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Integrating Hepatitis Care into Primary Care Settings HCV Advocate post cure

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Integrating Hepatitis Care into Primary Care Settings HCV Advocate post cure Powered By Docstoc
					Integrating Hepatitis C Care
into a Primary Care Setting




 Alan
 Franciscus
 Executive Director, Hepatitis C Support Project
 www.hcvadvocate.org
 www.hbvadvocate.org
 www.hepatitistattoos.org           Your Logo
Integrating Chronic HCV into Medical
Clinics – Test, Monitor and Treat

                              Objectives
 ✓   Understand the need for more HCV medical providers

 ✓
     Recognize the front line primary care provider as the
                                    •  This is an example text. Go ahead and replace
     critical link                     it




 ✓   Discuss how to integrate HCV into medical offices
          •Testing
          •Monitoring
          •Treating with HCV Protease Inhibitor combination
Reference publications:



 • Hepatitis B and C Guidelines – Colorado
   Clinical Guidelines Collaborative

 • HCSP: Management of Hepatitis C by the
   Primary Care Provider – Monitoring
   Guidelines
              The Need
 NHANES: 3.2 million persons chronically
 infected with hepatitis C

If 100 persons infected with HCV:

•75 to 85% will develop chronic infection

•20% will develop cirrhosis in 20 to 30 years

•1% to 5% will die of consequences of chronic
infection (liver cancer or cirrhosis)
Testing
Current Risk Factor Testing Isn’t Working

                             Risk Factor Assessment
                                                  Templates

  •Sharing needles and drug preparation tools

  •Blood products & solid organ transplantation before 1992

  •Clotting factors before inactivation in 1987

  •Sexual transmission

  •Mother-to-child

  •Healthcare workers

  •Hemodialysis




                            Age-Based Testing – Pilot
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Total U.S. Population with HCV



                                 1.   3.2 million persons chronically
           3.2 Million                infected with HCV

                                 2.   25% have been diagnosed =
                                      800,000 persons

                                 3.   75% have NOT been diagnosed =
      800,000        2,400,000        2,400,000 persons

     Diagnosed     Undiagnosed




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           Baby Boomers Account for the Majority of
                 HCV Cases in United States
             Estimated Prevalence by Age Group

                          1.6
Number With Chronic HCV




                          1.4
                          1.2
                          1.0
                          0.8
                          0.6
(millions)
Infection




                          0.4
                          0.2
                           0
                                <1920   1920s                                        1970s   1980s   1990+
                                                1930s      1940s     1950s   1960s


                                                        Birth Year Group


                                                 Intregating HCV
Baby Boomers Aging


 • Typically 10 to 40 years for serious HCV
   disease progression

 • Most HCV baby boomers have been
   infected ≥ 40 years
Future Burden of Hepatitis C
Current and projections


  • 2010:
     – 800,00 persons with HCV-related cirrhosis
     – 10,000 to 12,000 deaths

  • 2020 – 1 million persons with HCV-related
    cirrhosis

  • 2020-2029 = 283,378 deaths / ~14,000/yr
Increased Diagnosis and Treatment
    The Beginning of a New Era:
    Age-Based Testing     OraQuick HCV Antibody Test           New Antivirals
Templates

1   .Test everyone of a   2   • Finger Prick              3   tNew HCV
    certain age. Pilot        •Whole Blood Draw               Treatments –
    programs are being        •Oral Swab
    planned in:                                               •An HCV protease
                              •Results available within       inhibitor combined
    • New York,               20 minutes                      with pegylated
                                                              interferon, plus
    • Detroit, MI,            •More testing within            ribavirin will increase
              .               clinics and mobile sites        the cure rates up to
    •Houston, TX,             can lead to increased           79%
                              consultations about
    • Birmingham, AL          care, management and            •Higher cure rates will
                              treatment                       mean more treatment-
                                                              naive and prior non-
                                                              responders will seek
                                                              treatment


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Primary Care Providers and HCV


