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Boceprevir (BOC) Based Triple Therapy (TTx) for Hepatitis C Recurrence after Liver Transplantation: Six Month Results

M. Schilsky, T. Sam, D. Assis, C. Caldwell, B. Fortune, S. Jakab, A. Liapakis, M. Rodriguez-Davalos, E. Tichy, S. Emre

Yale New Haven Transplantation Center, New Haven

Meeting: 2013 American Transplant Congress

Abstract number: B1064

Background: Experience with treatment for HCV recurrence in liver transplant recipients (LTRs) using pegylated interferon, ribavirin (PR) and protease inhibitors (PIs) is limited.

Methods: Adult genotype 1 LTRs with biopsy-proven HCV recurrence were converted to a cyclosporine (CsA) based immunosuppression regimen (goal trough∼ 100ng/ml) prior to TTx. After successful conversion, protocol proceeded with a 2 week lead-in phase of low accelerating dose regimen of PR followed by BOC 800mg thrice daily. Interferon responsiveness (IFNr) was defined as >1 log drop in HCV viral load after 2 weeks of lead-in with PR, and complete early virological response (cEVR) was defined as viral clearance (VC) at 12 weeks of TTx.

Results: Eleven patients received TTx for a mean of 18.9±7.6 weeks. Mean age and time after transplant were 56.7±6.6 and 2.8±1.6 years, respectively. Nine of the 11 patients were male, and 8 were Caucasian. The mean steady state pre-BOC CsA dose was decreased by 29.7±12.6% during TTx. At 12 weeks, 9 of 11 (81.8%) achieved cEVR. Mean time to VC was 7.5±2.7 weeks (n=9). At 24 weeks, data were available on 7 patients, and 6 (85.7%) had VC. IFNr was achieved in 8/10 patients who received at least 2 weeks of lead-in, and 100% of those achieved cEVR. Those without IFNr (n=2) required early discontinuation due to futility. Anemia (hemoglobin <10 g/dl) developed in 91% of the cohort. Patients were transfused PRBC (mean 5.2 units) during TTx and all required erythropoietin. No episodes of rejection occurred.

Patient Genotype Prior PR treatment response Baseline HCV RNA (log)/ Pre-TTx Biopsy Stage CsA Dose Reduction Post-BOC (%) TTx Duration (weeks) IFNr/ cEVR VC at 24 weeks
1 1 Nonresponder 7.48/3 25 7** Y/Y NA
2 1A Naive 6.92/3 25 19 Y/Y NA
3 1 Naive >7.84/1* 37.5 23 Y/Y NA
4 1A Null responder 7.27/0 33.3 24 NA***/Y Y
5 1 Partial responder 5.62/4 0 24 Y/Y Y
6 1B Naive >7.84/0 33.3 6** N/N NA
7 1A Naive 7.54/2 40 24 Y/Y Y
8 1A Relapser 7.46/3 50 24 Y/Y Y
9 1B Naive 6.57/3 33.3 24 Y/Y Y
10 1A Relapser >7.84/3* 25 24 Y/Y Y
11 1A Nonresponder 7.69/3 25 9** N/N N
*FCH **Early discontinuation ***10 days of lead-in

Conclusions: 1) BOC based TTx demonstrated excellent early virological response in LTRs with HCV recurrence, even in recipients with advancing graft fibrosis. 2) IFNr during the lead-in phase may be a predictor of treatment efficacy and may help to determine which patients should receive TTx.

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To cite this abstract in AMA style:

Schilsky M, Sam T, Assis D, Caldwell C, Fortune B, Jakab S, Liapakis A, Rodriguez-Davalos M, Tichy E, Emre S. Boceprevir (BOC) Based Triple Therapy (TTx) for Hepatitis C Recurrence after Liver Transplantation: Six Month Results [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/boceprevir-boc-based-triple-therapy-ttx-for-hepatitis-c-recurrence-after-liver-transplantation-six-month-results/. Accessed May 17, 2025.

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