scholarly journals Comparison of Tenofovir with Telbivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang
Keyword(s):  
Hepatitis B ◽  
Alanine Aminotransferase ◽  
Late Pregnancy ◽  
High Viral Load ◽  
Hbv Dna ◽  
Intention To Treat ◽  
Hb S ◽  
Hepatitis B Transmission ◽  
Dna 2 ◽  
Lost To Follow Up

Abstract Background: Little data exist regarding comparison of efficacy and safety between tenofovir disoproxil fumarate (TDF) and Telbivudine (LdT) in late pregnancy to prevent hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods: We retrospectively included HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*105IU/mL to receive TDF or LdT after gestational weeks 24～32 weeks. All infants received standard immunoprophylaxis. Primary outcomes were MTCT rates at infants’ age of 52 weeks and safety of TDF or LdT use. Secondary outcomes were the decline of HBV-DNA levels at delivery and rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 upper limits of normal (ULN) during the study.Results: Of 1407 women, 209 received TDF and 1198 received LdT treatment. There were no differences between mean duration of TDF and LdT treatment (TDF vs. LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, p=0.47). At birth, 213 (9.8%) infants in the TDF-group were HBsAg positive, lower than 1180 (20.8%) in the LdT-group (p<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) women completed the 52-weeks study, intention‐to‐treat analysis indicated one infant (0.5 %) was lost to follow-up in TDF treated mothers and three (0.3 %) in LDT treated mothers (p=0.48). On-treatment analysis indicated no HBsAg positive infants in the two groups. Levels of HBV-DNA decline in TDF-treated mothers were observed comparable to LdT-treated mothers (4.05±0.93 log10IU/mlvs.3.99±1.30 log10IU/ml, p=0.50). TDF-treated mothers had complained more symptoms of the digestive system and less arthralgia than LdT-treated mothers. All adverse events in the two groups were grade I-II. Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were lower than in LdT-treated mothers (7.3% vs.15.7%, p<0.05).Conclusions: TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. However, TDF has fewer ALT abnormalities than LdT during treatment and is the preferred choice.

scholarly journals Comparison of Tenofovir with Telbivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

2020 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang
Keyword(s):  
Hepatitis B ◽  
Alanine Aminotransferase ◽  
Digestive System ◽  
Late Pregnancy ◽  
High Viral Load ◽  
Hbv Dna ◽  
Intention To Treat ◽  
Dna 2 ◽  
Lost To Follow Up

Abstract Background: Little data exist regarding the comparison of efficacy and safety between tenofovir disoproxil fumarate (TDF) and Telbivudine (LdT) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings. Methods: We retrospectively included HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*105IU/mL to receive TDF or LdT after gestational weeks 24～32 weeks. All infants received standard immunoprophylaxis. Primary outcomes were MTCT rates at infants’ age of 52 weeks and safety of TDF or LdT use. Secondary outcomes were the decline of HBV-DNA levels at delivery and rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 upper limits of normal (ULN) during the study.Results: Of 1407 women, 209 received TDF and 1198 received LdT treatment. There were no differences between mean duration of TDF and LdT treatment (TDF vs. LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, p>0.05). At birth, 213 (9.8%) infants in the TDF-group were HBsAg positive, lower than 1180 (20.8%) in the LdT-group (p<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) women completed the 52-weeks study, intention‐to‐treat analysis indicated 1 (0.5 %) (1 infant was lost to follow-up) in TDF treated mothers and 3(0.3 %) in LDT treated mothers (3 infants were lost to follow-up). There was no difference between TDF group and LdT (p=0.483). On-treatment analysis indicated 0% HBsAg positive infants in the two groups (p=1.0). Levels of HBV-DNA decline in TDF-treated mothers were observed comparable to LdT-treated mothers (4.05±0.93 log10IU/mlvs.3.99±1.30 log10IU/ml, p=0.499). TDF-treated mothers had complained more symptoms of the digestive system and less arthralgia than LdT-treated mothers. All adverse events of two groups were grade I-II. Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were lower in TDF-treated mothers than LdT-treated mothers (7.3% vs.15.7%, p<0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers (7.3% vs.15.7%, p< 0.05).Conclusions: TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. Although complained more digestive system symptoms, TDF treated mothers had fewer ALT abnormalities than LdT.

scholarly journals The Comparasion Tenofovir Disoproxil Fumarate with Telbivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

2019 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang
Keyword(s):  
Treatment Group ◽  
Hepatitis B ◽  
Tenofovir Disoproxil Fumarate ◽  
Alanine Aminotransferase ◽  
Late Pregnancy ◽  
High Viral Load ◽  
Hbv Dna ◽  
Dna 2 ◽  
Lost To Follow Up

