Transcript Epidemiologia HCV w Polsce

Clinical managment of hepatitis C
in an environment with limited
acces to treatment
Andrzej Horban
Hospital of Infectious Diseases
Warsaw, Poland
What means ” limited access” ?
1.
2.
3.
4.
5.
6.
Epidemiological situation
Surveillance study
Health care financing
Inclusions and exclusions criteria
Schema of treatment
Monitoring principles
Therapeutic programmes in limited
resources countries
• Who should be treated ?
– Staging
– Grading
HCV Epidemiology in Poland
2004
2005
2006
2007
-
2157
2342
2890
2693
Since 1990, when the anti-HCV tests were introduced
18 years x 2000 -2500 persons
= 36 000 – 45 000 persons
= appr. 0,1 % of population ?
HCV Epidemiology in Poland
• Cities: 6.5 / 100 000( male -7.1, female 6,0)
• Countryside: 2.9 / 100 000 ( male -3.6, female 2.1)
• Male:
• Female:
20-24 years – 10,8 /100 000
60-64 years - 9,4/ 100 000
Czaszkowski M., Kuszewski K., Przegl Epid 2005; 59(2):303-8
National Hygiene Institute Report 2006
HCV in Poland: therapeutic programs
• Therapeutic programs supported by National Health
Fund
• 2000 procedures carried out in 63 centres
• Number of treated is limited to 2500 per year
(patients are on waiting list)
Therapies in Poland
• Number of centres in Poland
– 63
• Number of therapies per month in all the centres
– 1569
• From 1 therapy (Łuków) to 250 (Warsaw Hospital
of Infectious Diseases)
Therapeutic programme using pegylated
interferon in the treatment of CHC
– reimbursed by the National Health Fund
(NFZ) in Poland
• Pegylated interferon alpha in the treatment
of chronic hepatitis C
• 1. Pelylated interferon alpha 2a
• 2. Pegylated interferon alpha 2b
• 3. other interferons
Inclusion criteria for CHC treatment
programmes – in Poland
• presence of HCV RNA in the serum or hepatic tissue
• determination of the number of HCV RNA units
in the tested material
• determination of viral genotype
• chronic hepatitis and compensated cirrhosis
Inclusion criteria for CHC treatment
programmes – in Poland
• inflammatory lesions and fibrosis in the histopathology
of the liver (patients with genotype 2 or 3 and those with
contraindications for biopsy do not require liver biopsy)
• patients with extrahepatic manifestations of HCV
infection should be treated irrespective of disease
severity in the histopathological score
• age - now no limitation
Exclusion criteria for CHC treatment
programmes
only medical contraindication
HCV in Poland:
therapeutic programmes
– pegylated interferon alpha
Pegylated interferon alpha may be used in patients
above 18 years of age
• in monotherapy – in patients with contraindications to
ribavirin
• in combination with ribavirin – in patients with chronic
hepatitis C, with recurrent infection or after an
unsuccesfull treatment with interferon alpha or interferon
alpha with ribavirin
Therapeutic programmes
– pegylated interferon alpha
Treatment of chronic hepatitis C is dependent
on the genotype, early viral response and
extrahepatic manifestations of HCV infection:
patients with genotype 2 or 3: 24-weeks therapy
note: in patients with genotype 3, in which
undetectable HCV RNA was not achieved after 24
weeks and with liver fibrosis (staging) > 2:
therapy up to 48 weeks
Therapeutic programmes
– pegylated interferon alpha
patients with genotype 1 or 4:
therapy depending on the early viral response and staging
- patients with liver fibrosis (staging) </= 2, decreasing
viraemia greater than 2 log is not seen after 12 weeks of
treatment – therapy should be discontinued
but
- in patients with liver fibrosis > 2 therapy should be
continue up to 48 weeks irrespective of reduction in
viraemia
Therapeutic programmes
– pegylated interferon alpha
patients with extrahepatic manifestations of HCV infection
should be treated for 48 weeks
irrespective of genotype and reduction in viraemia after 12
weeks
Therapeutic programmes
– pegylated interferon alpha
2008:
• in patients infected with HCV of genotype 1
(Pegasys or Pegintron) or genotype 4 (Pegasys),
with viraemia < 600 000 IU/ml at beginning of
treatment and undetectable HCV RNA after 4 weeks
(RVR)
it is recommended to cut
the duration of therapy down to 24 weeks
Therapeutic programmes in Poland
– outcome monitoring
• Since last year, a based internet system
was introduced to monitor proper
programme conducting
• It covers patient’s data at the point of
admittance to the programme (personal
ID, weight, drug name, dose, biopsy
results, genotype, viraemia level),RVR,
EVR, ETR, SVR , reasons for interruption
of treatment
Bosnia&Herzegovina
• Population - 3 500 000
• HCV Prevalence - % (number) -1 ( 35 000)
• Number of diagnosed – 554
• Number of treated - 543
• % treated of diagnosed - 98
• treatment reimbursment - no
• Limitation - yearly budget for treatment given every
year by government
Bosnia&Herzegovina
• Inclusion criteria - full diagnostic: HCV RNA (+),
biopsy, genotype
• Exclusion criteria – age( over65), drug addiction
(drug addicts, or less than 1 year of abstinence)
• Hospitals/Ambulatories – beginnging in hospitals,
continue in outpatients clinics
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks
• Monitoring– 12,48,72 weeks
• Response Guided Therapy - only with permission
Estonia
• Population – 1 300 000
• HCV Prevalence - % (number) - 1,5 ( 19 500)
