LT recipients with HCV met SVR with telaprevir, PEG-IFN/RBV

NEW YORK — Liver transplant recipients with hepatitis C virus genotype 1 achieved sustained virologic response by 12 weeks of therapy with telaprevir plus pegylated interferon and ribavirin, according to data presented at the AASLD/EASL Special Conference on Hepatitis C.

In phase 3 of the REPLACE study, researchers evaluated 74 liver transplant recipients (liver fibrosis scores, F0-F3) who received tacrolimus (n=50) or cyclosporine (n=24) for 6 months to 10 years after transplantation. All were assigned 750 mg telaprevir once every 8 hours, 180 mcg PEG-IFN once weekly and 600 mg ribavirin (RBV) once daily for 12 weeks. Patients then continued PEG-IFN/RBV for an additional 36 weeks. Nine patients discontinued telaprevir — four due to adverse events — and had tacrolimus and cyclosporine adjusted accordingly.

Seventy-two percent of patients — 66% of those receiving tacrolimus and 83% taking cyclosporine — reached SVR at 12 weeks.

Overall nine patients reported serious adverse events. Adverse events occurring most frequently during telaprevir administration were anemia (55%), pruritus (46%) and anorectal (45%) symptoms. At 12 weeks, there were no reports of graft rejection, however, 8% of patients had rejection after telaprevir therapy was completed (between 20 and 58 weeks); all were resolved.

“Telaprevir/PR after liver transplant substantially improved SVR rates compared with historical controls,” the researchers wrote. “Immunosuppression with tacrolimus or cyclosporine was manageable with close monitoring, with no new or unexpected adverse events. More anemia and creatinine elevations were seen than in previous telaprevir studies in nonliver transplant patients.”

For more information:

Forns X. Abstract #24. Presented at: AASLD/EASL Special Conference on Hepatitis C, Sept. 12-13, 2014; New York.

Disclosure: See the abstract for a full list of relevant financial disclosures.