| Aim To assess the antiviral efficacy of lamivudine(LAM), entecavir(ETV), telbivudine(LDT), and lamivudine and adefovir dipivoxil(CLA) combination in previously untreated hepatitis B patients at different time points during a 52-week treatment period. Methods A total of 164 patients were included in this prospective, open label, head to head study. Serum levels of alanine transaminase(ALT), hepatitis B virus(HBV) DNA, and hepatitis B e antigen(HBe Ag) were measured at baseline, and at 12, 24, and 52 weeks of treatment.Patients’ blood were collected from January 2011 to December 2013, and the collection site is Department of Infectious Disease, The First Affiliated Hospital of Anhui Medical University. Using automatic biochemical analyzer, measure the levels of serum ALT, using enzyme-linked immunoassay(ELISA), qualitative detection of hepatitis b five, fluorescence quantitative PCR method to detect the levels of serum HBV DNA. Analysis the antiviral effect of patients in different times, taking different antiviral nucleos(t)ide analogues. And to explore different nucleos(t)ide analogues in patients with chronic hepatitis b patients at 24 weeks of HBV DNA levels and the relationship between the subsequent clinical antiviral properties. Results:(1) For all of the included people, median reductions in serum HBV DNA levels at 12 weeks(log10 copies/m L) were as follows: LAM, 3.64; ETV, 3.90; LDT, 4.10; and CLA,4.06. The biochemical responses to nucleos(t)ide analogues:LAM, 70.5%; ETV, 55.6%; LDT, 72.0%; and CLA, 73.1%. The rates of HBe Ag loss:LAM, 34%; ETV, 39%, LDT, 28%; and CLA 35%; The rates of HBV DNA negative:LAM, 65.9%; ETV, 77.8%; LDT, 68.0%; and CLA, 73.1%. At the treatment of 24 weeks,median reductions in serum HBV DNA levels(log10 copies/m L): LAM, 4.00; ETV, 4.15; LDT, 4.27 and CLA,4.35. The rates of ALT normalization : LAM, 72.7%; ETV, 83.3%; LDT, 72.0% and CLA,76.9%. The serological responses to nucleos(t)ide analogues: LAM, 31.8%; ETV, 27.8%; LDT, 44.0%; and CLA,19.2%. The virological responses to nucles(t)ide analogues:LAM 72.7%; ETV 94.4%; LDT 80.0%; and CLA, 84.6%. Median reductions in serum HBV DNA levels at 52 weeks(log10 copies/m L) were as follows: LAM, 3.98; ETV, 3.89; LDT, 4.11; and CLA, 3.36. The corresponding HBV DNA undetectability rates were 83%, 96%, 91%, and 89%, respectively. These two measures showed no significant intergroup differences. The biochemical response to nuclestide analogues: LAM, 75.3%;ETV 88.0%;LDT 90.9%; and CLA, 75.6%. The rates of HBe Ag loss: LAM, 36.4%;ETV 38.9%;LDT 48.0%; and CLA, 34.6%. Data analysis showed that: the four groups existed no diffenence between the rates of ALT normalization and HBe Ag loss. Clinical efficacy appeared related to HBV DNA level reduction after 24 weeks of therapy. Patients were divided into three groups based on HBV DNA levels at week 24: Undetectable(<103 copies/m L), detectable but <104 copies/m L, and >104 copies/m L. Patients with levels below quantitation limit(QL) were analyzed at 52 weeks for HBV DNA undetectability rate(94%), ALT normalization rate(83%), and viral breakthrough rate(0%). The corresponding values in the QL 104 copies/m L group were 50%, 75%, and 13%, whereas those in the above 104 copies/m L group were 53%, 65%, and 18%. There were significant differences at week 52 for HBV DNA levels and viral breakthrough rate between the three groups.(2) For e antigen positive cases of the included people, median reductions in serum HBV DNA levels at 52 weeks(log10 copies/m L) were as follows: LAM, 4.41; ETV 4.24; LDT 4.33; and CLA, 4.37. The rates of serum HBV DNA negative respectively were: LAM, 75%; ETV, 94%; LDT, 88%; and CLA,85%. The bichemical rates: LAM, 75%; ETV, 88.9%; LDT, 88%; and CLA, 69.2%. The rates of HBe Ag loss: LAM, 36.4%;ETV, 38.9%; LDT, 48.0%; and CLA, 34.6%. Conclusions: Different nucleos(t)ide(NUC) analogues tested exhibited no significant differences in effectiveness for Chinese NUC naive HBV patients during 1 year treatment period. |
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