Effect of Prolonged Interferon Therapy on the Outcome of Hepatitis C Virus–Related Cirrhosis: A Randomized Trial
Background & Aims: The impact of interferon (IFN) treatment on the occurrence of complications related to hepatitis C virus (HCV)-related cirrhosis is debated because the majority of studies are retrospective. We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa...
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| Veröffentlicht in: | Clinical gastroenterology and hepatology 2007-04, Vol.5 (4), p.502-507 |
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| creator | Fartoux, Laetitia Degos, Françoise Trépo, Christian Goria, Odile Calès, Paul Tran, Albert Buffet, Catherine Poynard, Thierry Capron, Dominique Raabe, Jean–Jacques Roulot, Dominique Naveau, Sylvie Grange, Jean–Didier Poupon, Renée E Poupon, Raoul Serfaty, Lawrence |
| description | Background & Aims: The impact of interferon (IFN) treatment on the occurrence of complications related to hepatitis C virus (HCV)-related cirrhosis is debated because the majority of studies are retrospective. We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis. Methods: A total of 102 patients (mean age, 60.5 ± 9.5 y; male/female ratio, .82) with biopsy examination–proven HCV cirrhosis, Child–Pugh score A, who were hepatocellular carcinoma (HCC) free, and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months. Results: During the follow-up evaluation, the complication rate was 24.5%: HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients. The number of HCC patients was similar in both groups. The probability of complication-free survival was not significantly different between treated and untreated patients (98% and 72.3% vs 90% and 70.7% at 12 and 24 mo, respectively, P = .59). The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group ( P = .2). Conclusions: This randomized controlled trial showed that a 2-year course of IFN has little or no impact on complication-free survival in patients with high-risk compensated HCV cirrhosis. |
| doi_str_mv | 10.1016/j.cgh.2006.10.016 |
| format | Article |
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We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis. Methods: A total of 102 patients (mean age, 60.5 ± 9.5 y; male/female ratio, .82) with biopsy examination–proven HCV cirrhosis, Child–Pugh score A, who were hepatocellular carcinoma (HCC) free, and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months. Results: During the follow-up evaluation, the complication rate was 24.5%: HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients. The number of HCC patients was similar in both groups. The probability of complication-free survival was not significantly different between treated and untreated patients (98% and 72.3% vs 90% and 70.7% at 12 and 24 mo, respectively, P = .59). The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group ( P = .2). Conclusions: This randomized controlled trial showed that a 2-year course of IFN has little or no impact on complication-free survival in patients with high-risk compensated HCV cirrhosis.</description><identifier>ISSN: 1542-3565</identifier><identifier>EISSN: 1542-7714</identifier><identifier>DOI: 10.1016/j.cgh.2006.10.016</identifier><identifier>PMID: 17261383</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Antiviral Agents - therapeutic use ; Confidence Intervals ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Gastroenterology and Hepatology ; Hepatitis C, Chronic - diagnosis ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - mortality ; Humans ; Interferon-alpha - therapeutic use ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - mortality ; Liver Cirrhosis - virology ; Male ; Middle Aged ; Odds Ratio ; Probability ; Prognosis ; Proportional Hazards Models ; Prospective Studies ; Recombinant Proteins ; Reference Values ; Risk Assessment ; Severity of Illness Index ; Survival Analysis ; Time Factors ; Treatment Outcome</subject><ispartof>Clinical gastroenterology and hepatology, 2007-04, Vol.5 (4), p.502-507</ispartof><rights>AGA Institute</rights><rights>2007 AGA Institute</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c515t-63185da187d324a88b9761c6327165c67aed5ebdf62b01ab2a397bd76b7f1eab3</citedby><cites>FETCH-LOGICAL-c515t-63185da187d324a88b9761c6327165c67aed5ebdf62b01ab2a397bd76b7f1eab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1542356506010548$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17261383$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fartoux, Laetitia</creatorcontrib><creatorcontrib>Degos, Françoise</creatorcontrib><creatorcontrib>Trépo, Christian</creatorcontrib><creatorcontrib>Goria, Odile</creatorcontrib><creatorcontrib>Calès, Paul</creatorcontrib><creatorcontrib>Tran, Albert</creatorcontrib><creatorcontrib>Buffet, Catherine</creatorcontrib><creatorcontrib>Poynard, Thierry</creatorcontrib><creatorcontrib>Capron, Dominique</creatorcontrib><creatorcontrib>Raabe, Jean–Jacques</creatorcontrib><creatorcontrib>Roulot, Dominique</creatorcontrib><creatorcontrib>Naveau, Sylvie</creatorcontrib><creatorcontrib>Grange, Jean–Didier</creatorcontrib><creatorcontrib>Poupon, Renée E</creatorcontrib><creatorcontrib>Poupon, Raoul</creatorcontrib><creatorcontrib>Serfaty, Lawrence</creatorcontrib><title>Effect of Prolonged Interferon Therapy on the Outcome of Hepatitis C Virus–Related Cirrhosis: A Randomized Trial</title><title>Clinical gastroenterology and hepatology</title><addtitle>Clin Gastroenterol Hepatol</addtitle><description>Background & Aims: The impact of interferon (IFN) treatment on the occurrence of complications related to hepatitis C virus (HCV)-related cirrhosis is debated because the majority of studies are retrospective. We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis. Methods: A total of 102 patients (mean age, 60.5 ± 9.5 y; male/female ratio, .82) with biopsy examination–proven HCV cirrhosis, Child–Pugh score A, who were hepatocellular carcinoma (HCC) free, and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months. Results: During the follow-up evaluation, the complication rate was 24.5%: HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients. The number of HCC patients was similar in both groups. The probability of complication-free survival was not significantly different between treated and untreated patients (98% and 72.3% vs 90% and 70.7% at 12 and 24 mo, respectively, P = .59). The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group ( P = .2). 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We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis. Methods: A total of 102 patients (mean age, 60.5 ± 9.5 y; male/female ratio, .82) with biopsy examination–proven HCV cirrhosis, Child–Pugh score A, who were hepatocellular carcinoma (HCC) free, and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months. Results: During the follow-up evaluation, the complication rate was 24.5%: HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients. The number of HCC patients was similar in both groups. The probability of complication-free survival was not significantly different between treated and untreated patients (98% and 72.3% vs 90% and 70.7% at 12 and 24 mo, respectively, P = .59). The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group ( P = .2). Conclusions: This randomized controlled trial showed that a 2-year course of IFN has little or no impact on complication-free survival in patients with high-risk compensated HCV cirrhosis.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>17261383</pmid><doi>10.1016/j.cgh.2006.10.016</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Antiviral Agents - therapeutic use Confidence Intervals Disease-Free Survival Dose-Response Relationship, Drug Drug Administration Schedule Female Gastroenterology and Hepatology Hepatitis C, Chronic - diagnosis Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - mortality Humans Interferon-alpha - therapeutic use Liver Cirrhosis - drug therapy Liver Cirrhosis - mortality Liver Cirrhosis - virology Male Middle Aged Odds Ratio Probability Prognosis Proportional Hazards Models Prospective Studies Recombinant Proteins Reference Values Risk Assessment Severity of Illness Index Survival Analysis Time Factors Treatment Outcome |
| title | Effect of Prolonged Interferon Therapy on the Outcome of Hepatitis C Virus–Related Cirrhosis: A Randomized Trial |
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