Wei Xu1, Qiang Li2, Chenlu Huang1, Qiankun Hu1, Xun Qi1, Yuxian Huang1,3, Jiming Zhang3, Liang Chen4. 1. Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China. 2. Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China. liqiang66601@163.com. 3. Department of Infectious Disease, Huashan Hospital, Fudan University, Shanghai, China. 4. Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China. chenliang@shphc.org.cn.
Abstract
OBJECTIVE: This study aimed to evaluate the efficacy of Peg-interferon (Peg-IFN)-nucleoside analog (NA) sequential optimization therapy (SOT) in HBeAg-positive patients with chronic hepatitis B (CHB). METHODS: In this prospective two-center study, 132 CHB patients were assigned to receive Peg-IFN standard therapy for 48 weeks (65 patients) or Peg-IFN monotherapy for 12-24 weeks and NA add-on for those without early virological response (EVR) (67 patients). Both patient groups were monitored and followed for 24 weeks after treatments stop. RESULTS: At week 24 after treatments stop, the Peg-IFN-NA SOT group achieved more HBsAg levels drop (- 1.35 vs - 0.67 log10 IU/mL, p = 0.016), higher HBsAg ≤ 100 IU/mL (32.8% vs 9.2%, p = 0.001), HBV DNA undetectable (79.1% vs 49.2%, p < 0.001), and ALT normalization (80.6% vs 38.5%, p < 0.001) rates compared with Peg-IFN monotherapy. At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group. CONCLUSION: Starting with Peg-IFN followed by addition of NA achieved more HBsAg levels drop, and higher HBsAg ≤ 100 IU/mL, HBV DNA undetectable, and ALT normalization rates compared with Peg-IFN monotherapy.
RCT Entities:
OBJECTIVE: This study aimed to evaluate the efficacy of Peg-interferon (Peg-IFN)-nucleoside analog (NA) sequential optimization therapy (SOT) in HBeAg-positive patients with chronic hepatitis B (CHB). METHODS: In this prospective two-center study, 132 CHB patients were assigned to receive Peg-IFN standard therapy for 48 weeks (65 patients) or Peg-IFN monotherapy for 12-24 weeks and NA add-on for those without early virological response (EVR) (67 patients). Both patient groups were monitored and followed for 24 weeks after treatments stop. RESULTS: At week 24 after treatments stop, the Peg-IFN-NA SOT group achieved more HBsAg levels drop (- 1.35 vs - 0.67 log10 IU/mL, p = 0.016), higher HBsAg ≤ 100 IU/mL (32.8% vs 9.2%, p = 0.001), HBV DNA undetectable (79.1% vs 49.2%, p < 0.001), and ALT normalization (80.6% vs 38.5%, p < 0.001) rates compared with Peg-IFN monotherapy. At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group. CONCLUSION: Starting with Peg-IFN followed by addition of NA achieved more HBsAg levels drop, and higher HBsAg ≤ 100 IU/mL, HBV DNA undetectable, and ALT normalization rates compared with Peg-IFN monotherapy.