Background/Aims The World Health Organization set the goal of eliminating hepatitis C virus (HCV) by 2030, with 80% and 65% reductions in HCV incidence and mortality rates, respectively. We aimed to evaluate the health benefits, cost-effectiveness and return on investment (ROI) of HCV elimination.
Methods Using an HCV transmission compartmental model, we evaluated the benefits and costs of different strategies combining screening and treatment for Chinese populations. We identified strategies to achieve HCV elimination and calculated the incremental cost-effectiveness ratios (ICERs) per disability-adjusted life year (DALY) averted for 2022–2030 to identify the optimal elimination strategy. Furthermore, we estimated the ROI by 2050 by comparing the required investment with the economic productivity gains from reduced HCV incidence and deaths.
Results The strategy that results in the most significant health benefits involves conducting annual primary screening at a rate of 14%, re-screening people who inject drugs annually and the general population every five years, and treating 95% of those diagnosed (P14-R4-T95), preventing approximately 5.75 and 0.44 million HCV infections and deaths, respectively, during 2022–2030. At a willingness-to-pay threshold of $12,615, the P14-R4-T95 strategy is the most cost-effective, with an ICER of $5,449/DALY. By 2050, this strategy would have a net benefit of $120,997 million (ROI=0.868).
Conclusions Achieving HCV elimination in China by 2030 will require significant investment in large-scale universal screening and treatment, but it will yield substantial health and economic benefits and is cost-effective.
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Background/Aims We investigated the dynamics of serum HBV pre-genomic RNA (pgRNA) and hepatitis B core-related antigen (HBcrAg) in patients receiving nucleos(t)ide analogues (NAs) and their predictability for favourable suppression of serum hepatitis B surface antigen (HBsAg).
Methods Serum viral biomarkers were measured at baseline, weeks 4, 12, 24, 36, and 48 of treatment. Patients were followed up thereafter and serum HBsAg level was measured at end of follow-up (EOFU). Favourable HBsAg response (FHR) was defined as ≤100 IU/mL or HBsAg seroclearance upon EOFU.
Results Twenty-eight hepatitis B e antigen (HBeAg)-positive and 36 HBeAg-negative patients (median, 38.2 years old; 71.9% male) were recruited with median follow-up duration of 17.1 years (interquartile range, 12.8–18.2). For the entire cohort, 22/64 (34.4%) achieved FHR. For HBeAg-positive patients, serum HBV pgRNA decline at week 4 was significantly greater for patients with FHR compared to non-FHR (5.49 vs. 4.32 log copies/mL, respectively; P=0.016). The area under the receiver-operating-characteristic curve (AUROC) for week 4 HBV pgRNA reduction to predict FHR in HBeAg-positive patients was 0.825 (95% confidence interval [CI], 0.661–0.989). For HBeAg-negative patients, instead of increase in serum HBcrAg in non-FHR patients, FHR patients had median reduction in HBcrAg at week 4 (increment of 1.75 vs. reduction of 2.98 log U/mL; P=0.023). The AUROC for week 4 change of HBcrAg to predict FHR in HBeAg-negative patients was 0.789 (95% CI, 0.596–0.982).
Conclusions Early on-treatment changes of serum HBV pgRNA and HBcrAg at 4 weeks predict HBsAg seroclearance or ≤100 IU/mL in NA-treated CHB patients upon long-term FU.
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Over the past several decades, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) have remained the first-line antiviral agents in several international guidelines. These two antiviral agents have shown similar short to intermediateterm efficacy, including virologic, biochemical, serologic, and histologic responses. However, huge controversies regarding the antiviral efficacy of ETV and TDF in preventing the development of hepatocellular carcinoma (HCC) still exist. In this review, we summarized recent studies that compared the treatment efficacy of ETV and TDF in terms of HCC development.
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There is some dissatisfaction with the term “nonalcoholic fatty liver disease (NAFLD),” which overemphasizes alcohol and underemphasizes the importance of metabolic risk factors in this disease. Recently, a consensus recommended “metabolic (dysfunction)-associated fatty liver disease (MAFLD)” as a more appropriate term to describe fatty liver diseases (FLD) associated with metabolic dysfunction. During the definition change from NAFLD to MAFLD, subjects with FLD and metabolic abnormalities, together with other etiologies of liver diseases such as alcohol, virus, or medication who have been excluded from the NAFLD criteria, were added to the MAFLD criteria, while subjects with FLD but without metabolic abnormality, who have been included in the NAFLD criteria, were excluded from the MAFLD criteria. This means that there is an emphasis on the metabolic dysfunction in MAFLD which may underestimate the prognostic value of hepatic steatosis itself, whereas the MAFLD criteria might better identify subjects who are at a higher risk of hepatic or cardiovascular outcomes. However, non-metabolic risk NAFLD subjects who are excluded from the MAFLD criteria are missed from the diagnosis, and their potential risk can be the cause of future diseases. Although huge controversies remain, this review focused on summarizing recent studies that compared the clinical and prognostic characteristics between subjects with NAFLD and MAFLD.
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Clin Mol Hepatol 2016;22(3):366-371. Published online September 25, 2016
Background/Aims The relationship between patient survival and biopsy-proven acute rejection (BPAR) in liver transplant recipients with hepatitis C remains unclear. The aims of this study were to compare the characteristics of patients with and without BPAR and to identify risk factors for BPAR.
Methods We retrospectively reviewed the records of 169 HCV-RNA-positive patients who underwent LT at three centers.
Results BPAR occurred in 39 (23.1%) of the HCV-RNA-positive recipients after LT. The 1-, 3-, and 5-year survival rates were 92.1%, 90.3%, and 88.5%, respectively, in patients without BPAR, and 75.7%, 63.4%, and 58.9% in patients with BPAR (P<0.001). Multivariate analyses showed that BPAR was associated with the non-use of basiliximab and tacrolimus and the use of cyclosporin in LT recipients with HCV RNA-positive.
Conclusions The results of the present study suggest that the immunosuppression status of HCV-RNA-positive LT recipients should be carefully determined in order to prevent BPAR and to improve patient survival.
