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Cochrane Database of Systematic Reviews

Intervenciones farmacológicas para la infección aguda por el virus de la hepatitis C un intento de metanálisis en red

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Información

DOI:
https://doi.org/10.1002/14651858.CD011644.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 12 marzo 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Hepatobiliar

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Maria Kalafateli

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Elena Buzzetti

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Douglas Thorburn

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Brian R Davidson

    Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

  • Emmanuel Tsochatzis

    Sheila Sherlock Liver Centre, Royal Free Hospital and the UCL Institute of Liver and Digestive Health, London, UK

  • Kurinchi Selvan Gurusamy

    Correspondencia a: Department of Surgery, Royal Free Campus, UCL Medical School, London, UK

    [email protected]

Contributions of authors

MK and EB extracted data and provided them in a format that could be analysed.
DT, ET, and BD critically commented on the review.
KG wrote the review.
All review authors agreed on this version before publication.

Sources of support

Internal sources

  • University College London, UK.

External sources

  • National Institute for Health Research, UK.

    This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure, Cochrane Programme Grant, or Cochrane Incentive funding to the Cochrane Hepato‐Biliary and Upper Gastrointestinal and Pancreatic Diseases Groups. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, the National Health Service, or the Department of Health. The funding covered salary, equipment, and other resources to complete this review.

Declarations of interest

This report is independent research funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the review authors and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health.

MK: no financial disclosures.
EB: no financial disclosures.
DT: Astellas funded Douglas Thorburn for his attendance at the International Liver Transplantation Society meeting in 2014. Douglas Thorburn has also received GBP 25,000 from Boston Scientific to fund a clinical research fellow in 2013. There are no other financial disclosures to report.
BD: no financial disclosures.
ET: no financial disclosures.
KG: no financial disclosures.

Acknowledgements

We thank the Cochrane Comparing of Multiple Interventions Methods Group and the Cochrane Hepato‐Biliary Group for their support and advice. We thank the copy editors for their support.

Cochrane Review Group funding acknowledgement: the Danish State is the largest single funder of the Cochrane Hepato‐Biliary Group through its investment in The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark.

Disclaimer: the views and opinions expressed in this review are those of the review authors and do not necessarily reflect those of the Danish State or The Copenhagen Trial Unit.

Peer reviewers of review: Goran Poropat, Croatia; Karl Heinz Weiss, Germany.
Contact editor: Janus Christian Jakobsen, Denmark.
Sign‐off editor: Christian Gluud, Denmark.

Version history

Published

Title

Stage

Authors

Version

2018 Dec 03

Pharmacological interventions for acute hepatitis C infection

Review

Maria Kalafateli, Elena Buzzetti, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy

https://doi.org/10.1002/14651858.CD011644.pub3

2017 Mar 12

Pharmacological interventions for acute hepatitis C infection

Review

Maria Kalafateli, Elena Buzzetti, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy

https://doi.org/10.1002/14651858.CD011644.pub2

2015 Apr 14

Pharmacological treatments for acute hepatitis C infection: a network meta‐analysis

Protocol

Kurinchi Selvan Gurusamy, Douglas Thorburn, Emmanuel Tsochatzis, Brian R Davidson

https://doi.org/10.1002/14651858.CD011644

Differences between protocol and review

  • It was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta‐analysis, and we assessed the comparative benefits and harms of different interventions using standard Cochrane methodology. The methodology that we plan to use if we conduct a network meta‐analysis in the future is available in Appendix 1.

  • We performed Trial Sequential Analysis in addition to conventional methods of assessing the risk of random errors using P values.

Notes

Considerable overlap is evident in the 'Methods' sections of this review and those of several other reviews written by the same group of authors.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Trial Sequential Analysis of serious adverse events (proportion) for pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in trials (Pc = 7%), and observed heterogeneity in the trials (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS); so the trial sequential monitoring boundaries were not drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.
Figuras y tablas -
Figure 4

Trial Sequential Analysis of serious adverse events (proportion) for pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha performed using an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in trials (Pc = 7%), and observed heterogeneity in the trials (0%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS); so the trial sequential monitoring boundaries were not drawn. The Z‐curve (blue line) does not cross the conventional boundaries (dotted green line). There was a high risk of random errors.

