1.Influence of monotherapy with telbivudine or entecavir on renal function in patients with chronic hepatitis B.
Chinese Journal of Hepatology 2015;23(6):407-411
OBJECTIVETo compare renal function in chronic hepatitis B (CHB) patients before and after antiviral treatment with either telbivudine or entecavir administered as monotherapy,as well as to assess the impact of these antivirals on renal function in patients with mild renal impairment and to provide evidence for optimizing each as an antiviral treatment of CHB.
METHODSA total of 120 patients with CHB were enrolled for study and treated with either telbivudine (600 mg/d) or entecavir (0.5 mg/d). The normalization rate of alanine aminotransferase (ALT), the undetectable rate of HBV DNA, the level of serum creatinine (CR) and the estimated glomerular filtration rate (eGFR) were compared from the baseline period to post-treatment week 52 weeks and to post-treatment week 104. The chi-square test and t-test were used for statistical analyses.
RESULTSAfter 104 weeks of telbivudine monotherapy, the patients showed significant improvement in renal function (vs. baseline), with improved creatinine level (t=2.917, P=0.005) and eGFR (t=-2.736, P =0.008). Treatment with entecavir monotherapy did not provide significant improvement in renal function (at week 104, creatinine and eGFR: t=-2.727, P =0.007 and t=2.218, P=0.028). However, subgroup analysis of the mean change in eGFR indicated that both telbivudinetreated patients and entecavir-treated patients who entered the study with the poorest eGFR (at baseline, less than 90 mL/min/1.73 m-2) had better eGFR improvement after treatment (25.93 ± 2.21, n=11 vs. 8.17 ± 10.14, n=7), and there was a significant difference between the telbivudine group than the entecavir group (t=4.323, P =0.001). Virological breakthrough was more frequent in the telbivudine group than in the entecavir group (at week 104, 15.0% vs. 1.7%, P=0.017).
CONCLUSIONCompared with entecavir monotherapy, telbivudine monotherapy provides a renoprotective effect in patients with CHB. While these results may suggest a benefit of telbivudine monotherapy for CHB patients with high risk for renal impairment, they do not support the application of telbivudine as a first-line therapy for nucleos(t)ide-na(i)ve HBV patients because of the related high rate of virological resistance.
Alanine Transaminase ; Antiviral Agents ; Creatinine ; Guanine ; analogs & derivatives ; Hepatitis B, Chronic ; Humans ; Kidney ; Kidney Function Tests ; Thymidine ; analogs & derivatives
2.Effect of rebamipide on the acute gouty arthritis in rats induced by monosodium urate crystals.
Gui Hong WANG ; Ting ZUO ; Ran LI ; Zheng Cai ZUO
Journal of Peking University(Health Sciences) 2021;53(4):716-720
OBJECTIVE:
To investigate the role of rebamipide in the treatment of acute gout arthritis rats induced by monosodium urate (MSU) crystal.
METHODS:
Forty-two male rats were randomly divided into three groups (n=14). Group A was treated with oral rebamipide, group B with oral colchicine, and group C with oral placebo. The rats were monitored for the induction of arthritis with clinical manifestations and pathological changes, and the levels of interleukin (IL)-1β、IL-6、IL-10, and tumor necrosis factor (TNF)-α in serum were measured.
RESULTS:
In group C, the clinical score and swelling index reached the maximum in 24 h, and then gradually decreased to 72 h. After 24 h of model induced, the clinical scores in group C were significantly higher than those in group A and group B [2 (1-3) vs. 0 (0-1) vs. 1 (0-2), P < 0.01], the swelling indexes in group C were significantly higher than those in group A and group B [0.36 (0.16-0.52) vs. 0.11 (0-0.20) vs. 0.12 (0-0.16), P < 0.01]. Histologically, after 24 h of model induced, there was a large number of neutrophil infiltration in the synovium of group C [scale score: 4 (2-4)], and there was no significant inflammatory cell infiltration in group A [1 (0-2)] and group B [1 (0-2)], the difference was statistically significant (P < 0.001). After 24 h of model induced, the levels of IL-1β, IL-6, IL-10, and TNF-α in serum of group C were significantly higher than those in group A and B [IL-1β: (41.86±5.72) vs. (27.35±7.47) vs. (27.76±5.28) ng/L, IL-6: (1 575.55±167.11) vs. (963.53±90.22) vs. (964.08±99.31) ng/L, IL-10: (37.96±3.76) vs. (21.68±4.83) vs. (16.20±2.49) ng/L, TNF-α: (21.32±1.34) vs. (15.82±2.54) vs. (17.35±7.47) μg/L, P < 0.001].
