1. 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
- Author
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Marjan Mokhtare, Zahra Bagheri-Hosseinabadi, Mansour Bahardoust, Arman Karimi Behnagh, Hossein Keyvani, Mitra Barati, and Shahram Agah
- Subjects
0301 basic medicine ,Microbiology (medical) ,Hepatitis B virus ,medicine.medical_specialty ,Combination therapy ,030106 microbiology ,Iran ,medicine.disease_cause ,Antiviral Agents ,Gastroenterology ,Group B ,Polyethylene Glycols ,law.invention ,03 medical and health sciences ,Hepatitis B, Chronic ,0302 clinical medicine ,Randomized controlled trial ,law ,Pegylated interferon ,Internal medicine ,PEG ratio ,medicine ,Humans ,Pharmacology (medical) ,Hepatitis B e Antigens ,030212 general & internal medicine ,Tenofovir ,business.industry ,Interferon-alpha ,Viral Load ,Clinical trial ,Treatment Outcome ,Infectious Diseases ,HBeAg ,DNA, Viral ,business ,Follow-Up Studies ,medicine.drug - 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 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, 95%CI: 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, 95%CI: 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).
- Published
- 2020
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