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Laparoscopic liver resection (LLR) is becoming widely accepted for the treatment of hepatocellular carcinoma (HCC). Laparoscopic left lateral sectionectomy and minor laparoscopic liver resection are now considered standard approaches, especially for tumors located in the anterolateral segments of the liver. Laparoscopic left lateral sectionectomy in adult donors is also gaining acceptance for child liver transplantation in many centers. Major LLRs, including left hepatectomy and right hepatectomy, have been recently attempted. Laparoscopic donor hepatectomy is becoming more popular owing to increasing demand from young living donors who appreciate its minimal invasiveness and excellent cosmetic outcomes. Several centers have performed total laparoscopic donor right hepatectomy in adult-to-adult living donor liver transplantation. Many meta-analyses have shown that LLR is better than open liver resection in terms of short-term outcomes, principally cosmetic outcomes. Although no randomized control trials have compared LLR with open liver resection, the long-term oncologic outcomes were similar for both procedures in recent case-matched studies.
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Backgrounds/Aims The purpose of this study was to evaluate the cost-effectiveness of 1 year and up to 5 years of antiviral treatment for chronic hepatitis B (CHB). Methods: Two ten-health-state Markov models were developed for CHB patients. The proportion of patients remaining alive in each health state, and healthcare costs and quality-adjusted life years (QALYs) were determined during annual cycles of these Markov models. The total healthcare costs, life years, and QALYs over the 40-year time horizon of the model were calculated. The perspectives of the cost-effectiveness analysis were the Korean healthcare system and the healthcare needs of the CHB patient. Results: Short-course therapy with α-interferon or 1-year treatment with pegylated interferon α-2a, lamivudine (LMV), or adefovir (ADV) had limited impact on disease progression. In contrast, either LMV-ADV or ADV-LMV as rescue medication administered for 5 years resulted in a more sustained decrease in the rate of disease progression. The cost-effectiveness threshold in Korea was estimated to be approximately 25,000,000 South Korean won. LMV administered for 1 year is cost-effective in comparison with no treatment for both HBeAg-positive and HBeAg-negative CHB patients, but longer duration antiviral therapies administered for up to 5 years in CHB patients were found to be highly cost-effective by international standards. Conclusions: Antiviral treatment of CHB with LMV or ADV for up to 5 years using the alternative antiviral agent as rescue medication appears to be a cost-effective strategy for both HBeAg-positive and HBeAg-negative CHB patients in Korea. Economic evaluation of antiviral therapies should be studied further and updated, particularly for newer agents. (Korean J Hepatol 2008;15: 25-41)
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Virologic Response to Therapy Increases Health-Related Quality of Life for Patients With Chronic Hepatitis B Jeong Han Kim, So Young Kwon, Young Sok Lee, Joon Hyoek Lee, Yil–Seob Lee, Chang Hong Lee Clinical Gastroenterology and Hepatology.2012; 10(3): 291. CrossRef
A tool for communication with decision-makers: limitations and utilization of studies on cost of illness Kun-Sei Lee The Korean Journal of Hepatology.2011; 17(4): 258. CrossRef
Cost-Effectiveness of Switching to Biphasic Insulin Aspart 30 from Human Insulin in Patients with Poorly Controlled Type 2 Diabetes in South Korea Kyoung Hee Lee, Se Jin Seo, Jayne Smith-Palmer, James L. Palmer, Jeremy White, William J. Valentine Value in Health.2009; 12: S55. CrossRef
Ki Tae Yoon, M.D.1,2, Jong Won Choi, M.D.1,2, Jun Yong Park, M.D.1,2,
Sang Hoon Ahn, M.D., Ph.D.1,2, Yong Han Paik, M.D., Ph.D.1,2, Kwan Sik Lee, M.D., Ph.D.1,2,
Kwang Hyub Han, M.D.1,2, Chae Yoon Chon, M.D.1, Do Young Kim, M.D.1,2
Korean J Hepatol 2008;14(3):360-370. Published online September 30, 2008
Background/Aims Advanced hepatocellular carcinoma (HCC) with multiple lung metastases has a poor
prognosis with no effective treatment having been established. This study evaluated the outcomes of systemic
chemotherapy for advanced HCC with multiple lung metastases. Methods: Between January 2000 and
December 2006, 68 patients were diagnosed with HCC presenting with multiple lung metastases. Sixteen
patients in the terminal stage, such as Child-Pugh grade ‘C’ or an Eastern Cooperative Oncology Group
performance status exceeding grade 2, were excluded from the analysis. The following treatment modalities
were applied: 26 patients received primary tumor treatment (transarterial chemoembolization or intra-arterial
chemotherapy) with systemic chemotherapy, 10 patients received primary treatment only, 8 patients received
systemic chemotherapy only, and 8 patients received highly supportive care. The treatment responses and
median survival times for the modalities were analyzed and compared. Results: The median age of the 52
analyzed patients (45 males) was 52.4 years. The most common etiology of HCC was chronic hepatitis B virus
infection (n=44, 84.6%) followed by hepatitis C virus infection (n=2, 3.8%), with the etiology being unknown
in 6 cases (11.5%). The treatment modality had no significant effect on the treatment response rate (P=0.432)
or median survival time (133, 66, 74, and 96 days for primary tumor treatment with systemic chemotherapy,
primary tumor treatment only, systemic chemotherapy only, and highly supportive care, respectively; P=0.067).
