Background/Aims Despite the disproportionally high prevalence rates of hepatitis C virus (HCV) amongst the incarcerated population, eradication remains challenging due to logistic and financial barriers. Although treatment prioritization based on disease severity is commonly practiced, the efficacy of such approach remained uncertain. We aimed to compare the impact of unrestricted access to direct-acting antiviral (DAA) among incarcerated HCV-infected patients in Singapore.
Methods In this retrospective study, we reviewed all incarcerated HCV-infected patients treated in our hospital during the restricted DAA era (2013–2018) and unrestricted DAA access era (2019). Study outcomes included the rate of sustained virological response (SVR), treatment completion and treatment default. Subgroup analysis was performed based on the presence of liver cirrhosis, HCV genotype and HCV treatment types.
Results A total of 1,001 HCV patients was followed-up for 1,489 person-year. They were predominantly male (93%) with genotype-3 HCV infection (71%), and 38% were cirrhotic. The overall SVR during the restricted DAA access era and unrestricted DAA access era were 92.1% and 99.1%, respectively. Unrestricted access to DAA exponentially improved the treatment access among HCV-infected patients by 460%, resulting in a higher SVR rate (99% vs. 92%, P=0.003), higher treatment completion rate (99% vs. 93%, P<0.001) and lower treatment default rate (1% vs. 9%, P<0.001).
Conclusion In this large cohort of incarcerated HCV-infected patients, we demonstrated that unrestricted access to DAA is an impactful strategy to allow rapid treatment up-scale in HCV micro-elimination.
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Background/Aims Direct‐acting antivirals (DAAs) have been approved for hepatitis C virus (HCV) treatment in patients with end-stage renal disease (ESRD) on hemodialysis. Nevertheless, the complicated comedications and their potential drug-drug interactions (DDIs) with DAAs might limit clinical practice in this special population.
Methods The number, class, and characteristics of comedications and their potential DDIs with five DAA regimens were analyzed among HCV-viremic patients from 23 hemodialysis centers in Taiwan.
Results Of 2,015 hemodialysis patients screened in 2019, 169 patients seropositive for HCV RNA were enrolled (mean age, 65.6 years; median duration of hemodialysis, 5.8 years). All patients received at least one comedication (median number, 6; mean class number, 3.4). The most common comedication classes were ESRD-associated medications (94.1%), cardiovascular drugs (69.8%) and antidiabetic drugs (43.2%). ESRD-associated medications were excluded from DDI analysis. Sofosbuvir/velpatasvir/voxilaprevir had the highest frequency of potential contraindicated DDIs (red, 5.6%), followed by glecaprevir/pibrentasvir (4.0%), sofosbuvir/ledipasvir (1.3%), sofosbuvir/velpatasvir (1.3%), and elbasvir/grazoprevir (0.3%). For potentially significant DDIs (orange, requiring close monitoring or dose adjustments), sofosbuvir/velpatasvir/voxilaprevir had the highest frequency (19.9%), followed by sofosbuvir/ledipasvir (18.2%), glecaprevir/pibrentasvir (12.6%), sofosbuvir/velpatasvir (12.6%), and elbasvir/grazoprevir (7.3%). Overall, lipid-lowering agents were the most common comedication class with red-category DDIs to all DAA regimens (n=62), followed by cardiovascular agents (n=15), and central nervous system agents (n=10).
Conclusions HCV-viremic patients on hemodialysis had a very high prevalence of comedications with a broad spectrum, which had varied DDIs with currently available DAA regimens. Elbasvir/grazoprevir had the fewest potential DDIs, and sofosbuvir/velpatasvir/voxilaprevir had the most potential DDIs.
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Methods Between 2015 to 2019, 23 (0.5%) and 5,005 patients (99.5%) with genotype 1a and 1b HCV, respectively, were treated with a fixed-dose tablet containing 90 mg ledipasvir and 400 mg sofosbuvir for 12 weeks, and 81 patients (1.6%) with previous experience of interferon (IFN)-based treatment received additional 1,000 mg ribavirin. HCV RNA was measured at 4, 12, and 24 weeks after the first dose to determine rapid virologic response, end of treatment response (ETR), and sustained virologic response at 12 weeks after end of treatment (SVR12).
