Interferon-ribavirin for chronic hepatitis C with and without cirrhosis: Analysis of individual patient data of six controlled trials

Schalm, Solko W.; Weiland, Ola; Hansen, Bettina E.; Milella, Michele Stanislaw; Lai, Ming Yang; Hollander, A. Gerson; Michielsen, P.; Bellobuono, A.; Chemello, Liliana; Pastore, Giuseppe; Chen, Ding‐Shinn; Brouwer, Johannes T.

doi:10.1053/gast.1999.0029900408

Cited by 145 publications

(108 citation statements)

References 12 publications

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“…Although a biochemical sustained response without clearance of HCV-RNA is regarded as an ephemeral result portending future relapse of disease, the prolonged improvement of cytolysis induced by re-treatment in some patients may nevertheless be of clinical benefit in reducing progression to cirrhosis. [20][21][22] In accordance with previous reports, 23,24 our study showed that young age and genotype other than 1 are strong predictive factors of sustained response; we also confirmed 17 that the beneficial effect of combination therapy is extended to patients with advanced fibrosis or cirrhosis.…”

Section: Discussionsupporting

confidence: 92%

A randomized 4-arm multicenter study of interferon alfa–2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone

et al. 2001

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To determine whether a higher dosage of interferon (IFN) associated with ribavirin and/or prolonged time of administration may improve therapeutic efficacy, we conducted a 4-arm randomized trial on patients with chronic hepatitis C not responding to one or more previous treatment courses with IFN monotherapy. Group 1 (n ‫؍‬ 139) received 3 million units (MU) IFN-␣2b 3 times a week (t.i.w.) plus ribavirin 1,000 mg/d for 12 months; group 2 (n ‫؍‬ 162) received 5 MU t.i.w. plus ribavirin for 12 months; group 3 (n ‫؍‬ 142) received 3 MU t.i.w. plus ribavirin for 6 months; and group 4 (n ‫؍‬ 151) received 5 MU t.i.w. plus ribavirin for 6 months. The primary end point was hepatitis C virus (HCV)-RNA clearance at the end of 6-month follow-up. HCV-RNA was negative in 15% of group 1, 23% of group 2, 11% of group 3, 16% of group 4 (group 2 vs. group 3, P ‫؍‬ .04). Among patients with genotypes 1 and 4, sustained response was significantly higher in group 2 vs. group 3 (18% vs. 7%, P ‫؍‬ .03; group 1 ‫؍‬ 9%, group 4 ‫؍‬ 12%, P ‫؍‬ not significant [NS]). In patients with genotypes 2 and 3, sustained virologic response was not affected by the different regimens (group 1 ‫؍‬ 32%, group 2 ‫؍‬ 30%, group 3 ‫؍‬ 30%, group 4 ‫؍‬ 35%, P ‫؍‬ NS). In conclusion, about 23% of nonresponders to IFN monotherapy may achieve a sustained response if Combination therapy (interferon [IFN] plus ribavirin) is the first-line therapy for naive patients with chronic hepatitis C 1,2 ; patients who have relapsed after an initial treatment with IFN alone can also be re-treated with good results. 3 Unfortunately, there is no therapeutic option for patients who have not responded to IFN and to date consensus conferences 4,5 have not recommended any therapeutic schedule for IFN nonresponders; these patients nevertheless represent a high percentage of patients.Re-treatment of nonresponders with higher dosages of IFN and/or more aggressive approaches is ineffective 5 or induces a low rate of sustained responders 6 ; recent trials with IFN plus ribavirin combination protocols 7-11 have given disappointing results, but the small number of patients recruited into the studies and the low dosage of IFN used have made the results questionable.To address the question of whether higher than standard IFN dosages associated with ribavirin and/or prolonged time of administration may improve the rate of sustained responses, we conducted a 4-arm randomized trial on patients with chronic hepatitis C not responding to one or more previous treatment courses with IFN alone. The study was designed to compare the efficacy and safety of IFN given at 3 million units (MU) and 5 MU 3 times a week (t.i.w.) plus ribavirin 1,000 mg given daily over treatment durations of 6 and 12 months. PATIENTS AND METHODSDefinition of Nonresponse. According to the Consensus Conference held in Paris, February 26 to 27,1999, nonresponse to IFN monotherapy is defined by abnormal alanine transaminase (ALT) levels or by the presence of hepatitis C virus (HCV)-RNA during therapy; breakthroughs durin...

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Section: Discussionsupporting

confidence: 92%

A randomized 4-arm multicenter study of interferon alfa–2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone

et al. 2001

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“…Mais ces résultats doivent être confirmés par de plus larges études contrô-lées en cours de réalisation. Un autre cas particulier est celui des patients au stade de cirrhose, pour lesquels l'efficacité du traitement est moindre : moins de 5 % de réponses virologiques prolongées avec l'IFN seul [23], et 20 % à 30 % avec la bithérapie [24]. Certaines études ont suggéré que le traitement par l'IFN pouvait toutefois diminuer le risque de complications de la cirrhose et, en particulier, l'incidence du carcinome hépatocellulaire [25].…”

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Boyer

Marcellin

2002

Med Sci (Paris)

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“…However, the combination of interferonalpha and ribavirin is superior to interferon alpha alone in inducing sustained remission from HCV in patients who have not previously been treated with interferon alpha (581)(582)(583)(584)(585)(586). Similarly, the combination appears to be superior to alphainterferon alone in patients who have previously been treated with interferon alpha, but have relapsed (585,(589)(590)(591). The incidence of adverse effects of combination therapy is (71) Rx, treatment.…”

Section: The Evaluation Of Renal Transplant Candidates: Clinical Pracmentioning

confidence: 99%

The Evaluation of the Renal Transplant Candidates: Clinical Practice Guidelines

2001

American Journal of Transplantation

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Interferon-ribavirin for chronic hepatitis C with and without cirrhosis: Analysis of individual patient data of six controlled trials

Cited by 145 publications

References 12 publications

A randomized 4-arm multicenter study of interferon alfa–2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone

A randomized 4-arm multicenter study of interferon alfa–2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone

Traitement de l’hépatite C

The Evaluation of the Renal Transplant Candidates: Clinical Practice Guidelines

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