Simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy

Therapeutics and Clinical Risk Management, Apr 2018

Simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy Ching-Chih Hu,1,2 Cheng-Hao Weng,2,3 Liang-Che Chang,4 Chih-Lang Lin,1,2 Yen-Ting Chen,1 Ching-Fang Hu,5 Man-Chin Hua,2,6 Li-Wei Chen,1 Rong-Nan Chien2,7 1Department of Hepatogastroenterology, Chang Gung Memorial Hospital, Keelung, Taiwan; 2College of Medicine, Chang Gung University, Linkou, Taiwan; 3Department of Nephrology and Poison Center, Chang Gung Memorial Hospital, Linkou, Taiwan; 4Department of Pathology, Chang Gung Memorial Hospital, Keelung, Taiwan; 5Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Keelung, Taiwan; 6Department of Pediatrics, Chang Gung Memorial Hospital, Keelung, Taiwan; 7Department of Hepatogastroenterology, Chang Gung Memorial Hospital, Linkou, Taiwan Purpose: Eradication of chronic hepatitis C virus (HCV) after interferon-based therapy and its association with the reduction of risk of hepatocellular carcinoma (HCC) in HCV-infected patients with advanced fibrosis is controversial. The study is aimed to develop a simple scoring model for HCC prediction among advanced fibrotic chronic hepatitis C (CHC) patients after pegylated interferon (pegIFN) and ribavirin (RBV) therapy. Patients and methods: We enrolled 271 biopsy-proven CHC patients with advanced fibrosis between 2003 and 2016, and divided them into non-HCC (n=211) and HCC (n=60) groups. The median observation duration was 6.0 years (range: 0.9–12.6 years). Results: The HCC prevalence after pegIFN and RBV therapy in CHC patients with sustained virologic response (SVR) and without SVR was 14.7% and 32.2%, respectively. Multivariate Cox regression showed age ≥59.5 years old at initiation of therapy (HR: 2.542, 95% CI: 1.390–4.650, P=0.002), pretreatment total bilirubin ≥1.1 mg/dL (HR: 2.630, 95% CI: 1.420–4.871, P=0.002), pretreatment platelet counts <146.5 × 103/µL (HR: 2.751, 95% CI: 1.373–5.511, P=0.004), no achievement of SVR (HR: 2.331, 95% CI: 1.277–4.253, P=0.006), and no diabetes at treatment initiation (HR: 3.085, 95% CI: 1.283–7.418, P=0.012) were significant predictors of HCC development. The scoring model consisted of the five categorical predictors and had an optimal cutoff point of 2.5. The area under receiver operating characteristic (AUROC) of the scoring model was 0.774±0.035 (P<0.001). The sensitivity and specificity of the cutoff value to detect HCC were 81.3% and 57.5%. The 5-year and 10-year cumulative incidence of HCC was 4.9% and 10.0% in patients with simple score ≤2; and 25.9% and 44.6% in patients with simple score ≥3 (P<0.001). Conclusion: The simple clinical-guided score has high discriminatory power for HCC prediction in advanced fibrotic CHC patients after pegIFN and RBV therapy. Keywords: HCC, HCV, advanced fibrosis, SVR, score, cumulative incidence

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Simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy

Therapeutics and Clinical Risk Management simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy Cheng-hao Weng 0 1 2 3 5 Yen-Ting Chen 1 3 4 5 0 Department of Nephrology and Poison Center, Chang g ung Memorial hospital , linkou , Taiwan 1 Rong-n an Chien 2 College of Medicine, Chang Gung University , Linkou , Taiwan 3 Chih-lang lin 4 Department of Hepatogastroenterology, Chang gung Memorial hospital , Keelung , Taiwan 5 Ching-Chih hu 6 Department of Hepatogastroenterology, Chang Gung Memorial hospital , linkou , Taiwan 7 Department of Pediatrics, Chang gung Memorial hospital , Keelung , Taiwan 8 Department of Physical Medicine and Rehabilitation, Chang gung Memorial hospital , Keelung , Taiwan 9 Department of Pathology, Chang gung Memorial hospital , Keelung , Taiwan 8 1 0 2 - l u J - 3 1 n o 7 0 2 . 6 4 . 9 5 . 7 3 y b / m o c . s s e r p e v o d . w . w ly /w n / o : tsp se th lu a m n fro rso d e ldeao rpoF PowerdbyTCPDF(ww.tcpdf.org) O R i g i n a l R e s e a R C h liang-Che Chang 4 Purpose: Eradication of chronic hepatitis C virus (HCV) after interferon-based therapy and its association with the reduction of risk of hepatocellular carcinoma (HCC) in HCV-infected patients with advanced fibrosis is controversial. The study is aimed to develop a simple scoring model for HCC prediction among advanced fibrotic chronic hepatitis C (CHC) patients after pegylated interferon (pegIFN) and ribavirin (RBV) therapy. Patients and methods: We enrolled 271 biopsy-proven CHC patients with advanced fibrosis between 2003 and 2016, and divided them into non-HCC (n=211) and HCC (n=60) groups. The median observation duration was 6.0 years (range: 0.9-12.6 years). Results: The HCC prevalence after pegIFN and RBV therapy in CHC patients with sustained virologic response (SVR) and without SVR was 14.7% and 32.2%, respectively. Multivariate Cox regression showed age $59.5 years old at initiation of therapy (HR: 2.542, 95% CI: 1.390-4.650, P=0.002), pretreatment total bilirubin $1.1 mg/dL (HR: 2.630, 95% CI: 1.420-4.871, P=0.002), pretreatment platelet counts ,146.5 × 103/μL (HR: 2.751, 95% CI: 1.373-5.511, P=0.004), no achievement of SVR (HR: 2.331, 95% CI: 1.277-4.253, P=0.006), and no diabetes at treatment initiation (HR: 3.085, 95% CI: 1.283-7.418, P=0.012) were significant predictors of HCC development. The scoring model consisted of the five categorical predictors and had an optimal cutoff point of 2.5. The area under receiver operating characteristic (AUROC) of the scoring model was 0.774±0.035 (P,0.001). The sensitivity and specificity of the cutoff value to detect HCC were 81.3% and 57.5%. The 5-year and 10-year cumulative incidence of HCC was 4.9% and 10.0% in patients with simple score #2; and 25.9% and 44.6% in patients with simple score $3 (P,0.001). Conclusion: The simple clinical-guided score has high discriminatory power for HCC prediction in advanced fibrotic CHC patients after pegIFN and RBV therapy. HCC; HCV; advanced fibrosis; SVR; score; cumulative incidence - open access to scientific and medical research Ching-Fang hu 5 Man-Chin hua 2,6 li-Wei Chen 1 Introduction Chronic hepatitis C infection is a major global health problem and an important cause of morbidity and mortality from sequelae such as liver cirrhosis and HCC.1–4 It has been estimated that, globally, 27% of cirrhosis and 25% of HCC cases develop in HCVinfected people.5 In patients with HCV-related cirrhosis, the annual incidence rates of developing hepatic decompensation and HCC are 3.9% and 1.4%–8%, respectively.4,6,7 The main goals of therapy in patients with HCV-related cirrhosis are to eradicate HCV, improve liver histologic activity, and reduce fibrosis. In addition, several studies have shown that chronic HCV infected patients with advanced fibrosis achieving SVR after IFN-based therapy have reduced risks of developing liver decompensation, HCC, and liver-related mortality.8–13 Therefore, although these patients are considered to be a difficult-to-treat popula8 tion with less tolerability and poor therapeutic responses to -012 pegIFN and PBV therapy, they could still benefit from the l-Ju treatment with a lower risk of HCC, liver disease progression 31n and liver-related complications.14,15 There are several risk 0o7 factors associated with HCC development in CHC patients .246 with advanced fibrosis, including male gender, older age at ..59 treatment initiation, HCV genotype 1b, low serum albumin y73 and high serum total bilirubin levels, low platelet counts, /bm and presence of esophageal varices.2,11,16–18 However, another .cso report demonstrated a controversial result that achievement rsep of SVR after IFN-based therapy did not influence the rate veo of HCC development.19 .dw . Combination therapy with pegIFN plus RBV has greatly w ly //w no improved the rate of SVR compared to conventional IFN : ttsph lseu with and witho (...truncated)


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Ching-Chih Hu, Cheng-Hao Weng, Liang-Che Chang, Chih-Lang Lin, Yen-Ting Chen, Ching-Fang Hu, Man-Chin Hua, Li-Wei Chen, Rong-Nan Chien. Simple score to predict risk of hepatocellular carcinoma in chronic hepatitis C patients with advanced fibrosis after pegylated interferon and ribavirin therapy, Therapeutics and Clinical Risk Management, 2018, pp. 783-791, DOI: 10.2147/TCRM.S158424