CONCLUSION
Rebamipide has a protective effect on acute gout arthritis rats induced by MUS crystals.
Alanine/analogs & derivatives*
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Animals
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Arthritis, Gouty/drug therapy*
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Interleukin-1beta
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Male
;
Quinolones
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Rats
;
Uric Acid
3.Effective antiviral therapy with entecavir in chronic hepatitis B virus carriers.
Chengguo YAN ; Yunqing YAO ; Xiaoqin MAO
Chinese Journal of Hepatology 2014;22(12):900-903
OBJECTIVETo evaluate the short-term effect and safety of entecavir for the treatment of chronic hepatitis B (CHB) virus carriers.
METHODSNinety-three cases of CHB virus infection (hepatitis B surface antigen (HBsAg)-positive, hepatitis B e antigen (HBeAg)-positive, hepatitis B core antibody (HBcAb)-positive, HBV DNA≥1x10(5) copies/mL) were divided into two groups: CHB virus carrier (47 cases) and CHB (46 cases). All of the 93 cases were given 0.5 mg entecavir orally once a day for 48 weeks. Virology, serology and biochemistry tests were perrmed at treatment weeks 0, 4, 12, 24 and 48. Side effects of entecavir and the incidence of liver cirrhosis and hepatocellular carcinoma were recorded.
RESULTSThe CHB virus carrier and CHB group had complete virological response rates of 14.9% and 17.4% at week 4, 51.1% and 63.0% at week 12, 76.6% and 89.1% at week 24, and 97.9% and 100% at week 48, respectively; there was no significant difference between the two groups (P>0.05). The CHB virus carrier and CHB group had partial virological response rates of 42.6% and 47.8% at week 4, 57.44% and 65.2% at week 12, 85.0% and 89.1% at week 24, and 100% and 100% at week 48, respectively; there was no significant difference between the two groups (P>0.05). No cases in either group experienced virologic breakthrough during the treatment course. The CHB virus carrier and CHB group had serological response (HBeAg-negative) rates of 0 and 4.3% at week 4, 2.1% and 8.7% at week 12, 4.3% and 13.0% at week 24, and 8.5% and 21.7% at week 48, respectively; there was no significant difference between the two groups (P>0.05). The CHB virus carrier and CHB group had HBeAg seroconversion rates of 0 and 0 at week 4, 0 and 4.4% at week 12, 2.1% and 10.9% at week 24, and 6.4% and 17.4% at week 48, respectively; there was no significant difference between the two groups (P>0.05). No case in either group showed HBsAg-negativity and seroconversion during the treatment course. The CHB group had a biochemical response (alanine aminotransferase normalization) rate of 26.1% at week 4, 65.2% at week 12, 91.3% at week 24, and 97.8% at week 48.No case in either group showed biochemical breakthrough during the treatment course. There were no cases of liver cirrhosis or hepatocellular carcinoma in either group. There were no side effects of the entecavir treatment experienced in either group.
CONCLUSIONAntiviral therapy with entecavir is effective, safe and well tolerated in CHB virus carriers.
Alanine Transaminase ; Antiviral Agents ; Carcinoma, Hepatocellular ; Guanine ; analogs & derivatives ; Hepatitis B e Antigens ; Hepatitis B virus ; Hepatitis B, Chronic ; Humans ; Liver Neoplasms
4.Bioavailability of the amino acid-attached prodrug as a new anti-HIV agent in rats.
