Health Without Barriers. HCV in prison Barriers to treatment, new Strategies and Outcomes

Transcription

1 Health Without Barriers The European Federation for Prison Health HCV in prison Barriers to treatment, new Strategies and Outcomes Roberto Monarca HWBs President Vice President of the Italian Society for Prison Health

2 Nearly Everyone With HCV Can Now Be Treated Successfully Very high SVR rates; therapies highly tolerable All-oral therapy for almost every pt Treatment generally just 12 wks Standard Interferon 1991 Ribavirin Peginterferon Direct- Acting Antivirals Current IFN 6 Mos 16 IFN 12 Mos IFN/RBV 6 Mos IFN/RBV 12 Mos PegIFN 12 Mos PegIFN/ RBV 12 Mos PegIFN/ RBV + DAA DAA + RBV ± PegIFN All Oral DAA± RBV References in slidenotes. Slide credit: clinicaloptions.com

3 Approved DAAs in EU Future

4 Very few HCV+ prisoners treated in Italy (esteem 2013) infected 25-35% HCV aware 5% selected for treatment 0,4% treated Stime SIMSPe non pubblicate

5 Major Barriers to HCV treatment in Prison Testing policy (Opt-in) Structural/Environmental barriers Linked to the patient (hard to reach population) Linked to the therapy (duration, side- effects, drug-drug interactions etc.) Low retention to care and lack of linkage to community care

6 % inmates The low reliability of the Opt-in method Serological study on 973 inmates in 8 Italian Correctional Facilities HIV screening 2,4% 7,5% 5,9% 1,6% Prevalence x12 vs. community! = 5.1% [estimate: 2.012] 0 Ministry data Serum Clinical Diary Don't Know 6 Babudieri S. et al. J Med Virol 2005; 76 (3);

7 Individual Enviromental Structural Obstacles in the Good Medical Practice in Prison Inadequacy of Health Service Untrained Staff Lack of Guidelines Old Prison Structures/lack of technology overcrowding High Turnover of Prisoners Transfer to rehabilitation Centers Parole, house arrest Conflicts With prison guards With Health personnel - Inmates : patients difficult to reach Lack of continuity of care Refusals/interruptions of therapy 7

8 INMATES The difficult to reach patients Homeless IDUs Disrespect of the Authoritities, mistrust of heath-care personnel, anti-social behaviour etc. Alcoholics Foreigners (immigrants, religious/aethnic /cultural diversity, linguistic barriers etc..) Illiterates or poorly educated Lack of comprehension Depression Major mental pathologies 8

9 Cascade of HCV Care Living with HCV Infection HCV Antibody Diagnosed HCV RNA Diagnosed Linked to HCV Care Liver Disease Assessed Initiated HCV Treatment Cure (SVR) Grebely J, et al. Int J Drug Policy. 2015;26: Slide credit: clinicaloptions.com

10 New Direct Acting Antivirals (DAAs) in the Prison Setting The advent of well tolerated direct acting antivirals and the possibility to treat patients for a short time (8-12 weeks) with a high rate of SVR, appears particurarly favorable in the prison setting. The SVR rates could be even higher in detention, due to elevated adherence rates (DOT) overcoming many residual barriers, leading potentially to the eradication of the HCV epidemics.

11 Large real-world data confirm clinical trial results: GT-1 patients SIM/SOF SOF/LDV 3D SOF/DCV 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 93% 93% 95% 98% 94% 93% 96% 95% 97% 94% 94% 87% 88% 89% 86% 94% 95% VA VA / HIV TRIO N Italian Portugese Spanish German Nb =2363/4104/ /208/ / 73 / / /1836/390/528 No impact of HIV HBV, diabetes and obesity on SVR Follow the EASL Guideline (93% vs 87%) Hypo Alb <35g/l negative predictor of SVR McCombs J et al: LBP-510,McGinnis J et al: LBP-514, Afdhal N et al: LBP-519, Aghemo A et al: LBP-500, Marinho T et al: LBP-523, Crespo, J et al: LBP-511, Calleja JL et al: LBP-512, Mauss. S et al: SAT-263

12 SOF plus DCV ± RBV in EU EA AND French ATU confirms wide genotypic efficacy in advanced HCV patients 708 patients : 73-80% cirrhotic patients, 70-80% treatment experienced G1a N=161 G1b N=176 G2 N= 2 G3 N=102 G4 N=234 G5 N= 27 G6 N= 5 SOF/DCV (Petersen) SOF/DCV + RBV (Petersen) SOF/DCV ± RBV (Hezode) Hézode C et al. EASL 2016 abstr SAT131, Petersen J et al. EASL 2016 abstr. SAT-275,

