End of Treatment Liver Biopsy With Sofosbuvir: Histologic Changes Suggestive of Hepatitis C Activity in Liver Transplant Recipients With Achieved SVR

B. Ismail,¹ X. Zervos,¹ P. Bejarano,² M. Waton,¹ D. Beltran,³ D. Sears,¹ A. Tzakis.¹

¹Liver Transplant, Cleveland Clinic Florida, Weston, FL
²Pathology, Cleveland Clinic Florida, Weston, FL
³Pharmacy, Cleveland Clinic Florida, Weston, FL.

Meeting: 2015 American Transplant Congress

Abstract number: A197

Keywords: Biopsy, Hepatitis C, Liver transplantation, Viral therapy

Session Information

Session Name: Poster Session A: Liver Transplantation: Viral Hepatitis

Session Type: Poster Session

Date: Saturday, May 2, 2015

Session Time: 5:30pm-7:30pm

Presentation Time: 5:30pm-7:30pm

Location: Exhibit Hall E

Background: Interferon (IFN) free HCV regimens are associated with better tolerability and efficacy. The majority of studies report biochemical and virological response; however limited information has been published on histologic findings. Aim: Report histologic findings following sustained virological response (SVR) in LT patients (pts). Methods: HCV treatment was started between 12/2013 and 5/2014 on pts who underwent LT between 1990 and 2014. Sofosbuvir (SOF) started in all 17 pts, 8 pts treated with SOF and Ribavirin (RBV), 2 pts SOF/RBV switched to SOF and Simeprevir (SIM), 6 pts treated with SOF/SIM and one with SOF/RBV/IFN (co-infection with HIV). All but 1 pt was on tacrolimus.

Baseline characteristics
Mean age (range)	64 (53-80)
Gender (M:F)	11:6
Race (Caucasian:Hispanic)	15:2
Mean AST (range)	54 (12-172) U/L
Mean ALT (range)	59 (9-166) U/L
Mean prior to treatment RNA level (range)	29.6 (1.24 – 105.9) x10 ⁵ IU/mL
HCV Genotype	1a (11 patients), 1a or 1b (2), 1b (1), 2b (1), 3 (2)
Cirrhosis prior to treatment	5 patients

Liver biopsy (LB) was performed at 24 weeks end of treatment (EOT). Results: 2 pts underwent LT while on treatment. 14 pts completed 24 weeks of therapy. HCV RNA levels at week 4 and EOT were undetectable in all patients that completed treatment. Week 36 available RNA levels for 11 pts remained undetectable, 3 died prior to EOT, 3 are pending week 36 RNA. LB performed at EOT in 13 pts. Evidence of inflammation present in 12/13 patients, Metavir grade: 1 (3 pts), 2 (5 pts), 3 (3 pts), 4 (one pt)

Mild rejection reported in 2 pts both deemed to not be rejecting clinically. Conclusion: Treatment regimens were effective in achieving SVR. Persistent inflammation on LB at EOT present in most pts. This could represent delayed histological resolution, innate immune system activation, or presence of HCV in the tissue. We are pursuing HCV-PCR of the tissue for confirmation.

To cite this abstract in AMA style:

Ismail B, Zervos X, Bejarano P, Waton M, Beltran D, Sears D, Tzakis A. End of Treatment Liver Biopsy With Sofosbuvir: Histologic Changes Suggestive of Hepatitis C Activity in Liver Transplant Recipients With Achieved SVR [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/end-of-treatment-liver-biopsy-with-sofosbuvir-histologic-changes-suggestive-of-hepatitis-c-activity-in-liver-transplant-recipients-with-achieved-svr/. Accessed May 11, 2025.

« Back to 2015 American Transplant Congress