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A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
Faculty
Program Director
Danny Chu, MD
Clinical Instructor Albert Einstein School of Medicine New York, New York
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Faculty Disclosures
Danny Chu, MD, has disclosed that he has received consulting fees and fees for non-CME/CE services from Bristol-Myers Squibb and Gilead Sciences.
Chul S. Hyun, MD, PhD, has no significant financial relationships to disclose. Charles G. Phan, MD, AGAF, has disclosed that he has received consulting fees from Bristol-Myers Squibb, Gilead Sciences, and Merck and fees for non-CME/CE services from Bristol-Myers Squibb, Gilead Sciences, Merck, Otsuka, and Procter & Gamble.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
Weinbaum CM, et al. MMWR Recomm Rep. 2008;57(RR-8):1-20. Lok AS, et al. Hepatology. 2009;50:661-662.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
Positive
Negative
CHB*
Assess anti-HBs
Vaccinate
Immune to HBV
*Time from positive HBsAg test to diagnosis of CHB is 6 mos. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
Benefits
Likelihood of Patients age and Adverse outcome preference without treatment Costs Long-lasting response
Risks
Adverse effects Drug resistance
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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> 95%
Immune tolerance
Adulthood
< 5%
HBeAg+ CHB
HBeAg- CHB
5-Yr Incidence Rates Cirrhosis: 8% to 38% of chronically infected patients HCC: 10% to 17% of patients with cirrhosis
Inactive carrier
Cirrhosis
Chen DS, et al. J Gastroenterol Hepatol. 1993;8:470-475. Seeff L, et al. N Engl J Med. 1987;316:965-970. Fattovich G, et al. J Hepatol. 2008;48:335-352.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Phase
Immune Tolerant
Immune Clearance
Reactivation
Liver
Active inflammation
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Secondary endpoints
Decrease or normalize serum ALT Improve liver histology
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
HBeAg negative
Also known as precore mutant
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Both AASLD and US treatment algorithms recommend lower ULN levels for ALT when making treatment-initiation decisions
30 IU/L for men
19 IU/L for women
Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. Prati D, et al. Ann Intern Med. 2002;137:1-10. Lok AS, et al. Hepatology. 2009;50:661-662.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Histology
Liver biopsy
Establishes disease baseline before initiation of therapy Helps to exclude other causes of liver disease
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
Expert guidelines also published with recommendations specific for HBV management in US[5] and more recently for Asian Americans[6]
Some key differences between these guidelines
1. Lok AS, et al. Hepatology. 2009;50:661-662. 2. EASL. J Hepatol. 2009;50:227-242. 3. Liaw YF, et al. Hepatol Int. 2008;3:263-283. 4. Degerekin B, et al. Hepatology. 2009;S129-S137. 5. Keeffe EB, et al. Clin Gastroenterol Hepatol. 2008;6:1315-1341. 6. Tong MJ, et al. Dig Dis Sci. 2011;56:3143-3162.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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HBeAg positive
ALT < 1 x ULN HBV DNA < 20,000 IU/mL q3-6 mos ALT q6-12 mos HBeAg
ALT 1-2 x ULN HBV DNA > 20,000 IU/mL q3 mos ALT q6 mos HBeAg Consider biopsy if persistent or older than 40 yrs of age Treat as needed
ALT > 2 x ULN HBV DNA > 20,000 IU/mL q1-3 mos ALT, HBeAg Treat if persistent Liver biopsy optional Immediate treatment if jaundice or decompensated
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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HBeAg negative
ALT < 1 x ULN HBV DNA < 2000 IU/mL q3 mos ALT x 3, then q6-12 mos if ALT still < 1 x ULN
ALT 1-2 x ULN HBV DNA 2000-20,000 IU/mL q3 mos ALT and HBV DNA Consider biopsy if persistent Treat as needed
ALT 2 x ULN HBV DNA 20,000 IU/mL Treat if persistent Liver biopsy optional
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
When Should You Seek the Advice of an HBV Expert Before Initiating Therapy?
Seek advice in the following situations
Treatment-experienced patients Patients with advanced disease stage, especially decompensated cirrhosis Concern for antiviral resistance Patients with HIV or HCV coinfection Pregnant women Any time you have concerns about how best to manage a patient
Case Discussion
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
No symptoms
Only medical problem: mild hypertension Family history
No known history of hepatitis B or liver cancer Husband and 2 sons aged 20 and 25 yrs not yet tested for HBV
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Ultrasound
Liver normal size and texture with no mass, borderline splenomegaly
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Serial follow-up necessary to differentiate inactive carriers from patients with HBeAg-negative chronic hepatitis B and intermittently normal ALT
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Case 1: Follow-up
Repeat labs
Time Point Mo 3 Platelet Count, cells/mm3 154,000 AST, IU/L 25 ALT, IU/L 29 HBV DNA, IU/mL 45
Mo 6
Mo 9
148,000
137,000
35
42
41
59
1180
7375
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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For Discussion: What Would You Recommend for This Patient at This Time?
A. Start treatment
B. Liver biopsy C. Continue to observe
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Case 1: Recommended Monitoring for This Patient During Oral Antiviral Therapy
Serum HBV DNA: q3-6 mos
Liver panel, platelets: q3 mos HBsAg: q12 mos (after HBV DNA undetectable)
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
For Discussion: How Would You Classify His Chronic Hepatitis B Infection?
A. Chronic carrier
B. Immune clearance C. Immune tolerance
D. Reactivation
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Adefovir
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Entecavir Tenofovir
EASL. J Hepatol. 2009;50:227-242. Liaw YF, et al. Hepatol Int. 2008;2:263-283. Lok AS, et al. Hepatology. 2009;50:661-662.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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70
40
20 0
29 17 1.2 0
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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15
10
HBsAg loss
HBeAg Positive
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Biochemical breakthrough
2 ULN
0
-1 0 1 Yrs 2 3
Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50:661-662. Copyright 19992012 John Wiley & Sons, Inc. All Rights Reserved.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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*Particularly for HBeAg-positive patients with genotype A infection. Recent case report of lactic acidosis in severe liver failure. Lok AS, et al. Hepatology. 2007;45:507-539. Lok AS, et al. Hepatology. 2009;50:661-662. Lok AS. Hepatology. 2010;52:743-747. Buster EH, et al. Gastroenterology. 2008;135:459-467. Lange CM, et al. Hepatology. 2009;50:2001-2006.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Absence of comorbidities
Patient preference[1,2]
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
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Duration of therapy
48 wks
Virologic response to therapy defined as decrease in serum HBV DNA to undetectable levels by PCR at end of treatment and loss of HBeAg in patients who were initially HBeAg positive
Lok AS, et al. Hepatology. 2009;50:661-662.
A Mentorship Program Linking Primary Care Providers With Expert HBV Faculty
clinicaloptions.com/hepatitis
clinicaloptions.com/hepatitis