1Hepatology Department, Hospices Civils de Lyon, INSERM U1052, Lyon University, Lyon, France. Electronic address: Fabien.firstname.lastname@example.org.
2University of Brescia, Brescia, Italy.
3Toronto Digestive Disease Associates, Inc., Toronto, Canada.
4Silesian Medical University, Katowice, Poland.
5Alvarado Hospital Medical Center, San Diego, CA, USA.
6University of Miami, Miller School of Medicine, Miami, FL, USA.
7Liver Unit, University Hospital Pisa, Pisa, Italy.
8Research and Development, Bristol-Myers Squibb Company, Wallingford, CT, USA.
BACKGROUND AND AIMS:
Serum hepatitis B surface antigen (HBsAg) levels may predict treatment response in chronic hepatitis B (CHB). We examined the association between changes in HBsAg levels and response to treatment in the BE-LOW study.
In this open-label, multicenter study, 379 nucleos(t)ide-naïve patients with hepatitis B e antigen (HBeAg)-positive or -negative CHB were randomized and treated with daily entecavir 0.5 mg, alone (n = 182) or combined with tenofovir 300 mg (n = 197) for 100 weeks. HBsAg levels were quantified (Abbott Architect assay) at baseline and Weeks 12, 48 and 96.
Mean baseline HBsAg levels were comparable across subgroups by baseline alanine aminotransferase (ALT), genotype, age, and treatment type, but were higher in HBeAg-positive than in HBeAg-negative patients. Mean HBsAg changes from baseline at Weeks 12, 48, and 96 were more pronounced in HBeAg-positive than in HBeAg-negative patients, in patients with genotype A than in those with genotypes C or D, and in patients with elevated baseline ALT, but were similar between treatment groups and between patients of different age categories. Mean HBsAg changes over 96 weeks were also comparable in patients with or without HBV DNA <50 IU/mL at Week 96, but among patients HBeAg-positive at baseline, changes were greater for those with Week 96 HBeAg loss than for those without.
In this population of HBeAg-positive and HBeAg-negative, nucleos(t)ide-naïve patients, a greater HBsAg decline through 96 treatment weeks was observed in HBeAg-positive patients, especially in those who achieved subsequent HBeAg loss.