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HCV response to treatment in IDUs (PWID) in the Czech Republic Vratislav Rehak Remedis Clinic, Prague, Czech Republic 1 Institute of Public Health “Dr.

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Presentation on theme: "HCV response to treatment in IDUs (PWID) in the Czech Republic Vratislav Rehak Remedis Clinic, Prague, Czech Republic 1 Institute of Public Health “Dr."— Presentation transcript:

1 HCV response to treatment in IDUs (PWID) in the Czech Republic Vratislav Rehak Remedis Clinic, Prague, Czech Republic 1 Institute of Public Health “Dr. Milan Jovanovic Batut” Belgrade, Serbia May 24, 2014

2 Czech Republic and drug use Population of CR „Problematic“ drug users (EMCDDA) of them - injecting drug users opiate users metamphetamine users Office of the Government (2012) - data from the year 2011

3 Czech Republic - HCV prevalence In general population < 0.2 % In IDU‘s ≈ 30% Overall prevalence 0.3 % Very low prevalence of HIV IDU‘s Zabransky T, Mravcik V, Korcisova B, Rehak V. Hepatitis C Virus Infection among Injecting Drug Users in the Czech Republic - Prevalence and Associated Factors. European Addiction Research 2006; 12:

4 HIV/AIDS, Czech Republic 1985 – HIV + cumulatively 1887 M 1554 (82,4 %) F 333 (17,6 %) of them developed AIDS 366 of them died 187 4

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8 Remedis – Program of Comprehensive Care Goal: to concentrate all available „drug“ services in one place to promote effectiveness of interventions and patient compliance including adherence to antiviral treatment

9 On site available services Medical care Internal medicine, gastroenterology, hepatology (incl. liver biopsy), surgery, gynecology, primary care, X-ray, … Psychiatry, clinical psychology Easy to reach referrals BBD, STD, TB testing Counselling (psychosocial, harm reduction) Opiate substitution treatment Psychotherapy (group or individual) Social work Established collaboration with harm reduction centers in Prague

10 10 Study design – inclusion criteria   Prospective recruitment 2003 – 2010 in single center – Remedis Prague, Czech Republic   Proven chronic hepatitis C based on standard serological and histological criteria with detectable HCV RNA   History of past or current IDU   Psychosocially stabilized and motivated patient (including those on OST)   Individualized assessment of eligibility and suitability for antiviral therapy in multidisciplinary setting   No other selection, restriction or limitation to Tx   All efficacy analyses were conducted on →Modified intent-to-treat population – included are all subjects who received at least 1st dose of medication

11 11 Duration of IDU career (years)Self reported „main drug“ Study population  n = 345  Male : female – 204 : 141 (59:41%)  Average age – 28.4 (17-53)  Males 29.6 (19-52)  Females 26,5 (17-53)  Body weight  males 78.1 (51-125) median 77  females 63.1(44-130) median 60 HCV clinical characteristics  ALT WNL – 26%  Male : female % : 27.4%  HCV documented d.uration – 3.83 years  (0.5 – 17 years)  Treatment naive patients  No coinfections

12 12 HCV genotypes – 1 vs. non-1 HCV subtypes Histological stage (modif. Ishak) Opiate substitution treatment while on HCV therapy

13 PEG IFN + RBV in chronic HCV – published data PEG IFN alfa-2bPEG IFN alfa-2a Author:Manns et al. Lancet 2001 Fried et al. NEJM 2002 Hadzianys et al. J Hepatol 2002 Dose:1.5 mcg/w mg/d RBV 180 mcg mg/d RBV 180 mcg mg/d RBV SVR total (%) SVR genotype 1 (%) Prediction factors of SVR  Viral factors  genotype  viral load (HCV RNA),  Host (biological) factors  age up to 40 years  histology – fibrosis (stage), absent steatosis  duration of the disease (infection)  body weight (BMI)  race  HIV coinfection  compliance / adherence to Tx

14 14 Pre-treatment follow-up Mean 14,2 months (0-72 months) Prior dependency stabilization Psychosocial stabilization Other relevant interventions accomplished Treatment regimen - standard Pegylated interferon alfa weekly + Ribavirin mg/d weight based Genotype weeks Genotype 2,3 – 24 weeks

15 15 Results obtained - table RVR week 4 EVR week 12 ETR week 24/48 ITT - SVR week 24F/U Genotype1(4)non-11(4)non-11(4)non-11(4)non-1 HCV RNA negative 131 (55.0%)* 82 (82.8%)* 212 (88.7%)* 94 (94.0%)* 215 (89.2%)* 86 (85.1%)* 195 (80.9%) ITT 85 (84.2%) ITT HCV RNA positive result not available lost to F/U Total **101 ** RVR – rapid virological response, EVR – early virological response, ETR – end of treatment virological response, F/U - follow-up *data based on results available in particular period of therapy -not ITT, **2 subjectt with unknown genotype

16 16 On-treatment virological responses in genotypes 1(4) patients (included are only patients with available results in particular weeks – not ITT) RVR-week 4EVR-week 12ETR-week 48 n=239 n=239n=241

17 17 Sustained virological response, genotypes 1(4) – week 24 of F/U ITT population n=128

18 18 On-treatment virological responses in non-1 genotypes (3, 2) patients (included are only patients with available results in particular weeks – not ITT) RVR-week 4EVR-week 12ETR-week 24 n=99 n=100n=101

19 19 Sustained virological response, GENOTYPES non-1 (3, 2) – week 24 of F/U ITT population

20 20 Sustained virological response, ALL GENOTYPES – week 24 of F/U ITT population

21 Adverse events observed   Mood disorders 45,3%   Thyroid disorders 18,3%   Ribavirin dose reduction due to anemia 13,3%   AE‘s were managed individually, not á la carte   Adverse events frequency was generally comparable or lower than published elsewhere

