Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: A randomized open-label study

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Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients

with hepatic decompensation: A randomized open-label study

Hepatology, 04/19/2011 Clinical Article

Liaw YF et al. – Entecavir demonstrated superior virologic efficacy to

adefovir in CHB population with hepatic decompensation. Biochemical and clinical

benefits were also demonstrated. Entecavir was well tolerated and early

mortality rates were consistent with rates observed in similar populations with

lamivudine.

Methods

• Randomized, open-label comparative study of entecavir versus adefovir

therapy was performed in chronic hepatitis B (CHB) subjects with hepatic

decompensation (Child-Turcotte-Pugh [CTP] score ≥7).

• Adult subjects were randomized and treated (n=191) with entecavir 1.0 mg or

adefovir 10 mg daily for up to 96 weeks from the date of last subject

randomization.

• Subjects were hepatitis B e antigen-positive or -negative, and nucleos(t)ide

analog naïve or lamivudine experienced.

• Primary efficacy endpoint was the mean reduction in serum hepatitis B virus

(HBV) DNA by PCR at Week 24, adjusted for baseline HBV DNA and lamivudine

resistance status, by linear regression analysis.

Results

• Entecavir demonstrated superiority to adefovir for this endpoint (treatment

difference 1.74 log10 copies/mL [95% CI -2.30, -1.18]; p<0.0001).

• Entecavir group showed a greater change from baseline in HBV DNA at all

timepoints through Week 48 and higher proportion of subjects that achieved HBV

DNA <300 copies/mL at Weeks 24 (entecavir 49%; adefovir 16%; p<0.0001) and 48

(entecavir 57%; adefovir 20%; p<0.0001).

• Approximately two-thirds of subjects in both groups showed

improvement/stabilization in CTP status.

• Model for End-Stage Liver Disease score change at Week 48 was -2.6 for

entecavir and -1.7 for adefovir.

• Adverse event rates were comparable between groups.

• Cumulative hepatocellular carcinoma rates were 12% for entecavir and 20% for

adefovir.

• Cumulative death rates were 23% for entecavir and 33% for adefovir.

• Week 24 mortality rates were 12% for both groups.

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Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients

with hepatic decompensation: A randomized open-label study

Hepatology, 04/19/2011 Clinical Article

Liaw YF et al. – Entecavir demonstrated superior virologic efficacy to

adefovir in CHB population with hepatic decompensation. Biochemical and clinical

benefits were also demonstrated. Entecavir was well tolerated and early

mortality rates were consistent with rates observed in similar populations with

lamivudine.

Methods

• Randomized, open-label comparative study of entecavir versus adefovir

therapy was performed in chronic hepatitis B (CHB) subjects with hepatic

decompensation (Child-Turcotte-Pugh [CTP] score ≥7).

• Adult subjects were randomized and treated (n=191) with entecavir 1.0 mg or

adefovir 10 mg daily for up to 96 weeks from the date of last subject

randomization.

• Subjects were hepatitis B e antigen-positive or -negative, and nucleos(t)ide

analog naïve or lamivudine experienced.

• Primary efficacy endpoint was the mean reduction in serum hepatitis B virus

(HBV) DNA by PCR at Week 24, adjusted for baseline HBV DNA and lamivudine

resistance status, by linear regression analysis.

Results

• Entecavir demonstrated superiority to adefovir for this endpoint (treatment

difference 1.74 log10 copies/mL [95% CI -2.30, -1.18]; p<0.0001).

• Entecavir group showed a greater change from baseline in HBV DNA at all

timepoints through Week 48 and higher proportion of subjects that achieved HBV

DNA <300 copies/mL at Weeks 24 (entecavir 49%; adefovir 16%; p<0.0001) and 48

(entecavir 57%; adefovir 20%; p<0.0001).

• Approximately two-thirds of subjects in both groups showed

improvement/stabilization in CTP status.

• Model for End-Stage Liver Disease score change at Week 48 was -2.6 for

entecavir and -1.7 for adefovir.

• Adverse event rates were comparable between groups.

• Cumulative hepatocellular carcinoma rates were 12% for entecavir and 20% for

adefovir.

• Cumulative death rates were 23% for entecavir and 33% for adefovir.

• Week 24 mortality rates were 12% for both groups.

