The clinical management of hepatocellular carcinoma in China: Progress and challenges

Shan Shan,Jidong Jia 대한간학회 2023 Clinical and Molecular Hepatology(대한간학회지) Vol.29 No.2

Comprehensive approach to controlling chronic hepatitis B in China

Shan Shan,Xinyan Zhao,Jidong Jia 대한간학회 2024 Clinical and Molecular Hepatology(대한간학회지) Vol.30 No.2

Hepatitis B virus (HBV) infection was highly endemic in China, where the prevalence of HBsAg was 9.7% in 1992. Comprehensive strategies, including universal infant hepatitis B vaccination with emphasis on timely birth-dose and 3-dose coverage, dramatically reduced the mother-to-infant transmission and early childhood acquisition of HBV, resulting in estimated HBsAg prevalence rates of 5.6% and 0.1% in the general population and among children aged <5 years in 2022, respectively. Clinical guidelines on the prevention and treatment of chronic hepatitis B have been periodically updated based on emerging evidence from clinical research. The continuously improved reimbursement policy and the massively reduced price of antiviral drugs through government negotiation and central procurement have increased treatment accessibility and affordability. However, due to the low rates of diagnosis and treatment, China still faces a large challenge in achieving the 2030 goal of lowering HBV-related mortality by 65%. A public health approach involving concerted efforts from the government, medical community, industry, and society as a whole would be necessary to increase the uptake of HBV tests and treatment to achieve the global goal of eliminating viral hepatitis as a public health threat by 2030.

Changes in Markers of Liver Function in HCV 1b Patients with Compensated Cirrhosis Treated with Ombitasvir/Paritaprevir/ Ritonavir plus Dasabuvir with Ribavirin

( Jeong Heo ),( Yan Luo ),( Wan-long Chuang ),( Jidong Jia ),( Kwang-hyub Han ),( Ming-lung Yu ),( Hong Tang ),( Young-suk Lim ),( Cheng-yuan Peng ),( Min Xu ),( Maorong Wang ),( Bo Fu ),( Niloufar Mo 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: Patients chronically infected with HCV are at risk of developing extrahepatic manifestations of HCV as well as progressing to compensated or decompensated cirrhosis and HCC. Although current treatments have high rates of SVR, relatively little is known about possible regression of liver fibrosis after achieving an SVR. The ONYX-II trial examined the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus dasabuvir + ribavirin (RBV) in Asian patients with HCV genotype 1b infection and compensated cirrhosis. Here we report changes in key markers of liver fibrosis and function. Methods: Patients with chronic HCV GT1b infection and compensated cirrhosis were enrolled in China, South Korea and Taiwan and received 12 weeks of OBV/PTV/r (25 mg/150 mg/100 mg once daily) and DSV (250 mg twice daily) with weight-based RBV. The primary objective of ONYX-II was to assess efficacy (SVR12) and safety of the regimen. Changes in markers of liver fibrosis and function between baseline (BL) and post-treatment week (PTW) 12 are presented. Results: Overall, 104 patients were enrolled and treated in ONYX-II. All patients (104/104, 100%) achieved SVR12. BL and PTW12 data for FibroTest score, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, albumin, platelet count and alpha fetoprotein (AFP) are shown in Table 1. All selected parameters showed numerical improvements between BL and PTW12. Mean ALT and AST levels returned to within normal range and FibroTest scores demonstrated a numerical improvement, suggesting improvement in liver status. The complete set of data between BL and PTW12 will be presented for these parameters and other liver composite parameters at the conference. Conclusions: Measurement of key liver function markers during the ONYX-II trial showed a numerical improvement within 12 weeks of completion of treatment in HCV GT1b-infected patients with compensated cirrhosis. Further follow-up of these patients will determine the long-term durability of these changes.

Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Non-Cirrhotic Asian Patients with Genotype 1b HCV Infection: ONYX-I SVR24 Results

( Lai Wei ),( Jinlin Hou ),( Yan Luo ),( Jeong Heo ),( Chi-jen Chu ),( Zhongping Duan ),( Mong Cho ),( Jun Cheng ),( Jun Li ),( Jidong Jia ),( Wenjing Lu ),( Linda M Fredrick ),( Tami Pilot-matias ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: HCV genotype 1b is the most common genotype in Asian patients. ONYX-I is a phase 3, randomised, double-blind, placebo-controlled study of the 3-DAA regimen of OBV/PTV/r and DSV in treatment- naive and treatment-experienced non-cirrhotic patients with HCV GT1b infection in China, South Korea and Taiwan. Methods: In this study, the safety/efficacy of OBV/PTV/r + DSV administered for 12 weeks were evaluated in non-cirrhotic Asian patients. Patients in Arm A received active study drug during a 12-week double-blind (DB) period, while patients in Arm B received placebo during the same period followed by an open-label (OL) period in which they received 12 weeks of active study drug. Efficacy was assessed by SVR12 and SVR24. Efficacy and safety were assessed in all patients who received at least one dose of active study drugs. Results: 650 HCV GT1b patients (54% female, 100% Asian, 44% treatment-experienced) were enrolled from China (n=410) South Korea (n=120) and Taiwan (n=120), and randomised 1:1 to Arms A and B. In Arm A, SVR12 and SVR24 rates were 99.5% (183/184) in treatment-naive patients and 100% (141/141) in treatment- experienced patients. Most treatment-emergent adverse events (TEAEs) in patients receiving the active drug were mild in severity. The most common (≥5%) TEAEs in Arm A were upper respiratory tract infection (10.5%), headache (6.2%) and dizziness (5.2%). Seven patients had serious AEs during active treatment (Arm A) and one patient in Arm A discontinued treatment. Conclusions: In non-cirrhotic Asian adults with HCV GT1b-infection, treated with OBV/PTV/r + DSV for 12 weeks, SVR24 rates equalled previously reported SVR12 rates from this study (99.5% of treatment- naive and 100% of treatment-experienced patients), and are consistent with other clinical trials with this drug combination. The treatment was generally well tolerated with mostly mild TEAEs reported.

Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients

Xiaoning Wu,Xiaoqian Xu,Jialing Zhou,Yameng Sun,Huiguo Ding,Wen Xie,Guofeng Chen,Anlin Ma,Hongxin Piao,Bingqiong Wang,Shuyan Chen,Tongtong Meng,Xiaojuan Ou,Hwai-I Yang,Jidong Jia,Yuanyuan Kong,Hong Yo 대한간학회 2023 Clinical and Molecular Hepatology(대한간학회지) Vol.29 No.3

Background/Aims: Existing hepatocellular carcinoma (HCC) prediction models are derived mainly from pretreatment or early on-treatment parameters. We reassessed the dynamic changes in the performance of 17 HCC models in patients with chronic hepatitis B (CHB) during long-term antiviral therapy (AVT). Methods: Among 987 CHB patients administered long-term entecavir therapy, 660 patients had 8 years of follow-up data. Model scores were calculated using on-treatment values at 2.5, 3, 3.5, 4, 4.5, and 5 years of AVT to predict threeyear HCC occurrence. Model performance was assessed with the area under the receiver operating curve (AUROC). The original model cutoffs to distinguish different levels of HCC risk were evaluated by the log-rank test. Results: The AUROCs of the 17 HCC models varied from 0.51 to 0.78 when using on-treatment scores from years 2.5 to 5. Models with a cirrhosis variable showed numerically higher AUROCs (pooled at 0.65–0.73 for treated, untreated, or mixed treatment models) than models without (treated or mixed models: 0.61–0.68; untreated models: 0.51–0.59). Stratification into low, intermediate, and high-risk levels using the original cutoff values could no longer reflect the true HCC incidence using scores after 3.5 years of AVT for models without cirrhosis and after 4 years of AVT for models with cirrhosis. Conclusions: The performance of existing HCC prediction models, especially models without the cirrhosis variable, decreased in CHB patients on long-term AVT. The optimization of existing models or the development of novel models for better HCC prediction during long-term AVT is warranted.