Intervention Review

Interferon for acute hepatitis C

  1. Robert P Myers1,*,
  2. Corinne Regimbeau2,
  3. Thierry Thevenot3,
  4. Vincent Leroy3,
  5. Philippe Mathurin4,
  6. Pierre Opolon5,
  7. Jean Pierre Zarski3,
  8. Thierry Poynard6

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 23 OCT 2001

Assessed as up-to-date: 18 JUL 2001

DOI: 10.1002/14651858.CD000369


How to Cite

Myers RP, Regimbeau C, Thevenot T, Leroy V, Mathurin P, Opolon P, Zarski JP, Poynard T. Interferon for acute hepatitis C. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD000369. DOI: 10.1002/14651858.CD000369.

Author Information

  1. 1

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

  2. 2

    Groupe Hospitalier Pitie-Salpetriere, Service d`Hepatol-Gastroenterologie, Paris Cedex 13, France

  3. 3

    Paris, France

  4. 4

    Hôpital Claude Huriez, 2ème etage Est, Service d'Hépatogastroentérologie, CHRU Lille, France

  5. 5

    Groupe d`Hospitalier Pitie-Salpetriere, Service d'Hépato-Gastro-Entérologie, Paris Cedex 13, France

  6. 6

    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: 23 OCT 2001

SEARCH

 

Abstract

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

Background

Acute hepatitis C virus (HCV) infection progresses to chronicity in the majority of patients. In order to prevent the progression to chronic disease, several studies have assessed interferon in patients with acute hepatitis C.

Objectives

The aim of this review was to assess the efficacy of interferon in acute HCV infection.

Search methods

We searched MEDLINE, the Cochrane Controlled Trials Register, and the abstracts of the American Association for the Study of Liver Diseases (June 2001). We also contacted pharmaceutical companies to obtain unpublished trials.

Selection criteria

Randomised clinical trials comparing interferon with placebo or no treatment, and published as an article, abstract, or letter were selected. No language limitations were used.

Data collection and analysis

Two reviewers independently assessed trial quality and extracted data. The following endpoints were analysed: normalization of alanine aminotransferase (ALT) activity at the end of treatment (biochemical ETR); sustained ALT normalization at the end follow-up (biochemical SR); disappearance of serum HCV RNA by polymerase chain reaction assay at the end of treatment (virologic ETR) and at the end of follow-up (virologic SR). Histologic data and adverse events were also recorded. Assessment of drug efficacy used the methods of Peto and Der Simonian and Laird.

Main results

Six randomised trials involving 206 patients with acute hepatitis C met the inclusion criteria. Four trials assessing interferon alfa-2b in 141 patients, all with transfusion-acquired acute hepatitis C, were included. They demonstrated no significant heterogeneity in the outcomes assessed. When compared with no treatment, interferon alfa-2b was associated with an increase in the rates of virologic ETR and SR by 45% (95% CI 31-59%, P < 0.00001) and 29% (95% CI 14-44%, P = 0.0002), respectively. The virologic ETR was 42% (95% CI: 30-56%) in the interferon alfa-2b group versus 4% (95% CI 0-13%, P < 0.00001) in the control group. At the end of follow-up, a virologic SR was seen in 32% (95% CI 21-46%) of interferon-treated patients versus only 4% (95% CI 0-13%, P = 0.00007) of controls. Interferon also improved liver biochemistry to a similar extent. The tolerability of therapy, or the impact of interferon alfa-2b on hepatic histology, was not reported. Two trials assessed interferon beta in a total 65 patients. The efficacy of interferon beta could not be assessed, however, due to heterogeneity of these trials.

Authors' conclusions

Interferon alfa is effective in improving biochemical outcomes and achieving sustained virologic clearance in patients with transfusion-acquired acute hepatitis C. The effect on long-term clinical outcomes could not be assessed due to limitations in the current data.

 

Plain language summary

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

Interferon alfa improves liver biochemistry and viral clearance in transfusion-acquired acute hepatitis C

Acute hepatitis C is rarely diagnosed because in most cases it is asymptomatic. Treatment of patients with chronic hepatitis C with interferon can achieve viral clearance and improve liver biochemistry and histology. In this review, treatment with interferon alfa in the acute stage of transfusion-acquired hepatitis C infection improved liver biochemistry and enhanced viral clearance compared to the natural history of the disease. We cannot ascertain, however, the effect of interferon on clinical outcomes due to a lack of data. Because of the effect of therapy on biochemical and virologic outcomes, we recommend the treatment of acute hepatitis C with at least interferon alfa at a dosage of three million units thrice weekly for three months. Future trials should focus on the efficacy of combination therapy with ribavirin and pegylated interferons, which have shown superiority to interferon alfa in chronic hepatitis C.

