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Lai, Ching-Lung,Ahn, Sang Hoon,Lee, Kwan Sik,Um, Soon Ho,Cho, Mong,Yoon, Seung Kew,Lee, Jin-Woo,Park, Neung Hwa,Kweon, Young-Oh,Sohn, Joo Hyun,Lee, Jiyoon,Kim, Jeong-Ae,Han, Kwang-Hyub,Yuen, Man-Fung BMJ Publishing Group Ltd 2014 Gut Vol.63 No.6
<P><B>Background</B></P><P>Besifovir (LB80380) is an acyclic nucleotide phosphonate effective in hepatitis B virus (HBV) DNA suppression for both treatment-naive and lamivudine-resistant chronic hepatitis B (CHB) patients in preliminary studies.</P><P><B>Design</B></P><P>We aimed to compare the safety and antiviral activity of two doses of besifovir (90 mg and 150 mg daily) with entecavir 0.5 mg daily in CHB patients. 114 patients were randomised to receive besifovir 90 mg daily (n=36), besifovir 150 mg daily (n=39) or entecavir 0.5 mg daily (n=39). HBV DNA and liver biochemistry, including serum L-carnitine levels, were monitored.</P><P><B>Results</B></P><P>At week 48, in the intention-to-treat population, the proportion of patients achieving undetectable HBV DNA (<20 IU/mL) were 63.6%, 62.9% and 58.3%, respectively (p>0.05). The serum mean log<SUB>10</SUB> HBV DNA changes from baseline for the HBeAg-positive patients were −5.84, −5.91 and −6.18, respectively; and for the HBeAg-negative patients were −4.65, −4.55 and −4.67, respectively (p>0.05). There were no differences in the proportions of patients achieving normalisation of alanine aminotransferase (91.7%, 76.9%, 89.7%, respectively) and HBeAg seroconversion (11.11%, 15%, 9.52%, respectively) among all three groups. None of the patients had resistant mutations or increase in serum creatinine of >0.5 mg/dL from baseline. 64 (94.1%) patients on besifovir had lowering of serum L-carnitine (not tested in entecavir patients). L-carnitine levels returned to normal with carnitine supplement.</P><P><B>Conclusions</B></P><P>At 48 weeks, 90 mg and 150 mg daily of besifovir were non-inferior to entecavir 0.5 mg daily in treatment-naive CHB patients. The only significant side effect of besifovir was L-carnitine depletion, requiring carnitine supplementation.</P>
Review : Epidemiology of Hepatocellular Carcinoma in the Asia-Pacific Region
( Ran Xu Zhu ),( Wai Kay Seto ),( Ching Lung Lai ),( Man Fung Yuen ) 대한간학회 2016 Gut and Liver Vol.10 No.3
Hepatocellular carcinoma (HCC) is the predominant primary liver cancer in many countries and is the third most common cause of cancer-related death in the Asia-Pacific region. The incidence of HCC is higher in men and in those over 40 years old. In the Asia-Pacific region, chronic hepatitis B virus and hepatitis C virus infections are the main etiological agents; in particular, chronic hepatitis B infection (CHB) is still the major cause in all Asia-Pacific countries except for Japan. Over the past two decades, the incidence of HCC has remained stable in countries in the region except for Singapore and Hong Kong, where the incidence for both sexes is currently decreasing. Chronic hepatitis C infection (CHC) is an important cause of HCC in Japan, representing 70% of HCCs. Over the past several decades, the prevalence of CHC has been increasing in many Asia-Pacific countries, including Australia, New Zealand, and India. Despite advancements in treatment, HCC is still an important health problem because of the associated substantial mortality. An effective surveillance program could offer early diagnosis and hence better treatment options. Antiviral treatment for both CHB and CHC is effective in reducing the incidence of HCC. (Gut Liver 2016;10:332-339)