Conclusions We found that systemic chemotherapy was not effective in treating HCC presenting with
multiple lung metastases. Improving the effectiveness of systemic treatment and selecting patients who would
benefit from such treatment remains a major challenge. (Korean J Hepatol 2008;14:360-370)
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Arsenic trioxide intravenous infusion combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with pulmonary metastasis: Long‐term outcome analysis Hong Tao Hu, Quan Jun Yao, Yan Li Meng, Hai Liang Li, Hao Zhang, Jun Peng Luo, Chen Yang Guo, Xiang Geng Journal of Gastroenterology and Hepatology.2017; 32(2): 295. CrossRef
A novel benzimidazole derivative, MBIC inhibits tumor growth and promotes apoptosis via activation of ROS-dependent JNK signaling pathway in hepatocellular carcinoma Xiaoyun Dai, Lingzhi Wang, Amudha Deivasigamni, Chung Yeng Looi, Chandrabose Karthikeyan, Piyush Trivedi, Arunachalam Chinnathambi, Sulaiman Ali Alharbi, Frank Arfuso, Arunasalam Dharmarajan, Boon Cher Goh, Kam Man Hui, Alan Prem Kumar, Mohd Rais Mustafa, Oncotarget.2017; 8(8): 12831. CrossRef
Subclassification of Barcelona Clinic Liver Cancer B and C hepatocellular carcinoma: A cohort study of the multicenter registry database Sangheun Lee, Beom Kyung Kim, Kijun Song, Jun Yong Park, Sang Hoon Ahn, Seung Up Kim, Kwang‐Hyub Han, Do Young Kim Journal of Gastroenterology and Hepatology.2016; 31(4): 842. CrossRef
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Background/Aims Hepatitis C virus (HCV)-associated cirrhosis is an increasingly frequent indication for liver transplantation (LT). However, HCV recurrence is universal and this immediately occurs following LT, which endangers both the graft and patient survival. We investigated the frequency of posttransplant recurrence of HCV infection and the patient-graft survival, and we analyzed the responses to ribavirin and interferon therapy in the patients with recurrent HCV infection after living donor liver transplantation (LDLT). Methods: We retrospectively reviewed the clinical outcomes of 39 HCV-associated cirrhosis patients who underwent LDLT at Asan Medical Center between August 1992 and June 2006. In this study, the diagnosis of recurrent HCV was made on the basis of increased transaminases and serum HCV RNA levels greater than 10 million IU/mL because protocol liver biopsy was not performed. Results: HCV recurrence was seen in 26 of the 39 LDLT patients (66.7%). 86.7% of recurrence occurred within the first postoperative year. Antiviral treatment was used for all patients with recurrence of HCV. None of the 10 patients receiving ribavirin alone and 9 of 16 patients who received combination therapy with pegylated interferon alpha-2a plus ribavirin became HCV RNA negative and they remained persistently negative during the median follow-up of 24.9 months. Our data indicates that there is no significant factor influencing HCV recurrence except for the recipient`s age. The 2-year patient survival for the HCV patients with HCC and those patients without HCC were 81.2% and 81.3%, respectively (P=0.85) and the 2-year graft survival rates were 81.2% and 68.2%, respectively (P=0.29). No patient died from HCV recurrence during the follow-up period. Conclusions: Combination therapy with ribavirin and interferon appears to improve the outcome of recurrent HCV infected patients after LDLT. (Korean J Hepatol 2007;13:543-555)
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Current Status and Perspectives of Living Donor Liver Transplantation Shin Hwang, Deok-Bog Moon, Sung-Gyu Lee Journal of the Korean Medical Association.2008; 51(8): 700. CrossRef
Review: Clinical Outcome after Living Donor Liver Transplantation in Patients with Hepatitis C Virus-associated Cirrhosis Hyung Joon Kim The Korean Journal of Hepatology.2007; 13(4): 489. CrossRef
Kyung Woo Park, M.D.1, Joong-Won Park, M.D., Tae Hyun Kim, M.D., Jun Il Choi, M.D.,
Seong Hoon Kim, M.D., Hong Suk Park, M.D., Sang Jae Park, M.D., Woo Jin Lee, M.D.,
Hae Lim Shin, M.D.2, and Chang-Min Kim, M.D.
Korean J Hepatol 2007;13(4):530-543. Published online December 20, 2007
Background/Aims We investigated the five-year survival outcomes of a large cohort of hepatocellular carcinoma (HCC) patients who were treated at a single institute, and this is a follow-up study of a previous report. Methods: Nine hundred four HCC patients who were treated at the National Cancer Center Korea were enrolled and they were followed till February 2007. Results: The mean age of the patients was 56.0 years and 731 patients were male. Six hundred seventy-seven (74.9%) patients died and the overall 5-year survival rate (5-YSR) was 23.9%. The 5-YSRs of the patients with modified UICC stage I, II and III were 61.2%, 54.4% and 18.4%, respectively, and the median survival time was 4.3 and 3.7 months for the stage IVa and IVb patients, respectively. For the analysis of the treatment modality, surgical resection showed significantly better outcomes for the five-year survival as compared with transcatheter arterial chemoembolization (TACE) for Child-Pugh A patients with modified UICC stage I or II disease (80.1% vs 52.8%, respectively, P<.001), or stage III disease (60.7% vs 17.0%, respectively, P<.001). For patients with advanced stage IVb disease, TACE, systemic chemotherapy and radiotherapy increased the median survival period more than conservative management for the Child-Pugh class A patients. The serum alpha-fetoprotein level, portal vein tumor thrombosis, the Child-Pugh class, the tumor stage, the tumor type and symptoms were related to the prognosis. Conclusions: This study presented, for the first time, the 5-YSRs of a cohort of HCC patients. (Korean J Hepatol 2007;13:530-542)