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Trial Sequential Analysis of chronic hepatitis C virus for interferon‐alpha versus no intervention was performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in trials (Pc = 84%; upper figure) and Pc = 20% (lower figure), and observed diversity in the trials (0%). The upper figure with Pc = 84% shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS). The Z‐curve (blue line) crosses the conventional boundaries (dotted green line), but it does not cross any of the trial sequential monitoring boundaries (dotted red lines). The lower figure with Pc = 20% shows that the accrued sample size was so small that trial sequential monitoring boundaries were not drawn. There is a high risk of random errors.
Figuras y tablas -
Figure 5

Trial Sequential Analysis of chronic hepatitis C virus for interferon‐alpha versus no intervention was performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in trials (Pc = 84%; upper figure) and Pc = 20% (lower figure), and observed diversity in the trials (0%). The upper figure with Pc = 84% shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS). The Z‐curve (blue line) crosses the conventional boundaries (dotted green line), but it does not cross any of the trial sequential monitoring boundaries (dotted red lines). The lower figure with Pc = 20% shows that the accrued sample size was so small that trial sequential monitoring boundaries were not drawn. There is a high risk of random errors.

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Trial Sequential Analysis of chronic hepatitis C virus for interferon‐beta versus no intervention performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in the trials (Pc = 84%; upper figure) and a Pc of 20% (lower figure), and observed heterogeneity in the trials (84%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS); so the trial sequential monitoring boundaries were not drawn. The Z‐curve (blue line) crosses the conventional boundaries (dotted green line). There is a high risk of random errors.
Figuras y tablas -
Figure 6

Trial Sequential Analysis of chronic hepatitis C virus for interferon‐beta versus no intervention performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in the trials (Pc = 84%; upper figure) and a Pc of 20% (lower figure), and observed heterogeneity in the trials (84%) shows that the accrued sample size was only a small fraction of the diversity‐adjusted required information size (DARIS); so the trial sequential monitoring boundaries were not drawn. The Z‐curve (blue line) crosses the conventional boundaries (dotted green line). There is a high risk of random errors.

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Trial Sequential Analysis of chronic hepatitis C virus infection for pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20% (top figure and bottom figure) and 10% (middle figure), control group proportion observed in the trials (Pc = 84%; top figure and middle figure) and Pc = 20% (bottom figure), and observed heterogeneity in the trials (0%) shows that the Z‐curve (blue line) has reached the zone of futility for a RRR of 20% (top figure). However, when a RRR of 10% or when a Pc = 20% was used, the accrued sample size was only a small fraction of the diversity adjusted required information size (DARIS); the Z‐curve (blue line) does not cross the conventional boundaries (dotted green line) or trial sequential monitoring boundaries (dotted red line) (middle figure). For a Pc = 20%, the accrued sample size was so small that the trial sequential monitoring boundaries were not drawn. There is a high risk of random errors.
Figuras y tablas -
Figure 7

Trial Sequential Analysis of chronic hepatitis C virus infection for pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha performed using an alpha error of 1.6%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20% (top figure and bottom figure) and 10% (middle figure), control group proportion observed in the trials (Pc = 84%; top figure and middle figure) and Pc = 20% (bottom figure), and observed heterogeneity in the trials (0%) shows that the Z‐curve (blue line) has reached the zone of futility for a RRR of 20% (top figure). However, when a RRR of 10% or when a Pc = 20% was used, the accrued sample size was only a small fraction of the diversity adjusted required information size (DARIS); the Z‐curve (blue line) does not cross the conventional boundaries (dotted green line) or trial sequential monitoring boundaries (dotted red line) (middle figure). For a Pc = 20%, the accrued sample size was so small that the trial sequential monitoring boundaries were not drawn. There is a high risk of random errors.

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Comparison 1 Intervention versus control, Outcome 1 Serious adverse events (proportion).
Figuras y tablas -
Analysis 1.1

Comparison 1 Intervention versus control, Outcome 1 Serious adverse events (proportion).

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Comparison 1 Intervention versus control, Outcome 2 Serious adverse events (number).
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Analysis 1.2

Comparison 1 Intervention versus control, Outcome 2 Serious adverse events (number).

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Comparison 1 Intervention versus control, Outcome 3 Adverse events (proportion).
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Analysis 1.3

Comparison 1 Intervention versus control, Outcome 3 Adverse events (proportion).

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Comparison 1 Intervention versus control, Outcome 4 Adverse events (number).
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Analysis 1.4

Comparison 1 Intervention versus control, Outcome 4 Adverse events (number).

