Nucleos(t)ide Analogues in Treatment-Naive Patients .ppt
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Update on Hepatitis B Management
CCO Independent Conference Coverage
of the 2008 Annual Meeting of the European Association for the
Study of the Liver*
April 23-27, 2008
Milan, Italy
About These Slides
* Users are encouraged to include these slides in their own presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent.
* These slides may not be published or posted online or used for any other commercial purpose without written permission from Clinical Care Options.
* We are grateful to Daniel Shouval, MD with the Hadassah University Hospital in Jerusalem, Israel, for aiding in the content development of these slides.
Nucleos(t)ide Analogues in Treatment-Naive Patients
TDF vs ADV-to-TDF Switch in
HBeAg-negative and -positive Patients
Study 102, HBeAg- Patients: 72-Week TDF vs 48-Week ADV → 24-Week TDF
Study 102, HBeAg- Patients:
Other Outcomes
Study 103, HBeAg+ Patients: 72-Week TDF vs 48-Week ADV → 24-Week TDF
Study 103, HBeAg+ Patients:
Other Outcomes
TDF Therapy in Cirrhotic HCV Patients
HBeAg Loss and Seroconversion With Telbivudine vs Lamivudine
Off-Treatment Durability of HBeAg Responses with Telbivudine vs LAM
EARLY: ETV vs ADV in Naive HBeAg+ Patients With High HBV DNA, Week 96
Cost Effectiveness of Nucleos(t)ides in HBeAg- Patients in Italy, France, Spain
Peginterferon alfa in
Treatment-naive Patients
HBeAg- Patients Treated With PegIFN ± LAM: Outcomes 4 Years After EOT
HBsAg Decline at Week 48 Predicts Other Outcomes at Year 3 After EOT
* In multivariate logistic regression analysis, EOT HBsAg level (week 48) was significant predictor of HBsAg clearance by 3 years after EOT
- Week 48 log10 HBsAg OR = 0.12 (95%CI 0.04-0.37, P =.0002)
- No association with baseline age, baseline ALT, baseline or EOT HBV DNA level, treatment with peginterferon alfa-2a vs peginterferon alfa-2a plus lamivudine
* CART analysis for predictive value of HBsAg levels for subsequent HBsAg clearance and HBV DNA ≤400 copies/mL by 3 years after EOT
* Quantitative HBsAg assay not commercially available in the US
Management of Partial Response and Resistance
Pre-existing Resistance Mutations in Treatment-naive HBV Patients
* Factors associated with presence of resistance mutations
- Malesex (OR, 29; 95% CI, 1.2-684; P = .04)
- HBV DNA < 6 log10 IU/mL (OR, 0.2; 95% CI, 0.07-0.8; P = .02)
TDF in Nucleoside-Experienced Pts:Undetectable* HBV DNA at Month 12
TDF vs FTC/TDF in HBV Patients With Suboptimal Response to ADV
Transplantation and Hepatocellular Carcinoma
REVEAL Study: HBV DNA and ALT Relationship with Risk of HCC
* 3584 patients contributed 42,878 person-years of follow-up,- 131 new HCC cases (crude incidence rate = 305.5/100,000 person-years)
* HCC risk increased with increasing time-dependent HBV DNA and ALT levels
- Trend significant for both HBV DNA and ALT (P <.001)
REVEAL Subset Analysis: HBV DNA and Outcomes in Normal ALT Patients
HBIg Prophylaxis for HBc Antibody Positive Liver Grafts
Go Online for More CCO
Coverage of EASL 2008!
Update on Hepatitis B Management
CCO Independent Conference Coverage
of the 2008 Annual Meeting of the European Association for the
Study of the Liver*
April 23-27, 2008
Milan, Italy
About These Slides
* Users are encouraged to include these slides in their own presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent.
* These slides may not be published or posted online or used for any other commercial purpose without written permission from Clinical Care Options.
* We are grateful to Daniel Shouval, MD with the Hadassah University Hospital in Jerusalem, Israel, for aiding in the content development of these slides.
Nucleos(t)ide Analogues in Treatment-Naive Patients
TDF vs ADV-to-TDF Switch in
HBeAg-negative and -positive Patients
Study 102, HBeAg- Patients: 72-Week TDF vs 48-Week ADV → 24-Week TDF
Study 102, HBeAg- Patients:
Other Outcomes
Study 103, HBeAg+ Patients: 72-Week TDF vs 48-Week ADV → 24-Week TDF
Study 103, HBeAg+ Patients:
Other Outcomes
TDF Therapy in Cirrhotic HCV Patients
HBeAg Loss and Seroconversion With Telbivudine vs Lamivudine
Off-Treatment Durability of HBeAg Responses with Telbivudine vs LAM
EARLY: ETV vs ADV in Naive HBeAg+ Patients With High HBV DNA, Week 96
Cost Effectiveness of Nucleos(t)ides in HBeAg- Patients in Italy, France, Spain
Peginterferon alfa in
Treatment-naive Patients
HBeAg- Patients Treated With PegIFN ± LAM: Outcomes 4 Years After EOT
HBsAg Decline at Week 48 Predicts Other Outcomes at Year 3 After EOT
* In multivariate logistic regression analysis, EOT HBsAg level (week 48) was significant predictor of HBsAg clearance by 3 years after EOT
- Week 48 log10 HBsAg OR = 0.12 (95%CI 0.04-0.37, P =.0002)
- No association with baseline age, baseline ALT, baseline or EOT HBV DNA level, treatment with peginterferon alfa-2a vs peginterferon alfa-2a plus lamivudine
* CART analysis for predictive value of HBsAg levels for subsequent HBsAg clearance and HBV DNA ≤400 copies/mL by 3 years after EOT
* Quantitative HBsAg assay not commercially available in the US
Management of Partial Response and Resistance
Pre-existing Resistance Mutations in Treatment-naive HBV Patients
* Factors associated with presence of resistance mutations
- Malesex (OR, 29; 95% CI, 1.2-684; P = .04)
- HBV DNA < 6 log10 IU/mL (OR, 0.2; 95% CI, 0.07-0.8; P = .02)
TDF in Nucleoside-Experienced Pts:Undetectable* HBV DNA at Month 12
TDF vs FTC/TDF in HBV Patients With Suboptimal Response to ADV
Transplantation and Hepatocellular Carcinoma
REVEAL Study: HBV DNA and ALT Relationship with Risk of HCC
* 3584 patients contributed 42,878 person-years of follow-up,- 131 new HCC cases (crude incidence rate = 305.5/100,000 person-years)
* HCC risk increased with increasing time-dependent HBV DNA and ALT levels
- Trend significant for both HBV DNA and ALT (P <.001)
REVEAL Subset Analysis: HBV DNA and Outcomes in Normal ALT Patients
HBIg Prophylaxis for HBc Antibody Positive Liver Grafts
Go Online for More CCO
Coverage of EASL 2008!
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