Kyung Ae CHAE ; Hee Jung CHO ; Ji Min SUNG ; Hee LEE ; Dong Cheol SEO ; Jin Suk KIM ; Ho Chul SHIN
Journal of Veterinary Science 2007;8(3):263-267
The primary objective of this study was to compare thepharmacokinetics of a new anti-human immunodeficiencyvirus agent 1-(2-amino-pyridin-4-ylmethyl)-6-(3,5-dimethyl-benzoyl)-5-isopropyl-1H-pyrimidine-2,4-dione (VP-0502)with its amino acid prodrug alanine amide of VP-0502(VP-0502AL), following intravenous and oral administrationsto rats. The plasma concentrations of both analytes wereanalyzed via high-performance liquid chromatographycoupled with photodiode-array detection (HPLC-DAD).When VP-0502 was intravenously administered at 20mg/kg, the analyte appeared in low levels with an AUC of 0.3microg.h/ml, and C0 of 0.2microg/ml in plasma. However, boththe prodrug VP-0502AL and its metabolite VP-0502 appearedat comparatively higher levels following intravenousinjection of VP-0502AL at the same dose. VP-0502AL'spharmacokinetic parameters were Vd: 4.6 l/kg; AUC:3microg.h/ml; t1/2: 0.5h; C0: 6microg/ml; CLtot: 7l/h/kg; andMRT: 0.6h. Following oral administration of VP-0502(100mg/kg), it was not detectable in plasma (<50ng/ml),while after the oral administration of VP-0502AL, VP-0502 was quantitatively detected as an active metabolite forthe first 7h, with a maximum plasma concentration(Cmax) of 0.8microg/ml, and an area under the concentration-time curve (AUC) of 2microg.h/ml. The oral pharmacokineticparameters of VP-0502AL were calculated to be: maximumconcentration time (tmax) 2.7h; Cmax 0.2microg/ml; eliminationhalf-life (t1/2): 0.8h; and AUC 0.5microg.h/ml. Overall thefindings indicate that VP-0502AL has a favorable pharmaco-kinetic profile as a prodrug with rapid transformationinto the active metabolite, and that the attachment of theamino acid alanine to VP-0502 is an effective approach toimprove its oral bioavailability. VP-0502AL is predictedto become a new highly bioavailable anti-AIDS drugcandidate and/or lead compound.
Administration, Oral
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Alanine/*analogs & derivatives/pharmacokinetics
;
Aminopyridines/*pharmacokinetics
;
Animals
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Anti-HIV Agents/administration & dosage/blood/*pharmacokinetics
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Area Under Curve
;
Biological Availability
;
Half-Life
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Injections, Intravenous
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Male
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Prodrugs/administration & dosage/*pharmacokinetics
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Rats
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Rats, Sprague-Dawley
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Uracil/*analogs & derivatives/pharmacokinetics
5.A randomized controlled trial on 240-week monotherapy with entecavir or adefovir in patients with chronic hepatitis B and cirrhosis.
Jia LIAN ; Tao HAN ; Huiling XIANG ; Fang LIU ; Hongmin LYU ; Yanying GAO ; Fengmei WANG
Chinese Journal of Hepatology 2015;23(10):733-737
OBJECTIVETo compare the efficacies ofentecavir and adefovir in patients with chronic hepatitis B (CHB) and cirrhosis when administered as monotherapies using a 240-week course.
METHODSNinety patients diagnosed with CHB and cirrhosis (compensated or decompensated) were randomly divided into two treatment groups for administration of either entecavir (0.5 mg/day, oral; n =38) or adefovir (10 mg/day, oral; n =52) for 240 weeks. All participants underwent B-ultrasound and were tested for levels of HBV-DNA, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, creatinine, alpha-fetoprotein (AFP) and various serological markers of the hepatitis B virus at baseline and at treatment weeks 24, 48, 96, 144, 192, and 240. Instances of drug-related complications and adverse reactions were recorded. Patients who did not achieve complete virological response by treatment week 48 or who experienced virological breakthrough at any time during the study course were recorded and started on an appropriate combination therapy regimen. Statistical analyses were carried out using the t-test, chi-square test, and Cox regression modeling.
