North Dakota DOCR Hepatitis C Program

1
North Dakota DOCR Hepatitis C Program

• Jeff Hostetter, MD
• Medical Director North Dakota Dept. of
  Corrections and Rehabilitation
• Assistant Professor Dept. of Family Medicine UND
  School of Medicine Health Sciences

2
Recognizing the problem

• Hepatitis C in the North Dakota prison population
  
• (1300 inmates)

3
Recognizing the problem

• Hepatitis C in the North Dakota prison population
  
• (1300 inmates)
• 1999 - After federal pricing available for
  hepatitis A B vaccinations, able to lobby for
  starting a limited screening program

4
Recognizing the problem

• Hepatitis C in the North Dakota prison population
  
• (1300 inmates)
• 1999 - After federal pricing available for
  hepatitis A B vaccinations, able to lobby for
  starting a limited screening program
• 2000 - Only inmates with signs/symptoms tested
  for hepatitis C
• All inmates with hepatitis C vaccinated for
  hepatitis A B

5
Recognizing the problem

• Hepatitis C in the North Dakota prison population
  
• (1300 inmates)
• 1999 - After federal pricing available for
  hepatitis A B vaccinations, able to lobby for
  starting a limited screening program
• 2000 - Only inmates with signs/symptoms tested
  for hepatitis C
• All inmates with hepatitis C vaccinated for
  hepatitis A B
• 2001 - State legislature budgets 90,000 for
  prevention treatment of ALL infectious diseases
  in DOCR budget

6
Recognizing the problem

• 1/2003 - CDC recommends
• 1) testing all inmates for hepatitis C
• 2) immunization of long term prisoners for hep
  A B

7
Recognizing the problem

• 1/2003 - CDC recommends
• 1) testing all inmates for hepatitis C
• 2) immunization of long term prisoners for hep
  A B
• Legislature appropriates 265,000 over 2 years
  to fund this initiative

8
Recognizing the problem

• 1/2003 - CDC recommends
• 1) testing all inmates for hepatitis C
• 2) immunization of long term prisoners for hep
  A B
• Legislature appropriates 265,000 over 2 years
  to fund this initiative
• 5/2003 - State Health Dept. agrees to provide
  screening ELISA and confirmation RIBA for
  13/test

9
Recognizing the problem

• 1/2003 - CDC recommends
• 1) testing all inmates for hepatitis C
• 2) immunization of long term prisoners for hep
  A B
• Legislature appropriates 265,000 over 2 years
  to fund this initiative
• 5/2003 - State Health Dept. agrees to provide
  screening ELISA and confirmation RIBA for
  13/test
• 9/2003 - Current Screening Program Instituted
• 1) All new prison inmates screened for hepatitis
  C
• 2) All with gt5 year sentences vaccinated for hep
  A B
• 3) All new arrivals HCV positive vaccinated
  for hep A B

10
Recognizing the problem

• Results of Screening Program
• 6.3 positive for hepatitis C
• 25 of inmates vaccinated for
• hepatitis A B

11
Treating the Problem
12
Treating the Problem

• Hepatitis C therapy protocol development
• DOCR medical staff lobbies legislature to treat
  this as a serious public health problem.

13
Treating the Problem

• Hepatitis C therapy protocol development
• DOCR medical staff lobbies legislature to treat
  this as a serious public health problem.
• DOCR medical staff charged with developing a
  treatment protocol that meets these criteria
• 1) Effective
• 2) Equitable to all inmates
• 3) Legal
• 4) Affordable

14
Treating the Problem

• 2001 Dr. Kent Martin (Infectious Disease
  consultant) hired to propose treatment protocol
• ? Screening protocol for all HCV positive
• inmates implemented
• ? PEG-interferon based regimen instituted

15
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 1. Age 18-60
• 2. Confirmation hepatitis C RNA with genotype
• 3. Immunization and serology confirming immunity
• to hepatitis A and B

16
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 1. Age 18-60
• 2. Confirmation hepatitis C RNA with genotype
• 3. Immunization and serology confirming immunity
• to hepatitis A and B
• 4. Hgb A1c lt9
• 5. Adequately treated heart disease
• 6. Adequately treated thyroid disease

17
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 1. Age 18-60
• 2. Confirmation hepatitis C RNA with genotype
• 3. Immunization and serology confirming immunity
• to hepatitis A and B
• 4. Hgb A1c lt9
• 5. Adequately treated heart disease
• 6. Adequately treated thyroid disease
• 7. Absence of renal disease
• 8. Absence of decompensated cirrhosis with
  ascites
• 9. Hgb gt10 g

