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160
TENOFOVIR ALAFENAMIDE TO PREVENT PERINATAL
HEPATITIS B TRANSMISSION IN MOTHERS WITH HIGH VIRAL
LOAD: A MULTICENTER, PROSPECTIVE, OBSERVATIONAL
STUDY
Qing-Lei Zeng1, Zujiang Yu1 and Fu-Sheng Wang2, (1)
Department of Infectious Diseases and Hepatology, The First
Affiliated Hospital of Zhengzhou University, (2)Treatment and
Research Center for Infectious Diseases, The Fifth Medical
Center of Chinese PLA General Hospital, National Clinical
Research Centre for Infectious Diseases
Background: No safety and efficacy data are available
regarding the administration of tenofovir alafenamide
fumarate (TAF) during pregnancy for the prevention of motherto-
child transmission (MTCT) of hepatitis B virus (HBV) The
current study aimed to investigate the safety and efficacy of
TAF to prevent MTCT of HBV Methods: In this multicenter,
prospective, observational study, pregnant women with
HBV DNA levels higher than 200,000 IU/ml who received
TAF from gestational weeks 24-35 to delivery were enrolled
and followed until postpartum month 6 Infants received
immunoprophylaxis: (1) 100 IU of hepatitis B immunoglobin
and the first dosage of 10 μg of recombinant HBV vaccine
were administered within 12 hours of birth; (2) the second
injection of 10 μg of HBV vaccine was administered at one
month; and (3) the third dose of 10 μg of HBV vaccine was
given at 6 months The primary endpoint was the safety of
TAF use for mothers and infants The secondary endpoints
were maternal HBV DNA level < 200,000 IU/ml, hepatitis B
e antigen (HBeAg) and hepatitis surface antigen (HBsAg)
clearances at delivery and HBsAg positive rate at 7 months
for infants Results: In total, 116 mothers were enrolled, 107
of whom were HBeAg positive, and 117 infants were born
TAF was well tolerated, and no mothers discontinued therapy
due to adverse events The most common maternal adverse
event, complication, and laboratory abnormality were nausea
(19 0%), premature rupture of membranes (12 9%), and
anemia (30 2%), respectively One (0 9%), 3 (2 6%), and 9
(7 8%) mothers had abnormal alanine aminotransferase levels
at delivery, postpartum month 3, and 6, respectively No infants
had birth defects, and the infants’ physical and neurological
development at birth and at 7 months were comparable with
the China national and World Health Organization standards
(Table 1) At delivery, all mothers achieved an HBV DNA level
< 200,000 IU/ml, and none of them achieved HBeAg or HBsAg
loss The HBsAg positive rate was 0% at 7 months in 117
infants, including 46 (39 3%) breastfed infants Conclusion:
This study firstly demonstrated that TAF was safe for highly
viremic pregnant women and their infants until 7 months, and
reduced MTCT rate of HBV to 0%, which provides justification
for further studies and administration of TAF to prevent MTCT
of HBV. |
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发表于 2020-10-20 13:05