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HCV triple therapy post-liver transplant yields moderate response, significant adverse events

Liver transplant recipients with hepatitis C experienced moderate early response rates but frequent side effects from triple therapy with antivirals in a recent study.

Researchers evaluated 60 liver transplant recipients with recurrent HCV genotype 1 and significant fibrosis who underwent treatment with pegylated interferon alfa-2a and ribavirin (PEG/RBV) and either telaprevir (TVR) (n=35) or boceprevir (BOC) (n=25), with a minimum follow-up of 12 weeks (mean follow-up, 35 weeks). Most patients were successfully placed on immunosuppressive therapy with cyclosporine before treatment initiation, including 33 TVR patients and 23 BOC patients.

The TVR cohort was assigned 12 weeks of TVR and PEG/RBV followed by PEG/RBV alone for 36 weeks, and those in the BOC group received 4 weeks of lead-in with PEG/RBV followed by 44 weeks of PEG/RBV with BOC.

Undetectable HCV RNA levels were observed in 86% of TVR recipients (mean, 6 weeks), compared with 48% of BOC patients (mean, 11 weeks). After 24 weeks of treatment, undetectable RNA without viral breakthrough had occurred in 67% of the TVR group and 45% of the BOC group in intention-to-treat analysis. Upon completion of follow-up, undetectable RNA remained in 27 TVR cases and 11 BOC recipients.

One patient in each group died during therapy. Cytopenias were common in both groups, and all participants required either hematological growth factor administration or dose reductions of peginterferon and/or ribavirin. Biopsy-proven acute rejection occurred in two TVR patients and none of the BOC recipients during treatment. Infectious complications occurred in six TVR cases but were treated and resolved without interruption.

“Our study has produced some important insights into the management of immunosuppression while patients are on these medications and into the frequency and severity of adverse events, as well as early virological response data,” the researchers wrote. “We have demonstrated that TVR- or BOC-containing antiviral protocols can be used after transplantation and result in moderately successful early virological responses, but these regimens are associated with important toxicities that mitigate their potential benefit.”