Abstract Background Little observational data exist regarding the comparasion of efficacy and safety between tenofovir disoproxil fumarate(TDF) and Telbivudine(Ldt) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods We retrospectively enrolled HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*10 5 IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. The primary outcomes were the MTCT rates at infants’ age of 52 weeks and the safety of TDF or LdT use. The secondary outcomes were the decline of HBV-DNA levels at delivery and the rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 uper limit normal(ULN) during the study.Results Of 1407 patients enrolled, 209 patients received TDF treatment and 1198 patients received LdT treatment. There were no difference between the mean duration of TDF and Ldt treatment (TDF vs.LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, P >0.05) .At birth, 9.8% of infants in the TDF-treatment group were HBsAg positive, lower than 20.8% in the LDT-treatment group (P<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) patients completed the 52-week study, intention‐to‐treat analysis indicated 0.5% (1 infant was lost to follow-up) in TDF treated mother and 0.3% in LDT treated mothers (3 infant was lost to follow-up). There was no difference between TDF group and LdT(P>0.05). On-treatment analysis indicated 0% of HBsAg positive infants in the three group (P>0.05). The levels of HBV-DNA decline in TDF-treated mothers were observed comparable in LdT treated mother (4.05±0.93 log 10 IU/ml vs.3.99±1.30 log 10 IU/ml, P> 0.05).TDF treated mothers had complained more symptoms of .nausea,anorexia and dizziness and less arthralgia than LdT treated mothers. All the adverse events of three groups were grade I-II.Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were observed lower in TDF-treated mothers than LdT-treated mothers(7.3% vs.15.7%, P < 0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers(7.3% vs.15.7%, P < 0.05) .Conclusions TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. TDF treated mothers complained more symptoms of disgestive systemmore and had less ALT abnormalities than LdT.

scholarly journals The Comparasion Tenofovir Disoproxil Fumarate with Telbivudine or lamivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

2019 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang
Keyword(s):  
Treatment Group ◽  
Hepatitis B ◽  
Tenofovir Disoproxil Fumarate ◽  
Alanine Aminotransferase ◽  
Late Pregnancy ◽  
High Viral Load ◽  
Hbv Dna ◽  
Dna 2 ◽  
Lost To Follow Up

Abstract Background Little observational data exist regarding the comparasion of efficacy and safety between tenofovir disoproxil fumarate(TDF) and Telbivudine(Ldt) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods We retrospectively enrolled HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*10 5 IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. The primary outcomes were the MTCT rates at infants’ age of 52 weeks and the safety of TDF or LdT use. The secondary outcomes were the decline of HBV-DNA levels at delivery and the rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 uper limit normal(ULN) during the study.Results Of 1407 patients enrolled, 209 patients received TDF treatment and 1198 patients received LdT treatment. There were no difference between the mean duration of TDF and Ldt treatment (TDF vs.LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, P >0.05) .At birth, 9.8% of infants in the TDF-treatment group were HBsAg positive, lower than 20.8% in the LDT-treatment group (P<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) patients completed the 52-week study, intention‐to‐treat analysis indicated 0.5% (1 infant was lost to follow-up) in TDF treated mother and 0.3% in LDT treated mothers (3 infant was lost to follow-up). There was no difference between TDF group and LdT(P>0.05). On-treatment analysis indicated 0% of HBsAg positive infants in the three group (P>0.05). The levels of HBV-DNA decline in TDF-treated mothers were observed comparable in LdT treated mother (4.05±0.93 log 10 IU/ml vs.3.99±1.30 log 10 IU/ml, P> 0.05).TDF treated mothers had complained more symptoms of .nausea,anorexia and dizziness and less arthralgia than LdT treated mothers. All the adverse events of three groups were grade I-II.Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were observed lower in TDF-treated mothers than LdT-treated mothers(7.3% vs.15.7%, P < 0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers(7.3% vs.15.7%, P < 0.05) .Conclusions TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. TDF treated mothers complained more symptoms of disgestive systemmore and had less ALT abnormalities than LdT.

scholarly journals Lingmao Formula Combined with Entecavir for HBeAg-Positive Chronic Hepatitis B Patients with Mildly Elevated Alanine Aminotransferase: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Xiao-Jun Zhu ◽  
Xue-Hua Sun ◽  
Zheng-Hua Zhou ◽  
Shun-Qing Liu ◽  
Hua Lv ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Treatment Group ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Alanine Aminotransferase ◽  
Hbv Dna ◽  
Control Group ◽  
Hbeag Loss ◽  
Histological Improvement ◽  
Positive Chronic Hepatitis

Objective. To determine the efficacy and safety of Lingmao Formula combined with entecavir for HBeAg-positive chronic hepatitis B patients with mildly elevated alanine aminotransferase (ALT).Methods. 301 patients were randomly assigned to receive Lingmao Formula combined with entecavir (treatment group) or placebo combined with entecavir (control group) for 52 weeks. The outcomes of interest included the reduction of serum HBV DNA level, HBeAg loss, HBeAg seroconversion, ALT normalization, and histological improvement.Results. The mean decrease of serum HBV DNA level from baseline and the percentage of patients who had reduction in serum HBV DNA level ≥2 lg copies/mL in treatment group were significantly greater than that in control group (5.5 versus 5.4 lg copies/mL,P=0.010; 98.5% versus 92.6%,P=0.019). The percentage of HBeAg loss in treatment group was 22.8%, which was much higher than a percentage of 12.6% in control group (P=0.038). There was no significant difference between the two groups in histological improvement. Safety was similar in the two groups.Conclusions. The combination of Lingmao Formula with entecavir could result in significant decrease of serum HBV DNA and increase of HBeAg loss for HBeAg-positive chronic hepatitis B patients with mildly elevated ALT without any serious adverse events. Clinical trial registration number isChiCTR-TRC-09000594.