Results Most patients (n=5,008; 99.6%) achieved ETR and SVR12 without virologic relapse. Patients with genotype 1a showed low rates of ETR and SVR12 in only 16 patients (69.6%). There was no significant difference in SVR12 rate between patients regardless of IFN experience (n=81; 1.6%), cirrhosis (n=1,151; 22.9%), HCV RNA >6×106 IU/mL (n=866; 17.2%), or liver stiffness >9.6 kPa (n=1,721; 34.2%) (100.0%, 99.3%, 99.4%, and 99.4%, respectively). No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE. The most common AEs were headache (n=472; 9.4%), fatigue (n=306; 6.2%), abdominal discomfort (n=295; 5.9%), and skin rash (n=141; 2.8%).
Conclusions LDV/SOF showed high efficacy and safety for patients with genotype 1, especially 1b HCV, in Mongolia. The real-world data might be applicable to patients in other Asian-Pacific countries.
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Data on the trends in the prevalence of chronic liver disease (CLD) in Korea are scarce. This study aimed to evaluate whether the CLD prevalence changed between 1998–2001 and 2016–2017. Data were extracted from the Korea National Health and Nutrition Examination Survey (1998–2001 to 2016–2017; n=25,893). Non-alcoholic fatty liver disease (NAFLD) was defined as a hepatic steatosis index >36 in the absence of any other evidence of CLD. The definition of alcoholrelated liver disease (ALD) was excessive alcohol consumption (≥210 g/week for men and ≥140 g/week for women) and an ALD/NAFLD index >0. The prevalence of NAFLD increased from 18.6% (95% confidence interval [CI], 17.8–19.5%) in 1998–2001 to 21.5% (95% CI, 20.6–22.6%) in 2016–2017. During the same time period, increases were observed in the prevalence of obesity (27.0 vs. 35.1%), central obesity (29.4 vs. 36.0%), diabetes (7.5 vs. 10.6%), and excessive drinking (7.3 vs. 10.5%). ALD prevalence also increased from 3.8% (95% CI, 3.4–4.2%) to 7.0% (95% CI, 6.4–7.6%). In contrast, chronic hepatitis B decreased from 5.1% (95% CI, 4.6–5.5%) to 3.4% (95% CI, 3.0–3.8%). The prevalence of chronic hepatitis C was approximately 0.3% in 2016–2017. The prevalence of NAFLD and ALD increase among Korean adults. Our results suggest potential targets for interventions to reduce the future burden of CLD.
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Epigenetics involved in multiple normal cellular processes. Previous research have revealed the role of hepatitis C virus infection in accelerating methylation process and affecting response to treatment in chronic hepatitis patients. This work aimed to elucidate the role of promoter methylation (PM) in response to antiviral therapy, and its contribution to the development of fibrosis through hepatocarcinogenesis-related genes. A total of 159 chronic hepatitis Egyptian patients versus 100 healthy control group were included. The methylation profile of a panel 9 genes (SFRP1, p14, p73, APC, DAPK, RASSF1A, LINE1, O6MGMT, and p16) was detected in patients’ plasma using methylation-specific polymerase chain reaction (MSP). Clinical and laboratory findings were gathered for patients with combined pegylated interferon and ribavirin antiviral therapy. Regarding the patients’ response to antiviral therapy, the percentage of non-responders for APC, O6MGMT, RASSF1A, SFRP1, and p16 methylated genes were significantly higher versus responders (P<0.05). Of the 159 included patients, the most frequent methylated genes were SFRP1 (102/159), followed by p16 (100/159), RASSF1A (98/159), then LINE1 (81/159), P73 (81/159), APC (78/159), DAPK (66/159), O6MGMT (66/159), and p14 (54/159). A total of 67/98 (68.4%) cases of RASSF1A methylated gene (P=0.0.024), and 62/100 (62%) cases of P16 methylated gene (P=0.03) were associated with mild-degree fibrosis. To recapitulate, the PM of SFRP1, APC, RASSF1A, O6MGMT, and p16 genes increases in chronic hepatitis C patients, and can affect patients’ response to antiviral therapy. The RASSF1A and P16 genes might have a role in the distinction between mild and marked fibrosis.
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Clin Mol Hepatol 2019;25(4):400-407. Published online May 28, 2019
Background/Aims In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.
Methods This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or ChildPugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).
Results SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.
Conclusions In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.
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Christian Mölleken, Maike Ahrens, Anders Schlosser, Julia Dietz, Martin Eisenacher, Helmut E. Meyer, Wolff Schmiegel, Uffe Holmskov, Christoph Sarrazin, Grith Lykke Sorensen, Barbara Sitek, Thilo Bracht
Clin Mol Hepatol 2019;25(1):42-51. Published online November 19, 2018
Background/Aims An estimated 80 million people worldwide are infected with viremic hepatitis C virus (HCV). Even after eradication of HCV with direct acting antivirals (DAAs), hepatic fibrosis remains a risk factor for hepatocarcinogenesis. Recently, we confirmed the applicability of microfibrillar-associated protein 4 (MFAP4) as a serum biomarker for the assessment of hepatic fibrosis. The aim of the present study was to assess the usefulness of MFAP4 as a biomarker of liver fibrosis after HCV eliminating therapy with DAAs.