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Background/Aims Telbivudine is an L-nucleoside analogue with potent antiviral activity against hepatitis B virus (HBV). Clinical trials have shown that telbivudine is more potent than lamivudine for suppressing virus. Methods: A total 101 Korean patients among 1,367 patients who participated in the phase III GLOBE trial were randomized in this study. All 101 HBeAg positive or HBeAg negative patients were assigned to treatment with 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy endpoint (the "therapeutic response") was defined as suppression of the serum HBV DNA to less than 5 log10 copies/mL coupled with either normalization of the serum alanine aminotransferase level or loss of HBeAg. The secondary endpoints included the histologic response, serum HBV DNA reduction, serum alanine aminotransferase normalization and HBeAg loss for the HBeAg positive patients. This analysis includes the data collected at 52 weeks of treatment. Results: Fifty four of 101 patients were assigned to telbivudine treatment and 47 patients were assigned to lamivudine treatment. At week 52, significantly more patients who were treated with telbivudine than those treated with lamivudine had a therapeutic response (83% vs 62%, respectively, P=0.017), their mean serum HBV DNA levels were more reduced (6.6 vs 5.6 log10 copies/mL, respectively, P=0.027), and they more often achieved PCR-undetectable levels of serum HBV DNA (74% vs 34%, P<0.0001). No virologic resistance to telbivudine was detected (0% vs 18%, respectively, P=0.001). Telbivudine was well tolerated and it had a safety profile comparable to lamivudine. Conclusions: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine. (Korean J Hepatol 2007;13:503-512)
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Korean J Hepatol 2007;13(3):387-395. Published online September 20, 2007
Background/Aims Hepatocellular carcinoma (HCC) with an extension to the inferior vena cava (IVC) or right atrium is uncommon, and its prognosis remains unclear due to the few case reports. In order to elucidate the natural history and treatment outcome, this study investigated advanced HCC patients with an IVC invasion or atrial tumor thrombus. Methods: Between November 1987 and June 2004, a total of 41 patients were diagnosed as having HCC with IVC or right atrial involvement using the new imaging techniques including a two-dimensional echocardiography. Those patients were stratified into the untreated ‘control group’ (n=17) and ‘treated group’ (n=24). The clinical features, treatment outcome and prognosis including patient survival were analyzed. Results: The mean age of the total patients was 55 years (male:female, 33:8). The most common cause of HCC was a hepatitis B virus infection (85.4%), followed by a hepatitis C virus infection (7.4%). According to the Child-Pugh classification, 24 patients were Child-Pugh class A (58.5%), 15 were Child-Pugh class B (36.6%), and 2 were Child-Pugh class C (4.9%). Lung metastases were identified in 10 patients (24.5%). The treatment modalities of the treated group included 11 systemic chemotherapy regimens (5-FU and cisplatin), 10 transarterial chemotherapy regimens, 2 chemoradiation procedures and 1 hepatic resection. The overall survival was 3.0 months (range, 1-29 months). The 6 month survival rate was 23.5% (4/17) in the control group and 29.2% (7/24) in the treated group. The 12 months survival rate was 0% (0/17) and 25.0% (6/24), respectively. Independent prognostic factor affecting the survival was whether or not any treatment had been carried out. Conclusions: Although the prognosis of advanced HCC with IVC invasion or a right atrial tumor thrombi is poor, treatment might improve the survival rate. (Korean J Hepatol 2007;13: 387-395)
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Korean J Hepatol 2007;13(3):378-386. Published online September 20, 2007
Background/Aims The treatment efficacy for advanced hepatocellular carcinoma is poor. This study examined the efficacy and toxicity of 3-dimensional conformal radiotherapy (3D-CRT) in combination with transarterial chemolipiodolization (TACL) for a huge hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). Methods: From March 2001 to November 2004, 49 patients with advanced HCC with PVTT (size>8 cm, modified UICC stage IVa) were enrolled in this retrospective study. Twenty two patients underwent more than 2 cycles of TACL (adriamycin 50 mg/m2, cisplatin 60 mg/m2, 5-fluorouracil 200 mg/m2 every 4-6 weeks) without 3D-CRT, while 27 patients underwent consecutive TACL with 3D-CRT (40-45 Gy for 4-5 weeks) that was started one week after the 1st TACL. The response was assessed by a computed tomography (CT) and the serum alpha-fetoprotein (AFP) level at 1-2 month intervals. Results: The objective response rates in the TACL group and TACL with 3D-CRT group were 18% and 48% at 3 months (P=0.051), and 10.5% and 42% at 6 months (P=0.024) respectively. The median survival time was 13 months and 13.5 months in TACL and TACL with 3D-CRT groups, respectively (P=0.502). The treatment response was better in the TACL with 3D-CRT group but there was no significant difference in survival between the two groups. Most toxicities in the two groups were mild, not exceeding grade 1 according to the WHO criteria. Conclusions: For patients with a huge HCC with PVTT, TACL with 3D-CRT achieved some meaningful clinical benefit. Prospective controlled trials will be needed to confirm the real benefit of TACL combined with 3D-CRT. (Korean J Hepatol 2007;13:378-386)
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Sang Hoon Ahn, M.D., Kwang-Hyub Han, M.D., Young Hoon Youn, M.D.,Myoung Hwan Kim, M.D.,
Kun Hoon Song, M.D., Kwan Sik Lee, M. D., Chae Yoon Chon, M.D., Young Myoung Moon, M.D.,
Do Yun Lee, M.D.* and Jong Tae Lee, M.D.*
Background/Aims The study proposed to evaluate the efficacy of anticancer drugs of intraarterial chemoinfusion and investigate prognostic factors influencing survival. Methods: A total of 127 patients diagnosed as having advanced hepatocellular carcinoma(HCC) of same stage (TNM stage IVa) from 1996 to 1998 were examined. Two intraarterial infusion chemotherapeutic regimens were employed: Adriamycin(Group I) and Cisplatin(Group II). Results: Overall survival was significantly diffrent(10.0 vs 5.7months) and favored Group I. By the univariate analysis, significant prognostic factors included: age, portal vein thrombosis(PVT), size(>5cm) and type of tumor, response rate (size & -fetoprotein) at 3 months after therapy, level of albumin, alkaline phosphatase, and total bilirubin. After repeated therapy, Group I showed better survival (14.0 vs 7.9 months), but there was no statistical difference in survival rate between two groups in the case of large size, PVT, and diffuse type. Conclusion: Group I showed better survival than Group II in advanced HCC of TNM stage IVa. But, considering prognostic factors, there was no significant difference in survival rate between two groups except small size or nodular type of HCC. TNM classification of stage IVa should be reconsidered to include prognostic factors influencing survival rate such as PVT, size and type of HCC.
