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Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.
Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.
- Source :
-
Journal of gastroenterology [J Gastroenterol] 2020 Oct; Vol. 55 (10), pp. 977-989. Date of Electronic Publication: 2020 Jul 14. - Publication Year :
- 2020
-
Abstract
- Background: A prospective pilot study of tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN) add-on therapy was conducted to evaluate its efficacy in reducing viral antigen levels in Japanese patients with chronic hepatitis B (UMIN 000020179).<br />Methods: Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level > 800 IU/ml were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). Both groups were followed for 96 weeks after baseline measurements.<br />Results: Almost all patients in the control arm displayed a slow and constant reduction in HBsAg during follow-up. In contrast, roughly half of the add-on arm exhibited a sharp decline in HBsAg during P-IFN administration, which disappeared after halting P-IFN. At 96 weeks after baseline, 41% (13/32) of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% (1/51) in the control arm (p < 0.001). Add-on therapy and increased cytotoxic T-cell response were significant factors associated with a rapid decrease in HBsAg according to multivariate analysis. In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.<br />Conclusions: TDF and P-IFN add-on therapy in Japanese patients with chronic hepatitis B facilitated rapid decreases in HBsAg and HBcrAg. Further studies are needed to improve early HBsAg clearance rate.
- Subjects :
- Adult
Cohort Studies
Drug Therapy, Combination
Female
Follow-Up Studies
Hepatitis B Core Antigens blood
Hepatitis B Surface Antigens blood
Hepatitis B, Chronic blood
Hepatitis B, Chronic virology
Humans
Japan
Male
Middle Aged
Pilot Projects
Prospective Studies
Recombinant Proteins administration & dosage
Antiviral Agents administration & dosage
Hepatitis B, Chronic drug therapy
Interferon-alpha administration & dosage
Polyethylene Glycols administration & dosage
Tenofovir administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1435-5922
- Volume :
- 55
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Journal of gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 32666202
- Full Text :
- https://doi.org/10.1007/s00535-020-01707-6