Abstract
BACKGROUND: Peginterferon (PEG-IFN) α-2a has been shown to induce a sustained virologic response (SVR) in 20-30% of "hepatitis B e antigen (HBeAg)"-negative patients. AIM: To determine the safety and efficacy of PEG-IFN α-2a in HBeAg-negative, genotype D-naive patients and to analyze the predictors of response. METHODS: This prospective, multicenter, open-label, nonrandomized trial was conducted at four hospitals. A total of 35 consecutive HBeAg-negative naive genotype D patients received PEG-IFN α-2a for 48 weeks. RESULTS: Based on a cutoff of hepatitis B virus (HBV) DNA <400 copies ml(-1), an early virologic response (EVR) at week 12, end of treatment virologic response (ETVR) at week 48, and SVR at week 72 were achieved by 3 (9%), 9 (26%), and 8 patients (23%), respectively. The EVR rate improved to 43%, ETVR to 49%, and SVR to 57%, when a HBV DNA cutoff level of <20,000 copies ml(-1) was used. Pretreatment HBsAg level was not a predictor for SVR on univariate analysis, but correlated with decline in HBV DNA levels at weeks 48 and 72. On multivariate logistic regression analysis, low body weight, high alanine aminotransferase (ALT), low HBV DNA, and low triglyceride levels were identified as baseline predictors of SVR. CONCLUSION: HBeAg-negative genotype D-naive patients treated with PEG-IFN α-2a achieved SVR in 23 (HBV <400 copies ml(-1)) and 57% (HBV <20,000 copies ml(-1)) of patients, a better response than previously reported that might be related to the absence of drug resistance in these naive patients. Pretreatment predictors of SVR were low body weight, high ALT, low HBV DNA, and low triglycerides.