JR., BERNSTEIN D., RIZZETTO M., ZEUZEM S., POCKROS P.J., LIN A., ACKRILL A.M; PEGASYS INTERNATIONAL STUDY GROUP. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepa-titis C: a randomized study of treatment duration and ribavirin dose. Ann. Intern. Med., 2004, 140: 346-355.
HERRINE S.K., BROWN R.S. JR., BERNSTEIN D.E., ONDOVIK M.S., LENTZ E., TE H. Peginterferon alpha-2a combination therapies in chronic hepatitis C patients who relapsed after or had a viral breakthrough on therapy with standard interferon alpha-2b plus ribavirin: a pilot study of efficacy and safety. Dig. Dis. Sci., 2005, 50: 719-726.
JACOBSON I.M., GONZALEZ S.A., AHMED F., LEBOVICS E., MIN A.D., BODENHEIMER H.C. JR., ESPOSITO S.P., BROWN R.S. JR., BRÄU N., KLION F.M., TOBIAS H., BINI E.J., BRODSKY N., CERULLI M.A., AYTAMAN A., GARDNER P.W., GEDERS J.M., SPIVACK J.E., RAHMIN M.G., BERMAN D.H., EHRLICH J., RUSSO M.W., CHAIT M., ROVNER D., EDLIN B.R. A randomized trial of pegylated interferon alpha-2b plus ribavirin in the retreatment of chronic hepatitis C. Am. J. Gastroenterol., 2005, 100: 2453-2462.
SHERMAN M., YOSHIDA E.M., DESCHENES M., KRAJDEN M., BAIN V.G., PELTEKIAN K., ANDERSON F., KAITA K., SIMONYI S., BALSHAW R., LEE S.S; CANADIAN PEGASYS STUDY GROUP. Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy. Gut, 2006, 55: 1631-1638.
BASSO M., TORRE F., GRASSO A., PERCARIO G., AZZOLA E., ARTIOLI S., BLANCHI S., PELLI N., PICCIOTTO A. Pegylated interferon and ribavirin in re-treatment of responder-relapser HCV patients. Dig. Liver Dis., 2007, 39: 47-51.
BROUWER J.T., NEVENS F., BEKKERING F.C., BOURGEOIS N., VAN VLIERBERGHE H., WEEGINK C.J., LEFEBVRE V., VAN HATTUM J., HENRION J., DELWAIDE J., HANSEN B.E., SCHALM S.W., FOR THE BENELUX STUDY GROUP ON TREATMENT OF CHRONIC HEPATITIS. Reduction of relapse rates by 18-month treatment in chronic hepatitis C. A Benelux randomized trial in 300 patients. J. Hepatol., 2004, 40: 689-695.
DE MAEGHT S., HENRION J., BOURGEOIS N., DE GALOSCY C., LANGLET P., MICHIELSEN P., REYNAERT H., ROBAEYS G., SPRENGERS D., ORLENT H., ADLER M. A pilot observational survey of hepatitis C in Belgium. Acta Gastroenterol. Belg., 2008, 71: 4-8.
MANNS M.P., MCHUTCHISON J.G., GORDON S.C., RUSTGI V.K., SHIFFMAN M., REINDOLLAR R., GOODMAN Z.D., KOURY K., LING M., ALBRECHT J.K. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet, 2001, 358: 958-965.
BERG T., SARRAZIN C., HERRMANN E., HINRICHSEN H., GERLACH T., ZACHOVAL R., WIEDENMANN B., HOPF U., ZEUZEM S. Prediction of treatment outcome in patients with chronic hepatitis C: significance of baseline parameters and viral dynamics during therapy. Hepatology, 2003, 37: 600-609.
BUTI M., VALDES A., SANCHEZAVILA F., ESTEBAN R., LURIE Y. Extending combination therapy with peginterferon alfa-2b plus ribavirin for genotype 1 chronic hepatitis C late responders: a report of 9 cases. Hepatology, 2003, 37: 1226-1227.
BERG T., VON WAGNER M., NASSER S., SARRAZIN C., HEINTGES T., GERLACH T., BUGGISCH P., GOESER T., RASENACK J., PAPE G.R., SCHMIDT W.E., KALLINOWSKI B., KLINKER H., SPENGLER U.,MARTUS P., ALSHUTH U., ZEUZEM S. Extended treatment duration for hepatitis C virus type 1: comparing 48 versus 72 weeks of peginterferonalfa- 2a plus ribavirin. Gastroenterology, 2006, 130: 1086-1097.
SANCHEZTAPIAS J.M., DIAGO M., ESCARTIN P., ENRIQUEZ J., ROMEROGOMEZ M., BARCENA R., BÁRCENA R., CRESPO J., ANDRADE R., MARTÍNEZBAUER E., PÉREZ R., TESTILLANO M., PLANAS R., SOLÁ R., GARCÍABENGOECHEA M., GARCIASAMANIEGO J., MUÑOZSÁNCHEZ M., MORENOOTERO R; TERAVIC-4 STUDY GROUP. Peginterferon-alfa2a plus ribavirin for 48 versus 72 weeks in patients with detectable hepatitis C virus RNA at week 4 of treatment. Gastroenterology, 2006, 131: 451-460.