RESULTSThe dropout rate in the entecavir group was 2.6% and in the adefovir group was 13.5%. At treatment week 240, significantly more patients in the entecavir group had undetectable serum HBV-DNA (91.9% vs. adefovir group: 57.8%; x2=10.362, P=0.001), a negative conversion rate of hepatitis B e antigen (HBeAg) (46.2% vs. adefovir group: 24%; x2=5.055, P=0.025), and rate of HBeAg seroconversion (23.1% vs. adefovir group: 8%, P=0.047).The entecavir group and the adefovir group showed no significant differences upon per-protocol analysis and intention-to-treat analysis, nor in the rates of hepatocellular carcinoma development (entecavir group: 8.1% vs. adefovir group: 6.7%; x2=0.000, P=1.000) or mortality (entecavir group: 8.1% vs. adefovir group: 4.4%; x2=0.051, P=0.821). The possibility of achieving undetectable serum HBV-DNA was 2.761 times higher in the entecavir group than in the adefovir group (95.0% CI: 1.630 to 4.679). The possibility of HBeAg seroconversion was 0.192 times higher for males than for females (95.0% CI: 0.046 to 0.806).
CONCLUSIONCompared to adefovir, entecavir provides high efficiency and rapid viral suppression as a monotherapy for CHB patients when administered in a 240-week course.
Adenine ; analogs & derivatives ; Aged ; Alanine Transaminase ; Antiviral Agents ; Aspartate Aminotransferases ; Biomarkers ; Carcinoma, Hepatocellular ; Female ; Guanine ; analogs & derivatives ; Hepatitis B e Antigens ; Hepatitis B, Chronic ; Humans ; Liver Cirrhosis ; Liver Neoplasms ; Male ; Organophosphonates ; Time Factors ; alpha-Fetoproteins
6.Magnesium isoglycyrrhizinate prevention of chemotherapy-induced liver damage during initial treatment of patients with gastrointestinal tumors.
Yulan YAN ; Yongsen MO ; Dongmei ZHANG
Chinese Journal of Hepatology 2015;23(3):204-208
OBJECTIVETo investigate the preventive effect of magnesium isoglycyrrhizinate against acute drug-induced liver damage from initial chemotherapy treatment in patients with gastrointestinal cancer.
METHODSA total of 216 cases with early stage gastric cancer and indications for systemic chemotherapy that had been diagnosed with gastrointestinal malignant tumors by pathology in our hospital were enrolled for study during the period of January 2011 to June 2013.Using a prospective randomized controlled study design,differences were assessed between groups treated with glycyrrhizic acid magnesium (experimental group; n=114) or glutathione (control group; n=102) and the FOLFOX regimen (n=104) or the XELOX regimen (n=112).Patients in the FOLFOX group received intravenous infusion of L-OHP (85 mg/m²) at day 1,followed by a bolus injection of 5-FU (400 mg/m²) at days 1-2 and continuous intravenous infusion of 5-FU (600 mg/m²) for 22 h at days 1-2,with one cycle comprising 2 weeks. Patients in the XELOX group received intravenous infusion of L-OHP (130 mg/m²) at day 1, followed by capecitabine (1 000 mg/m²) oral twice a day at days 1-14,with one cycle comprising 3 weeks.In the first cycle of chemotherapy,serum was extracted from the patients at 1 day before chemotherapy and 1 week after chemotherapy.An automated biochemistry analyzer was used to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) and alkaline phosphatase (ALP). Differences between groups were statistically analyzed by the t-test and x² test.
RESULTSAmong the total 216 cases treated with chemotherapy,40 showed hepatic biochemical abnormalities (12 cases in the experimental group, 28 cases in the control group), and the effect of prevention was significantly different between the two groups (10.53% vs. 27.25%; x² =10.219, P less than 0.005).The acute and subacute hepatic toxicity reaction degrees for the experimental and the control groups were: 0:94.78% vs. 88.2%; 1:5.3% vs. 11.8% (x² =6.99, P < 0.01). One week after chemotherapy, the liver biochemical indexes in the experimental group (ALT:35.93 ± 8.33 U/L; AST:24.84 ±2.91 U/L; TBil:13.29 ± 5.89 mumol/L; ALP:125.1 ± 53.61 U/L) were statically different from those in the control group (all P < 0.05). The liver biochemical indexes before and after chemotherapy were also significantly different between the experimental group (ALT:13.18t3.23 U/L; AST:5.39 ± 2.57 U/L; TBil:2.79 ± 0.23 mumol/L; ALP:52.08 ± 4.83 U/L) and the control group (all P < 0.05).One week after chemotherapy in the experimental group, the groups treated with the FOLFOX regimen or the XELOX regimen showed no statistical differences in the liver biochemical indexes.One week after chemotherapy in the control group, though, the groups treated with the FOLFOX regimen showed significantly lower AST (26.24 ± 3.50 U/L vs. 29.80 ± 6.57 U/L, t=-2.431, P < 0.05),but the residual liver biochemical indexes were not significantly different.In the experimental group, the FOLFOX group showed significantly lower ALP (53.44 ± 2.47 U/L vs. 56.58 ± 6.70 U/L, t =-2.201, P < 0.05), AST (6.48 ± 3.15U/L vs. 9.88 ± 4.57 U/L, t =-5.223, P < 0.05), but the residual liver biochemical index was not significantly different.
