Tenofovir rescue therapy in pregnant females with chronic hepatitis B.
OBJECTIVE
To evaluate the safety and efficacy of tenofovir monotherapy in pregnant females resistant to lamivudine or telbivudine. The effect of tenofovir on the fetus was also assessed.


METHODS
The clinical data of 17 females were reviewed in this study. Adverse events and pregnancy outcomes from January 1, 2011 to June 30, 2013 were evaluated in the Department of Gynecology and Obstetrics of Beijing Ditan Hospital, Capital Medical University, Beijing, China. These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated.


RESULTS
The median hepatitis B virus (HBV) DNA level in the pregnant females with LAM or LdT resistance was 5.9 (range, 4.2-7.2) log10 copies/mL before the initiation of TDF. Ten of these females had abnormal alanine aminotransferase (ALT) levels. The patients were treated with TDF for a median of 24 wk (range, 12-40 wk). Fourteen females (82.4%) had an HBV DNA level of <500 copies/mL at the time of delivery. This decrease was statistically significant (P<0.0001). Serum ALT levels were normalized in all subjects with an elevated serum ALT level at baseline (P=0.0003). There were no significant changes in serum creatinine and phosphorus levels during TDF treatment. In addition, no adverse events related to TDF treatment were observed. Seventeen females delivered 17 live infants, and all infants had good Apgar scores. The mean birth weight was 3226.5±331.7 g, and the mean length at birth was 50.4±1.1 cm. The growth and development of the infants was normal at birth, and no infants had birth defects related to TDF treatment. Eleven infants completed HBV vaccination and had no evidence of vertical transmission.


CONCLUSIONS
The use of TDF in pregnant females with chronic HBV and LAM or LdT resistance was safe and effective.
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Yu-Hong
YH
Hu
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Min
M
Liu
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Wei
W
Yi
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Yan-Jun
YJ
Cao
Yu-Hong Hu, Min Liu, Wei Yi, Yan-Jun Cao, Hao-Dong Cai, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Hao-Dong
HD
Cai
D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001034:Apgar Score; D015415:Biomarkers / Q000097:blood; D001724:Birth Weight; D002681:China; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D057915:Drug Substitution; D005260:Female; D005838:Genotype; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D019259:Lamivudine / Q000627:therapeutic use; D050498:Live Birth; D008297:Male; D008875:Middle Aged; D009154:Mutation; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D012189:Retrospective Studies; D000077712:Telbivudine; D000068698:Tenofovir; D013936:Thymidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014611:Vaccination; D019562:Viral Load; D055815:Young Adult
D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D017325:Hepatitis B Vaccines; D063065:Organophosphonates; D000077712:Telbivudine; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine; D013936:Thymidine
Birth defects; Chronic hepatitis B; Pregnancy; Safety; Tenofovir