Long-term effects of peginterferon alfa-2a therapy in Japanese patients with chronic hepatitis B virus infection

摘要

There is no information on the long-term effects of peginterferon (PEG-IFN) alfa-2a therapy for chronic hepatitis B (CHB) in Japan. This double-blind, randomized trial investigated the efficacy of PEG-IFN therapy. We analyzed 22 Japanese patients with CHB (hepatitis B e antigen [HBeAg]-positive: 17, HBeAg-negative: 5) treated with PEG-IFN alfa-2a and followed-up posttreatment for 5?years. Responders represented patients who showed persistent normalization of alanine transferase (ALT) levels, HBeAg clearance, and low hepatitis B virus (HBV) DNA levels (HBeAg-positive patient; <5 log copies/mL, HBeAg-negative patient; <4.3 log copies/mL) at end of treatment, and at 1, 2, 3, 4 and 5?years posttreatment. In addition, baseline HBeAg-positive patients who showed sustained normalization of ALT level, HBeAg clearance, and low HBV DNA level for more than 6?months until at 1, 2, 3, 4, and 5?years after completion of PEG-IFN were also classified as “triple responders” and the proportion of triple responders relative to all patients was termed the “triple response rate”. The response rates among HBeAg-positive patients were 13?%, 25?%, 14?%, 21?% and 21?% at end of treatment, and at 1, 2, 3, 4, and 5?years, respectively. The response rate tended to be higher in patients treated for 48 than 24?weeks. The respective response rates among HBeAg-negative patients were 0?%, 20?%, 20?%, 20?% and 25?%. During the treatment period, hepatitis B surface antigen (HBsAg) clearance at 3.5?years was noted in one patient, who was 37-year-old, male, had genotype C and received PEG-IFN alfa-2a at 90?μg for 48?weeks. At 5?years after completion of PEG-IFN, the triple response rate in HBeAg-positive patients and combined response rate in HBeAg-negative patients were 21?% (3/14) and 25?% (1/4), respectively. The triple response was seen in three patients who had all been treated with PEG-IFN for 48?weeks.