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Shruti H. Mehta, PhD MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health July 2, 2013 www.ias2013.org Kuala Lumpur, Malaysia, 30 June.

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Presentation on theme: "Shruti H. Mehta, PhD MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health July 2, 2013 www.ias2013.org Kuala Lumpur, Malaysia, 30 June."— Presentation transcript:

1 Shruti H. Mehta, PhD MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health July 2, Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Unmet Needs for Persons with HIV/ HCV Coinfection

2 Burden of HIV/HCV co-infection Rockstroh JID 2005; Sulkowski Ann Intern Med 2003; Alter Hepatology 2006; Rotman J Virol 2009; Aceijas Sex Trans Inf 2006; Aceijas Int J Drug Policy 2007; *Where data was not available, # of HIV/HCV co-infected estimated based on distribution of HIV infections by risk group Western & Central Europe ~ Middle East & North Africa ~60,000 Sub-Saharan Africa 23.5 million ~1.8 million Eastern Europe & Central Asia 1.4 million ~ South & South-East Asia 4 million ~ ~ Oceania ~ North America 1.4 million ~ Latin America 1.4 million ~ East Asia ~ Caribbean ~ million HIV infected4-5 million co-infected with HCV*

3 HIV/HCV co-infected patients are unique in some ways… Higher HCV RNA levels 1 More rapid disease progression 2 Impaired treatment response (to Peg/RBV) 3 1 Thomas JID 1996; 2 Goedert Blood 2002; 3 Adapted from Sulkowski New Paradigm of HCV Treatment 2013; Torriani N Engl J Med 2004; Chung N Engl J Med 2004; Carrat R JAMA 2004; Nunez AIDS Res Human Retrovir 2007; Rodriguez-Torre HIV Clin Trials 2012; Laguno Hepatology 2009

4 0 Multi-morbid clinical conditions among HIV/HCV co-infected IDUs in Baltimore (n=362) Multimorbid conditions included diabetes (HbA1c and medication use), obstructive lung disease (Ratio of FEV to forced vital capacity), anemia (hemoglobin), obesity (BMI), kidney dysfunction (urine protein-creatinine, GFR), Hypertension (blood pressure and medication use), liver cirrhosis (Fibroscan) Salter M et al, CID 2011 Stability factors among HIV/HCV co- infected IDUs in Baltimore (n=560) Daily injection drug use, noninjection drug use, alcohol abuse, >1 mental health condition, suicidal ideation, incarceration, income < 5000 per year, lack of health insurance, no primary care HIV/HCV co-infected patients are unique in some ways…

5 Mehta et al, AIDS 2006 …and not unique in others

6 The hepatitis C care continuum Adeyemi 2004, Cachay 2013, Cacoub 2006, Falck-Ytter 2002, Fishbein 2004, Fleming 2003, Gheorghe 2010, Grebely 2009, Groom 2008, Hall 2004, Hallinan 2007, Jowett 2001, Mehta 2006, Morrill 2005, Restrepo 2005, Rocca 2004, Schackman 2007; Stoove 2005, Mehta 2008, Reiberger 2011, Scott 2009, Vellozi 2011 Percent of persons 1. Referral to a specialist/someone who can treat (from a primary care doctor, HIV clinic, opiate substitution clinic, needle exchange program) 2. Attending an appointment 1. Receive pre-treatment work-up 2. Meet eligibility criteria 3. Agree to initiate treatment 1. Efficacious regimen 2. Treatment adherence At least 50% of infected persons are unaware of their status Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Retention

7 There are multiple layered barriers : Patient Patient Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Provider Structural General barriers General health care access ( primary care provider, insurance, health literacy, patient provider-relationship, stigma) Competing health priorities (mental health, comorbidities) Stability factors (substance use, employment, income, housing, drug treatment, social support HCV-specific barriers Poor knowledge Lack of symptoms Fears about treatment Bova 2010, Cacoub 2006, Delwaide 2005, Denniston 2012, Evon 2007, Evon 2010, Gidding 2011, Grebely 2008, Grebely 2011, Hall 2004, Kar-Lung Yan 2010, Khaw 2007, Lally 2008, McLaren 2008, McNally 2006, Mehta 2008, Mendes-Correa 2010, Morrill 2005, Munoz-Plaza 2006, Neale 2007, Ong 2005, Rhodes 2007, Salmon-Ceron 2012, Strauss 2007, Swan 2010

8 Patient Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Provider Structural General barriers General health care access ( primary care provider, insurance, health literacy, patient provider-relationship) Competing health priorities (mental health, comorbidities) Stability factors (substance use, employment, income housing, drug treatment, social support HCV-specific barriers Poor knowledge Lack of symptoms Fears about treatment There are multiple layered barriers: Provider Specialist barriers Knowledge (some providers may have limited HCV treatment experience) Perceptions (concerns about non-adherence, drug use, relapse, risk of re-infection) Primary care provider barriers Knowledge (misconceptions about who to screen, progression risk and treatment) Perceptions (may only refer good candidates who they perceive to need treatment) Cacoub 2006, Grebely 2011, Fishbein 2004, Hallinan 2007, McGowan 2012; Mehta 2008, Morrill 2005, Rocca 2004, Salmon-Ceron 2012, Scott 2009, Stoove 204, Strauss 2007, Talal 2013, Wagner 2009, Zickmund 2007