scholarly journals Hepatitis B e Antigen (HBeAg) Rapid Test and Alanine Aminotransferase Level–Based Algorithm to Identify Pregnant Women at Risk of HBV Mother-to-Child Transmission: The ANRS 12345 TA PROHM Study

2020 ◽  
Vol 71 (10) ◽  
pp. e587-e593 ◽  
Author(s):  
Olivier Segeral ◽  
Bunnet Dim ◽  
Christine Durier ◽  
Sophearot Prak ◽  
Kearena Chhim ◽  
...  
Keyword(s):  
At Risk ◽  
Hepatitis B ◽  
Pregnant Women ◽  
Sensitivity And Specificity ◽  
Alanine Aminotransferase ◽  
Rapid Test ◽  
Perinatal Transmission ◽  
Hbv Dna ◽  
Dna Quantification ◽  
Low Middle Income Countries

Abstract Background The paucity of hepatitis B virus (HBV) DNA measurement in low-/middle-income countries hinders the identification of HBV-infected pregnant women at risk of perinatal transmission. This study evaluates the validity of an algorithm selecting HBeAg-positive women and HBeAg-negative women with alanine aminotransferase (ALT) ≥40 IU/L as a predictor of high HBV DNA level. Methods All women with reactive samples for hepatitis B surface antigen (HBsAg) were assessed with an SD BIOLINE HBeAg rapid test and HBV DNA quantification was performed. Validities of HBeAg and of the algorithm to identify HBV DNA &gt;2 thresholds (5.3 and 7.3 log10 IU/mL) were evaluated. Results For the 515 HBsAg-positive women, median age was 29 years, 92 (17.9%) were HBeAg positive, 47 (9.1%) were HBeAg negative with ALT ≥40 IU/L, and 144 (28.0%) had an HBV DNA &gt;5.3 log10 IU/mL. Sensitivity and specificity of HBeAg were 61.8% and 99.2% for HBV DNA &gt;5.3 log10 IU/mL and 81.3% and 96.7% for HBV DNA &gt;7.3 log10 IU/mL. For the algorithm, sensitivity and specificity were 79.2% and 93.3% for HBV DNA level &gt;5.3 log10 IU/mL and 92.7% and 88.1% for HBV DNA &gt;7.3 log10 IU/mL. The AUCs for the algorithm (0.92 and 0.94 for HBV DNA &gt;5.3 and 7.3, respectively) were significantly greater (P &lt; .001) than the AUCs for HBeAg (0.81 and 0.89 for HBV DNA &gt;5.3 and 7.3, respectively). Conclusions An algorithm using HBeAg and ALT level could be an effective strategy to identify HBV-infected pregnant women at risk of perinatal transmission in countries where HBV DNA quantification is not routinely available.

scholarly journals Early Viral Kinetics of Telbivudine and Entecavir: Results of a 12-Week Randomized Exploratory Study with Patients with HBeAg-Positive Chronic Hepatitis B

2009 ◽  
Vol 54 (3) ◽  
pp. 1242-1247 ◽  
Author(s):  
Dong Jin Suh ◽  
Soon Ho Um ◽  
Eva Herrmann ◽  
Ju-Hyun Kim ◽  
Young Sok Lee ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Alanine Aminotransferase ◽  
Hbv Dna ◽  
Viral Production ◽  
Viral Kinetics ◽  
Hepatitis B Virus Dna ◽  
B Virus ◽  
Infected Cells ◽  
Early Viral Kinetics

ABSTRACT We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B. Forty-four patients were enrolled in this open-label, parallel-group, multicenter study and randomized to receive telbivudine or entecavir for 12 weeks. Reductions in hepatitis B virus DNA and alanine aminotransferase levels from baseline to weeks 2, 4, 8, and 12 were assessed. Viral kinetic parameters, including viral clearance per day, loss of infected cells per day, and efficiency of inhibition of viral production, were estimated by using a biphasic mathematical model. Statistical analyses were limited to descriptive analyses. The 2 treatment groups achieved similar reductions in HBV DNA and alanine aminotransferase levels. Mean reductions in levels of hepatitis B virus DNA at week 12 were 6.6 ± 1.6 and 6.5 ± 1.5 log10 copies/ml for the telbivudine- and entecavir-treated patients, respectively. There were no significant differences between groups in values for mean viral clearance per day, mean loss of infected cells per day, or efficiency of blocking viral production. The safety profiles for both medications were favorable. During the first 12 weeks of treatment, telbivudine and entecavir demonstrated similar antiviral potencies, resulting in a rapid and profound suppression of serum hepatitis B virus DNA and reduction of alanine aminotransferase levels. No differences in the effects of these 2 agents on early viral kinetics were observed. Both medications were well tolerated.

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