Intervention Review

You have free access to this content

Antiviral prophylaxis for the prevention of chronic hepatitis C virus in patients undergoing liver transplantation

  1. Kurinchi Selvan Gurusamy1,*,
  2. Emmanuel Tsochatzis2,
  3. Clare D Toon3,
  4. Brian R Davidson1,
  5. Andrew K Burroughs4

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 2 DEC 2013

Assessed as up-to-date: 14 FEB 2013

DOI: 10.1002/14651858.CD006573.pub3


How to Cite

Gurusamy KS, Tsochatzis E, Toon CD, Davidson BR, Burroughs AK. Antiviral prophylaxis for the prevention of chronic hepatitis C virus in patients undergoing liver transplantation. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD006573. DOI: 10.1002/14651858.CD006573.pub3.

Author Information

  1. 1

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

  2. 2

    Royal Free Hampstead NHS Foundation Trust and UCL Institute of Liver and Digestive Health, Sheila Sherlock Liver Centre, London, UK

  3. 3

    West Sussex County Council, Public Health, Chichester, West Sussex, UK

  4. 4

    Royal Free Hampstead NHS Foundation Trust, Sheila Sherlock Liver Centre, London, UK

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, NW3 2PF, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 2 DEC 2013

SEARCH

[Figure 1]
Figure 1. Study flow diagram.
[Figure 2]
Figure 2. Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
[Figure 3]
Figure 3. Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
[Figure 4]
Figure 4. Trial sequential analysis of 90-day mortality (hepatitis C virus antibody versus placebo)The diversity-adjusted required information size (DARIS) was calculated with 10,577 patients, based on the proportion of patients in the control group with the outcome of 6.3%, 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 53 participants in three trials, only 0.5% of the DARIS was 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.
[Figure 5]
Figure 5. Trial sequential analysis of 90-day mortality (hepatitis C virus antibody (high dose) versus hepatitis C virus antibody (low dose))The diversity-adjusted required information size (DARIS) was calculated with 11,338 patients, based on the proportion of patients in the control group with the outcome of 5.9%, 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 31 participants in two trials, only 0.27% 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.
[Figure 6]
Figure 6. Trial sequential analysis of mortality at maximal follow-up (interferon versus no intervention)The diversity-adjusted required information size (DARIS) was calculated with 3796 patients, based on the proportion of patients in the control no intervention group with the outcome of 17.2%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 8.54%. 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 105 participants in two trials, only 2.77% 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.
[Figure 7]
Figure 7. Trial sequential analysis of retransplantation at maximal follow-up (interferon versus no intervention)The diversity-adjusted required information size (DARIS) was calculated with 20,141 patients, based on the proportion of patients in the no intervention control group with the outcome of 3.4%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 8.54%. 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 105 participants in two trials, only 0.52% 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.
[Figure 8]
Figure 8. Trial sequential analysis of graft rejection requiring steroids or equivalent drugs (interferon versus no intervention)The diversity-adjusted required information size (DARIS) was calculated with 1079 patients, based on the proportion of patients in the no intervention control group with the outcome of 41.2%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 8.54%. 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 136 participants in three trials, only 12.60% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the futility area. Neither the trial sequential boundaries (continuous red line) nor the conventional boundaries (dotted red line) have been crossed by the cumulative Z-curve.
[Analysis 1.1]
Analysis 1.1. Comparison 1 Intervention versus control, Outcome 1 90-day mortality.
[Analysis 1.2]
Analysis 1.2. Comparison 1 Intervention versus control, Outcome 2 Mortality at maximal follow-up.
[Analysis 1.3]
Analysis 1.3. Comparison 1 Intervention versus control, Outcome 3 Mortality (hazard ratio).
[Analysis 1.4]
Analysis 1.4. Comparison 1 Intervention versus control, Outcome 4 90-day retransplantation.
[Analysis 1.5]
Analysis 1.5. Comparison 1 Intervention versus control, Outcome 5 Retransplantation at maximal follow-up.
[Analysis 1.6]
Analysis 1.6. Comparison 1 Intervention versus control, Outcome 6 Serious adverse events.
[Analysis 1.7]
Analysis 1.7. Comparison 1 Intervention versus control, Outcome 7 Anaemia.
[Analysis 1.8]
Analysis 1.8. Comparison 1 Intervention versus control, Outcome 8 Leukopenia.
[Analysis 1.9]
Analysis 1.9. Comparison 1 Intervention versus control, Outcome 9 Graft rejection requiring retransplantation.
[Analysis 1.10]
Analysis 1.10. Comparison 1 Intervention versus control, Outcome 10 Graft rejection requiring steroids or equivalent drugs.
[Analysis 1.11]
Analysis 1.11. Comparison 1 Intervention versus control, Outcome 11 Graft rejection (others).
[Analysis 1.12]
Analysis 1.12. Comparison 1 Intervention versus control, Outcome 12 Fibrosis worsening.
[Analysis 1.13]
Analysis 1.13. Comparison 1 Intervention versus control, Outcome 13 Recurrence (hazard ratio).