CONCLUSIONMagnesium isoglycyrrhizinate is an effective drug for the prevention of drug-induced liver damage after initial chemotherapy in patients with early stage gastrointestinal cancer.
Alanine Transaminase ; Alkaline Phosphatase ; Antineoplastic Combined Chemotherapy Protocols ; Aspartate Aminotransferases ; Bilirubin ; Chemical and Drug Induced Liver Injury ; Deoxycytidine ; analogs & derivatives ; Fluorouracil ; analogs & derivatives ; Gastrointestinal Neoplasms ; Glycyrrhizic Acid ; Humans ; Leucovorin ; Organoplatinum Compounds ; Prospective Studies ; Saponins ; Triterpenes
7.Treatment options in HBeAg-positive chronic hepatitis B patients with a poor response to 24-week interferon monotherapy.
Xinxin WANG ; Guosheng YUAN ; Jinglan LAI ; Nianhuan YANG ; Hao ZHANG ; Junjie WANG ; Yuanping ZHOU
Journal of Southern Medical University 2015;35(6):807-811
OBJECTIVETo evaluate the efficacy and safety of 4 treatment options for HBeAg-positive chronic hepatitis B (CHB) patients following a suboptimal response to 24-week interferon monotherapy.
METHODSThe data of 193 HBeAg-positive CHB patients with suboptimal response to 24-week interferon monotherapy were collected from Nanfang Hospital between September, 2010 and January, 2013. According to the subsequent treatments, the patients were divided into group A with additional entecavir or adefovir, group B with further interferon monotherapy, group C with conversion to NAs therapy, and group D with direct therapy withdrawal, and the biochemical and virological results at weeks 24, 48 and 72 were analyzed in the 4 groups.
RESULTSAt week 48, the HBV DNA negative rates and serum alanine aminotransferase (ALT) normalization rates were both significantly higher in group A and C than in group B (P<0.05); in group A, ETV therapy subgroup had a significantly higher HBV DNA negative rate than ADV therapy subgroup at week 48 (90.3% vs 59.5%, Χ=8.255, P=0.004). At week 72, 39.7%(27/68) of the patients in group A achieved HBeAg seroconversion, a rate significantly higher than those in groups B (Χ=4.238, P=0.040) and C (Χ=7.681, P=0.006); the HBV DNA negative rate and ALT normalization rate in group A were 85.3%(58/68) and 86.8%(59/68), respectively, both significantly higher than those in group B (Χ=23.018, P<0.001; Χ=5.987, P=0.014) but comparable to those in group C (P>0.05). In the two subgroups in group A, the HBV DNA negative rate and HBeAg seroconversion rate were both significantly higher in ETV subgroup (Χ=9.823, P=0.002; Χ=5.450, P=0.020). In group D, all the patients remained HBeAg-positive with abnormal ALT levels and high level of HBV DNA.
CONCLUSIONFor HBeAg-positive CHB patients with suboptimal response to 24-week interferon monotherapy, combined treatment with NAs (especially ETV) and extension of the treatment course can significantly improve the HBeAg seroconversion rates, HBV DNA negative rates, and ALT normalization rates.
Adenine ; analogs & derivatives ; therapeutic use ; Alanine Transaminase ; blood ; Antiviral Agents ; therapeutic use ; DNA, Viral ; blood ; Drug Therapy, Combination ; Guanine ; analogs & derivatives ; therapeutic use ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; drug therapy ; Humans ; Interferons ; therapeutic use ; Organophosphonates ; therapeutic use
8.Efficacy and safety of telbivudine alone and combined with adefovir for the treatment of nucleos(t)ide-naive chronic hepatitis B in patients with high-level hepatitis B virus load.