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Comparison 1 Intervention versus control, Outcome 5 Chronic HCV infection.
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Analysis 1.5

Comparison 1 Intervention versus control, Outcome 5 Chronic HCV infection.

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Summary of findings for the main comparison. Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: primary outcomes

Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: primary outcomes

Patient or population: people with acute hepatitis C infection

Intervention: multiple

Control: multiple

Settings: secondary or tertiary care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

Control

Intervention

Mortality: there was 1 mortality within 6 months (in the pegylated interferon‐alpha group (1/95 = 1.1%). There was no mortality in the remaining groups. There was no further mortality in the trials which reported mortality until maximal follow‐up.

Serious adverse events: there were no serious adverse events in either group in the comparisons interferon‐beta versus control and MH‐68/B vaccine versus control. Trials in interferon‐alpha versus control did not report serious adverse events.

Serious adverse events (proportion) ‐ pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

70 per 1000

115 per 1000
(50 to 242)

OR 1.72
(0.7 to 4.21)

237
(2 RCTs)

⊕⊝⊝⊝
Very low1,2,3

Serious adverse events (number) ‐ pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

92 per 1000

251 per 1000
(128 to 488)

Rate ratio 2.74
(1.40 to 5.33)

237
(2 RCTs)

⊕⊝⊝⊝
Very low1,2

Adverse events (proportion) ‐ interferon‐alpha versus no intervention

10 per 1000

672 per 1000
(83 to 979)

OR 203
(9.01 to 4574.81)

33
(1 RCT)

⊕⊝⊝⊝
Very low1,2

Adverse events (proportion) ‐ interferon‐beta versus no intervention

10 per 1000

220 per 1000
(15 to 842)

OR 27.88
(1.48 to 526.12)

40
(1 RCT)

⊕⊝⊝⊝
Very low1,2

Adverse events: there were no adverse events in the comparison MTH‐68/B vaccine versus control. The number of adverse events was not reported for the comparison interferon‐alpha versus control. The proportion of people with adverse events and number of adverse events was not reported for the comparison pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha.

Adverse events (number) ‐ interferon‐beta versus no intervention

10 per 1000

147 per 1000
(10 to 748)

OR 17
(0.98 to 294.53)

40
(1 RCT)

⊕⊝⊝⊝
Very low1,2,3

Health‐related quality of life

None of the trials reported this outcome.

None of the trials reported health‐related quality of life, cirrhosis, decompensated liver disease, liver transplantation, or hepatocellular carcinoma.

*The basis for the assumed risk is the mean control group proportion (or control group rate) unless there were no events in the control group when the control group proportion (or control group rate) was considered as 1%. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; OR: odds ratio; RCT: randomised clinical trial.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Downgraded 2 levels for high risk of bias.
2 Downgraded 1 level for small sample size (i.e. imprecision).
3 Downgraded 1 level for wide confidence intervals (i.e. imprecision).

Figuras y tablas -
Summary of findings for the main comparison. Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: primary outcomes
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Summary of findings 2. Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: secondary outcomes

Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: secondary outcomes

Patient or population: people with acute hepatitis C infection

Intervention: multiple (see below)

Control: multiple (see below)

Settings: secondary or tertiary care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

Control

Intervention

Liver transplantation

None of the trials reported this outcome.

Decompensated liver disease

None of the trials reported this outcome.

Cirrhosis

None of the trials reported this outcome.

Hepatocellular carcinoma

None of the trials reported this outcome.

Chronic HCV infection†‐ interferon‐alpha versus no intervention

848 per 1000

601 per 1000
(334 to 809)

OR 0.27
(0.09 to 0.76)

99
(3 RCTs)

⊕⊝⊝⊝
Very low1,2

Chronic HCV infection†‐ interferon‐beta versus no intervention

833 per 1000

259 per 1000
(0 to 861)

OR 0.07
(0 to 1.24)

90
(3 RCTs)

⊕⊝⊝⊝
Very low1,2,3,4

Chronic HCV infection†‐ MTH‐68/B vaccine versus no intervention

263 per 1000

91 per 1000
(18 to 371)

OR 0.28
(0.05 to 1.65)

41
(1 RCT)

⊕⊝⊝⊝
Very low1,2,3

Chronic HCV infection†‐ pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

204 per 1000

181 per 1000
(95 to 315)

OR 0.86
(0.41 to 1.79)

237
(2 RCTs)

⊕⊝⊝⊝
Very low1,2,3

*The basis for the assumed risk is the mean control group proportion. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

†Chronic HCV infection was measured by absence of sustained virological response (i.e. the presence of circulating virus at least 6 months after cessation of treatment).

