The Use of Tenofovir Disoproxil Fumarate in Hepatitis B e Antigen–Positive Patients With Normal Levels of Alanine Aminotransferase

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 or lamivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

10.21203/rs.2.14867/v1 ◽

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.

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