18
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 1. Age 18-60
• 2. Confirmation hepatitis C RNA with genotype
• 3. Immunization and serology confirming immunity
• to hepatitis A and B
• 4. Hgb A1c lt9
• 5. Adequately treated heart disease
• 6. Adequately treated thyroid disease
• 7. Absence of renal disease
• 8. Absence of decompensated cirrhosis with
  ascites
• 9. Hgb gt10 g
• 10. Absence of autoimmune disease
• 11. Absence of life threatening non-hepatic
  disease
• 12. Satisfactory clinic compliance
• 13. If HIV , recent CD4 countgt200

19
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 14. Two negative alcohol and drug tests
• 6 months apart
• 15. Prison stay certain for at least 8 months for
• genotype 2, 3 once treatment begins
• 16. Prison stay certain for at least 14 months
• for genotype 1 once treatment begins

20
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 14. Two negative alcohol and drug tests
• 6 months apart
• 15. Prison stay certain for at least 8 months for
• genotype 2, 3 once treatment begins
• 16. Prison stay certain for at least 14 months
• for genotype 1 once treatment begins
• 17. Female inmate recent neg. pregnancy test
• and documentation of counseling in
• avoiding pregnancy until 6 months
• after treatment complete

21
Treating the Problem

• Hepatitis C Pretreatment Screening protocol
• 14. Two negative alcohol and drug tests
• 6 months apart
• 15. Prison stay certain for at least 8 months for
• genotype 2, 3 once treatment begins
• 16. Prison stay certain for at least 14 months
• for genotype 1 once treatment begins
• 17. Female inmate recent neg. pregnancy test
• and documentation of counseling in
• avoiding pregnancy until 6 months
• after treatment complete
• 18. Compliant with drug and alcohol treatment
• recommendations
• 19. Absence of severe Axis I diagnosis or
• psychiatric clearance for therapy
• 20. No body piercing or tattoos for 6 months

22
Treating the Problem

• Results of Pretreatment Screening

23
Treating the Problem

• Results of Pretreatment Screening

341 prisoners with HCV 95 eligible to enter
Screening Protocol
24
Treating the Problem

• Early experience with PEG-interferon/Ribavirin
  reveals the cost of medication and of adjunct
  therapy for side effects (including growth
  factors) not sustainable within budget

25
Treating the Problem

• Early experience with PEG-interferon/Ribavirin
  reveals the cost of medication and of adjunct
  therapy for side effects (including growth
  factors) not sustainable within budget
• Dr. Martin, once again, to the rescue!

26
THERAPY FOR HEPATITIS CConsensus Interferon
ProtocolDevelopment

• Kent Martin MD, MPH
• (infectious diseases)
• Consultant, ND Dept. of Corrections and
• Rehabilitation

27
Interferons in Hepatitis C Therapy(in
combination with Ribavirin)

• Interferon-a2b, marketed as Peg-Intron by
  Schering-Plough (precursor Intron)-330/wk
• Interferon-a2a, marketed as Pegasys by
  Roche-330/wk
• Consensus, marketed as Alfacon-1(Infergen) by
  Valeant-172/wk

28
Interferon alfacon-1, InfergenFDA Approved
Indications

• Infergen is indicated for the treatment of
  chronic hepatitis C virus infection in patients
  18 years of age or older with compensated liver
  disease

29

• 1 amino acid difference between IFN ?-2a and IFN
  ?-2b
• 18 amino acid difference between IFN ?-2a and
  CIFN
• 19 amino acid difference between IFN ?-2b and
  CIFN

30
Pegylation of IFN ?-2b
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Interferons in Hepatitis C Therapy(in
combination with Ribavirin)

• Maria Sjogren et. al. report early favorable
  experience using consensus/ribavirin, Toronto
  8/2002
• Subsequent results published 4/2005 after study
  interrupted when Peg-Intron became available

34
Consensus/ribavirin vs. Interferon
a-2b/ribavirin (2005)

• Statistical significant not reached due to trial
  termination (128/160 enrolled)
• 63 pts consensus arm, 65 pts IFN-a2b
• 20 cirrhosis, 70 genotype 1, 68 male, 65
  Caucasian

35
Consensus(Alfacon-1)/ribavirin vs. Interferon
a-2b/ribavirin (2005)

• End of treatment
• IFN cons./ribavirin 64 IFN alfa
  2b/ribavirin 49
• Sustained viral response IFN
  cons./ribavirin 57 IFN alfa
  2b/ribavirin 40

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Consensus(CIFN)/ribavirin vs. Peginterferon
a-2b/ribavirin (2005)(genotype 1, proof of
concept)

• 59 pts-30 CIFN/ribavirin, 29 PIFN/ribavirin
• CIFN 15mcg 3/wk wt. based ribavirin
• PIFN 1.5mcg/kg per wk wt. based ribavirin
• All pts complete 48 wks, 56 pts gt72 wks
• Groups similar in gender, age, wt, race, viral
  load
• SVR-37 CIFN/riba, 35 PEGIFN/ribavirin

