聚乙二醇干扰素α-2a治疗对日本慢性乙型肝炎病毒感染患者的长期影响。
Long-term effects of peginterferon alfa-2a therapy in Japanese patients with chronic hepatitis B virus infection.
作者信息
Masaki Keiichi, Suzuki Fumitaka, Hara Tasuku, Kawamura Yusuke, Sezaki Hitomi, Hosaka Tetsuya, Akuta Norio, Kobayashi Masahiro, Saitoh Satoshi, Suzuki Yoshiyuki, Arase Yasuji, Ikeda Kenji, Kobayashi Mariko, Kumada Hiromitsu
机构信息
Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
Research Institute for Hepatology, Toranomon Hospital, Tokyo, Japan.
出版信息
Virol J. 2015 Dec 23;12:225. doi: 10.1186/s12985-015-0453-7.
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.
背景
在日本，关于聚乙二醇干扰素（PEG-IFN）α-2a治疗慢性乙型肝炎（CHB）的长期影响尚无相关信息。这项双盲随机试验研究了PEG-IFN治疗的疗效。
方法
我们分析了22例接受PEG-IFNα-2a治疗的日本CHB患者（乙肝e抗原[HBeAg]阳性：17例，HBeAg阴性：5例），并在治疗后进行了5年的随访。应答者指在治疗结束时以及治疗后1、2、3、4和5年时，丙氨酸转氨酶（ALT）水平持续正常、HBeAg清除且乙肝病毒（HBV）DNA水平较低（HBeAg阳性患者；<5 log拷贝/mL，HBeAg阴性患者；<4.3 log拷贝/mL）的患者。此外，基线HBeAg阳性患者在完成PEG-IFN治疗后1、2、3、4和5年期间，ALT水平持续正常、HBeAg清除且HBV DNA水平较低超过6个月的患者也被归类为“三联应答者”，三联应答者相对于所有患者的比例被称为“三联应答率”。
结果
HBeAg阳性患者在治疗结束时以及治疗后1、2、3、4和5年的应答率分别为13%、25%、14%、21%和21%。接受48周治疗的患者应答率往往高于接受24周治疗的患者。HBeAg阴性患者的相应应答率分别为0%、20%、20%、20%和25%。在治疗期间，一名37岁男性、基因型为C且接受90μg PEG-IFNα-2a治疗48周的患者在3.5年时出现乙肝表面抗原（HBsAg）清除。
结论
在完成PEG-IFN治疗5年后，HBeAg阳性患者的三联应答率和HBeAg阴性患者的联合应答率分别为21%（3/14）和25%（1/4）。三名三联应答者均接受了48周的PEG-IFN治疗。
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