Analysis Of Indicatrix Of Early Prediction For Efficacy In Nucleoside-Treated Hepatitis B E Antigen-Positive Chronic Hepatitis B

Objective: To evaluate the efficacy of nucleoside analogue for the treatment of hepatitis B e antigen-positive patients with chronic hepatitis B at 48 weeks or at 72 weeks and to predict prospective iathergy through the degree of week 24 HBV suppression .Method: The data were collected from the phaseⅡandⅢclinical trial at our hepatitis drugs research center from August 2002 to August 2004. The patients were enrolled with hepatitis B e antigen-positive chronic hepatitis B . According to clinical trial project , those patients were treated with a nucleoside analogue initially or changed with another one for 72 weeks , including adefovir dipivoxil (ADV) 10mg daily, or entecavir(ETV) 0.5mg or 1.0mg daily, or telbivudine(LdT) 600 mg daily, or lamivudine(LMV) 100 mg daily . According to HBV DNA level of every patient at week 24 , those patients were divided into two groups : negative group (HBV DNA<1.0×103 copies/ml) and positive group ( HBV DNA≥1.0×103 copies /ml), serum HBV DNA levels were detected by a polymerase-chain-reaction assay(log(10) copies/ml . The analysis of difference of efficacy between negative group and positive group at week 48 or 72 during therapy period and that of the relationship of the degree of week 24 HBV suppression and therapeutic effect at weeks 48 or 72 during therapy period . Results: One hundred patients were enrolled according to selection standard .Those patients had thirty-nine patients treated with adefovir dipivoxil, forty-eight patients treated with entecavir, eight patients treated with telbivudine and seven patients treated with lamivudine . There were the similar characteristics of sexuality and age in two groups'patients . A majority of patients were men (73 percent), mean age ( 28.1±7.5 years ). The mean baseline serum HBV DNA was as follows: 8.25 log10 copies/ml in negative group and 8.71 log10 copies/ml in positive group . The mean baseline serum HBV DNA was lower in negative group than in positive group (t=2.2026,P=0.0300).The mean baseline serum ALT was as follows: 167.0 u/l in negative group and 107.1 u/l in positive group . The mean baseline serum ALT was higher in negative group than in positive group(t=2.6305,P=0.0099). At week 48 during therapy period , the efficacy of the negative group was significantly superior to that of the positive group on HBeAg seroconversion, HBV suppression , aminotransferase (ALT) normalization , complete response or total effective rates (complete response and partial response ) ,(P<0.01) ; The efficacy of the negative group was aslo significantly superior to that of the positive group at week 72 during therapy period ,(P<0.01). There was no significant difference in the change of the rates of virologic rebound between two groups at week 48 or 72 during therapy period(P>0.05). Compared with week 48 , the differences were no significant in respect of the efficacy and the rates of virologic rebound in positive group or negative group at week 72 during therapy period(P>0.05). Conclusion: HBV DNA PCR-negative in initial phase of treatment (at week 24) in nucleoside-treated hepatitis B e antigen-positive chronic hepatitis B, suggests a better efficacy at week 48 or 72 during therapy period . In contrast , the results of prospective therapeutic reaction will be not satisfactory in positive group . It is of the considerable value to clinical application that the degree of week 24 suppression on HBV DNA in initial phase of treatment may be used as a predictor of outcome at week 48 or 72 during therapy period to institute therapeutic regimen of individual character and instruct the patients who be required to maintain antiviral therapy or be switched promptly to other medicine or be required therapeutic alliance with other drugs.