恩替和拉米对纤维化HBV患者的有效性和安全性(56 AASLD)

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Efficacy and Safety of Entecavir and Lamivudine in HBV Patients with Cirrhosis?

The long-term outcome of chronic HBV treatment depends upon potent virologic control; antiviral treatment has been shown to slow or reverse disease progression in patients with advanced liver disease.

Entecavir (ETV) [Baraclude] was superior to lamivudine (LVD) [Epivir-HBV] in achieving histologic improvement in Phase III studies of compensated, treatment-na飗e and LVD-refractory patients. This report investigates if severity of liver disease at baseline influenced treatment response in the ETV Phase III program.

Study ETV-022 and ETV-027 enrolled treatment-na飗e, HBeAg(+) and HBeAg(-) patients, respectively. ETV-026 enrolled LVD-refractory, HBeAg(+) patients.

Liver biopsies were performed before study entry and after 48 weeks of therapy. Baseline

cirrhosis was defined in patients with evaluable biopsies as a Knodell fibrosis score of 4.

Results

• Approximately 8% of patients had cirrhosis at baseline; the distribution of cirrhotic patients was balanced between treatment groups.

• Cirrhotic patients on ETV were more likely than those on LVD to have histologic improvement, ALT normalization and undetectable HBV DNA, although the relatively small patient number limits interpretation.
  
  
• Efficacy results after 48 weeks of therapy for treatment-na飗e patients according to baseline cirrhosis status are presented below:?

Baseline Cirrhosis Treatment-naive Patients
	HBeAg(+)				HBeAg(+) 牋?/b>
	牋ETV ?/b>		LVD		ETV		LVD
	Present	Absent	Present	Absent	Present	Absent	Present	Absent
Week 48	N=25	N=304	N=27	N=303	N=19	N=284	N=28	N=265
HBV DNA <300 c/mL?/b>	96%	66%	59%	36%	95%	91%	57%	72%
ALT <1.0 X牋 ULN牋	60%	70%	52%	62%	79%	79%	57%	73%
Histologic Improvement*牋	76%	72%	67%	62%	74%	70%	54%	61%

* >/= 2 point decrease in baseline Knodel inflammatory Score with no worsening of fibrosis. Patients had baseline Knodell Inflammatory Score >/= 2.

11/16/05

LACE w:st="on">E SchiffLACE> and others. Efficacy and Safety of Entecavir (ETV) and Lamivudine (LVD) in Compensated, Cirrhotic Patients with Chronic Hepatitis B. Abstract 986.

Reference
LACE w:st="on">E SchiffLACE> and others. Efficacy and Safety of Entecavir (ETV) and Lamivudine (LVD) in Compensated, Cirrhotic Patients with Chronic Hepatitis B. Abstract 986. Program and Abstracts of the 56^th annual meeting of the American Association for the Study of Liver Diseases. November 11-15, 2005. LACE w:st="on">San Francisco, CALACE>.