Background/Aims Recently, acute toxic liver injury has been reported to be the most common cause of acute hepatitis. The frequency and clinical manifestations of acute toxic liver injury was evaluated. Methods: The medical records of 68 patients demonstrating clinically significant acute toxic liver injury were retrospectively reviewed. Patients with mild biochemical abnormalities were excluded. Results: The annual retrospectively reviewed. Patients with mild biochemical abnormalities were excluded. Results: The annual percentage of toxic liver injury ranged from 50% to 90% among acute hepatitis groups. Among the causes, prescribed drugs (group D) accounted for 55%, herbs or plant products (group H) for 42% and both accounted for 3%. Antibiotics and anti-inflammatory drugs were the most common agents (78%) among group D. The mean age of the patients was 43 and 70% of patients were female. Of the population, common symptoms were jaundice, weakness, fatigue, and nausea. Initial ALT and AST levels were 847 879 and 664 625 IU/L, and initial total bilirubin was 7.5 8.1 ㎎/dL. Acute toxic liver injury occurred after a mean of 32 days after first exposure. Liver injury resolved within a mean of 32 days. Hepatocellular, mixed, and cholestatic type was 45.2%, 32.3%, 22.5%, respectively. Conclusions: Recently, acute toxic liver injury has been the most common cause of acute hepatitis in Korea. Prescribed drugs and herbs or plant products are equally important etiologic agents of toxic liver injury. However, etiologic difference may not affect clinical courses or outcomes. A nationwide investigation of the hepatotoxicity of drugs, herbs or other plant products is required. (Korean J Hepatol 2004;10:125-134)
Background/Aims Combination therapy with peginterferon and ribavirin is a standard therapy for western patients with chronic hepatitis C; however, its efficacy remains unclear in East Asian patients. We evaluated the efficacy and safety of administering peginterferon alfa-2a plus ribavirin in native Korean patients with chronic hepatitis C. Methods: Seventy-five patients with detectable HCV RNA (52.0% male, median age: 50.8 years) were eligible for the study. The patients were treated with peginterferon alfa-2a 180 mcg/week plus ribavirin 800 mg/day for 24 weeks (for genotype non-1, n=46) or 1000-1200 mg/day for 48 weeks (for genotype 1, n=29). The early virologic response (EVR), the end of treatment virologic response (ETVR), the sustained virologic response (SVR), the biochemical response and the adverse event were analyzed. Results: EVR was seen in 86.2% of the patients with genotype 1. The ETVR was 58.6% in the genotype 1 group and 84.8% in the genotype non-1 group (P=0.02). The overall SVR was 70.7%: 55.2% in the genotype 1 group and 80.4% in the non-1 group (P=0.04). The sustained biochemical response was 64.0%. Multivariate analysis showed that the baseline HCV RNA level (Odds ratio: 0.045, 95% CI: 0.011-0.183, P<0.001) and genotype (Odds ratio: 0.247, 95% CI: 0.063-0.969, P=0.045) had an independent effect on the SVR. Neutropenia, anemia, flu-like symptoms and itching were the common adverse events. Aggravated liver function led to discontinuation of therapy for six patients. Dose modification in twenty-nine patients was effective without producing a significant reduction of the SVR. Conclusions: Our data suggest that the efficacy of peginterferon plus ribavirin therapy in Koreans is comparable to those from studies on Western patients as an initial treatment for chronic hepatitis C patients. The baseline HCV RNA level and the genotype can be significant factors influencing the SVR. (Korean J Hepatol 2006;12:31-40)
Jeong Chul Seo, M.D., Won Joong Jeon, M.D., Sung Soon Park, M.D., Seok Hyung Kim, M.D.1,
Ki Man Lee, M.D., Hee Bok Chae, M.D., Seon Mee Park, M.D. and Sei Jin Youn, M.D.
Background/Aims Although many individual cases of toxic hepatitis have been reported in Korea, there are few comprehensive systematic studies on acute toxic hepatitis. The first aim of this study is to investigate the frequency and clinical characteristics of acute toxic hepatitis patients. The second aim of this study is to investigate the efficacy of steroid therapy for immunoallergic idiosyncrasy. Methods: Between March 1998 and March 2004 forty eight patients were included in this study. The medical records were reviewed retrospectively. Acute toxic hepatitis was diagnosed by score of more than 3 in RUCAM criteria. All the patients were tested for hepatitis A, B and C. Other tests included antibodies to CMV and EBV, ANA, AMA and SMA. Results: Seventy-three percent of the patients were female and the mean age of the patients was 47. Twenty cases of acute toxic hepatitis (42%) were related to prescribed medications. The other causes were herbs (35%) and traditional therapeutic preparations (23%). Common symptoms were jaundice (35%), fatigue (10%), fever (9%) and abdominal pain (9%). The biochemical pattern of hepatotoxicity was divided into three groups: hepatocellular (81%), mixed (13%), and cholestatic types (6%). Three patients who have prolonged and severe jaundice were classified into immunoallergic idiosyncrasy based upon clinical and histologic findings. Prednisolone was prescribed in all three cases whose bilirubin levels had been higher than 15 mg/dL for at least 7 days. Jaundice and the laboratory findings rapidly improved within 8 days since the treatment began. Conclusions: In a demographic point of view, most patients of acute toxic hepatitis were middle aged women. Jaundice was the most commonly observed symptom. Prescribed drugs were the most common cause of acute toxic hepatitis. Although most cases of toxic hepatitis will recover with supportive care after cessation of the causative agent, steroid treatment may be helpful for the patients with severe jaundice patients who have immunoallergic idiosyncrasy. (Korean J Hepatol 2006;12:74-81)
Nae Yun Heo , Young Suk Lim , Jeong Min Kang , Se Il Oh , Chan Sun Park , Seok Won Jung , Yoon Sun Lee , Kang Mo Kim , Han Chu Lee , Young Hwa Chung , Yung Sang Lee ,