Methods MFAP4 was measured using an immunoassay in 50 hepatitis C patients at baseline (BL), the end-of-therapy (EoT), and the 12-week follow-up visit (FU). Changes in MFAP4 from BL to FU and their association with laboratory parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), platelets, the AST to platelet ratio index (APRI), fibrosis-4 score (FIB-4), and albumin were analyzed.
Results MFAP4 serum levels were representative of the severity of hepatic fibrosis at BL and correlated well with laboratory parameters, especially APRI (Spearman correlation, R²=0.80). Laboratory parameters decreased significantly from BL to EoT. MFAP4 serum levels were found to decrease from BL and EoT to FU with high statistical significance (Wilcoxon P<0.001 for both).
Conclusions Our findings indicate that viral eradication resulted in reduced MFAP4 serum levels, presumably representing a decrease in hepatic fibrogenesis or fibrosis. Hence, MFAP4 may be a useful tool for risk assessment in hepatitis C patients with advanced fibrosis after eradication of the virus.
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Background/Aims The combination of daclatasvir (DCV) and asunaprevir (ASV) has demonstrated a high sustained virologic response at 12 weeks (SVR12) and a low rate of adverse events in previous clinical studies. The purpose of this study was to clarify the results of treatment and side effects in Korean patients with chronic hepatitis C virus (HCV) genotype Ib infection.
Methods We retrospectively analyzed clinical data from chronic HCV genotype Ib patients treated with DCV+ASV from August 2015 to September 2016 at five hospitals in the Daejeon-Chungcheong area.
Results A total of 152 patients were examined for resistance associated variants (RAVs). Among them, 15 (9.9%) were positive for Y93 and one (0.7%) was positive for L31. Of 126 patients treated with DCV+ASV, 83 patients completed treatment and 76 patients were included in safety and efficacy analysis. Five (6.6%) were positive for Y93 and 12 (15.8%) exhibited cirrhotic change. DCV+ASV was the first-line treatment for 58 (76.3%) patients. Eleven (14.5%) patients relapsed after previous treatment that included interferon and seven (9.2%) of these patients were found to be intolerant of interferon. Adverse events occurred in 10 (13.2%) patients and two patients stopped the medication because of severe itching and skin rash. SVR12 was 89.5% (68/76) in all patients and 91.5% (65/71) in RAV-negative patients.
Conclusions DCV+ASV showed good efficacy in patients with HCV Ib infection in Korea. Close monitoring is needed for severe adverse events and treatment failure, which were uncommon.
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Yun Nah Lee, M.D., Soung Won Jeong, M.D., Jae Hee Lim, M.D., Yang Seon Ryu, M.D.,
Seong Ran Jeon, M.D., Sang Kyun Kim, M.D., Jae Young Jang, M.D.,
Young Seok Kim, M.D., Boo Sung Kim, M.D., Mi Oh Roh, M.D.1
Korean J Hepatol 2010;16(2):187-191. Published online June 25, 2010
Combined pegylated interferon and ribavirin therapy for chronic hepatitis C infection cause a wide range of side effects, including flu-like syndrome, hematological abnormalities, cardiovascular symptoms, gastrointestinal symptoms, pulmonary dysfunction, depression, and retinopathy. Interferon-alpha has been shown to be related to the development of various autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, and type 1 diabetes mellitus (DM). Type 1 DM and thyroid disease respectively develop in 0.08～2.61% and 10～15% of patients treated with combined interferon-alpha and ribavirin for chronic hepatitis C. The coexistence of type 1 DM and autoimmune thyroiditis was rarely reported. We report a case of a 33-year-old female patient with chronic hepatitis C who simultaneously developed diabetic ketoacidosis and autoimmune thyroiditis after treatment with pegylated interferon-alpha 2b and ribavirin.