Na YAO ; Chunfu WANG ; Zhuoran YU ; Ke ZHAO ; Wen KANG ; Qing LIU ; Bianli DANG ; Yongtao SUN
Chinese Journal of Hepatology 2015;23(4):250-253
OBJECTIVETo compare the efficacy of telbivudine monotherapy and telbivudine combination therapy with adefovir in patients with nucleos(t)ide-naive chronic hepatitis B, high-level hepatitis B virus (HBV) load and hepatitis B e antigen (HBeAg)-positivity, and to explore the relationship between treatment regimen adherence and treatment outcomes.
METODSA retrospective study was performed with 123 HBeAg-positive, high-level viral load (HBV DNA≥10(7) copies/ml), nucleos(t)ide-naive chronic hepatitis B patients. Fifty-three of the patients received combination therapy with telbivudine and adefovir dipivoxil,while 70 patients received the telbivudine monotherapy. All patients were tested for rates of conversion to HBV DNA-negative status,alanine aminotransferase (ALT) normalization, HBeAg seroconversion, drug resistance, and side effects at treatment weeks 12, 24, and 48. Treatment regimen adherence was assessed through self-reporting, and interviews were used to explore the relationships to treatment outcomes. The chisquare test, t test and Fisher's exact test were used for statistical analyses.
RESULTSThe rates of HBV DNA negative conversion in the combination group at treatment weeks 12, 24 and 48 were 62.3% (33/53), 88.7% (47/53) and 94.3% (50/53) and were significantly different from those in the monotherapy group at weeks 12 and 24.The rates of ALT normalization were significantly different between the two groups at treatment week 12 (94.3% vs. 77.1%). The rate of HBeAg seroconversion in the combination group at treatment week 48 was 39.6%, and significantly different than that of the monotherapy group. The rates of drug-resistance in the combination and monotherapy groups at treatment week 48 were 3.8% and 11.4%, and the proportion of non-adherence to the treatment regimen was 53.3%, which significantly affected treatment outcome. No side effects occurred in either treatment group.
CONCLUSIONTelbivudine combination treatment with adefovir was more effective than telbivudine monotherapy and elicited a low drug resistance rate in nucleos(t)idenaive chronic hepatitis B patients with high-level HBV load and HBeAg-positivity. Adherence to the therapy regimen was a key factor influencing treatment outcomes.
Adenine ; analogs & derivatives ; Alanine Transaminase ; Drug Therapy, Combination ; Hepatitis B e Antigens ; Hepatitis B virus ; Hepatitis B, Chronic ; Humans ; Organophosphonates ; Retrospective Studies ; Thymidine ; analogs & derivatives ; Treatment Outcome ; Viral Load
9.Comparison of tenofovir alafenamide and entecavir for hepatitis B virus-related acute-on-chronic liver failure.
Wenting PENG ; Huimin GU ; Chuan JIANG ; Jinqing LIU ; Jian ZHANG ; Lei FU
Journal of Central South University(Medical Sciences) 2022;47(2):194-201
OBJECTIVES:
Hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) is the most common type of liver failure in China, with a high mortality. Early rapid reduction of HBV-DNA load can improve the survival rate of HBV-ACLF patients. At present, the commonly used drugs are nucleoside (acid) analogues, such as entecavir (ETV), tenofovir, and so on. The newly listed tenofovir alafenamide fumarate (TAF) has attracted great attention of clinicians because of its stronger antiviral effect, higher transaminase normalization rate, better bone and kidney safety, and zero drug resistance. However, there are few clinical research data on the efficacy and safety of TAF in the treatment of Chinese HBV-ACLF patients, and there is a lack of pharmacoeconomic evaluation. This study aims to compare the efficacy, safety, and cost-effectiveness between TAF and ETV in patients with HBV-ACLF.
