Boceprevir (BOC) Based Triple Therapy (TTx) for Hepatitis C Recurrence after Liver Transplantation: Six Month Results
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 |
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.
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 December 13, 2024.« Back to 2013 American Transplant Congress