clinical managment of hepatitis c in an environment with limited acces to treatment andrzej horban...

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. Epidemiological situation

2. Surveillance study

3. Health care financing

4. Inclusions and exclusions criteria

5. Schema of treatment

6. Monitoring principles

Therapeutic programmes in limited resources countries

• Who should be treated ?

– Staging

– Grading

HCV Epidemiology in Poland

2004 - 2157 2005 - 23422006 - 28902007 - 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: 20-24 years – 10,8 /100 000

• Female: 60-64 years - 9,4/ 100 000

Czaszkowski M., Kuszewski K., Przegl Epid 2005; 59(2):303-8National 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 Hospitalof 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 treatmentof 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 unitsin 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 dependenton 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


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


patients with extrahepatic manifestations of HCV infection should be treated for 48 weeks

irrespective of genotype and reduction in viraemia after 12 weeks


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


• 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 –



• Monitoring– 4,12,48,72 weeks

• Response Guided Therapy - Yes

Hungary


• HCV Prevalence - % /number– 0.70/ 70 000

• Number of diagnosed - 1000


• % treated of diagnosed – 100


• Limitation - no

Hungary

• Inclusion criteria - full diagnosis: HCV RNA (+), biopsy, genotype

• Exclusion criteria – only medical contrindication

• Hospitals/Ambulatories – hepatology outpatients clinics



• Monitoring – 12,48,72 weeks

• Response Guided Therapy - Yes

Czech Republic


• HCV Prevalence % /number– 0.20/ 20 400



• % treated of diagnosed – 30


• Limitation - no

Czech Republic

• Inclusion criteria - full diagnostic: HCV RNA (+), biopsy, genotype

• Exclusion criteria – active drug addicts

• Hospitals/Ambulatories – ambulatories


• Treatment rules Genotype 2,3 – 24 weeks/ sometimes 48 weeks


• Response Guided Therapy – not yet

Bulgaria


• HCV Prevalence % /number – 1.38/ 106 260



• % treated of diagnosed – 14.48


• Limitation - yes, only 300 yearly

Bulgaria

• Inclusion criteria - full diagnosis: HCV RNA (+), biopsy, genotype, elevated Alat

• Exclusion criteria – NA



• Treatment rules Genotype 2,3 – 24 weeks/ sometimes 48 weeks



Slovenia



• Number of diagnosed – approximately 2000 since 1993, 115 in 2008


• % treated of diagnosed –


• Limitation - no

Slovenia

• Inclusion criteria - full diagnosis: HCV RNA (+), biopsy, genotype, elevated AlAT

• Exclusion criteria – NA






Romania



• Number of diagnosed – approximately 2100


• % 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






Macedonia


• HCV Prevalence - % /number – 1,20/ 24 000



• % 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 2,3 – 24 weeks/



Russia

• Population – 142 200 000

• HCV Prevalence - % /number– 1,30/ 1 848 600

• Number of diagnosed – 77 000

• Number of treated - 20 000


• 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




• Monitoring – 4,12,48,72 weeks

• Response Guided Therapy – yes

Croatia


• HCV Prevalence - % /number– 1,4/ 61 600

• Number of diagnosed – 700



• Full treatment reimbursment – yes

• Limitation - hospitals

Croatia

• Inclusion criteria - HCV – RNA positive, age<65, naiveor relapser (not NR), elevated ALT(>2x), Normal ALT activity (F2 and more) normal or high, liver biopsy score >= F1

• Exclusion criteria –

• Hospitals/Ambulatories – hospitals



• Monitoring– standard 12,48,72 week, week 4 only in pts with genotype 1 with low wiremia

• Response Guided Therapy – yes


• Lack of surveillance study

• Gap between estimated seroprevalence and reality

• Access to treatment is limited


• Who should be treated ?

– Staging ?

– Grading ?

clinical managment of hepatitis c in an environment with limited acces to treatment andrzej horban...

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