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Randomized Controlled Trial
. 2015 Dec 23:12:225.
doi: 10.1186/s12985-015-0453-7.

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

Keiichi Masaki  1 , Fumitaka Suzuki  2 , Tasuku Hara  3 , Yusuke Kawamura  4 , Hitomi Sezaki  5 , Tetsuya Hosaka  6 , Norio Akuta  7 , Masahiro Kobayashi  8 , Satoshi Saitoh  9 , Yoshiyuki Suzuki  10 , Yasuji Arase  11 , Kenji Ikeda  12 , Mariko Kobayashi  13 , Hiromitsu Kumada  14
Affiliations
Randomized Controlled Trial

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

Keiichi Masaki et al. Virol J. .

Abstract

Background: 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.

Methods: 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".

Results: 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.

Conclusion: 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.

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Figures

Fig. 1
Fig. 1
Clinical course of the patient who achieved HBsAg loss. EOT: End of treatment
Fig. 2
Fig. 2
ALT levels of individual patients from pretreatment to end of treatment, and at 0.5, 1, 2, 3, 4 and 5 years after completion of treatment according to the duration of PEG-IFN treatment a with ALT levels rebound, b without ALT levels rebound. EOT: End of treatment
Fig. 3
Fig. 3
Schematic diagram of the clinical course of study participants including HBeAg-positive and HBe-negative patients
See this image and copyright information in PMC

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