Background/Aims: Striking geographic differences have been noted in the etiology of fulminant hepatic failure (FHF). The prognosis of patients with FHF who do not receive liver transplantation in a timely manner is quite dismal. This study intended to identify the etiology and outcome of FHF in Korean adults and to examine the role of urgent living-donor liver transplantation (LDLT) for treating this unique situation. Methods: We identified all the adult FHF patients who were referred to our unit between 1999 and 2004. FHF was defined as severe acute hepatitis complicated by the rapid development of hepatic encephalopathy within 8 weeks of the initial symptoms in the patients without a previous history of liver disease. Results: One hundred fourteen patients (47 males and 67 females) were identified. The mean age was 39.5±15.3 years. Drugs were the most common cause (28.1%) of FHF (herbal medications, 9.6%), and acute viral infection accounted for 23.7% (HBV accounted for 15.8%). Indeterminate etiologies were noted in 34%. The 90-day survival rate of the nontransplant group was only 15%. Fourteen patients received liver transplants (13 right- lobe LDLT, 1 cadaveric whole liver), and 12 of these (85.7%) survived and showed good graft function during 22 months of median follow-up. Conclusions: Although the causes of FHF in Korea were diverse, HBV infection and herbal medications were responsible for a significant proportion of the cases. Since urgent LDLT improved the overall survival rate of patients with FHF, this should be considered as an important treatment option for patients suffering with FHF. (Korean J Hepatol 2006;12:82-92)
Background/Aims: Lamivudine is an effective therapy in chronic hepatitis B patients, but the emergence of resistant hepatitis B virus (HBV) mutants is a major concern. This study was performed to investigate whether serum viral DNA levels during lamivudine therapy are related with viral breakthrough in patients with chronic HBV infection. Methods: This study consisting of 103 patients was performed retrospectively and prospectively. Follow-up duration was 24 months after lamivudine therapy. Serum HBV DNA levels were quantified by PCR-based assay every 6 months. Results: Cumulative rate of viral breakthrough was 0%, 19.4%, 36%, and 48.5% in 6, 12, 18, and 24 months respectively. The rate of viral breakthrough in 24 months increased as serum HBV DNA levels increased at 6 months. When serum HBV DNA levels were 2-3 log10, 3-4 log10, 4-5 log10, and 5 log10 copies/mL or more, the breakthrough rates were significantly higher than that of the HBV DNA level less than 2 log10 copies/mL. The relative risks were 1.10, 1.93, 2.69, 3.21 respectively (P<0.001). The viral breakthrough rate also increased as serum HBV DNA levels at 12 months increased. When the HBV DNA levels were 2-3 log10, 3-4 log10, 4-5 log10, and 5 log10 copies/ mL or more, the breakthrough rate were significantly higher than those of HBV DNA level less than 2 log10 copies/mL. The relative risks were 2.42, 4.35, 3.73, 2.61, respectively (P=0.002). Conclusions: The serum HBV DNA levels at 6 months and 12 months during lamivudine therapy can be closely correlated with the rate of viral breakthrough in 24 months. (Korean J Hepatol 2006;12:173-183)
Backgrounds/Aims: Continuation of lamivudine therapy is controversial for patients with chronic hepatitis B when viral breakthrough occurs. Moreover, the effect of continuous lamivudine therapy is unknown in patients with acute exacerbation after viral breakthrough. We assessed clinical course of acute exacerbation after viral breakthrough in patients who continued and discontinued lamivudine therapy. Methods: Medical records of 109 patients with viral breakthrough during lamivudine therapy were reviewed. Of 40 patients with acute exacerbation (ALT level >5×ULN), adefovir dipivoxil was unavailable in 38 patients. These 38 patients (mean age 42.6 years; male/female, 34/6) were divided into continuation (n=21) and discontinuation (n=17) groups. Clinical courses of the 2 groups were compared. Results: During follow- up period (mean, 27 months; range, 6-60 months), ALT levels decreased to <2×ULN in 11 patients (52%) of continuation group and 9 patients (53%) of discontinuation group, varied from 2× to 5×ULN in 9 (43%) and 5 (29%), respectively, and increased to >5×ULN in 1 (5%) and 3 (18%), respectively, with no statistical significance (P=.417). Conclusions: When acute exacerbation of ALT levels occurs after viral breakthrough during lamivudine administration in patients with compensated chronic hepatitis B, continuation of lamivudine may have no advantage over discontinuation. (Korean J Hepatol 2006;12:184-190)
Backgrounds/Aims: The prognosis of cirrhotic patients with hepatocellular carcinoma (HCC) depends on both residual liver function and tumor characteristics. The aims of this study was to construct a new prognostic index for HCC patients: the modified CLIP score, and to compare its discriminatory ability and predictive power with those of the CLIP score that is currently the most commonly used integrated staging score in patients of HCC. Methods: A retrospective analysis of 237 cases of HCC diagnosed at Dong-A university hospital was performed. Prognostic analysis was performed for single variables by estimating survival distributions with the Kaplan-Meier’s method, and statistically compared by the log-rank test. Results: Patients had a mean age of 57.5 years and were predominantly males (79.7%). The overall median survival period was 25.7 months. It was correlated to ascites, portal vein thrombosis, AFP, tumor size, and Child-Pugh classification. The median survival period was 41.0, 25.2, 13.8, 13.4, and 6.5 months for CLIP scores 0, 1, 2, 3, and 4 to 6, respectively (P<0.001), and 42.1, 34.0, 25.7, 14.0, and 6.8 months for modified CLIP scores 0, 1, 2, 3, and 4 to 6, respectively (P<0.001). The Kaplan-Meier’s curve showed that the modified CLIP score had additional explanatory power above that of the CLIP score. Conclusions: The modified CLIP score, compared with the CLIP score, particularly in the score 2- to 3- patient groups of HCC, had greater discriminant ability and survival predictive power, but was not able to discriminate 4- to 6- patient group. (Korean J Hepatol 2006;12:209-220)