13 New paradigm for Hep-C in Prison Test all Treat Hard and Short Cure Most

14 HCV RNA < LLOQ, TD/TND (%) Effective but Still Not Ideal in Gt3 Cirrhosis Cirrhotic GT3 HCV pts treated with SOF + DCV ± RBV for 12 or 24 wks in French EAP DCV + SOF DCV + SOF + RBV 20 n/n = 0 23/ 33 4/ 4 116/ Wks 24 Wks 24 weeks necessary Unclear role of RBV No real trial data hard to interpret 39/ 48 Hezode C, et al. AASLD Abstract 206.

15

16 Despite the excellent efficacy of DAA containing regimens reported in clinical trials, virological failures can occur, often associated with development of resistance Pawlotsky JM, Gastroenterology 2016

17 Even in the era of DAAs, 47,000 patients would fail to achieve SVR in Europe Chhatwal J et al., EASL 2017 poster #FRI-233

18 Depletion of HCV reservoir (treatment as prevention) Treat any individual with high risk behaviours Drug addicts Tattoing in prison, piercing Younger with sexual activities and multiple partners Treat where they are concentrated most Prisons Rehabilitation centers for drug addicts

19 An outlook of the HCV treatment scenario F3 and F4, Child A, F4, Child B and C F0-F > 2020

20 Italy: WHO Recommendation Scenario Increase screening, treatment and eligibility to reduce new infections 90% and liver related deaths 65% Switch to direct acting anti-virals with higher SVR in 2015 Increase treatment to achieve a 65% reduction in liver related deaths, 90% reduction in total & new infections Expand screening to find infected individuals to treat Will run out of eligible patients to treat by Treated 10,482 41,928 41,928 41,928 41,928 41,928 Newly Diagnosed 30,403 33,443 40,132 52,172 78, Fibrosis Stage F2 F2 F0 F0 F0 F0 Treated Age SVR 46% 85% 85% 88% 89% 89% After 2030, fewer than 500 individuals need to be treated annually

21 Total Cases Total Cases Total Cases Total Cases Compared to base, total number of HCV infections will be reduced by 95%, and liver related deaths, HCC & decomp. cirrhosis by 94-96% Total Infected Cases (Viremic) - Italy 1,000, , , , ,000-8,000 6,000 4,000 2,000 - Liver related Deaths - Italy Base Base 2015 WHO Recommendations Base Base 2015 WHO Recommendations HCC - Italy Decompensated Cirrhosis - Italy 8,000 15,000 6,000 4,000 2,000 12,000 9,000 6,000 3, Base Base 2015 WHO Recommendations Base Base 2015 WHO Recommendations

22 Treatment outcomes in the Peg-IFN era in Prison

23 Treatment with DAAs in a multicenter cohort of HCV-infected prisoners in Italy E. Pontali S.C. Malattie Infettive - E.O. Galliera & ASL3 Genovese Genova

24 Results inmates starting DAAs Mainly Italians (93.7%) and males (98.6%) Mean age 49.4 years (median 50) Advanced liver disease: 76.1% cirrhotics (mainly CP A) Normal transam. only in 7

25 Results - 2 Most frequent genotypes: 1a 35.9% % 1b 14.8% High baseline HCV-RNA: mean 2.3x10 6 UI (median 7.2x10 5 UI)

26 Most frequent regimens Regimen Number % sofosbuvir/daclatasvir/ribavirin sofosbuvir/ledipasvir/ribavirin % sofosbuvir/ledipasvir % paritaprevir/ritonavir/ombitasvir / dasabuvir/ribavirin % sofosbuvir/daclatasvir % simeprevir/rbv/peg-ifn 10 7%

27 Outcomes Treatment duration 24 weeks in 60% Treatment completion: 94.4% 8 discontinuations; 1 AEs SVR 12 w: 90% ITT 20 EOT response 4 relapses

28 Conclusions HCV infection particurarly concentrates in Prison Prisoners are an underserved population regarding HCV treatment and care, so far The availability of new drugs with high efficacy and tolerability and the short duration of the treatment can overcome many inveterate problems linked to side effects, the high turnover of the inmates and the continuity of care. With an extensive use of the new DAAs it is possible to speculate that in few years we could observe a depletion of the prison reservoir composed of HCV infected prisoners.

29 Prison Health is Public Health * * DUBLIN DECLARATION ON HIV/AIDS IN PRISONS IN EUROPE AND CENTRAL ASIA,