METHODS:
The data were collected from 196 HBV-ACLF patients (80 patients in the TAF group and 116 patients in the ETV group) who were hospitalized in Xiangya Hospital, Central South University from May 2020 to March 2021. Biochemistry and virology were detected before and after treatment (at baseline, Week 2, 4, and 12). Clinical features, disease prognosis, and cost-effectiveness were compared between the 2 groups. According to the baseline, HBV-ACLF patients were divided into 4 stages including pre-liver failure stage, early stage, medium stage, and end stage. And the liver transplantation rate and mortality was also compared. Pharmacoeconomic evaluation was taken using cost-effectiveness analysis and cost minimization analysis..
RESULTS:
After 4 weeks of treatment, there were no significant differences in the efficacy (liver function, viral load) between the 2 groups (all P>0.05). The TAF group showed lower creatinine [(80.35±18.77) μmol/L vs (105.59±82.32) μmol/L, P<0.05] and higher estimated glomerular filtration rate (eGFR) levels [(95.65±23.21) mL/(min·1.73 m2) vs (82.68±26.32) mL/(min·1.73 m2), P<0.05] than the ETV group. After 12 weeks of treatment, the analysis of overall the liver transplantation rate and mortality between the 2 groups showed similar conclusion. However, the TAF group had a lower the liver transplantation rate and mortality than the ETV group in patients with pre-liver failure (0vs13.89%, P<0.05). No evident distinction was found in the liver transplantation rate and mortality during the early, medium, or end stages of liver failure (13.04% vs 17.65%, 37.50% vs 37.04%, and 54.55% vs 68.42%, respectively). Ratio of cost to effectiveness in the ETV group was higher than that in the TAF group.
CONCLUSIONS
TAF is not more efficient than ETV group in improving liver function and reducing viral load for HBV-ACLF patients and they also show similar safety. However, TAF has a greater advantage over ETV not only in preserving renal function, but also in reducing the liver transplantation rate and mortality in patients with pre-liver failure. TAF can provide economic benefit to patients with HBV-ACLF.
Acute-On-Chronic Liver Failure/drug therapy*
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Alanine/therapeutic use*
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Antiviral Agents/therapeutic use*
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Guanine/analogs & derivatives*
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Hepatitis B virus/genetics*
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Hepatitis B, Chronic/drug therapy*
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Humans
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Tenofovir/analogs & derivatives*
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Treatment Outcome
10.Carbohydrate-deficient Transferrin as a Marker of Heavy Drinking in Korean Males.
Seong Min KIM ; Jong Sung KIM ; Kyoung Min KIM ; Han Ju PACK ; Dong Hoon LEE ; Sung Soo KIM ; Jin Gyu JUNG
Journal of Korean Medical Science 2007;22(4):652-655
This study was performed to evaluate the usefulness of carbohydrate-deficient transferrin (CDT) as a marker of heavy drinking in Korean males. The subjects (143 Korean males) were classified into 2 groups according to the amount of drinking, moderate drinkers (72 individuals) who drank 14 drinks or less per week and heavy drinkers (71 individuals) who drank more than 14 drinks per week. Using %CDT, gamma glutamyl transferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) as clinical markers for heavy drinking, sensitivity, specificity, positive and negative predictive values were investigated. Sensitivities of %CDT, GGT, AST, and ALT were 83.1%, 67.6%, 52.1% and 46.5%, respectively. Specificities were 63.9%, 45.8%, 72.2%, and 54.2%, respectively. Positive predictive values were 69.4%, 55.2%, 64.9%, and 50.0% respectively. Negative predictive values were 79.3%, 58.9%, 60.5%, and 50.6% respectively. The areas under the receiver operating characteristic curve (95% confidence interval) for %CDT, GGT, AST, and ALT were 0.823 (0.755-0.891), 0.578 (0.484-0.673), 0.622 (0.528-0.717), and 0.516 (0.420-0.613), respectively. CDT is considered as the most reliable marker for detecting heavy drinking in Korean males.
Adult
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Alanine Transaminase/blood
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Alcoholism/blood/*diagnosis/ethnology
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*Asian Continental Ancestry Group
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Aspartate Aminotransferases/blood
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Biological Markers/*blood
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Humans
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Korea
;
Male
;
Middle Aged
;
Sensitivity and Specificity
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Transferrin/*analogs & derivatives/analysis
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gamma-Glutamyltransferase/blood