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Interferón para la hepatitis C aguda
Robert P Myers, Corinne Regimbeau, Thierry Thevenot, Vincent Leroy, Philippe Mathurin, Pierre Opolon, Jean Pierre Zarski, Thierry Poynard | 23 octubre 2001

Topics

Temas

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Methodological quality graph: Review authors' judgements about each methodological quality item presented as percentages across all included studies.
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Figure 2

Methodological quality graph: Review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Methodological quality summary: Review authors' judgements about each methodological quality item for each included study.
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Figure 3

Methodological quality summary: Review authors' judgements about each methodological quality item for each included study.

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Trial Sequential Analysis of mortality (ribavirin plus peg interferon versus peg interferon) 
 The diversity‐adjusted required information size (DARIS) was calculated to 16,594 patients, based on the proportion of patients in the control group with the outcome of 4.1%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. To account for zero event groups, a continuity correction of 0.01 was used in the calculation of the cumulative Z‐curve (blue line). After accruing 98 participants in two trials, only 0.59% of the DARIS has been reached. Accordingly, the Trial Sequential Analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries (dotted red line) have also not been crossed by the cumulative Z‐curve.
Figuras y tablas -
Figure 4

Trial Sequential Analysis of mortality (ribavirin plus peg interferon versus peg interferon)
The diversity‐adjusted required information size (DARIS) was calculated to 16,594 patients, based on the proportion of patients in the control group with the outcome of 4.1%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. To account for zero event groups, a continuity correction of 0.01 was used in the calculation of the cumulative Z‐curve (blue line). After accruing 98 participants in two trials, only 0.59% of the DARIS has been reached. Accordingly, the Trial Sequential Analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries (dotted red line) have also not been crossed by the cumulative Z‐curve.

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Trial Sequential Analysis of fibrosis worsening (ribavirin plus peg interferon versus control) 
 The diversity‐adjusted required information size (DARIS) was calculated to 4066 patients, based on the proportion of patients in the control group with the outcome of 65.1%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 88.93%. After accruing 126 participants in two trials, only 3.1% of the DARIS has been reached. Accordingly, the Trial Sequential Analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries (dotted red line) was no longer crossed by the cumulative Z‐curve after two trials although the conventional boundaries were crossed after the first trial.
Figuras y tablas -
Figure 5

Trial Sequential Analysis of fibrosis worsening (ribavirin plus peg interferon versus control)
The diversity‐adjusted required information size (DARIS) was calculated to 4066 patients, based on the proportion of patients in the control group with the outcome of 65.1%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 88.93%. After accruing 126 participants in two trials, only 3.1% of the DARIS has been reached. Accordingly, the Trial Sequential Analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries (dotted red line) was no longer crossed by the cumulative Z‐curve after two trials although the conventional boundaries were crossed after the first trial.

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Comparison 1 Intervention versus control, Outcome 1 Mortality.
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Analysis 1.1

Comparison 1 Intervention versus control, Outcome 1 Mortality.

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Comparison 1 Intervention versus control, Outcome 2 Retransplantation after start of therapy.
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Analysis 1.2

Comparison 1 Intervention versus control, Outcome 2 Retransplantation after start of therapy.

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Comparison 1 Intervention versus control, Outcome 3 Treatment‐related serious adverse events (proportion).
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Analysis 1.3

Comparison 1 Intervention versus control, Outcome 3 Treatment‐related serious adverse events (proportion).

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Comparison 1 Intervention versus control, Outcome 4 Treatment‐related serious adverse events (number of serious adverse events).
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Analysis 1.4

Comparison 1 Intervention versus control, Outcome 4 Treatment‐related serious adverse events (number of serious adverse events).

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Comparison 1 Intervention versus control, Outcome 5 Graft rejection requiring retransplantation after start of therapy.
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Analysis 1.5

Comparison 1 Intervention versus control, Outcome 5 Graft rejection requiring retransplantation after start of therapy.

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Comparison 1 Intervention versus control, Outcome 6 Graft rejection requiring medical treatment.
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Analysis 1.6

Comparison 1 Intervention versus control, Outcome 6 Graft rejection requiring medical treatment.

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Comparison 1 Intervention versus control, Outcome 7 Graft rejection (others with unknown treatment).
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Analysis 1.7

Comparison 1 Intervention versus control, Outcome 7 Graft rejection (others with unknown treatment).

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Comparison 1 Intervention versus control, Outcome 8 Fibrosis worsening.
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Analysis 1.8

Comparison 1 Intervention versus control, Outcome 8 Fibrosis worsening.

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Summary of findings for the main comparison. Antiviral therapy for recurrent liver graft infection with hepatitis C virus (mortality)

Mortality

Patient or population: Participants with recurrent liver graft infection with hepatitis C virus.
Settings: Secondary or tertiary setting.
Intervention: Various interventions.
Comparison: Various controls.

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Intervention

Peg interferon vs.control

62 per 1000

30 per 1000
(3 to 318)

RR 0.48
(0.05 to 5.09)

65
(1 study)

⊕⊝⊝⊝
very low1,2

The assumed risk was the control group risk.

Peg interferon plus ribavirin vs.control

63 per 1000

189 per 1000
(8 to 1000)

RR 3
(0.13 to 70.53)

54
(1 study)

⊕⊝⊝⊝
very low1,2

Since there were no deaths in the control group, the assumed risk was the control group risk in a different trial included in this review.

Ribavirin plus peg interferon vs.peg interferon

41 per 1000

20 per 1000
(2 to 212)

RR 0.5
(0.05 to 5.2)

98
(2 studies)

⊕⊝⊝⊝
very low1,2

The assumed risk was the control group risk.

