초치료 만성 B형간염 환자에서 엔테카비어의 장기 치료 효과 및 그 예측인자
Clinical Efficacy of Entecavir and Factors Predicting Long-Term Treatment Response in Nucleoside-Naïve Patients with Chronic Hepatitis B
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목적:초치료 만성 B형간염 환자들에서 엔테카비어의 치료 효과와 그 예측인자에 대해 분석하였다. 방법:2007년 3월부터 2011년 5월까지 과거 항바이러스제 치료 경험이 없는 만성 B형간염 환자로서 엔테카비어 0.5 mg을 매일 최소 48주 이상 복용한 환자 77명을 후향적으로 조사하였다. 엔테카비어 투여 중 혈청 HBV DNA치가 116 copies/mL 이하로 감소하여 검출되지 않는 경우인 바이러스 반응과 혈청 ALT치의 정상화되는 경우인 생화학적 반응, HBeAg의 혈청 소실과 혈청전환을 각각 평가하였다. 결과:치료 12, 24, 48, 96, 144주에 대한 누적 바이러스 반응률은 각각 59.7%, 82%, 88.3%, 89.6%, 93.1%였다; 누적 생화학적 반응률은 각각 51.9%, 74%, 84.4%, 94.8%, 98.3%였다; HBeAg의 누적 혈청 소실률은 10.5%, 18.4%, 28.9%, 36.8, 47.4%였다; 누적 HBeAg 혈청 전환율은 7.9%, 18.4%, 21.1%, 28.9%, 39.5%였다. 다변량 분석을 시행한 결과 혈청 HBV DNA 음전과 관련된 독립적 예측인자는 기저 HBeAg 음성(p = 0.006)과 치료 12주 후 바이러스 반응인 초기 바이러스 반응(p = 0.027)이었다. 또한 HBeAg 혈청 소실과 관련된 독립적 예측인자도 초기 바이러스 반응(p = 0.001)이었다. 결론:엔테카비어는 초치료 만성 B형간염 환자에서 뛰어난 생화학적 반응과 바이러스 반응을 보였다. 초기 바이러스 반응은 혈청 HBV DNA 음전과 HBeAg 혈청 소실을 예측할 수 있는 독립적 인자로 확인되어 치료 중 초기 바이러스 반응이 엔테카비어의 장기적인 치료 반응을 예측하는 데 유용할 것으로 생각된다.
Abstract
Background/Aims:The aims of this study were to characterize the treatment response to entecavir and to examine factors affecting that response. Methods:A total of 77 nucleoside-naïve patients with chronic hepatitis B who had received entecavir (0.5 mg daily) for at least 48 weeks were consecutively enrolled between March 2007 and March 2011. The rates of virological response (hepatitis B virus [HBV] DNA < 116 copies/mL), biochemical response (alanine aminotransferase ≤ upper limit of normal), hepatitis B e antigen (HBeAg) loss, and seroconversion were retrospectively analyzed. Results:The cumulative rates of virological response at 12, 24, 48, 96, and 144 weeks were 59.7%, 82%, 88.3%, 89.6%, and 93.1%, respectively; biochemical response rates were 51.9%, 74%, 84.4%, 94.8%, and 98.3%, respectively; HBeAg loss rates were 10.5%, 18.4%, 28.9%, 36.8%, and 47.4%, respectively; and HBeAg seroconversion rates were 7.9%, 18.4%, 21.1%, 28.9%, and 39.5%, respectively. In multivariate analysis, independent predictors associated with HBV DNA polymerase chain reaction (PCR) negativity were the absence of HBeAg at baseline (p = 0.006) and early virological response (HBV DNA < 2,000 copies/mL after 12 weeks of therapy; p = 0.027). In univariate analysis, early virological response was an independent factor predicting HBeAg loss (p = 0.001). Conclusions:Entecavir induced excellent biochemical and virological responses in nucleoside-naïve patients with chronic hepatitis B. Early virological response was an independent factor predicting HBV PCR negativity and HBeAg loss, and can be used to predict long-term treatment response to entecavir.
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