 

摘要

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

背景

干擾素(interferon)在急性 C 型肝炎的治療

受到急性C 型肝炎病毒(HCV)感染後,大多數的病人會發展成慢性病。為了防止病情發展成慢性疾病,已有數項研究在評估干擾素用於治療急性C型肝炎的病患。

目標

此研究的目的是評估干擾素治療急性C 型肝炎病毒感染的效果。

搜尋策略

我們檢索了MEDLINE,Cochrane 對照試驗註冊資料庫,以及美國肝臟疾病研究學會文章摘要[2001年6月)。我們還收集製藥公司未發表的臨床研究資料。

選擇標準

選擇隨機臨床試驗比較干擾素與安慰劑或不治療的情況,並發表的文章,摘要,或致編輯函。沒有語言使用的限制。

資料收集與分析

兩名作者獨立評估研究品質與資料分析。分析如下的研究終點:在治療結束時為正常的丙氨酸轉氨(ALT)活性(生化學上的ETR); 持續ALT正常化直到最後的追蹤(生化學上的SR); 在治療結束時利用RNA聚合脢鏈反應法(PCR)在血清中已找不到血清C型肝炎病毒的RNA(病毒學上的ETR)和在最後的追蹤時利用RNA聚合脢鏈反應法(PCR)在血清中已找不到血清C型肝炎病毒的RNA(病毒學上的SR)。組織學數據和不良事件也列入記錄。藥物的療效評估採用的方法為皮托(Peto)和德西蒙尼安(Der Simonian)和Laird。

主要結論

6個隨機試驗研究,包括206例急性C型肝炎患者符合收案標準。四個評估干擾素α−2b用於因輸血得到性急性C型肝炎的141患者試驗研究被列入,結果顯示沒有明顯的差異性。與不治療作比較,干擾素α−2b可以分別增加病毒學上的ETR達45%(95%CI為31 – 59%,P<0.00001)與病毒學上的SR 達29%(95% CI 14 – 44%, P = 0.0002)。干擾素α−2b組在病毒學上的ETR為42%(95%CI:30 – 56%)而對照組為4%(95%CI為0 – 13%,P< 0.00001)。在治療結束時,干擾素治療患者的病毒學上的SR為32%(95%CI 21 – 46%)而控制組只有4%(95%CI 0 – 13%,P = 0.00007)。在肝臟生化檢查方面,干擾素也有類似程度的改善。患者對於治療的耐受性、或者干擾素α−2b對肝組織學的影響則沒有報導。在干擾素β方面有兩項試驗評估共65例,由於這些試驗異質性,干擾素β的療效無法評估。

作者結論

干擾素α用於因輸血而得到急性C型肝炎的患者,可以有效改善生化數值和持續的病毒清除。由於數據上的限制,長期的臨床結果仍無法評估。

翻譯人

本摘要由臺中榮民總醫院黃芳亮翻譯。

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

總結

干擾素α用於因輸血而得到急性C型肝炎的患者,可以有效改善生化數值和持續的病毒清除。急性C型肝炎感染患者大多數無症狀,所以急性C型肝炎診斷並不多。用干擾素治療慢性C型肝炎可以達到清除病毒,改善肝臟生化數值和組織學上的變化。在此回顧研究,在與自然的疾病過程作比較,干擾素α用於因輸血而得到C型肝炎的急性期患者,可以有效改善肝臟生化數值和促進的病毒清除。然而由於缺乏數據我們不能確定干擾素的臨床結果。基於對生化和病毒學的治療效果,我們建議干擾素α治療急性C型肝炎,至少劑量300萬單位每週三次,為期三個月。未來研究的重點應該聚焦在結合ribavirin與長效型(pegylated)干擾素之合併療法的療效,因為這種合併療法在治療慢性C型肝炎的療效上已經証實超越干擾素α。

 

Laički sažetak

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

Interferon alfa poboljšava biokemijske pokazatelje jetre i odstranjenje virusa u hepatitisu C koji je stečen transfuzijom

Akutni hepatitis C se rijetko dijagnosticira jer u većini slučajeva nema nikakvih simptoma. Terapija interferonom u pacijenata s kroničnim hepatitisom C može potaknuti odstranjenje virusa i poboljšati jetrene biokemijske i histološke pokazatelje. U ovom Cochrane sustavnom pregledu pronađeni su dokazi koji pokazuju da je terapija interferonom alfa u akutnoj fazi hepatitisa C stečenog transfuzijom poboljšala biokemijske pokazetelje funkcije jetre i pojačala odstranjenje virusa u usporedbi s prirodnim tijekom bolesti. Ipak nije moguće procijeniti učinak interferona na kliničke ishode zbog nedostatka podataka. Zbog učinka terapije na biokemijske i virološke ishode, preporučuje se akutni hepatitis C liječiti barem interferonom alfa u dozi od tri milijuna jedinica tri puta tjedno tri mjeseca. Daljnje studije bi se trebale usredotočiti na učinkovitost kombinirane terapije s ribavirinom i pegiliranim interferonim, koji su se pokazali bolji nego interferon alfa za kronični hepatitis C.

Bilješke prijevoda

Hrvatski Cochrane
Preveo: Adam Galkovski
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr