Outcome of recurrent hepatitis C virus after liver transplantation in a randomized trial of tacrolimus monotherapy versus triple therapy

✍ Scribed by Pinelopi Manousou; Dimitrios Samonakis; Evangelos Cholongitas; David Patch; James O'Beirne; Amar P. Dhillon; Keith Rolles; Aiden McCormick; Peter Hayes; Andrew K. Burroughs

• Publisher: John Wiley and Sons
• Year: 2009
• Tongue: English
• Weight: 181 KB
• Volume: 15
• Category: Article
• ISSN: 1527-6465
• DOI: 10.1002/lt.21907

✦ Synopsis

Less potent immunosuppression is considered to reduce the severity of hepatitis C virus (HCV) recurrence after liver transplantation. An optimal regimen is unknown. We evaluated tacrolimus monotherapy versus triple therapy in a randomized trial of 103 first transplants for HCV cirrhosis. One hundred three patients who underwent transplantation for HCV were randomized to tacrolimus monotherapy (n ϭ 54) or triple therapy with tacrolimus, azathioprine, and steroids (n ϭ 49), which were tapered to zero by 3 to 6 months. Both groups had serial transjugular biopsies with hepatic venous pressure gradient (HVPG) measurement. The time to reach Ishak stage 4 was the predetermined endpoint. All factors documented in the literature as being associated with HCV recurrence and the allocated treatment were evaluated for reaching stage 4 and HVPG Ն 10 mm Hg. No significant preoperative, perioperative, or postoperative differences, including the frequency of biopsies between groups, were found. During a mean follow-up of 53.5 months, 9 monotherapy patients and 6 triple therapy patients died, and 5 monotherapy patients and 4 triple therapy patients underwent retransplantation. Stage 4 fibrosis was reached in 17 monotherapy patients and 10 triple therapy patients (P ϭ 0.04), with slower fibrosis progression in the triple therapy patients (P ϭ 0.048). Allocated therapy and histological acute hepatitis were independently associated with stage 4 fibrosis. HVPG increased to Ն10 mm Hg more rapidly in monotherapy patients versus triple therapy patients (P ϭ 0.038). In conclusion, long-term maintenance immunosuppression with azathioprine and shorter term prednisolone with tacrolimus in HCV cirrhosis recipients resulted in a slower onset of histologically proven severe fibrosis and portal hypertension in comparison with tacrolimus alone, and this was independent of known factors affecting fibrosis.