Simon Janes Antoine van Sint Fiet Giovanni Pintaldi “The five pillars of care” An inclusive and equitable medical approach to hepatitis C care in people who inject drugs Simon Janes Antoine van Sint Fiet Giovanni Pintaldi MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Context MSF present in Manipur state in the north-east of India, since 2004 Currently operates two ART centers under public private partnership with NACO, in Churachandpur and Moreh providing care for HIV, (DR)-Tuberculosis (TB), and Hepatitis C virus (HCV) infection HIV and HCV epidemic in Manipur has been driven by the use of intra-venous drugs. MSF India, "The five pillars of care"

Substance Use Disorder Inter-related Morbidities Estimate prevalence HCV infection in India: 1- 1.5%1 Estimated prevalence of HIV infection in: India (2015): 0.26%2 Manipur (2015): 1.22%2 Estimated prevalence's of HIV and HCV in people who inject drugs (PWID’s) in Manipur3: HIV infection: 27.9% - 43.3% HCV infection: 45.5% - 68.4% HIV / HCV co-infection: 21.0 % - 29.2% Substance Use Disorder Tuberculosis Mental Health Illness HIV Hepatitis C Puri,et al. Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL); 2014. National AIDS control Organisation: India HIV Estimations 2015, Technical Report. Solomon, et al. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study; 2014.

Barriers to HCV care for PWID’s Barriers present at multiple levels of “HCV cascade of care” Stigma and discrimination Treatment domain of specialist hospital system Absence of peer and adherence support Separation of treatment from Harm reduction / oral substitution treatment services Cost MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Exclusion Limited treatment with overwhelming demand Complexity of treatment with interferon containing regimens Programmatic desire for good performance resulting in exclusion of patients with multiple co-morbidities Prioritisation of patients with advanced liver disease Concerns of re-infection, poor adherence and poor outcomes in PWID’s MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Inclusion Holistic patient centered approach required, focusing on individualised priorities and not specific diseases Ethical considerations of autonomy, beneficence, non-maleficence, justice and respect for persons have been largely ignored Provides important opportunity for behavioral modification and uptake of harm reduction services Highest burden of incident cases amongst PWID’s Treatment as prevention Improved care for related co-morbidities through increased awareness and development of expertise MSF India, "The five pillars of care"

MSF India, "The five pillars of care"

Psychosocial assessment ASSESSMENT AND PRIORITISATION Medical assessment Clinical assessment Routine baseline blood Screen for: TB /Opportunistic infection Review HIV care HIV Viral Load HCV Viral Load / Genotype APRI: AST platelet ratio index Fibroscan Psychosocial assessment Demographics Social support and coping skills Mental Health Status Depression screening tool: PHQ9 ASSIST questionnaire AUDIT Alcohol use tool Motivation and barriers to treatment Adherence factors Clinical Case Review ASSIST: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) MSF India, "The five pillars of care"

INDIVIDUALISED CARE HIV TB / Opportunistic infection Hepatitis C New patients: existing schedule for pre-treatment and on-going HIV counselling Existing patients: Adherence counselling: second weekly Clinical case review: 4/12 TB / Opportunistic infection Counselling as required Clinical Case review at completion of medical treatment of existing co-infection Hepatitis C Pre-treatment counselling Adherence counselling: 1, 2, 4, 6, 8, 12, wks Clinical case review at completion of HCV treatment Substance Use Disorder Counselling as required OST referral for PWID’s as required Regular counselling with OST Repeat ASSIST / AUDIT Clinical case review: 4/12 Mental Illness Counselling as required Sever illness: psychiatrist referral Individualised counselling plan Repeat PHQ9 at 3/12 Clinical case review: 4/12 Regular medical r/v Adherence: Repeat VL at 3 /12 of counselling Specific TB/OI treatment Regular medical r/v Regular medical r/v Monitor HCV viral load Test of cure at 12 wks Routine medical care. Care for complications of intravenous drug use Psychiatrist review Pharmacotherapy if required MSF India, "The five pillars of care"

Morbidity identified as primary treatment priority CLINICAL CASE REVIEWS 92 Morbidity identified as primary treatment priority HIV 11 TB Opportunistic Infection 1 Hepatitis C 54 Substance Use Disorder 15 Mental Health illness 8 Repeated clinical case review of 31 patients: 18 re-prioritised for HCV treatment RE-PRIORITISATION TO HCV TREATMENT FOLLOWING INITIAL INTERVENTION 3 1 9 5 MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Overall average duration from initial case review to prioritisation for HCV treatment for all types of intervention = 7.5 months Average duration between initial clinical case review and prioritisation for HCV treatment for each initial priority: Substance use disorder: 7.8 months Mental health illness: 5.9 months HIV adherence: 8 months TB / Opportunistic infection: 3.5 months MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Conclusions Through a multi-disciplinary model to assess, prioritise and manage related co-morbidities, the most vulnerable populations can be equitably included in treatment of Hepatitis C There is a requirement for program managers and treatment providers to understand, accept and adapt care models to issues of social function and stigmatisation specific to PWID that currently limit access to treatment including the parallel provision of effective harm reduction services There are sound ethical and scientific justifications for the creation of models of care delivery specifically tailored for the needs of PWID’s MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Acknowledgements We would like to thank the MSF specialist advisors Dr Michiel Lekkerkerker and Dr Krzysztof Herboczek We would like to thank the MSF team in Manipur for their unyielding dedication and hard work. We would like to acknowledge Dr Till Kinkel whose contribution to initial discussions were responsible for a reorientation from an “exclusive” to “inclusive” mentality. We also acknowledge Dr Julian Sheather’s valuable contributions to the ethical considerations MSF India, "The five pillars of care"

MSF India, "The five pillars of care" Thank-you MSF India, "The five pillars of care"