Published online May 18, 2016. doi: 10.4254/wjh.v8.i14.625
Peer-review started: January 27, 2016
First decision: March 9, 2016
Revised: March 30, 2016
Accepted: April 14, 2016
Article in press: April 18, 2016
Published online: May 18, 2016
AIM: 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.
CONCLUSION: 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.
Core tip: Chronic hepatitis D is a difficult to treat infection. Six months post treatment response is seen only in one quarter of the patients treated with pegylated interferon alfa (PEG-IFNα). In an attempt to improve the response of PEG-IFN, we combined entecavir. This is the first study to evaluate the efficacy of PEG-IFN with entecavir compared to PEG-IFN alone for the treatment of hepatitis D infection. Our study showed that the combination treatment did not have any additional benefit in terms of hepatitis D virus RNA suppression and hepatitis B surface antigen reduction as compared to PEG-IFN alone.