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

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.

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

10.21203/rs.2.14867/v2 ◽

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

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

10.21203/rs.2.14867/v3 ◽

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.

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

10.21203/rs.2.14867/v4 ◽

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.

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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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/620230 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 1

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.

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Sa1046 Efficacy of 5 Years of Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients With High Viral Load (HBV DNA =9 Log10 Copies/Ml)

Gastroenterology ◽

10.1016/s0016-5085(12)63699-3 ◽

2012 ◽

Vol 142 (5) ◽

pp. S-954

Author(s):

Stuart C. Gordon ◽

Patrick Marcellin ◽

Zahary Krastev ◽

Andrzej Horban ◽

Jörg Petersen ◽

...

Keyword(s):

Chronic Hepatitis ◽

Viral Load ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Tenofovir Disoproxil Fumarate ◽

High Viral Load ◽

Hbv Dna

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Trends in the Diagnosis and Treatment of Chronic Hepatitis B in Karachi, Pakistan

Journal of Medicine ◽

10.3329/jom.v14i1.14538 ◽

2013 ◽

Vol 14 (1) ◽

pp. 57-61

Author(s):

Fakhsheena Anjum ◽

Sana Ghayas ◽

Viqas Shafi ◽

Lubna Bashir ◽

Shazia Naz

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Alanine Aminotransferase ◽

Liver Function Tests ◽

Hbv Dna ◽

Interferon Alfa ◽

Response To Treatment ◽

Management Decision

Aims: Aim of this study was to analyze diagnostic and therapeutic trends of physicians regarding Chronic Hepatitis B (CHB) in Karachi since Pakistan is endemic area for viral hepatitis B.Methods: A questionnaire was distributed to about 100 physicians / doctors in different hospitals of Karachi. The questionnaire assessed diagnostic trends, prescribing habits for Chronic Hepatitis B (CHB) treatment and patients monitoring and follow ups by the physician.Results: About 100 doctors from Karachi participated in the study (response rate: 72%). 34.72% doctors had experience of treating less than 10 patients per month. Majority of the doctors (79.16%) used HBsAg (anti-HBsAg seroconversion), (61.11%) used liver function tests (LFTs) and hepatitis B virus (HBV) DNA levels were used by doctors (47.22%) as diagnostic parameters for CHB. HBV-DNA levels were the most commonly used parameter to confirm diagnosis and was used by 86.11 % doctors. Treatment of CHB was started upon various indications i.e. 58.33% doctors used HBV DNA level when it is e20,000 IU/mL (105 copies/mL) ; 36.11% used HBV DNA when it is e 2000 IU/mL (104 copies/mL) and 29.16% doctors used Serum alanine aminotransferase (ALT) when it was elevated for 3-6 months. Most of the doctors (38.88%) had experience with Interferon alfa and Pegylated IFN-a 2a, (26.38%) with Lamivudine and (25%) with Entecavir. For treatment, 41.66% of doctors recommended Pegylated IFN-a 2a for HBeAg positive CHB patients whereas 22.22% of doctors treated HBeAg negative CHB Patients with Entecavir. HBV DNA levels and alanine aminotransferase (ALT) levels were most commonly used to monitor therapy by 73.61% and 52.77% doctors respectively. Frequency of follow-up was after 3 months by most of the doctors (63.88%). According to 23.61% doctors, 5 to 10% of patients required add- on treatment or switching from the previous regimen. According to most doctors (68.05%), polymerase chain reaction (PCR) - negativity was an important indication of improved response and outcome to anti-viral therapy.Conclusion: CHB management decision varies from physicians perspective and is not always based on scientific decision. Mostly doctors used HBV DNA level as indication for treatment when it is e 2000 IU/mL (104 copies/mL) and prescribed Interferon alfa and Pegylated IFN-a 2a to their patients. Monitoring of therapy was usually done by observing HBV DNA levels and alanine aminotransferase (ALT) levels of patients and frequency of follow-up was after 3 months by most of the doctors. Add- on treatment or switching is also required by some patients and improved response to treatment was assessed by PCR negativity. Management of CHB can be improved through CME (continual medical education) and practical training.DOI: http://dx.doi.org/10.3329/jom.v14i1.14538 J MEDICINE 2013; 14 : 57-61

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EFFICACY OF TENOFOVIR IN PATIENTS OF HBV-RELATED CIRRHOSIS

Journal of Medicine and Pharmacy ◽

10.34071/jmp.2016.2.4 ◽

2016 ◽

pp. 25-29

Author(s):

Van Huy Tran ◽

Thi Huyen Thuong Nguyen

Keyword(s):

Side Effects ◽

Serum Creatinine ◽

Key Words ◽

Tenofovir Disoproxil Fumarate ◽

Hbv Dna ◽

Treatment Side Effects ◽

Background Data ◽

Key Words Cirrhosis

Background: Data about efficacy of Tenofovir in patients of HBV –related cirrhosis in Vietnam was still limited. This study is aimed at: - evaluating the clinical, biochemical, virological and Child-Pugh score responses 3,6,9 months after Tenofovir therapy; - assessing possible side effects of tenofovir. Patients and methods: 40 patients with HBV-related cirrhosis were enrolled. All has received Tenofovir disoproxil fumarate 300mg/day. Follow-up after 3,6 and 9 months. Results: Anorexia, oedema and ascites were significantly improved after treatment. HBV DNA became undetectable in 92.5%, 94.55 and 100% after 3,6 and 9 months, respectively. Child- Pugh score was improved after treatment (5.94±0.22 after treatment vs 7.47±0.28 before treatment). Side effects were minors (nausea, vomiting). No case of increase in serum creatinine was found. Conclusion: Tenofovir showed effective and safe in patients of HBV-related cirrhosis. Key words: Cirrhosis, tenofovir, HBV. Key words: cirrhosis, tenofovir, HBV

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