[Guest guest]

http://www.mdlinx.com/infectious-disease/newsl-article.cfm/3568294/ZZ68065536792\

5639220014/?news_id=497 & newsdt=041911 & subspec_id=130

Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients

with hepatic decompensation: A randomized open-label study

Hepatology, 04/19/2011 Clinical Article

Liaw YF et al. – Entecavir demonstrated superior virologic efficacy to

adefovir in CHB population with hepatic decompensation. Biochemical and clinical

benefits were also demonstrated. Entecavir was well tolerated and early

mortality rates were consistent with rates observed in similar populations with

lamivudine.

Methods

• Randomized, open-label comparative study of entecavir versus adefovir

therapy was performed in chronic hepatitis B (CHB) subjects with hepatic

decompensation (Child-Turcotte-Pugh [CTP] score ≥7).

• Adult subjects were randomized and treated (n=191) with entecavir 1.0 mg or

adefovir 10 mg daily for up to 96 weeks from the date of last subject

randomization.

• Subjects were hepatitis B e antigen-positive or -negative, and nucleos(t)ide

analog naïve or lamivudine experienced.

• Primary efficacy endpoint was the mean reduction in serum hepatitis B virus

(HBV) DNA by PCR at Week 24, adjusted for baseline HBV DNA and lamivudine

resistance status, by linear regression analysis.

Results

• Entecavir demonstrated superiority to adefovir for this endpoint (treatment

difference 1.74 log10 copies/mL [95% CI -2.30, -1.18]; p<0.0001).

• Entecavir group showed a greater change from baseline in HBV DNA at all

timepoints through Week 48 and higher proportion of subjects that achieved HBV

DNA <300 copies/mL at Weeks 24 (entecavir 49%; adefovir 16%; p<0.0001) and 48

(entecavir 57%; adefovir 20%; p<0.0001).

• Approximately two-thirds of subjects in both groups showed

improvement/stabilization in CTP status.

• Model for End-Stage Liver Disease score change at Week 48 was -2.6 for

entecavir and -1.7 for adefovir.

• Adverse event rates were comparable between groups.

• Cumulative hepatocellular carcinoma rates were 12% for entecavir and 20% for

adefovir.

• Cumulative death rates were 23% for entecavir and 33% for adefovir.

• Week 24 mortality rates were 12% for both groups.

[Guest guest]

http://www.mdlinx.com/infectious-disease/newsl-article.cfm/3568294/ZZ68065536792\

5639220014/?news_id=497 & newsdt=041911 & subspec_id=130

Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients

with hepatic decompensation: A randomized open-label study

Hepatology, 04/19/2011 Clinical Article

Liaw YF et al. – Entecavir demonstrated superior virologic efficacy to

adefovir in CHB population with hepatic decompensation. Biochemical and clinical

benefits were also demonstrated. Entecavir was well tolerated and early

mortality rates were consistent with rates observed in similar populations with

lamivudine.

Methods

• Randomized, open-label comparative study of entecavir versus adefovir

therapy was performed in chronic hepatitis B (CHB) subjects with hepatic

decompensation (Child-Turcotte-Pugh [CTP] score ≥7).

• Adult subjects were randomized and treated (n=191) with entecavir 1.0 mg or

adefovir 10 mg daily for up to 96 weeks from the date of last subject

randomization.

• Subjects were hepatitis B e antigen-positive or -negative, and nucleos(t)ide

analog naïve or lamivudine experienced.

• Primary efficacy endpoint was the mean reduction in serum hepatitis B virus

(HBV) DNA by PCR at Week 24, adjusted for baseline HBV DNA and lamivudine

resistance status, by linear regression analysis.

Results

• Entecavir demonstrated superiority to adefovir for this endpoint (treatment

difference 1.74 log10 copies/mL [95% CI -2.30, -1.18]; p<0.0001).

• Entecavir group showed a greater change from baseline in HBV DNA at all

timepoints through Week 48 and higher proportion of subjects that achieved HBV

DNA <300 copies/mL at Weeks 24 (entecavir 49%; adefovir 16%; p<0.0001) and 48

(entecavir 57%; adefovir 20%; p<0.0001).

• Approximately two-thirds of subjects in both groups showed

improvement/stabilization in CTP status.

• Model for End-Stage Liver Disease score change at Week 48 was -2.6 for

entecavir and -1.7 for adefovir.

• Adverse event rates were comparable between groups.

• Cumulative hepatocellular carcinoma rates were 12% for entecavir and 20% for

adefovir.

• Cumulative death rates were 23% for entecavir and 33% for adefovir.

• Week 24 mortality rates were 12% for both groups.