                                    1.   Percentage of US
                                         Population with HCV

                                    2.   Average number of
  1.6% of                                patients in PCP
               2000      32 HCV          practice
   U. S.      Patients
 Population              Patients   3.   Number of patients
                                         with HCV per PCP
     1           2          3            practice




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    The Primary Care Provider Office

1   The Passion



2   Staff



3   The Team Approach



4   Mechanics




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Passion




 • Passion to provide services that will have
   a dramatic impact on the lives of people
   affected by HCV
                              Staff


 Physician      A physician to provide and oversee patient care




   Nurse        Medical team to provide provide support to physican
Practicioner,   and patients
 Nurse, etc.



                 Office staff – billing, reception – knowledgeable and
   Office        able to provide support to medical team and patients.




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Team Approach

 •Phsyican Office
    -Working together to provide services

 •Patient
     Part of the Team Process
         -involvement with decision process
         contract with provider




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The Mechanics

                Diagnosis
 1




                Management
 2




                Treatment


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Testing: Risk Factors
•   Injection Drug Use (illicit drugs, hormones,
    vitamins, steroids) – needles, cookers,
    cottons, water, ties, etc. – even just once


• Persons with HIV



• Received blood products, organ
  transplant, or transfusion before 1992

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Testing: Risk Factors – con’t

•   Children born to HCV-infected Mothers


• Healthcare, emergency medical and public
  safety workers after a needle-stick injury or
  mucosal exposure to HCV-positive blood


• Current sexual partners of HCV-positive
  person – although the risk is low

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Diagnosis
Antibody, viral load test




                   HCV
                             HCV RNA
                  Antibody
Management: Counseling Patients
Prevent transmission, encourage lifestyle changes




                Primary               Secondary
               Prevention             Prevention
Management: Counseling Patients

         Primary Prevention              Secondary Prevention


     HCV is spread by blood-            Lifestyle Changes:
     to-blood contact with HCV
     infected blood:                    •Avoid Alcohol

     •Do not share anything used        •Exercise
     to inject drugs for recreational
     use, hormones, vitamins, etc.
                                        •Diet
     •Do not share razors or
     toothbrushes                       •Advise on Herbs, Vitamins &
                                        Supplements
     •Stable monogamous
     relationship –no barriers
     unless worried about potential     •Avoid Raw or Undercooked
     risk                               Shellfish
     •Safer sex outside of stable
     monogamous relationship

     •Safer Tattoos & Piercings

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Management: Test & Vaccinate
Vaccinate against HAV & HBV




                Test for      Vaccinate if
               HAV, HBV       unprotected
Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level).
Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy.




       Clinical Assessment

       1       Physical exam for evidence of liver damage

       2        Blood work – CBC, CMP, INR, TSH, ANA, HIV.

        3
               Ferritin % Saturation


       4
               Hep A ab total,
               Hep B Surface Ab/Ag, Hep B Core Ab total

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Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level).
Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy.




       Clinical Assessment

           5        Hep C gentoype, Hep C viral load

           6        HOMA Score
           7        Hep A & Hep B vaccination series if needed
           8
                    Influenza and pneumococcal vaccinations
           5        Pregnancy Test



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Monitor & Consideration of Treatment


                                         Monitor:
                           •   Annual physical (6-12 months)
                           •   Complete Blood Panel
                           •   Hepatic Function Panel (HFP)
                           •   Liver biopsy (3-5 yrs)
    Stage 0 – 1 Fibrosis



                                  May consider
                                   Treatment
Monitor & Consideration of Treatment


                                        Monitor:
                          •   Annual physical (6-12 months)
                          •   Complete Blood Panel
                          •   HFP
                          •   Liver biopsy (3-5 yrs)
     Stage 2 Fibrosis


                              Consider treatment
Monitor & Consideration of Treatment

                                        Monitor:
                          •   Annual physical (6-12 months)
                          •   Complete Blood Panel
                          •   HFP
                          •   Liver biopsy (3-5 yrs)
                          •   Ultra Sound (every 6 months)
     Stage 3 Fibrosis



