Twelve-Week Posttreatment Follow-Up to Predict Sustained Virologic Response for Recurrent Hepatitis C Infection in Liver Recipients

Transplantation. 2012 Jan 18. [Epub ahead of print]

Campos-Varela I, Castells L, Esteban JI, Bes M, Rodríguez-Frías F, Sapisochin G, Allende H, Charco R, Esteban R.

1Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain. 2Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. 3Transfusion Safety Laboratory, Banc de Sang i Teixits (BST), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. 4Biochemistry Laboratory, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain. 5Liver Transplant Unit, Department of HPB-Surgery and Transplant, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain. 6Pathology Department, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.

Abstract

BACKGROUND: The current standard for determining sustained virologic response (SVR) in patients treated for hepatitis C virus (HCV) infection is undetectable serum HCV-RNA 24 weeks after treatment. This study evaluates the value of HCV-RNA determination at 12 weeks posttreatment (W+12) to predict SVR in liver transplant (LT) patients treated with pegylated interferon and ribavirin for recurrent HCV infection.

METHODS: This study, performed in 2001 to 2010, included HCV-LT patients with an end-of-treatment response (undetectable serum HCV-RNA) and HCV-RNA testing at 12 and 24 weeks posttreatment (W+12/W+24). HCV-RNA was detected with a qualitative polymerase chain reaction assay (detection limit 50 IU/mL) and, when positive, measured by quantitative PCR (detection limit 600 IU/mL) up to 2006. Since 2007, a real-time PCR-based test (detection limit 15 IU/mL) has been used. The positive predictive value (PPV) was defined as the probability that SVR would occur in patients with undetectable HCV-RNA at W+12 and W+24.

RESULTS: Of 162 patients treated during the study period, 57 (35%) had end-of-treatment response and were included. Of these, 45 (79%) had SVR and 12 (21%) had virologic relapse. At W+12, HCV-RNA was undetectable in 45 (79%) patients, all of whom had SVR, yielding a PPV for SVR at W+12 of 100% (95% confidence interval, 75.8%-100%).

CONCLUSIONS: Undetectable HCV-RNA at W+12 posttreatment has a high PPV for predicting SVR. HCV-RNA testing to assess SVR at this time point seems as valid as W+24 testing and could be considered for predicting SVR in HCV-LT patients receiving treatment with pegylated interferon and ribavirin.

Source