Interferon vs.control

63 per 1000

105 per 1000
(5 to 1000)

RR 1.67
(0.08 to 33.75)

12
(1 study)

⊕⊝⊝⊝
very low1,2

Since there were no deaths in the control group, the assumed risk was the control group risk in a different trial included in this review.

Interferon plus ribavirin vs.control

42 per 1000

12 per 1000
(0 to 281)

RR 0.29
(0.01 to 6.74)

52
(1 study)

⊕⊝⊝⊝
very low1,2

The assumed risk was the control group risk.

Ribavirin vs.interferon

There were no deaths in either group.

Not estimable

30
(1 study)

⊕⊝⊝⊝
very low1,2

‐

Ribavirin vs.placebo

There were no deaths in either group.

Not estimable

77
(1 study)

⊕⊝⊝⊝
very low1,2

‐

*The basis for the assumed risk is provided in the comments section. 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; peg: pegylated; RR: risk ratio.

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 The trial(s) was (were) of high risk of bias.
2 The confidence intervals overlapped 1 and either 0.75 or 1.25 or both. The number of events in the intervention and control group was fewer than 300.

Figuras y tablas -
Summary of findings for the main comparison. Antiviral therapy for recurrent liver graft infection with hepatitis C virus (mortality)
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Summary of findings 2. Antiviral therapy for recurrent liver graft infection with hepatitis C virus (retransplantation)

Retransplantation

Patient or population: Participants with recurrent liver graft infection with hepatitis C virus.
Settings: Secondary or tertiary setting.
Intervention: Various interventions.
Comparison: Various controls.

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Intervention

Retransplantation after start of therapy ‐ ribavirin vs.placebo

No retransplantation in either group

Not estimable

77
(1 study)

⊕⊝⊝⊝
very low1,2

Retransplantation after start of therapy ‐ interferon vs.control

10 per 1000

17 per 1000
(1 to 338)

RR 1.67
(0.08 to 33.75)

12
(1 study)

⊕⊝⊝⊝
very low1,2

There was no retransplantation in the control group. So, we used an assumed risk of 1%.

*The basis for the assumed risk is provided in the comments section. 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; RR: risk ratio.

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 The trial(s) was (were) of high risk of bias.
2 The confidence intervals overlapped 1 and either 0.75 or 1.25 or both. The number of events in the intervention and control group was fewer than 300.

Figuras y tablas -
Summary of findings 2. Antiviral therapy for recurrent liver graft infection with hepatitis C virus (retransplantation)
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Comparison 1. Intervention versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Peg interferon versus no intervention control

1

65

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.05, 5.09]

1.2 Peg interferon plus ribavirin versus no intervention control

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.13, 70.53]

1.3 Ribavirin plus peg interferon versus peg interferon

2

98

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.05, 5.20]

1.4 Interferon versus no intervention control

1

12

Risk Ratio (M‐H, Fixed, 95% CI)

1.67 [0.08, 33.75]

1.5 Interferon plus ribavirin versus no intervention control

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.29 [0.01, 6.74]

1.6 Ribavirin versus interferon

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Ribavirin versus placebo

1

77

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Retransplantation after start of therapy Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Interferon versus no intervention control

1

12

Risk Ratio (M‐H, Fixed, 95% CI)

1.67 [0.08, 33.75]

2.2 Ribavirin versus placebo

1

77

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Treatment‐related serious adverse events (proportion) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Ribavirin plus peg interferon versus peg interferon

1

56

Risk Ratio (M‐H, Fixed, 95% CI)

3.4 [1.46, 7.94]

3.2 Ribavirin versus placebo

1

77

Risk Ratio (M‐H, Fixed, 95% CI)

5.55 [0.70, 43.95]

4 Treatment‐related serious adverse events (number of serious adverse events) Show forest plot

2

Rate Ratio (Fixed, 95% CI)

Subtotals only

4.1 Peg interferon versus no intervention control

1

65

Rate Ratio (Fixed, 95% CI)

1.15 [0.52, 2.57]

4.2 Ribavirin plus peg interferon versus peg interferon

1

42

Rate Ratio (Fixed, 95% CI)

1.20 [0.36, 3.96]

5 Graft rejection requiring retransplantation after start of therapy Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Peg interferon plus ribavirin versus no intervention control

1

72

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.07, 15.38]

5.2 Interferon versus no intervention control

1

12

Risk Ratio (M‐H, Fixed, 95% CI)

1.67 [0.08, 33.75]

6 Graft rejection requiring medical treatment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Ribavirin plus peg interferon versus peg interferon

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.04, 2.95]

7 Graft rejection (others with unknown treatment) Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 Peg interferon versus no intervention control

1

65

Risk Ratio (M‐H, Fixed, 95% CI)

24.26 [1.50, 393.41]

7.2 Peg interferon plus ribavirin versus no intervention control

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

3.0 [0.13, 70.53]

7.3 Ribavirin plus peg interferon versus peg interferon

1

56

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.07, 15.21]

7.4 Peg interferon (1.5 μg/kg/week) plus ribavirin versus peg interferon (0.5 μg/kg/week) plus ribavirin

1

13

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.5 Interferon plus ribavirin versus no intervention control

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

2.59 [0.11, 60.69]

8 Fibrosis worsening Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

8.1 Peg interferon versus no intervention control

1

45

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.30, 2.19]

8.2 Peg interferon plus ribavirin versus no intervention control

2

126

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.51, 0.98]

8.3 Ribavirin plus peg interferon versus peg interferon

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.20, 20.41]

8.4 Amantadine plus peg interferon plus ribavirin versus peg interferon plus ribavirin

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.28, 2.02]

8.5 Interferon plus ribavirin versus no intervention control

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.29 [0.01, 6.74]

8.6 Ribavirin versus interferon

1

30

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.28, 1.88]
Figuras y tablas -
Comparison 1. Intervention versus control
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