                               Should be treated
Monitor & Consideration of Treatment


                          Monitor:
                          •   Annual physical (6-12 months)
                          •   Complete Blood Panel
                          •   HFP
                          •   Liver biopsy (3-5 yrs)
    Stage 4 Cirrhosis
                          •   Ultra-sound & AFP every 6 mos)


                        Compensated:
                        • Treat (with liver specialist)
Refer to Specialist




                        Liver
                      Specialist


                        HIV
                      Specialist
HCV Treatment: Goals


 1   HCV Eradication – Viral Cure



 2   Improve health & reduce complications and death from HCV



 3
     Improve Histology
     .




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Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level).
Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy.



        Evaluation: Absolute Contraindications


           1
                   Pregnancy or patients unwilling or unable to practice
                   two forms of birth control

           2        Poorly controlled psychiatric disease
           3        Poorly controlled coronary disease
           4
                    Kidney or heart transplant
           5        Renal failure or insufficiency



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Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level).
Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy.



        Evaluation: Relative Contraindications


           1
                   History of severe depression – evaluate and treat
                   depression

           2        Minor or on-going depression
           3        Decompensated cirrhosis
           4
                    Autoimmune disease
           5        History of coronary heart disease

           6         Blood deficiencies (anemia, neutropenia and
                     thrombocytopenia
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Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level).
Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy.



        Evaluation: Patient Criteria


           1
                   Willing to start treatment

           2        Stable work/life environment
           3        Support Network – support group
           4
                    Willingness to be evaluated for depression
           5        Willingness to keep appointments and lab work

           6         Team approach with medical team

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HCV Medical Treatments – Advances


                                                                                           Approval expected
                                                                                           Mid-2011 Mid-2011
                                           HCV Medical Treatments


             0.9
             0.8
             0.7
             0.6
   Percent




             0.5                                                                                       Genotype 1
             0.4                                                                                       Genotype 2, 3

             0.3
             0.2
             0.1
              0
                   Mono INF   INF + Riba    Peg-Intron + Riba   Pegasys + Riba   Peg INF + Riba + PI
                                               Gentotype



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Telaprevir, Pegylated Interferon plus ribavirin




 • Telaprevir (every 8 hrs)
 • Treatment naïve: Telaprevir,
   PegIFN/RBV 12 weeks followed by 12
   weeks of PegIFN/RBV
 • Treatment experienced patients:
   Telaprevir, PegIFN/RBV 24 weeks
   followed by 24 weeks of PegIFN/RBV
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Boceprevir, Pegylated Interferon plus ribavirin




 • Boceprevir (three times a day) – 4 week
   lead-in: PegIFN/RBV
 • Treatment naïve: Boceprevir,
   PegIFN/RBV for 28 or 48 weeks
 • Treatment experienced: Boceprevir,
   PegIFN/RBV for 48 weeks
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Laboratory Monitoring
Response Guided Therapy




 • Treatment duration will be dictated by
   response at certain time points during
   therapy (RVR – eRVR – EVR)
 • A consideration to stopping therapy if
   patient is HCV positive during certain time
   points to prevent drug exposure and
   resistance
                    Side-effects
  • Interferon                         Ribavirin

• Physical                   • Anemia, rash, dry cough
   – fatigue, muscle/joint   • Black box warning:
     pain, headaches, dry          – Women of childbearing age, their
                                     partners and female partners of male
     skin, insomnia,                 patients taking ribavirin must practice
   – Anxiety, depression,            two forms of effective contraception
                                     during to 6 months post-treatment
     mania


• Neutropenia (Low white     • Anemia (Low red blood
  blood cells)                 cells)
• Thrombocytopenia (Low
  platelets)
                Side-effects
 • Boceprevir                  Telaprevir



• Increased anemia       • Slight increase in
                           anemia
• Metal taste            • Body rash
THANK YOU!

Questions?

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