( Robert G Gish ),( Ting Tsung Chang ),( Ching Lung Lai ),( Robert A De Man ),( Adrian Gadano ),( Song Yu ),( Cyril Llamoso ),( Hong Tang ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: Entecavir (ETV) 0.5 mg demonstrated superior virologic, histologic, and biochemical benefit compared to lamivudine in phase III study ETV-022. Through 96 weeks of treatment and 24 weeks post-treatment follow-up, 5% of the patients achieved HBsAg loss. We present the changes in quantitative HBsAg levels in patients with HBeAg-positive nucleoside naive chronic hepatitis B patients treated with ETV in study ETV-022. Methods: The nucleoside-naive HBeAg-positive patients received ETV 0.5mg daily in study ETV-022. HBsAg levels were assessed qualitatively and quantitatively every 12 weeks. The quantitative HBsAg levels were measured with the Abbott Architect Assay. Mean HBsAg levels were calculated at baseline, week 12, 24, 36 and 48 for the overall cohort and cohorts with HBeAg loss or HBsAg loss. Results: A total of 95 ETV-treated patients from study ETV-022 had available blood samples and were analyzed for quantitative HBsAg levels. Baseline characteristics of patients include mean age 38 years old, mean HBV DNA 9.64 log10 copies/mL and ALT 156.65 U/L. The quantitative HBsAg levels over time in different patient groups are listed below Conclusion: Quantitative HBsAg levels decreased overtime during the first 48 weeks of ETV therapy in HBeAg-positive nucleoside naive patients. A greater declination in quantitative HBsAg value was observed among subjects who had HBeAg loss or HBsAg loss.
( Robert G Gish ),( Ting Tsung Chang ),( Ching Lung Lai ),( Robert A De Man ),( Adrian Gadano ),( Song Yu ),( Cyril Llamoso ),( Hong Tang ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.-
Background: Entecavir (ETV) 0.5 mg demonstrated superior virologic, histologic, and biochemical benefit compared to lamivudine in phase III study ETV-022. Through 96 weeks of treatment and 24 weeks post-treatment follow-up, 5% of the patients achieved HBsAg loss. We present the changes in quantitative HBsAg levels in patients with HBeAg-positive nucleoside naive chronic hepatitis B patients treated with ETV in study ETV-022. Methods: The nucleoside-naive HBeAg-positive patients received ETV 0.5mg daily in study ETV-022. HBsAg levels were assessed qualitatively and quantitatively every 12 weeks. The quantitative HBsAg levels were measured with the Abbott Architect Assay. Mean HBsAg levels were calculated at baseline, week 12, 24, 36 and 48 for the overall cohort and cohorts with HBeAg loss or HBsAg loss. Results: A total of 95 ETV-treated patients from study ETV-022 had available blood samples and were analyzed for quantitative HBsAg levels. Baseline characteristics of patients include mean age 38 years old, mean HBV DNA 9.64 log10 copies/mL and ALT 156.65 U/L. The quantitative HBsAg levels over time in different patient groups are listed below: Conclusion: Quantitative HBsAg levels decreased overtime during the first 48 weeks of ETV therapy in HBeAg-positive nucleoside naive patients. A greater declination in quantitative HBsAg value was observed among subjects who had HBeAg loss or HBsAg loss.
