α‐Fetoprotein is a surrogate marker for predicting treatment failure in telaprevir‐based triple combination therapy for genotype 1b chronic hepatitis C Japanese patients with the IL 28 B minor genotype

Even when treated with telaprevir‐based triple therapy, some patients fail to achieve a sustained virological response. This study identified factors related closely to treatment failure. A total of 146 Japanese genotype 1b chronic hepatitis C patients were enrolled in this prospective, multicenter study and received a 24‐week regimen of triple therapy. The end‐of‐treatment response rate was significantly lower in patients with the interleukin 28B ( IL28B ) (rs8099917) non‐TT genotype (85.2%) than in those with the TT genotype (100%, P  = 0.0002). Multiple logistic regression analysis identified high α‐fetoprotein levels as an independent factor related to non‐end‐of‐treatment response in patients with the non‐TT genotype. A cut‐off value of 20 ng/ml was determined for a non‐end‐of‐treatment response; sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were 75.0%, 95.7%, 75.0%, 75.0%, and 92.6%, respectively. Multiple logistic regression analysis for a sustained virological response identified the IL28B TT genotype, low α‐fetoprotein levels, non‐responders, and a rapid virological response. The sustained virological response rate was significantly lower in patients with the non‐TT genotype (59.3%) than in those with the TT genotype (96.7%, P  < 0.0001). In patients with the non‐TT genotype, α‐fetoprotein was the most significant predictor for non‐sustained virological response by univariate analysis. A cut‐off value of 7.4 ng/ml α‐fetoprotein was determined for non‐sustained virological response; sensitivity, specificity, PPV, NPV, and accuracy were 63.6%, 87.5%, 77.8%, 77.8%, and 77.8%, respectively. For the non‐TT patients, serum α‐fetoprotein levels may be a surrogate marker for predicting treatment failure in telaprevir‐based therapy for genotype 1b chronic hepatitis C. J. Med. Virol. 86:461–472, 2014 . © 2013 Wiley Periodicals, Inc.