title: Co-treatment with pegylated interferon alfa-2a and entecavir for hepatitis D: A randomized trial.
abstract: OBJECTIVE
  To investigate the efficacy of pegylated interferon alfa (PEG-IFNα) therapy with and without entecavir in patients with chronic hepatitis D.
  
  
  METHODS
  Forty hepatitis D virus (HDV) RNA positive patients were randomized to receive either PEG-IFNα-2a 180 μg weekly in combination with entecavir 0.5 mg daily (n = 21) or PEG-IFNα alone (n =19). Patients who failed to show 2 log reduction in HDV RNA level at 24 wk of treatment, or had detectable HDV RNA at 48 wk of therapy were considered as treatment failure. Treatment was continued for 72 wk in the rest of the patients. All the patients were followed for 24 wk post treatment. Intention to treat analysis was performed.
  
  
  RESULTS
  The mean age of the patients was 26.7 ± 6.8 years, 31 were male. Two log reduction in HDV RNA levels at 24 wk of therapy was achieved in 9 (43%) patients receiving combination therapy and 12 (63%) patients receiving PEG-IFNα alone (P = 0.199). Decline in hepatitis B surface antigen (HBsAg) levels was insignificant. At the end of treatment, HDV RNA was negative in 8 patients (38%) receiving combination therapy and 10 patients (53%) receiving PEG-IFNα-2a alone. Virological response persisted in 7 (33%) and 8 (42%) patients, respectively at the end of the 24 wk follow-up period. One responder patient in the combination arm lost HBsAg and became hepatitis B surface antibody positive. Six out of 14 baseline hepatitis B e antigen reactive patients seroconverted and four of these seroconverted patients had persistent HDV RNA clearance.
  
  
  CONCLUSIONS
  Administration of PEG-IFNα-2a with or without entecavir, resulted in persistent HDV RNA clearance in 37% of patients. The addition of entecavir did not improve the overall response.
authors.affiliation: Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan.
authors.forename: Zaigham
authors.initials: Z
authors.lastname: Abbas
authors.affiliation: Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan.
authors.forename: Mohammad Sadik
authors.initials: MS
authors.lastname: Memon
authors.affiliation: Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan.
authors.forename: Muhammad Amir
authors.initials: MA
authors.lastname: Umer
authors.affiliation: Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan.
authors.forename: Minaam
authors.initials: M
authors.lastname: Abbas
authors.affiliation: Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan.
authors.forename: Lubna
authors.initials: L
authors.lastname: Shazi
keywords: Entecavir; Hepatitis B surface antigen; Hepatitis D; Hepatitis D virus RNA; Pegylated interferon; Treatment