E+HBV中FTC200mg/d治疗结果和基因型无关(AASLD)

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Response Among HBeAg Positive Patients with Chronic HBV Receiving Emtricitabine 200 mg Once Daily for 1 Year Is Not Significantly Different Based on HBV Genotype at Baseline The aim of the current study was to evaluate the interaction of genotypic variations at Baseline (BL) and antiviral response among HBeAg positive (HBeAg+) patients with chronic hepatitis B virus (CHB) receiving emtricitabine (FTC) 200 mg QD.

Patients were enrolled in one of two double-blind, randomized 48-week studies. Serum HBV DNA levels were assessed by Digene Hybrid Capture II; lower limit of detection (LOD) of 4700 copies/mL [cp/mL]. Sequence analysis of the HBV POL and HBsAg reading frames was performed by di-deoxy sequencing. Results

Two hundred patients were randomized to receive FTC 200 mg QD for 48 weeks [B102; 33 (21 na飗e, 12 experienced from FTCB 101), B301; 167 na飗e]. One hundred ninety one patients were evaluable for virologic, serologic and biochemical responses and for the emergence of drug resistance mutations based on BL genotype.

Sixty four percent (64%, 123/191) were HBeAg+. Phylogenetic analysis at BL revealed that 26, 37, 49 and 10 harbored HBV of genotype A, B, C and D, respectively.

At 1 year, improvement in liver histology, i.e., reduction of at least 2 points in the Knodell necroinflammatory score and lack of fibrosis progression was observed in 59% (A), 74% (B), 68% (C) and 70% (D) of HBeAg+ patients (missing=excluded).

Median log10 decreases in HBV VL at 1 year were -3.03, -3.36, -3.20 and -3.28 cp/mL and proportion of patients with undetectable VL was observed in 40%, 48.5%, 49% and 30% of patients with genotype A, B, C and D virus, respectively.

Median changes in ALT values were -54, -48, -54 and -41 IU/L at 1 year across genotypes A-D, respectively.

In the first year, seroconversion rates were 8%, 9.4% 24% and 0% in the genotype A, B, C and D groups, respectively.

Resistance surveillance for patients with detectable viremia at 1 year revealed that 36% (A), 15.2% (B) 16.3% (C) and 10% (D) of HBeAg+ patients harbored HBV DNA with mutations associated with resistance (rt204I/V+/-rt180M+/-rt173L).

There were no statistically significant differences between genotypes in any of the markers of response evaluated (p>0.05). Conclusions

In conclusion, the authors write, 揂ntiviral response among HBeAg positive patients with CHB receiving FTC 200 mg QD for 1 year was not significantly different based on HBV genotype at Baseline.?/span>

揙verall, treatment with FTC 200 mg QD produced potent viral suppression, loss of HBeAg with seroconversion to anti HBe, demonstrated a low incidence of resistance mutations and ultimately resulted in improvement in liver histology in approximately 68% of these HBeAg+ patients.?/span>

11/08/04

Reference A Snow and others. CORRELATION BETWEEN BASELINE GENOTYPE AND ANTIVIRAL RESPONSE TO EMTRICITABINE 200 MG QD AMONG HBEAG POSITIVE PATIENTS WITH CHRONIC HEPATITIS B INFECTION. Abstract 559 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.