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Triple therapy resulted in reduced fibrosis among patients with HCV

Liver transplant patients with recurrent hepatitis C virus displayed less fibrotic progression when treated with tacrolimus, azathioprine and steroids compared with those patients receiving tacrolimus monotherapy in a recent study.

Researchers in the UK and Ireland evaluated 97 consecutive patients who had undergone liver transplantation and were randomly assigned to tacrolimus monotherapy (n=49) or triple therapy with tacrolimus, azathioprine and methylprednisolone (n=48) for 6 months. Patients received 0.1 mg/kg tacrolimus daily or 20 mg prednisolone daily, tapered to stop by 6 months; 0.1 mg/kg tacrolimus daily and 1 mg/kg azathioprine daily.

Ishak stage and collagen proportionate area (CPA) assessed fibrosis progression in annual liver biopsies for a median follow-up of 8 years. Nineteen monotherapy patients reached at least Ishak stage 4 in a median of 32 months, while 11 triple therapy patients reached the same level in a median of 49 months (P=.009). At the last biopsy CPA was 12% and 8% for monotherapy and triple therapy patients, respectively (P=.004).

Among 33 biopsies performed in the monotherapy cohort, 11 patients reached HVPG levels of at least 10 mm HG, considered clinically significant portal hypertension, while four of 31 patients receiving triple therapy who received biopsies attained a similar threshold.

Nine monotherapy and four triple therapy patients were decompensated. Using Cox regression analysis, only monotherapy was significantly associated with decompensation (OR=3.23; 95% CI, 1.01-10.3).

Researchers reported that 14 tacrolimus-only patients died and five required retransplantation compared with seven and four who received triple therapy.

“Long-term immunosuppression with tacrolimus, azathioprine and short-term prednisolone in HCV cirrhosis recipients resulted in slower progression to severe fibrosis … less portal hypertension and decompensation, compared with tacrolimus alone,” the researchers concluded.

Disclosure: Researchers Andrew K. Burroughs, FRCP, FMedSci, and Amar P. Dhillon, MD, (FRCPath), have an unrestricted education grant from Pfizer.