Clinical effect of 24-week TDF versus ADV sequential therapy in HBeAg-positive chronic hepatitis B patients with suboptimal response to 48-week pegylated interferon-α-2a treatment

Objective To investigate the clinical effect of 24- week tenofovir disoproxil fumarate( TDF) sequential therapy in HBeAg- positive chronic hepatitis B( CHB) patients with suboptimal serological response to 48- week pegylated interferon- α- 2a( Peg- IFN- α- 2a) monotherapy. Methods A total of 21 patients who did not achieve HBeAg seroconversion after the 48- week Peg- IFN- α- 2a monotherapy at a dose of 180 μg / week were enrolled. Among these patients,11 were given TDF 300 mg / d in addition,the withdrawal of Peg- IFN- α- 2a after 12 weeks,and TDF monotherapy for 12 weeks; 10 were given sequential adefovir dipivoxil( ADV) monotherapy at a dose of 10 mg / d for 24 weeks. The indicators including HBV DNA,liver and renal function,and HBV serological markers were measured at weeks 12 and 24 of treatment,and the clinical outcome was compared between the two groups. The independent samples t- test was used for comparison of normally distributed continuous data between groups and the paired t- test was used for comparison of normally distributed continuous data within one group; the Mann- Whitney U test was used for comparison of non- normally distributed continuous data between groups. The Fisher's exact test was used for comparison of categorical data. Results At weeks 12 and 24 of treatment,there were no significant differences in HBs Ag and HBeAg levels between groups( both P > 0. 05). At week 24 of treatment,there was no significant difference in HBeAg seroconversion rate between the TDF group and the ADV group [18. 2%( 2 /11) vs 10. 0%( 1 /10),P > 0. 05]. At weeks 12 and 24 of treatment,the TDF group had significant reductions in HBeAg compared with baseline( 1. 75 ± 0. 59 log10 S / CO、1. 61 ± 0. 70 log10 S / CO vs1. 86 ± 0. 58 log10 S / CO,P = 0. 017 and 0. 027). At week 24 of treatment,the TDF group had a significantly lower alanine aminotransferase( ALT) level than the ADV group[21. 0( 15.0-27.0) U/L vs 33. 0( 21. 5-63. 5) U/L,P =0.046]. There were no significant differences in estimated glomerular filtration rate at weeks 12 and 24 of treatment between the two groups( both P > 0. 05). Conclusion As for CHB patients with suboptimal serological response to 48- week Peg- IFN- α- 2a monotherapy,addition of TDF for 12 weeks and then TDF monotherapy for 12 weeks helps to achieve greater reductions in serum ALT and HBeA g levels compared with sequential ADV therapy.