Bahardoust, M. and Mokhtare, M. and Barati, M. and Bagheri-Hosseinabadi, Z. and Karimi Behnagh, A. and Keyvani, H. and Agah, S. (2020) A randomized controlled trial of pegylated interferon-alpha with tenofovir disoproxil fumarate for hepatitis B e antigen-negative chronic hepatitis B: A 48-week follow-up study. Journal of Infection and Chemotherapy, 26 (12). pp. 1265-1271.
Full text not available from this repository.Abstract
Background: Recent studies report incongruent finds regarding the addition of pegylated interferon -alpha (Peg- IFNα) to nucleos(t)ide analogues. This study was designed to compare the efficacy of Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy with each of the treatments separately. Methods: In this open-label, randomized clinical trial, treatment-naive hepatitis B e antigen (HBeAg)-negative patients were randomly assigned to three treatment groups: Group A: Peg- IFNα (180 mcg/week) with TDF (300 mg/day); Group B: TDF (300 mg/day); and Group C: Peg- IFNα (180 mcg/week). The intervention spanned 48 weeks and patients were followed up every 12 weeks. The primary end-point was HBV DNA load <20 IU/mL. Results: Groups A, B and C each comprised of 22, 23 and 22 patients, respectively. The number of patients with HBV DNA suppression in group A was significantly higher compared to groups B and C (P = 0.034). No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082). At week 48, combination therapy was significantly more effective in suppressing HBV DNA concentration to below the level of detection than TDF monotherapy (OR = 2.1, 95CI: 1.18�4.15; P = 0.034). Furthermore, a comparison between monotherapy arms revealed that both interventions had similar effects on the overall outcome (OR = 1.24, 95CI: 1.02�5.8; P = 0.062). Conclusion: A Peg- IFNα and TDF combination therapy resulted in improved virologic response and was safe in HBeAg negative patients. Monotherapy with Peg-IFNα or TDF procured limited benefits in comparison. Trial registration: This study was registered in the Iranian Registry of Clinical Trials (IRCT20181113041635N1). © 2020 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases
| Item Type: | Article |
|---|---|
| Additional Information: | cited By 1 |
| Uncontrolled Keywords: | alanine aminotransferase; aspartate aminotransferase; hepatitis B(e) antigen; peginterferon alpha; tenofovir disoproxil; virus DNA, abdominal pain; adolescent; adult; alanine aminotransferase blood level; anemia; antiviral therapy; Article; aspartate aminotransferase blood level; chronic hepatitis B; clinical outcome; combination drug therapy; comparative study; controlled study; disease severity; drug tolerance; fatigue; febrile neutropenia; female; flu like syndrome; follow up; human; immunotherapy; major clinical study; male; monotherapy; open study; randomized controlled trial; virus load |
| Subjects: | WH Hemic and Lymphatic Systems |
| Depositing User: | eprints admin |
| Date Deposited: | 03 May 2021 06:55 |
| Last Modified: | 03 May 2021 06:55 |
| URI: | http://eprints.iums.ac.ir/id/eprint/33469 |
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