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Intervention Review

Interferon for interferon nonresponding and relapsing patients with chronic hepatitis C

  1. Thierry Poynard2,
  2. Robert P Myers1,*

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 21 OCT 2002

Assessed as up-to-date: 27 AUG 2002

DOI: 10.1002/14651858.CD003617


How to Cite

Poynard T, Myers RP. Interferon for interferon nonresponding and relapsing patients with chronic hepatitis C. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD003617. DOI: 10.1002/14651858.CD003617.

Author Information

  1. 1

    AHFMR Clinical Investigator, Director, Viral Hepatitis Unit, Calgary, Canada

  2. 2

    Groupe Hospitalier Pitie-Salpetriere, Paris, France, Service d'Hepato-Gastroenterologie, Paris Cedex 13, France

*Robert P Myers, Director, Viral Hepatitis Unit, AHFMR Clinical Investigator, University of Calgary, Calgary, AB T2N 4N1, Canada. rpmyers@ucalgary.ca. drrobpmyers@hotmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 OCT 2002

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This is not the most recent version of the article. View current version (31 JAN 2013)

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Interferon monotherapy leads to sustained virologic clearance in a minority of patients with chronic hepatitis C. Studies have yielded conflicting results regarding retreatment with interferon in nonresponders and relapsers.

Objectives

To assess the beneficial and harmful effects of retreatment with interferon in chronic hepatitis C nonresponders and relapsers to previous interferon treatment.

Search methods

Trials were identified through electronic databases, manual searches, authors, and pharmaceutical companies (August 2001).

Selection criteria

Randomised trials comparing interferon versus control or different interferon regimens in chronic hepatitis C patients being nonresponders and relapsers to previous interferon were included.

Data collection and analysis

The primary outcome was failure to achieve a sustained virologic response defined as positive serum hepatitis C virus RNA at least six months following treatment. Secondary outcomes included liver-related morbidity, mortality, biochemical responses, adverse events, and histology.

Main results

Ten randomised trials involving 686 nonresponders and eight trials involving 484 relapsers were included; their methodological quality was poor. In nonresponders, interferon reduced the risk of not achieving an end of treatment biochemical response compared with no treatment (relative risk [RR] 0.77, 95% confidence interval [CI] 0.66 to 0.91); however, virologic responses were not reported. In a post hoc subgroup analysis, doses greater than 3 million units (MU) three times weekly offered no advantage compared with 3 MU three times weekly for biochemical sustained response. Failure to obtain a virologic sustained response was less likely with 48 than 24 weeks of therapy (RR 0.87, 95% CI 0.79 to 0.96). Adverse events did not differ significantly regardless of treatment dose or duration. In relapsers, none of the trials compared interferon with no treatment. In a post hoc analysis, doses greater than 3 MU three times weekly were no more effective in achieving a virologic systained response than 3 MU three times weekly. Compared with 24 weeks, treatment durations of 48 weeks were less likely to fail to achieve a virologic sustained response (RR 0.69, 95% CI Random 0.51 to 0.95), but associated with more frequent dosage reduction (RR 9.07, 95% CI 1.20 to 68.63). No data regarding clinical outcomes or histology was available in either patient group.

Authors' conclusions

Retreatment with interferon leads to sustained virologic clearance in a minority of chronic hepatitis C patients with nonresponse or relapse following interferon monotherapy. Treatment durations of 48 weeks are superior to 24 weeks, but doses greater than 3 MU three times weekly are no more effective. No data exists regarding the effect on clinical outcomes.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Retreatment with interferon leads to sustained clearance of hepatitis C virus from the blood in a minority of patients with previous nonresponse to or relapse following interferon therapy

Interferon leads to sustained clearance of the hepatitis C virus from the blood in less than 20 per cent of patients. In the remaining patients, nonresponders and relapsers, additional treatment options have been studied. This systematic Review shows that retreatment with interferon leads to sustained clearance of the virus in a small proportion of these patients. Prolonging the treatment duration from 24 to 48 weeks enhances the rate of response. This Review could not determine the impact of interferon retreatment on clinical outcomes such as the need for liver transplantation or death. The methodological quality of the included trials and reporting of adverse events were suboptimal.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

對患有慢性C肝且對干擾素無反應和復發性病人使用干擾素

干擾素單一療法可以清除多數慢性C肝病人的病毒。研究對干擾素治療無反應病人和復發性病人得出的結果頗有爭議。

目標

評估干擾素治療慢性C肝且對之前干擾素治療無反應和復發性病人的利弊。

搜尋策略

透過電子資料庫、手動搜索、聯繫作者和製藥公司找出試驗(2001年8月).

選擇標準

包括比較干擾素,控制組或不同的干擾素方案治療慢性C肝且對之前干擾素治療無反應和復發性病人的隨機試驗。

資料收集與分析

初步結果是指治療後至少6個月內無法達到持續病毒學反應,定義為陽性血清HCV RNA 。次級結果包括和肝臟有關的併發症、死亡率、生化反應、不良事件和病理組織。

主要結論

納入10個隨機試驗,共686位無反應病人,8個試驗包含484位復發性病人;無反應病人組的方法學品質較差。 在無反應病人組,干擾素相對於無干預法,可降低治療終期無法改善肝功能的風險(相對風險度[RR] 0.77, 95% 信賴區間 [CI] 0.66 0.91); 但是,沒有記錄病毒學反應。 在事後亞組分析中, 每週使用3次300萬單位(MU)以上的劑量比起每週使用3次300萬單位的劑量,對於持續生化反應沒有益處。. 48週治療比24週治療時間更能達到持續病毒學反應(RR 0.87, 95% CI 0.79 – 0.96)。無論何種治療劑量或持續時間,不良事件沒有顯著差異。在復發性病人組,沒有試驗比較干擾素和無干預法。事後分析(post hoc analysis)中,每週使用3次300萬單位以上的劑量比每週使用3次300萬單位的劑量,不會更加有效的達到持續病毒學反應。48週治療比起24週更能達到持續病毒學反應(RR 0.69, 95% CI Random 0.51 0.95), 但是更常遇到減劑量的問題 (RR 9.07, 95% CI 1.20  68.63)。 沒有從各組病人獲得有關臨床結果或病理學的資料。

作者結論

干擾素治療可以持續廓清多數慢性C肝且在干擾素單一療法之後無反應或復發病人的病毒。48週治療優於24週治療時間,但是每週使用3次3MU以上的劑量不會更加有效。 沒有獲得有關臨床結果的資料。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

對於干擾素單一療法之後無反應或復發的慢性C肝病人,再次給予干擾素治療仍在少部份病人可以達到持續廓清病毒。只有不到20%的慢性C肝病人,接受干擾素治療可以持續廓清血液中的C肝病毒。 其餘病人(也就是無反應病人和復發病人)的後續治療,亦有其他相關研究。本系統性文獻回顧指出,對於之前干擾素治療無反應和復發病人,再次給予干擾素治療仍可持續廓清少數病人的病毒。治療時間從24週延長至48周,可以提高反應率。 本次文獻回顧無法決定干擾素再治療對於臨床結果的影響(例如肝移植或死亡率)。我們納入的試驗,其方法學品質和不良事件的記錄均未達標準。