Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone

An Italian multicenter, randomized, controlled, clinical study

Giuseppe Barbaro, Gabriella Di Lorenzo, Maurizio Soldini, Giuseppe Giancaspro, Giorgio Bellomo, Giancarlo Belloni, Benvenuto Grisorio, Mauro Annese, Donato Bacca, Ruggiero Francavilla, Giovanni Rizzo, Giorgio Barbarini

Research output: Contribution to journalArticle

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Abstract

Objective: The aim of the study was to assess the efficacy of interferon (IFN)-α-2b and ribavirin in combination in the treatment of chronic hepatitis C (CHC) patients unresponsive to a previous treatment with IFN-α- 2b alone. Methods: We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombinant IFN-α-2b (3 MU thrice weekly) and ribavirin (1000-1200 mg/daily per os), whereas 151 received IFN-α-2b alone (6 MU thrice weekly). Both ribavirin and IFN-α-2b were given for 24 wk, regardless of treatment response. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk. Results: Normal ALT levels were observed in 64.5% of the patients treated with IFN-α and ribavirin and in 22.6% of the patients treated with IFN-α alone. In the group of patients receiving IFN-α and ribavirin HCV RNA was not detectable in 40% of patients responders and remained undetectable in 44.2% of sustained responders. In the group of patients receiving IFN-α alone HCV RNA was not detectable in 24.2% of patients responders and remained not detectable in 33.3% of sustained responders. Conclusions: A 24-wk treatment course with IFN-α and ribavirin given to patients with a previous lack of response to IFN-α alone offers a chance of a sustained biochemical and virological response, at least in a subset of such patients. The role of long-term therapy in inducing prolonged remission still remains to be explored.

Original languageEnglish
Pages (from-to)2445-2451
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume93
Issue number12
DOIs
Publication statusPublished - Dec 1998

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Ribavirin
Chronic Hepatitis C
Interferons
RNA
Alanine Transaminase
Clinical Studies
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone : An Italian multicenter, randomized, controlled, clinical study. / Barbaro, Giuseppe; Di Lorenzo, Gabriella; Soldini, Maurizio; Giancaspro, Giuseppe; Bellomo, Giorgio; Belloni, Giancarlo; Grisorio, Benvenuto; Annese, Mauro; Bacca, Donato; Francavilla, Ruggiero; Rizzo, Giovanni; Barbarini, Giorgio.

In: American Journal of Gastroenterology, Vol. 93, No. 12, 12.1998, p. 2445-2451.

Research output: Contribution to journalArticle

Barbaro, Giuseppe ; Di Lorenzo, Gabriella ; Soldini, Maurizio ; Giancaspro, Giuseppe ; Bellomo, Giorgio ; Belloni, Giancarlo ; Grisorio, Benvenuto ; Annese, Mauro ; Bacca, Donato ; Francavilla, Ruggiero ; Rizzo, Giovanni ; Barbarini, Giorgio. / Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone : An Italian multicenter, randomized, controlled, clinical study. In: American Journal of Gastroenterology. 1998 ; Vol. 93, No. 12. pp. 2445-2451.
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abstract = "Objective: The aim of the study was to assess the efficacy of interferon (IFN)-α-2b and ribavirin in combination in the treatment of chronic hepatitis C (CHC) patients unresponsive to a previous treatment with IFN-α- 2b alone. Methods: We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombinant IFN-α-2b (3 MU thrice weekly) and ribavirin (1000-1200 mg/daily per os), whereas 151 received IFN-α-2b alone (6 MU thrice weekly). Both ribavirin and IFN-α-2b were given for 24 wk, regardless of treatment response. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk. Results: Normal ALT levels were observed in 64.5{\%} of the patients treated with IFN-α and ribavirin and in 22.6{\%} of the patients treated with IFN-α alone. In the group of patients receiving IFN-α and ribavirin HCV RNA was not detectable in 40{\%} of patients responders and remained undetectable in 44.2{\%} of sustained responders. In the group of patients receiving IFN-α alone HCV RNA was not detectable in 24.2{\%} of patients responders and remained not detectable in 33.3{\%} of sustained responders. Conclusions: A 24-wk treatment course with IFN-α and ribavirin given to patients with a previous lack of response to IFN-α alone offers a chance of a sustained biochemical and virological response, at least in a subset of such patients. The role of long-term therapy in inducing prolonged remission still remains to be explored.",
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T1 - Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone

T2 - An Italian multicenter, randomized, controlled, clinical study

AU - Barbaro, Giuseppe

AU - Di Lorenzo, Gabriella

AU - Soldini, Maurizio

AU - Giancaspro, Giuseppe

AU - Bellomo, Giorgio

AU - Belloni, Giancarlo

AU - Grisorio, Benvenuto

AU - Annese, Mauro

AU - Bacca, Donato

AU - Francavilla, Ruggiero

AU - Rizzo, Giovanni

AU - Barbarini, Giorgio

PY - 1998/12

Y1 - 1998/12

N2 - Objective: The aim of the study was to assess the efficacy of interferon (IFN)-α-2b and ribavirin in combination in the treatment of chronic hepatitis C (CHC) patients unresponsive to a previous treatment with IFN-α- 2b alone. Methods: We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombinant IFN-α-2b (3 MU thrice weekly) and ribavirin (1000-1200 mg/daily per os), whereas 151 received IFN-α-2b alone (6 MU thrice weekly). Both ribavirin and IFN-α-2b were given for 24 wk, regardless of treatment response. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk. Results: Normal ALT levels were observed in 64.5% of the patients treated with IFN-α and ribavirin and in 22.6% of the patients treated with IFN-α alone. In the group of patients receiving IFN-α and ribavirin HCV RNA was not detectable in 40% of patients responders and remained undetectable in 44.2% of sustained responders. In the group of patients receiving IFN-α alone HCV RNA was not detectable in 24.2% of patients responders and remained not detectable in 33.3% of sustained responders. Conclusions: A 24-wk treatment course with IFN-α and ribavirin given to patients with a previous lack of response to IFN-α alone offers a chance of a sustained biochemical and virological response, at least in a subset of such patients. The role of long-term therapy in inducing prolonged remission still remains to be explored.

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