• Number of diagnosed - NA
• Number of treated - NA
• % treated of diagnosed - NA
• Full treatment reimbursment - yes
• Limitation - no
Estonia
• Inclusion criteria - full diagnostic: HCV RNA (+),
biopsy, genotype
• Exclusion criteria –
• Hospitals/Ambulatories –
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks
• Monitoring– 4,12,48,72 weeks
• Response Guided Therapy - Yes
Hungary
• Population – 10 000 000
• HCV Prevalence - % /number– 0.70/ 70 000
• Number of diagnosed - 1000
• Number of treated - 1000
• % treated of diagnosed – 100
• Full treatment reimbursment - yes
• Limitation - no
Hungary
• Inclusion criteria - full diagnosis: HCV RNA (+),
biopsy, genotype
• Exclusion criteria – only medical contrindication
• Hospitals/Ambulatories – hepatology outpatients
clinics
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks
• Monitoring – 12,48,72 weeks
• Response Guided Therapy - Yes
Czech Republic
• Population – 10 200 000
• HCV Prevalence % /number– 0.20/ 20 400
• Number of diagnosed - 2000
• Number of treated - 600
• % treated of diagnosed – 30
• Full treatment reimbursment - yes
• Limitation - no
Czech Republic
• Inclusion criteria - full diagnostic: HCV RNA (+),
biopsy, genotype
• Exclusion criteria – active drug addicts
• Hospitals/Ambulatories – ambulatories
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks/
sometimes 48 weeks
• Monitoring – 12,48,72 weeks
• Response Guided Therapy – not yet
Bulgaria
• Population – 7 700 000
• HCV Prevalence % /number – 1.38/ 106 260
• Number of diagnosed - 2072
• Number of treated - 300
• % treated of diagnosed – 14.48
• Full treatment reimbursment - yes
• Limitation - yes, only 300 yearly
Bulgaria
• Inclusion criteria - full diagnosis: HCV RNA (+),
biopsy, genotype, elevated Alat
• Exclusion criteria – NA
• Hospitals/Ambulatories – ambulatories
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks/
sometimes 48 weeks
• Monitoring – 12,48,72 weeks
• Response Guided Therapy – not yet
Slovenia
• Population – 2 000 000
• HCV Prevalence - % /number– 1.38/ 106 260
• Number of diagnosed – approximately 2000 since
1993, 115 in 2008
• Number of treated - 115
• % treated of diagnosed –
• Full treatment reimbursment - yes
• Limitation - no
Slovenia
• Inclusion criteria - full diagnosis: HCV RNA (+),
biopsy, genotype, elevated AlAT
• Exclusion criteria – NA
• Hospitals/Ambulatories – ambulatories
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks
• Monitoring – 12,48,72 weeks
• Response Guided Therapy – not yet
Romania
• Population – 19 600 00
• HCV Prevalence - % /number– 4.90/ 960 400
• Number of diagnosed – approximately 2100
• Number of treated - 420
• % treated of diagnosed – 20%
• Full treatment reimbursment – 100% Pegasys, 25%
Copegus
• Limitation - no
Romania
• Inclusion criteria - full diagnosis: HCV RNA (+),
age < 65, biopsy score >= 1, genotype, normal or
elevated AlAT, naive or relapser ( Not NR)
• Exclusion criteria – age >65, liver biopsy <1
• Hospitals/Ambulatories – ambulatories
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks
• Monitoring – 12,48,72 weeks
• Response Guided Therapy – not yet
Macedonia
• Population – 2 000 000
• HCV Prevalence - % /number – 1,20/ 24 000
• Number of diagnosed - 1326
• Number of treated - 360
• % treated of diagnosed – 27,15
• Full treatment reimbursment – yes for limited group
of patients
• Limitation - yes - hospital budget
Macedonia
• Inclusion criteria - elevated ALT , biopsy result hepatic damage
• Exclusion criteria – drug users with less than 6
months abstinence
• Hospitals/Ambulatories – hospitals
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks/
• Monitoring – 12,48,72 weeks
• Response Guided Therapy – not yet
Russia
• Population – 142 200 000
• HCV Prevalence - % /number– 1,30/ 1 848 600
• Number of diagnosed – 77 000
• Number of treated - 20 000
• % treated of diagnosed – 25,97
• Full treatment reimbursment – no
• Limitation - only some group of patience (cirrhosis,
diabetes, haemophilia).Regional AIDS centres
receive Pegays for treatment HIV-HCV coinfected
pts in the frame of National priority project „Health”
Russia
• Inclusion criteria
• Exclusion criteria
• Hospitals/Ambulatories – ambulatories
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks/
• Monitoring – 4,12,48,72 weeks
• Response Guided Therapy – yes
Croatia
• Population – 4 400 000
• HCV Prevalence - % /number– 1,4/ 61 600
• Number of diagnosed – 700
• Number of treated - 320
• % treated of diagnosed – 45,71
• Full treatment reimbursment – yes
• Limitation - hospitals
Croatia
• Inclusion criteria - HCV – RNA positive, age<65, naive
or relapser (not NR), elevated ALT(>2x), Normal ALT activity
(F2 and more) normal or high, liver biopsy score >= F1
• Exclusion criteria –
• Hospitals/Ambulatories – hospitals
• Treatment rules Genotype 1,4 – 48 weeks
• Treatment rules Genotype 2,3 – 24 weeks/
• Monitoring– standard 12,48,72 week, week 4 only in pts with
genotype 1 with low wiremia
• Response Guided Therapy – yes
Therapeutic programmes in limited
resources countries
• Lack of surveillance study
• Gap between estimated seroprevalence
and reality
• Access to treatment is limited
Therapeutic programmes in limited
resources countries
• Who should be treated ?
– Staging
?
– Grading ?