Table 1.
Comparison between two clinical trials on prevention of mother-to-child transmission of hepatitis B virus
| Chinese | Thailand | |
|---|---|---|
| Design | Open-labelled, randomized | Double blinded, placebo-controlled, randomized |
| Inclusion | HBeAg positive, HBV DNA >200,000 IU/mL | HBeAg positive, ALT <60 U/L |
| HBV DNA | 8.2 log (TDF) vs. 8.0 log (Control) | 7.6 log (TDF) vs. 7.3 log (Placebo) |
| Viruses | Genotype C wild-type with no genotypic mutations | Genotype B with no TDF-resistance mutations |
| Start of antiviral | At week 30-32 | At week 28 |
| Vaccine | 3 doses (month 0, 1, 6)+HBIg | 5 doses (month 0, 1, 2, 4, 6)+HBIg |
| First dose | Within 6 hours | 1.2 (IQR: 0.7-2.2) hours |
| Breast-feeding | No | Yes |
| Mode of delivery (%) | Caesarean section (53%) | Caesarean section (26%) |
HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; ALT, alanine aminotransferase; TDF, tenofovir disoproxil fumarate; HBIg, hepatitis B immunoglobulin; IQR, interquartile range.