Vivarelli 2007.
| Methods | Trial design: randomised, multicentre, open‐label clinical trial Mean follow‐up: 841 days (range: 130 to 1376) Study duration: not reported Language: English Type of information: journal article Judgement on quality: high risk |
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| Participants | Setting: 2 transplantation centres in Italy Allocation of participants: 47 participants, 22 allocated to Intervention A, 25 allocated to Intervention B Sex ratio: total: not reported Intervention A: not reported Intervention B: not reported Mean age: total: not reported Intervention A: 58.9 (range: 43 to 66) Intervention B: 57.2 (range: 41 to 67) Indication (no. (%)): HCV cirrhosis: total: 47 (100.0%), Intervention A: 22 (100.0%), Intervention B: 25 (100.0%) Type of donor: deceased donors Inclusion criteria: HCV positive first‐time whole liver recipients from deceased donors Exclusion criteria: HBsAg‐positive, previous transplant, partial grafts, living donors Other: HCV‐RNA titres (Meq/mL): total: not reported, Intervention A: 0.755 (range: < 0.003 to 4.3), Intervention B: 0.765 (< 0.003 to 8.04) MELD score: total: not reported, Intervention A: 16 (range: 8 to 25), Intervention B: 15 (range: 7 to 28) Pretransplant diabetes mellitus: total: 11 (23.4%), Intervention A: 5 (22.7%), Intervention B: 6 (24.0%) |
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| Interventions | Intervention A: prednisone: tapered from 25 mg/day to 15 mg/day from days 6 to day 30, 15 mg/day on days 31 to 45, 10 mg/day on days 46 to 60, 5 mg/day on days 61 to 75, 2.5 mg/day on days 76 to 90) and stopped at day 91 Intervention B: prednisone: 25 mg/day on day 6 tapered to 15 mg/day by day 31, 15 mg/day on days 31 to 90, 10 mg/day on days 91 to day 180, 7.5 mg/day on days 181 to 270, 5 mg/day from day 271 to the end of the first postoperative year, 2.5 mg for the second postoperative year and stopped at the end of the second postoperative year Concomitant immunosuppression: Methylprednisolone: intraoperatively and on days 1 to 5 (dose not reported) Tacrolimus: aiming for trough level of 5 ng/mL to 15 ng/mL for the first 3 months and then 5 ng/mL to 10 ng/mL thereafter |
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| Outcomes | Mortality, graft loss, acute rejection, treatment failure, recurrent hepatitis C, HCV‐RNA levels, Scheuer fibrosis, acute rejection requiring steroids, acute rejection requiring multiple steroids, need for antiviral treatment (anti‐HCV), diabetes mellitus, tacrolimus levels | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: Astellas Pharma Italia |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: Generation of randomisation sequence not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from the publication: "The study was conducted at the Liver Transplant Centres of Bologna and Padua, Italy, in an open‐label, not‐blinded, prospective and randomized fashion." Comment: Blinding of participants and medical staff not performed |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from the publication: "The study was conducted at the Liver Transplant Centres of Bologna and Padua, Italy, in an open‐label, not‐blinded, prospective and randomized fashion." Comment: Blinding of outcome assessors not performed |
| Incomplete outcome data (attrition bias) | Low risk | Quote from the publication: "Median follow‐up was 841 days (130‐1376); apart from those who died or lost their graft earlier, all patients had at least 2 year follow‐up." Comment: Missing data unlikely to affect outcome results |
| Selective reporting (reporting bias) | Low risk | Comment: All outcomes appear to be fully reported |
| Other bias | High risk | Quote from the publication: "The authors declare that FG is employed by Astellas Pharma Italia and he coordinated the Centres involved in the study and helped in the data collection. Astellas Pharma Italia supported the study financially and coordinated the Centres involved (EPASTER Study, investigator originated and driven)." Comment: No sample size calculation reported; study industry sponsored |
| Free of early stopping? | Low risk | Comment: Study not stopped early |
| Free of baseline imbalance? | Low risk | Comment: Baseline characteristics are listed in Table 1. All listed characteristics are similar between the groups with P values > 0.05. Study is free from baseline imbalance |