22 Reinfection rate (data not updated) 3 years standard F/U in 76% of patients 2 reinfection documented Frequency of 0.6% per person/year 1 reinfection after 5 years

23 Reasons for good treatment response Low age and short duration of HCV infection Early stages of HCV infection (low fibrosis) Low body weight (BMI) Low somatic comorbidity Good adherence / compliance → comprehensive care setting in Remedis HCV antiviral Tx is an integral part of addiction treatment HCV antiviral therapy is considered as one of the steps of an addicted patient recovery

24 24 Conclusions   Chronic hepatitis C in certain settings can be nearly fully treatable disease even with current standard of therapy   IDU‘s can be successfully treated with higher than average efficacy   HCV antiviral therapy should optimally be initiated and performed within a comprehensive service setting promoting good adherence   HCV antiviral therapy can be one of the most powerful preventative measure in low prevalence countries such as the Czech Republic

25 The cost-effectiveness of HCV antiviral treatment for injecting drug user populations Natasha K. Martin 1,2,*,†, Natasha K. Martin 1,2,*,†,† Peter Vickerman 1,2, Peter Vickerman 1,2, Alec Miners 2, Alec Miners 2, Graham R. Foster 3, Graham R. Foster 3, Sharon J. Hutchinson 4,5, Sharon J. Hutchinson 4,5, David J. Goldberg 4, David J. Goldberg 4, Matthew Hickman 1 Matthew Hickman 1 DOI: /hep DOI: /hep.24656

26 Abstract Background & Aims: Background & Aims: Injecting drug use is the main risk of hepatitis C virus transmission in most developed countries. HCV antiviral treatment (peginterferon- α+ribavirin) has been shown to be cost-effective for patients with no reinfection risk. We examined the cost-effectiveness of providing antiviral treatment for injectors (IDUs) as compared to treating ex/non-IDUs or no treatment. Injecting drug use is the main risk of hepatitis C virus transmission in most developed countries. HCV antiviral treatment (peginterferon- α+ribavirin) has been shown to be cost-effective for patients with no reinfection risk. We examined the cost-effectiveness of providing antiviral treatment for injectors (IDUs) as compared to treating ex/non-IDUs or no treatment. Methods: Methods: A dynamic model of HCV transmission and disease progression was developed, incorporating: a fixed number of antiviral treatments allocated at the mild HCV stage over 10 years, no retreatment after treatment failure, potential reinfection, and three baseline IDU HCV prevalence scenarios (20%, 40%, and 60%). We performed a probabilistic cost-utility analysis estimating long-term costs and outcomes measured in Quality Adjusted Life Years (QALYs) and calculating the incremental cost-effectiveness ratio (ICER) comparing treating IDUs, ex/non-IDUs or no treatment. A dynamic model of HCV transmission and disease progression was developed, incorporating: a fixed number of antiviral treatments allocated at the mild HCV stage over 10 years, no retreatment after treatment failure, potential reinfection, and three baseline IDU HCV prevalence scenarios (20%, 40%, and 60%). We performed a probabilistic cost-utility analysis estimating long-term costs and outcomes measured in Quality Adjusted Life Years (QALYs) and calculating the incremental cost-effectiveness ratio (ICER) comparing treating IDUs, ex/non-IDUs or no treatment. Results: Results: Antiviral treatment for IDUs is the most cost-effective option in the 20% and 40% baseline chronic prevalence settings, with ICERs compared to no treatment of £521 and £2,539 per QALY saved, respectively. Treatment of ex/non-IDUs is dominated in these scenarios. At 60% baseline prevalence treating ex/non-IDUs is slightly more likely to be the more cost-effective option (with an ICER compared to no treatment of £6,803), and treating IDUs dominated due to high reinfection. A sensitivity analysis indicates these rankings hold even when IDU sustained viral response rates as compared to ex/non-IDUs are halved. Antiviral treatment for IDUs is the most cost-effective option in the 20% and 40% baseline chronic prevalence settings, with ICERs compared to no treatment of £521 and £2,539 per QALY saved, respectively. Treatment of ex/non-IDUs is dominated in these scenarios. At 60% baseline prevalence treating ex/non-IDUs is slightly more likely to be the more cost-effective option (with an ICER compared to no treatment of £6,803), and treating IDUs dominated due to high reinfection. A sensitivity analysis indicates these rankings hold even when IDU sustained viral response rates as compared to ex/non-IDUs are halved. Conclusions: Conclusions: Despite the possibility of reinfection, the model suggests providing antiviral treatment to IDUs is the most cost-effective policy option in chronic prevalence scenarios less than 60%. Further research on how HCV treatment for injectors can be scaled up, and its impact on prevalence is warranted. (HEPATOLOGY 2011.) Despite the possibility of reinfection, the model suggests providing antiviral treatment to IDUs is the most cost-effective policy option in chronic prevalence scenarios less than 60%. Further research on how HCV treatment for injectors can be scaled up, and its impact on prevalence is warranted. (HEPATOLOGY 2011.)

27 Seroprevalence study in prisons in the Czech Republic Total inmates tested 971 Total inmates tested 971 Results – 2 HIV + (0,2%) Results – 2 HIV + (0,2%) 1 HIV+, HCV+ 1 HIV+, HCV+ 1 HIV +, HCV- 1 HIV +, HCV- 274 HCV + (28,12%) 274 HCV + (28,12%)

28 Opportunity for prevention of HCV? Prisons! In many countries a considerable gap in testing is in incarcerated populations. Prisons provide an excellent opportunity to diagnose and treat the largest known reservoir of infected individuals and provides the single most effective HCV public health strategy. Intake testing and councelling should be mandatory, treatment should be made available based on the patients will and local conditions. 28


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