Yuen, Man-Fung,Lee, Sung-Hack,Kang, Hyang-Mi,Kim, Chung Ryeol,Kim, John,Ngai, Vincent,Lai, Ching-Lung American Society for Microbiology 2009 Antimicrobial agents and chemotherapy Vol.53 No.5
<B>ABSTRACT</B><P>LB80380, a dipivoxil ester prodrug of LB80331 (metabolite, LB80317), is a novel antiviral agent for chronic hepatitis B (CHB). The pharmacokinetics of LB80331/LB80317 were evaluated in two clinical studies and a study with mice. The clinical studies were dose-escalating pharmacokinetic studies with six healthy subjects per single-dose group and six CHB patients per repeated-dose group. The mouse study was designed to measure the amounts of the phosphorylated portions of LB80331 and LB80317 in the liver. In healthy subjects receiving a single dose of LB80380, the plasma level of LB80331 increased as the dose increased. Although a high-fat diet delayed the time to the maximum concentration in plasma (<I>T</I>max) of LB80331, the area under the concentration-time curve from time zero to infinity was similar between the subjects in the fasted group and those in the group who consumed a high-fat diet. In CHB patients, the mean <I>T</I>max of LB80331 was 1.0 to 2.0 h postdosing at steady state. The steady-state plasma concentration of LB80331 declined in a monoexponential manner, and the apparent elimination half-life was 2.5 to 3.3 h. The steady-state plasma concentration of LB80317 was maximum at 3 to 8 h postdoing and declined in a monoexponential manner; the apparent elimination half-life was 45 to 62 h at the 30- to 240-mg doses, while LB80317 was measurable in plasma only at higher doses of 120 and 240 mg after the administration of the first dose of LB80380. Forty percent of the amount of LB80331/LB80317 in the mouse liver was detected as the phosphorylated form. In conclusion, LB80380 is rapidly absorbed and converted to LB80331. LB80317 has a long half-life at steady-state, supporting the use of a once-daily dosing regimen. The ingestion of a high-fat diet delays the rate of absorption of LB80380 without affecting the extent of absorption.</P>
( Zobair Younossi ),( Maria Stepanova ),( Linda Henry ),( Kwanghyub Han ),( Sang Ahn ),( Youngsuk Lim ),( Wanloung Chuang ),( Jia Horng Kao ),( Nguyen Kinh ),( Ching Lung Lai ),( Man Fung Yuen ),( Hen 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: We aim to assess HRQL in east Asian (EA) HCV patients treated with different anti-HCV sofosbuvir (SOF)-based regimens. Methods: 1070 EA HCV subjects were enrolled in two phase 3 clinical trials [China: 55.6%, S. Korea: 20.7%, Taiwan: 16.1%, Vietnam: 4.7%, and Hong Kong: 2.9%]. Patients received IFN+SOF+RBV for 12 weeks (n=155, GT 1 and 6) or SOF+RBV for 12-24 weeks (n=531, GT 1, 2, 3 and 6) or IFN-free RBV-free LDV/SOF (n=384, GT1 only). The SVR-12 rates were 95.5%, 96.0%, and 99.2%, respectively (P=0.008). EA HCV patients completed Short Form-36 before, during, and after treatment and HRQL scores compared between regimens. Results: Baseline HRQL scores were similar between treatment groups. After 2 weeks of treatment, HRQL scores for the IFN+RBV- containing regimen became significantly lower as compared to the IFN-free regimens (average decline up to -11.2 points, P<0.0001). By the end of treatment, IFN-treated group experienced significant declines in most HRQL scores (up to -13.3 points, P<0.02 for 7/8 HRQL scales). Patients on SOF+RBV had milder HRQL impairments (up to -5.4 points, P<0.05 for 5/8 scales). However, patients receiving LDV/SOF had improvement in their HRQL scores (up to +4.3 points by the end of treatment, P<0.001 for 3/8 scales). Achieving SVR-12 with IFN+RBV+ SOF and SOF+RBV was associated with improvement in General Health (GH) and Vitality (VT) (up to +2.9 points, P<0.05), while SVR-12 with LDV/SOF was associated with improvement in Physical Functioning, GH, VT, Mental Health, and Role Emotional (up to +5.9 points, P<0.03). In multivariate analysis, receiving IFN was independently associated with HRQL impairment during treatment (β: -10.4 to -17.3 points, P<0.0001). Conclusions: Treatment of EA HCV patients with IFN or RBV containing regimens is associated with HRQL impairment, while treatment with LDV/SOF is associated with improvement of HRQL during treatment. SVR-12 was associated with greater improvements in HRQL.