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Chronic HBV A Case Study

WORLDWIDE

350,000,000
Reference: Hepatitis B virus. http://www.wikidoc.org/index.php/Hepatitis_B_virus. Accessed February 2011.

UNITED STATES

1,250,00 0
Reference: Hepatitis B virus. http://www.wikidoc.org/index.php/Hepatitis_B_virus. Accessed February 2011.

15

ASIAN/PACIFIC ISLANDER

1 in 10
Reference: HepBfree. http://www.SFHepBfree.org. Accessed February 2011.

Trip

Reference: Pictures. http://www.lookatvietnam.com. Accessed February 2011.

TP Case

TP is a 36 yo Asian male with history of DM and chronic HBV, who comes to the clinic for 6 months follow-up appointment with the following symptoms
Fatigue Abdominal

pain Nausea/vomiting Bloating Itchy skin Yellowing of the eye

Lab (3 months ago)


Value Hemoglobin A1C Alb ALT AST HBsAg HBeAg HBV DNA Reference

8.3%
Value

6.5%
Reference

3.8 g/dL 81 IU/L 29 IU/L


Value

3.5 5.0 g/dL 9 40 IU/L 10 35 IU/L

+ 7.64 log10copies/mL

Lab (Today)
Value Hemoglobin A1C Alb ALT AST HBsAg HBeAg HBV DNA Reference

7.8%
Value

6.5%
Reference

4.2 g/dL 139 IU/L 37 IU/L


Value

3.5 5.0 g/dL 9 40 IU/L 10 35 IU/L

+ 8.38 log10copies/mL

Liver biopsy

Knodell Score

8.4

To treat or not to treat?

Reference: Hepatitis web study. http://depts.washington.edu/hepstudy/hepB/mgmt/hbvrx/discussion.html

Question

What should we do?


A. B. C. D.

Monitor ALT every 3 months Monitor HBV DNA every 3 months Initiate drug therapy All of the above

Question

Which drug should we use?


A. B. C. D. E. F. G. H.

Entecavir Tenofovir Adefovir Lamivudine Telbivudine IFN- Peg-IFN Peg-IFN + lamivudine

Back to TP

References: 1.Drug picture. http://www.healthspablog.org/tag/drug. Accessed February 2011. 2.Syringe picture. http://www.mediray.com/Pages/Products/SyringeShields.html. Accessed February 2011.

Back to TP
HmmmI want the pill NOT the injection.

AASLD Practice Guideline 2009

Reference: Chronic Hepatitis B: Update 2009. AASLD practice guideline. September 2009.

Responses to Approved Antiviral Therapies Among Treatment-Nave Patients with HBeAg(-) Chronic HBV
Control/Pla Entecavi Tenofovi AdefovirLamivudine cebo r r Loss of serum HBV DNA* ALT normalization

0-20%

90%

93% 76% 72%

51% 60-73% 72% 60-79% 64% 60-66%

10-29% 78% 33% 70%

Histologic improvement

* Hybridization or branched chain DNA assays (lower limit of detection 20,000-200,000 IU/mL or 5-6 log copies/mL) in standard IFN- studies and some lamuvidine studies, and PCR assays (lower limit of detection approximately 50IU/mL) in other studies Reference: Chronic Hepatitis B: Update 2009. AASLD practice guideline. September 2009.

Entecavir or tenofovir?

Reference: Clinical trial picture. http://www.medicineandbiotech.com/Clinical.html. Accessed February 2011.

Entecavir 0.5mg once daily versus lamivudine 100mg once daily for a minimum of 52 weeks in 638 nucleosidenave subjects with HBeAg(-) chronic HBV
Entecavir 0.5mg (296) Knodell Score Improvement No improvement HBV DNA Proportion undetectable (<300 copies/mL) Mean change from baseline (log10copies/mL) ALT normalization (1x ULN)
* p<0.05 Reference: Baraclude package insert. Bristol-Myers Squibb. July 2009.

Lamivudine 100mg (287)

70%* 19% 90%* -5.04* 78%*

61% 26% 72% -4.53 71%

Patient population (638)


Mean Age Male Asian Caucasian

44 76% 39% 58%

Baseline
Mean Knodell score Mean HBV DNA Mean ALT

7.8 7.58 log10copies/mL 142 IU/L

Reference: Baraclude package insert. Bristol-Myers Squibb. July 2009.

Tenofovir 300mg once daily compared to adefovir 10mg once daily in 375 HBeAg(-) nucleoside-nave patients with compensated liver function for 48 weeks
Tenofovir 300mg (250) Complete Response Knodell scorea HBV DNA (<400 copies/mL) ALT normalizationb
a. b.

Adefovir 10mg (125)

71% 72% 93% 76%

49% 69% 63% 77%

Knodell necroinflammatory score improvement 2 points without worsening in Knodell fibrosis The population used for analysis of ALT normalization included only patients with ALT above ULN at baseline

Reference: Viread package insert. Gilead. November 2008.

Patient population (375)


Mean Age Male Asian Caucasian

44 77% 25% 65%

Baseline
Mean Knodell score Mean HBV DNA Mean ALT

7.8 6.9 log10copies/mL 140 IU/L

Reference: Viread package insert. Gilead. November 2008.

Back to TP
Asian male
Entecavir (189) Histologic improvement ALT normalization Tenofovir (48)

170 147 132

44 37 35

Loss of serum HBV DNA

Back to TP

Question

Which antiviral should we use?


A. B. C.

Entecavir Tenofovir Any of the above

One more thing

1 person every 90
Reference: http://www.hepbfreephiladelphia.org/html/hep_b_and_liver_cancer.html. Accessed February 21, 2011.