HBV Smart Card

Amplifying the potential

COBAS® TaqMan® HBV Test
Roche assays have been at the forefront
of pharmaceutical research and clinical
research of therapeutics for Hepatitis B
Virus. Roche’s HBV viral load tests have
supported major pivotal clinical trials for
HBV clinical drug trials submitted to the
Food and Drug Administration for approval
since 1991. Hepatitis B viral load testing
enables clinicians to quantify the amount
of hepatitis B virus DNA in a patient’s
blood, optimize treatment for patients,
predict and assess individual responses to
therapy support personalized regimens.
As the world’s leading molecular
diagnostics company we develop and
commercialize highly sensitive tests based
on the company’s Nobel-prizing winning
PCR and now industry-standard real-time
PCR technologies. Our products give
doctors more specific information about
clinically relevant aspects of disease,
enabling more targeted treatment planning
and monitoring of an individual patient’s
response to therapy.

Amplifying the potential of HBV DNA Testing

COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test
COBAS® TaqMan® HBV Test, v2.0* (for use with High Pure System)

Dynamic Range 20-170,000,000 IU/mL 29-110,000,000 IU/mL

Analytical Specificity 100% 100%
Limit of Detection 20 IU/mL 6 IU/mL
(using WHO HBV Standard)

Genotype Inclusivity Genotype A-H Genotype A-G

plus Pre-Core Mutants plus Pre-Core Mutants
Specimen Input 650 µL Serum/EDTA Plasma 500 µL Serum/EDTA Plasma

The preferred assay in major reference labs worldwide

• Excellent sensitivity, specificity, and linear range, minimizing the need for repeat
testing or dilutions
• Multiple layers of contamination control ensure sample/data integrity while reducing
hands-on time, which increases laboratory efficiency
• From the company that has supplied assays for the majority of clinical trials for
Hepatitis B therapeutics

* Not available in the United States.

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 HBV Smart Card

Recommendations for initial treatment in chronic Hepatitis B patients: (Consensus guidelines)

APASL 20081 EASL 20092 AASLD 20093

HBeAg status + — + or — + —
HBV DNA > 20,000 IU/mL > 2,000 IU/mL > 2,000 IU/mL > 20,000 IU/mL > 2,000 IU/mL
ALT* > 2x ULN > 1x ULN > 2x ULN
Disease stage/grade Moderate/severe necroinflammation and/or significant fibrosis
* Persistant (3-6 months)

Recommendations for initial treatment in chronic Hepatitis B patients4:

Note: Proposed new normal ALT levels = Male (<30 U/L): Female (< 19 U/L)

Initiate Therapy
Based on HBV DNA, ALT and stage of liver disease

Week 12 Assess
Assess for Primary Non Responses < 1 Log10 IU/mL Reduction from Baseline

Week 24 Assess
HBV DNA monthly for 1st 3 months; For cirrhotic / HBV DNA patients HBV DNA every 3-6 months thereafter

Virologic Response
Complete Partial Inadequate
< 60 IU/mL > 60 IU/mL to < 2000 IU/mL > 2000 IU/mL

Continue Therapy Add another Drug Add/Switch to more potent drug

Monitor HBV DNA every 6 months Monitor HBV DNA every 3 months Monitor HBV DNA every 6 months

Definition of response to antiviral therapy of chronic Hepatitis B

and drug resistance 3

Time of assessment for Virological response Decrease in serum HBV DNA to undetectable
virologic response 3: levels by PCR assays, and loss of HBeAg in
patients who were initially HBeAg-positive
• During therapy
• Throughout the course of treatment Primary non-response Decrease in serum HBV DNA by < 2 Log10 IU/mL
• At the end of a defined course of therapy
(not applicable to interferon therapy) after at least 24 weeks of therapy
• After discontinuation of therapy Virological relapse Increase in serum HBV DNA of 1 Log10 IU/mL
• 6 and 12 months after discontinuation after discontinuation of treatment in at least two
determinations more than 4 weeks apart
of therapy
Virological breakthrough Increase in serum HBV DNA by > 1 Log10 (10-fold)
above nadir after achieving virologic response,
during continued treatment

Viral rebound Increase in serum HBV DNA to > 20,000 IU/mL or

above pretreatment level after achieving virologic
response, during continued treatment
- 0.5 WW

References:
1 Liaw YF. 2008 APASL guidelines for HBV management. APASL 2008, Seoul, Korea.
2 EASL HBV Guidelines. J Hepatology. 2009;50:227-242.
3 Lok, AF. and MacMohan BJ. AASLD Practice Guidelines. Chronic Hepatitis B: Update 2009. Hepatology 2009. Vol 50;3,1:36.
4 Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international
workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol 2007;5:890-897.

ROCHE, AMPLIPREP, TAQMAN, COBAS, and LIFE NEEDS ANSWERS are trademarks of Roche.
©2010 Roche Molecular Systems, Inc. All Rights Reserved Roche Molecular Diagnostics 4300 Hacienda Drive Pleasanton, CA 94588 USA http://molecular.roche.com

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