Background/Aims The Barcelona Clinic Liver Cancer (BCLC) classification offers a prognostic stratification of patients with hepatocellular carcinoma (HCC). We recently demonstrated the BCLC’s peculiar prognostic ability in a retrospective cohort of HCC patients. The aim of this study was to evaluate the BCLC system prospectively in a subsequent separate group of HCC patients enrolled at the same surgically oriented liver unit. Methods: One hundred and ninety- five consecutive HCC patients were prospectively enrolled and their liver disease was staged before therapy. Unlike the BCLC treatment protocol, nodule size and number were not used as absolute exclusion criteria for radical treatment. Predictors of survival were identified using the Cox model. Results: The median survival time was 23 months overall, and 53, 16, 7 and 3 months, respectively, for BCLC categories A, B, C, and D. In our cohort, BCLC had the best independent predictive power for survival when compared with the Okuda, CLIP, UNOS-TNM, and JIS prognostic systems (linear trend χ2=43.01, likelihood χ2=57.94, AIC 885.98). Moreover, the BCLC classification showed a better prognostic ability than the AJCC-TNM 2002 system in surgical patients. Conclusions: The discriminating power of BCLC staging was prospectively assessed in an Italian cohort of HCC patients treated mainly with radical therapies. [Abstract reproduced by permission of J Hepatol 2006;44:723-31]
Background/Aims Gastric variceal bleeding is a severe complication of cirrhosis, and it has a high mortality rate. This study was conducted to evaluate the efficacy of n-butyl-2-cyanoacrylate injection therapy for patients suffering with gastric variceal bleeding. Methods: A total of 86 patients diagnosed with gastric variceal bleeding underwent endoscopic n-butyl-2-cyanoacrylate (HistoacrylⓇ) injection therapy at our department between April, 2002 and July, 2005, with a mean follow-up period of 44 weeks (range: 2 to 136 weeks). The initial hemostasis rate and the rebleeding rate of endoscopic sclerotherapy were analyzed. Also, the cumulative survival rate was analyzed according to the status of hepatocellular carcinoma and hyponatremia, the MELD score, the Child-Pugh score and the amount of injected HistoacrylⓇ. Results: The initial hemostasis rate of HistoacrylⓇ injection therapy was 93% and the 1 month rebleeding rate was 16.1%. The total number of session for treating the initial hemostasis was 1.2±0.4 and the total volume of HistoacrylⓇ was 2.7±1.2 mL. The cumulative rebleeding-free rates for the patients treated by the HistoacrylⓇ injection method at 1 month, 12 months and 34 months period were 95.1%, 83.2% and 74%, respectively. The cumulative survival rates were 78.3% at 1 month, 61.9% at 12 months and 54.6% at 34 months, respectively. No thromboembolic phenomenon occurred. According to the Cox’s proportional hazards analysis, only the MELD score (<15) was an independent predicting factor for survival of the patients with gastric variceal bleeding. Conclusions: Endoscopic sclerotherapy using n-butyl-2-cyanoacrylate was a safe and effective hemostatic method for patients with gastric variceal bleeding. Also, the MELD score (<15) contributed to predicting survival of the patients with gastric variceal bleeding.
Background/Aims Sclerosing hepatocellular carcinoma (HCC) is an unusual subtype of HCC that is
characterized by an embedded dense fibrous stroma in the tubular neoplastic structures. We aimed to
assess the surgical approaches and outcomes of sclerosing HCC. Methods: We retrospectively analyzed
the clinicopathologic features of 6 patients with sclerosing HCC who underwent surgical treatment at Asan
Medical Center between July 1989 and December 2005. Results: Six HCC patients with sclerosing HCC were
diagnosed out of the total 1390 HCC patients (0.43%) during the study period. The mean age was 58 years and
4 patients were male. Weight loss and abdominal pain were the most common symptoms. The serum calcium
and phosphorus levels were normal in all the patients. All of them were hepatitis B surface antigen-positive,
but none was positive for hepatitis C. All the lesions were solitary. The tumor size ranged from 45 to 150 mm
in diameter (median size: 81 mm). We performed right trisegmentectomy (n=1), central bisegmentectomy (n=1),
right anterior segmentectomy (n=1), ex-vivo resection and autotransplantation (n=1) and right posterior
segmentectomy (n=2). The median overall survival and disease free-survival periods were 24 months and 9.5
months, respectively. Conclusions: The incidence of sclerosing HCC was very low. Sclerosing HCC was often
not correctly diagnosed before an operation, but performing resection prolonged the patients’ survival and their
prognosis was not worse than that for ordinary HCC. Our experience implicates that aggressive surgical
treatment for sclerosing HCC is beneficial for patient survival. (Korean J Hepatol 2006;12:412-419)
Adefovir dipivoxil (ADV) is effective in the treatment of chronic hepatitis patients with wild type and lamivudine-resistant hepatitis B virus. The occurrence of viral resistance to long-term adefovir therapy is rare, the cumulative rates of resistance were 0%, 3%, 11%, 18%, and 28% at 1, 2, 3, 4, and 5 years of therapy, respectively. The emergence of adefovir resistant mutant in patients with lamivudine resistance is more common than in treatment-naive patients. Two major mutations of adefovir resistance are rtN236T and rtA181V/T. Other mutations in the HBV polymerase (rtP237H, rtN238T/D, rtV84M, rtS85A, rtV214A, rtQ215S) reduce sensitivity to adefovir, but the significance of these mutations is unclear. The adefovir mutations slightly decrease adefovir susceptibility in vitro, suggesting mild clinical course after the occurrence of adefovir resistance. However, some patients show viral rebound and hepatic decompensation. Lamivudine, entecavir, and tenofovir are used currently for salvage therapy in patients with adefovir resistance. To reduce adefovir resistance, combination therapy with adefovir and lamivudine in patients with lamivudine resistance may be a treatment option. (Korean J Hepatol 2006;12:484-492)
Background/Aims There are many models for predicting prognosis of liver cirrhosis including Child
Turcotte Pugh (CTP), the model for end-stage liver disease (MELD) score and its changes over time (ΔCTP
and ΔMELD/month). We investigated the ability of these models to predict the mortality of liver cirrhosis
patients with the first episode of variceal bleeding and which model can be usefully applied in practice.