AASLD abstract, Hepatology, Sjogren et al, 2005
38
Consensus(CIFN)/ribavirin vs. Peginterferon
a-2b/ribavirin (2005)(genotype 1, proof of
concept)

• No relapsers in CIFN/riba
• Adverse event profile for CIFN/riba with less
  neutropenia and dose reductions
• Undetectable HCV RNA high viral
  load low viral
  loadgroups wk 48 wk 72
  wk 48 wk 72CIFN/riba
  6/22(27) 6/22(27) 5/8(63)
  5/8(63)PEG/riba 10/22(48) 5/19(26)
  5/7(71) 4/7(57)

AASLD abstract, Hepatology, Sjogren et al, 2005
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ND DOCR Prison Population
40
ND DOCR Prison Population
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ND DOCR Prison Population
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ND DOCR Prison Population
43
Treating the Problem
Treatment Protocol
Genotype 1 1) Planned 48 weeks
consensus interferon/weight-based ribavirin
2) at 12 weeks, if 2 log reduction not achieved,
then stop therapy 3) at 24 weeks if
qualitative HCV , then stop therapy Genotypes
23 24 weeks of consensus interferon/ ribavir
in 400 mg BID
44
Treating the Problem

• Sources of cost savings
• 1. Consensus interferon is cheaper
• PEG-Intron Average/Patient 21,165
• Consensus interferon Average/Patient 13,681
  

45
Treating the Problem

• Sources of cost savings
• 1. Consensus interferon is cheaper
• PEG-Intron Average/Patient 21,165
• Consensus interferon Average/Patient 13,681
  
• 2. Consensus interferon has fewer side effects

46
Treating the Problem

47
Treating the Problem

• Sources of cost savings
• 1. Consensus interferon is cheaper
• PEG-Intron Average/Patient 21,165
• Consensus interferon Average/Patient 13,681
  
• 2. Consensus interferon has fewer side effects
• PEG-Intron Average cost of extra
• drugs/Patient 4,748
• Consensus interferon Average cost of extra
• drugs/Patient 1,833

48
Treating the Problem

• Sources of cost savings
• 1. Consensus interferon is cheaper
• PEG-Intron Average/Patient 21,165
• Consensus interferon Average/Patient 13,681
  
• 2. Consensus interferon has fewer side effects
• PEG-Intron Average cost of extra
• drugs/Patient 4,748
• Consensus interferon Average cost of extra
• drugs/Patient 1,833
• 3.Total savings 10,399/Patient (40)

49
Education, Education, Education!
50
Education

• High Risk Behaviors (BEFORE prison)

?
51
Education

• Orientation

52
Education

• Orientation
• One hour class for all inmates including
• nursing didactics and video presentation

53
Education

• Orientation
• One hour class for all inmates including
• nursing didactics and video presentation
• Red Cross presentation covering HIV and
• HCV

54
Education

• Orientation
• One hour class for all inmates including
• nursing didactics and video presentation
• Red Cross presentation covering HIV and
• HCV
• Intake physical

55
Education

• Orientation
• One hour class for all inmates including
• nursing didactics and video presentation
• Red Cross presentation covering HIV and
• HCV
• Intake physical
• Medical staff strongly reiterates warnings and
• educates further about high-risk behaviors
• on an individual level

56
Education

• Orientation
• One hour class for all inmates including
• nursing didactics and video presentation
• Red Cross presentation covering HIV and
• HCV
• Intake physical
• Medical staff strongly reiterates warnings and
• educates further about high-risk behaviors
• on an individual level
• Opportunity to answer individual questions

57
Education

• If HCV positive
• nursing individually gives a pamphlet that
  discusses the treatment options available to the
  inmate and answers any questions

58
Education

• Prevention

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Education

• Prevention
• Vaccination Hepatitis AB immunization
• for prisoners who are HCV positive or who
• have a sentence 5 years

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Education

• Prevention
• Vaccination Hepatitis AB immunization
• for prisoners who are HCV positive or who
• have a sentence 5 years
• Needle control

61
Education

• Prevention
• Vaccination Hepatitis AB immunization
• for prisoners who are HCV positive or who
• have a sentence 5 years
• Needle control
• Mandatory concurrent Chemical Dependency
• treatment for all inmates receiving HCV
• treatment

62
Questions Comments
63
Thank yous

• Kathleen M. Bachmeier, RN
• Director of Medical Services North Dakota
  Dept. of
• Corrections and Rehabilitation
• John J. Hagan, MD
• Staff Physician North Dakota Dept. of
  Corrections and
• Rehabilitation
• Beth E. Taghon, RN
• Staff Nurse North Dakota State Penitentiary
• Olimpia Rauta, MD
• Senior Resident UND Center for Family
  Medicine,
• Bismarck, ND

64
In the Interest of the Trees
If you would like copies of these slides or
our screening or treatment protocols, please
e-mail me jhostett_at_medicine.nodak.edu