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Resolution of Type 2 Diabetes Mellitus Following Interferon-α Therapy for Chronic Hepatitis C Hee Su Park, Yoon Jung Kim, Soo Yoon Moon, Ji Young Woo, Jae Kyun Choi, Kyung Up Kim, Ju Ri Park, Ho Young Son, Doo-Man Kim The Journal of Korean Diabetes.2015; 16(4): 315. CrossRef
There has been an increase in the number of patients treated with pegylated interferon (PEG-IFN) and ribavirin due to the better antiviral efficacy. The main serious adverse events of PEG-IFN plus ribavirin combination therapy are bone marrow suppression and hemolytic anemia. However, there are few reports of vasculitis occurring during PEG-IFN therapy. We describe a patient who developed vasculitis during the treatment of chronic hepatitis C with PEG-IFN and ribavirin. (Korean J Hepatol 2007;13:419-422)
Hepatitis C virus (HCV) infection is a worldwide problem in terms of public health. It causes chronic hepatitis C in 60-80% of patients after acute hepatitis C. Chronic hepatitis C can progress to liver cirrhosis and hepatocellular carcinoma. In the present time, combination therapy of pegylated interferon-α and ribavirin is the standard therapy for hepatitis C, but it results in sustained virologic response only in 45-80% of treated patients. In addition, there is no available effective vaccine for HCV. To develop effective immunotherapy or preventive vaccine, understanding of the immune response against HCV is prerequisite. Among several components of immune system, T cells play a key role in the clearance of HCV and immunopathology during hepatitis C. In the study of HCV infection, however, the most important limiting factor is the absence of small animal model as only humans and chimpanzees can be infected by HCV. In this review, T cell response against HCV, which has been known from the studies of the HCV-infected patients and chimpanzees, will be discussed in several circumstances, including acute hepatitis C, chronic hepatitis C and recovered status from hepatitis C. (Korean J Hepatol 2006;12:140-153)
Jae Young Jang, M.D., Yun Soo Kim, M.D.2, Sang Gyune Kim, M.D., Young Seok Kim, M.D.,
Young Deok Cho, M.D., Joon Sung Lee, M.D., So Young Jin, M.D.1, Moon Sung Lee, M.D.,
Ju Hyun Kim, M.D.2, Chan Sup Shim, M.D., and Boo Sung Kim, M.D.
Background/Aims This study was carried out to identify the correlation between the serum HCV RNA and the liver HCV RNA level in chronic hepatitis C patients and to evaluate the differences of biochemistry, histology, HCV genotype and their response to antiviral therapy according to intrahepatic HCV RNA levels. Methods: For thirty-six chronic hepatitis C patients (M:F=22:14, CH:LC=27:9), percutaneous liver biopsy was performed, and serum and liver HCV RNA level were measured. Seventeen patients were treated with IFN-α and ribavirin. Results: There was a significant correlation between intrahepatic and serum HCV RNA levels (intrahepatic HCV RNA: 1.9±3.1×107 copies/g vs. serum HCV RNA: 3.2±3.2×106 copies/mL)(r=0.538, P<0.01). Total histological activity score (r=0.346, P=0.04) and periportal inflammation (r=0.398, P=0.01) were correlated with intrahepatic HCV RNA level. However, serum HCV RNA level was not correlated with histological activity. Serum ALT was not correlated with intrahepatic HCV RNA level. Intrahepatic HCV RNA level was higher in genotype 1 than genotype 2 or 3 (P=0.07). Intrahepatic HCV RNA level was not correlated with response to anti-viral therapy. Conclusion: Intrahepatic HCV RNA level was correlated with serum HCV RNA level and periportal inflammation in patients with chronic hepatitis C. It seems that intrahepatic HCV RNA level is more closely related to histological features than serum HCV RNA level. (Korean J Hepatol 2006;12:515-523)
The combination therapy with pegylated interferon α and ribavirin has increasingly prescribed for chronic
hepatitis C. Although many side effects of interferon such as flu-like symptoms, gastrointestinal and
neuropsychiatric symptoms are well known, only several cases of interferon-induced pulmonary toxicity have
been reported. Interferon-induced pulmonary toxicity usually develops from 2 weeks to 12 weeks after
treatment for HCV infection. Diagnosis is commonly based on clinical findings such as a dry cough, dyspnea,
hypoxemia, and a restrictive pattern in pulmonary function testing, bilateral diffuse parenchymal infiltrations,
histopathological findings of interstitial pneumonitis, and exclusion of any other causative agents. Prompt
withdrawal of the drug is the cornerstone of treatment. We report a case of PEG-IFN α-2a induced pulmonary
toxicity in a 50-year-old male patient with hepatitis C. To our knowledge, this is the first case of pegylated
interferon α-2a induced pulmonary toxicity in Korea. (Korean J Hepatol 2007;13:103-107)
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