CI: confidence interval; HCV: hepatitis C virus; OR: odds ratio; RCT: randomised clinical trial.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Downgraded 2 levels for high risk of bias (i.e. within study risk of bias).
2 Downgraded 1 level for small sample size (i.e. imprecision).
3 Downgraded 1 level for wide confidence intervals (i.e. imprecision).
4 Downgraded 1 level (substantial heterogeneity in magnitude of effect) (i.e. heterogeneity).

Figuras y tablas -
Summary of findings 2. Intervention versus no intervention or control intervention (control) for acute hepatitis C infection: secondary outcomes
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Table 1. Characteristics table

Study name

Intervention

Control

Period of follow‐up (months)

Randomisation

Blinding of participants and healthcare professionals

Blinding of outcome assessors

Missing outcome bias

Selective outcome reporting bias

For‐profit bias

Genesca 1993

Interferon‐alpha

No intervention

12

Unclear

High

Unclear

Low

High

Unclear

Hwang 1994

Interferon‐alpha

No intervention

12

Unclear

High

Unclear

High

Low

High

Lampertico 1994

Interferon‐alpha

No intervention

18

Unclear

High

Unclear

High

High

High

Omata 1991

Interferon‐beta

No intervention

36

Low

High

Unclear

High

High

Unclear

Omata 1994

Interferon‐beta

No intervention

36

Unclear

High

Unclear

Low

High

Unclear

Calleri 1998

Interferon‐beta

No intervention

22.5

Unclear

High

High

Low

Low

Low

Csatary 1998

MTH‐68/B vaccine

No intervention

12

Unclear

High

Unclear

Low

Low

Unclear

Wang 2005

Pegylated interferon‐alpha

No intervention

6

Unclear

Unclear

Unclear

High

High

Unclear

Deterding 2013

Pegylated interferon‐alpha

Pegylated interferon‐alpha plus ribavirin

6

Unclear

High

Low

High

Low

High

Santantonio 2014

Pegylated interferon‐alpha

Pegylated interferon‐alpha plus ribavirin

12

Unclear

High

Unclear

Low

High

High
Figuras y tablas -
Table 1. Characteristics table
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Comparison 1. Intervention versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Serious adverse events (proportion) Show forest plot

4

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Interferon‐beta versus no intervention

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 MTH‐68/B vaccine versus no intervention

1

41

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

2

237

Odds Ratio (M‐H, Fixed, 95% CI)

1.72 [0.70, 4.21]

2 Serious adverse events (number) Show forest plot

4

Rate Ratio (Fixed, 95% CI)

Subtotals only

2.1 Interferon‐beta versus no intervention

1

40

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 MTH‐68/B vaccine versus no intervention

1

41

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

2

237

Rate Ratio (Fixed, 95% CI)

2.74 [1.40, 5.33]

3 Adverse events (proportion) Show forest plot

3

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Interferon‐alpha versus no intervention

1

33

Odds Ratio (M‐H, Fixed, 95% CI)

203.0 [9.01, 4574.81]

3.2 Interferon‐beta versus no intervention

1

40

Odds Ratio (M‐H, Fixed, 95% CI)

27.88 [1.48, 526.12]

3.3 MTH‐68/B vaccine versus no intervention

1

41

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Adverse events (number) Show forest plot

2

Odds Ratio (Fixed, 95% CI)

Subtotals only

4.1 Interferon‐beta versus no intervention

1

40

Odds Ratio (Fixed, 95% CI)

17.00 [0.98, 294.53]

4.2 MTH‐68/B vaccine versus no intervention

1

41

Odds Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Chronic HCV infection Show forest plot

9

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 Interferon‐alpha versus no intervention

3

99

Odds Ratio (M‐H, Random, 95% CI)

0.27 [0.09, 0.76]

5.2 Interferon‐beta versus no intervention

3

90

Odds Ratio (M‐H, Random, 95% CI)

0.07 [0.00, 1.24]

5.3 MTH‐68/B vaccine versus no intervention

1

41

Odds Ratio (M‐H, Random, 95% CI)

0.28 [0.05, 1.65]

5.4 Pegylated interferon‐alpha plus ribavirin versus pegylated interferon‐alpha

2

237

Odds Ratio (M‐H, Random, 95% CI)

0.86 [0.41, 1.79]
Figuras y tablas -
Comparison 1. Intervention versus control
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