Methods Seventy-one liver cirrhosis patients hospitalized for the first episode of esophageal variceal bleeding
were retrospectively analyzed. The predictive power of initial CTP, MELD score, ΔCTP and ΔMELD/month
was compared through c-statistics and multiple logistic regression. Results: All of the prognostic predictors
measured higher in patients who survived than in those who died. The area under the receiver operating
characteristic (ROC) curve for ΔMELD/month in 6 months was 1, a higher value than 0.81 for initial CTP,
0.75 for initial MELD, and 0.84 for ΔCTP/month; the area of ΔMELD/month in 12 months was 0.81, also
showing a higher value than others. ΔMELD/month > 0.27 was a strong significant prognostic predictor in 6
(odds ratio: 40.1, p=0.001) and 12 months (odds ratio: 14.1, p<0.001). Only the ΔMELD/month was an
independent prognostic predictor with a risk ratio of 1.604 (95% CI: 1.119-2.302, p=0.01) in 6 months and 1.627
(95% CI: 1.294-2.047, p<0.001) in 12 months. Conclusions: The ΔMELD/month is superior to initial CTP,
MELD and ΔCTP/month to predict 6 and 12 months mortality in liver cirrhosis patients with the first episode
of variceal bleeding. (Korean J Hepatol 2007;13:51-60)
Kee Sup Song, M.D., Min Ju Kim, M.D., Chang Soo Jang, M.D., Hyuk Sang Jung, M.D.,
Hyun Hee Lee, M.D., Oh Sang Kwon, M.D., Yun Soo Kim, M.D., Duck Joo Choi, M.D.,
Ju Hyun Kim, M.D., Seung Yeon Ha, M.D.1
Background Most patients with acute viral hepatitis A (AVHA) spontaneously recover, but a few patients
experience complications. This study was carried out to examine clinical features of AVHA complicated with
acute renal failure (ARF). Method: Medical records of 404 patients with AVHA were reviewed. Clinical
features of AVHA patients with ARF (group A) were compared with those of AVHA patients without ARF
(group B). Result: ARF complication was present in 11 patients (3%). There were no differences between
group A and B in sex ratio and age. Microscopic hematuria (7 cases), proteinuria (7 cases), metabolic acidosis
(4 cases), oliguria (4 cases), pulmonary edema (3 cases) and hyperkalemia (2 cases) were found in group A.
The prevalence of heavy alcohol drinking (64% vs 3%, p<0.001) and diabetes mellitus (18% vs 1%, p=0.01) was
higher in group A than B. The peak value of ALT (median: 4,290 IU/L vs 1,266 IU/L, p=0.006) and total
bilirubin (median: 10.8 mg/dL vs 6.0 mg/dL, p=0.001) was higher in group A than B. Duration of admission
was longer in group A than B (median: 14 days vs 5 days, p<0.001). Four patients of group A recovered with
renal replacement therapy, while 7 patients recovered with conservative treatment. Conclusions: The AVHA
patients with ARF experienced more severe hepatitis than those without ARF, but they had a good prognosis
with the proper treatment. (Korean J Hepatol 2007;13:166-173)
Background/Aims The aims of this study were to validate the prognostic value of the JIS score for HCC
and to compare discriminatory ability and predictive power with other staging systems such as Okuda, TNM
and CLIP. Methods: We analyzed the clinical records of 210 patients who were diagnosed as HCC from 2000
to 2002. Univariate and multivariate survival analyses were done to find out factors to affect survival. To
validate prognostic value of those staging systems, survival curve was obtained and analyzed by the
Kaplan-Meier’s method, and to compare discriminatory ability and predictive power, Homogeneity LR X2 test
and AIC score were used. Results: The median survival was 19.5 months (19.1±14.9). The number of patients
and 3-year survival rate for those staging systems were Okuda 1(126, 57.7%), 2(63, 9.0%) and 3(21, 0.0%)
(p<0.001); TNM I (34, 63.1%), II (71, 59.4%), III (50, 22.4%), IV-A (6, 14.3%) and IV-B (1, 6.5%) (p<0.001);
CLIP 0 (79, 68.5%), 1 (39, 34.2%), 2 (36, 16.7%), 3 (25, 20.0%), 4 (18, 5.1%), 5 (9, 11.1%) and 6 (4, 0.0%)
(p<0.001) and JIS 0 (26, 78.9%), 1 (65, 65.3%), 2 (43, 21.9%), 3 (40, 25, 8.0%) and 5 (11, 2.0%)(p<0.001) in
univariate analysis using Kaplan-Meier analysis. Homogeneity LR X2 test showed more stratification power in
JIS (Okuda, 102.8; TNM, 128.2; CLIP, 148.4 and JIS, 185.6) and AIC score showed superior predictive power
in JIS system (Okuda, 1228.5; TNM, 1130.3; CLIP, 1117.1 and JIS, 1093.6). Conclusions: The proposed JIS
system is useful system to predict survival of HCC patients. The discriminate ability of the JIS score is much
better than other staging systems and has better prognostic predictive power compared to other staging
systems. (Korean J Hepatol 2007;13:196-207)
Backgrounds/Aims Although the survival rate after surgical resection of peripheral cholangiocarcinoma is
low, surgical resection is only potentially curative therapy. The aim of this study is to evaluate
clinicopathological factors affecting survival after surgical resection of peripheral cholangiocarcinoma. Methods:
Between February 1990 and December 2005, surgical intervention with curative intent was performed on 318
patients and 292 patients underwent resection. We retrospectively analyzed survival data of 318 patients and
clinicopathological factors affecting survival by reviewing the medical record. Results: Among the 292 cases
of resection, curative resection with tumor-free margin (R0) has been resulted in 221 cases. The 1-, 3-, 5- and
10-year survival rate of R0 resection were 74.9, 46.9, 36.9 and 15.2%, respectively. The survival rate of patient
undergoing R0 resection was significantly better than that of R1, R2 or nonresection. Multivariate analysis
showed that curative resectability, macroscopic type of tumor and lymph node metastasis were statically
significant independent prognostic factors. Conclusions: The survival after surgical resection of peripheral
cholangiocarcinoma depends on curability of surgical resection, macroscopic type of tumor and status of lymph
node. Particullary in R0 resection for intraductal growth type without lymph node metastasis, there is great
chance for long-term survival. Surgical resection attaining tumor free margin should be attempted if liver
function and general condition of patient are acceptable for hepatectomy. (Korean J Hepatol 2007;13:208-221)
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