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

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.

• Authors: Keiichi Masaki, Fumitaka Suzuki, Tasuku Hara, Yusuke Kawamura, Hitomi Sezaki, Tetsuya Hosaka, Norio Akuta, Masahiro Kobayashi, Satoshi Saitoh, Yoshiyuki Suzuki, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, Hiromitsu Kumada
• Journal: Virology journal (Virol J) Vol. 12 Pg. 225 (Dec 23 2015) ISSN: 1743-422X [Electronic] England
• PMID: 26700861 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• Alanine Transaminase
• peginterferon alfa-2a

Topics

• Adult
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage)
• Asian People
• DNA, Viral (blood)
• Double-Blind Method
• Female
• Follow-Up Studies
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Interferon-alpha (administration & dosage)
• Male
• Middle Aged
• Polyethylene Glycols (administration & dosage)
• Recombinant Proteins (administration & dosage)
• Time
• Treatment Outcome
• Young Adult