9 Patient Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Provider Structural General barriers General health care access ( primary care provider, insurance, health literacy, patient provider-relationship) Competing health priorities (mental health, comorbidities) Stability factors (substance use, employment, income housing, drug treatment, social support HCV-specific barriers Poor knowledge Lack of symptoms Fears about treatment There are multiple layered barriers: Structural Specialist barriers Knowledge (some providers may have limited HCV treatment experience) Perceptions (concerns about non-adherence, drug use, relapse, risk of re-infection) Primary care provider barriers Knowledge (misconceptions about who to screen, progression risk and treatment) Perceptions (may only refer good candidates who they perceive to need treatment) Health care system issues Accessibility of HCV antivirals & care locations Overburdened health systems Cost / insurance Segregated service delivery Criminalization of drug use Accessibility to drug use-related services Workforce issues Inconsistent screening/treatment guidelines Insufficient number of providers who can treat HCV Insufficient resources for case managers, navigators, social workers Gidding 2012, Mehta 2006, Mehta 2008, Morrill 2005, Strauss 2007

10 There are multiple layered barriers Patient Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Provider Structural Health care system issues Accessibility of HCV antivirals & care locations Overburdened health systems Cost / insurance Segregated service delivery Criminalization of drug use Accessibility to drug use services Workforce issues Inconsistent screening/treatment guidelines Insufficient number of providers who can treat HCV Insufficient resources for case managers, navigators, social workers General barriers General health care access ( primary care provider, insurance, health literacy, patient provider-relationship, stigma) Competing health priorities (mental health, comorbidities) Stability factors (substance use, employment, income, housing, drug treatment, social support HCV-specific barriers Poor knowledge Lack of symptoms Fears about treatment Specialist barriers Knowledge (some providers may have limited HCV treatment experience) Perceptions (concerns about non-adherence, drug use, relapse, risk of re-infection) Primary care provider barriers Knowledge (misconceptions about who to screen, progression risk and treatment) Perceptions (may only refer good candidates who they perceive to need treatment)

11 Do patient, provider or structural barriers predominate? McGowan Hepatology 2012

12 Impact of all oral (interferon-free) therapies? Patient Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Provider Structural Health care system issues Accessibility of HCV antivirals & care locations Overburdened health systems Cost / insurance Segregated service delivery Criminalization of drug use Accessibility to drug use services Workforce issues Inconsistent screening/treatment guidelines Insufficient number of providers who can treat HCV Insufficient resources for case managers, navigators, social workers General barriers General health care access ( primary care provider, insurance, health literacy, patient provider-relationship, stigma) Competing health priorities (mental health, comorbidities) Stability factors (substance use, employment, income, housing, drug treatment, social support HCV-specific barriers Poor knowledge Lack of symptoms Fears about treatment Specialist barriers Knowledge (some providers may have limited HCV treatment experience) Perceptions (concerns about non-adherence, drug use, relapse, risk of re-infection) Primary care provider barriers Knowledge (misconceptions about who to screen, progression risk and treatment) Perceptions (may only refer good candidates who they perceive to need treatment)

13 13 Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance PREVENT Patient Provider Structural Workforce challenges Standard screening/treatment guidelines Multidisciplinary team care 4 Telemedicine 5 Health Care System Non-invasive disease staging Integrated services HIV & HCV 1 HCV & primary care 2 HCV and opiate substitution 3 Primary Care & Specialist Education at all levels (specialists, ID physicians, HIV providers, Primary care) Sensitization to substance use and related comorbidities HCV specific barriers Education & counseling Peer support Interventions can target all levels General barriers Directly observed therapy 6 Peer Navigation 7 Case-management 8 Incentives Brief interventions (e.g., for alcohol use) 1 Cachay 2013; 2 Evon 2011; 3 Belfori 2007, Krook 2007, Harris 2010, Litwn 2005, Martinez 2012, Mauss 2004, Schaefer , Sylvestre , Treloar 2010; 4 Evon 2011, Sylvestre 2007, Knott 2006, Moussalli 2010; 5 Arora 2010, Hill CROI 2013; 6 Grebely 2007; 7 8 Evon 2011

14 What is the best way to move forward?  Need combination strategies that address all levels (patient, provider, structural)  Will shorter duration of treatment change the model needed? – Public health strategy vs. a more holistic approach – From a specialist model to a primary care model  Apply the HIV test & treat concept to HCV: with HCV, the model is Seek, Test, Treat and Cure  Treatment as prevention? (who is prioritized for treatment?)  What about resource-limited settings?

15 HCV care continuum in the developing world 15 Percent of persons Chronic HCV infection HCV diagnosis Linkage to care Treatment initiation Viral clearance Retention Estimates from multiple studies in developed country settings Estimates from a sample of 7,092 injection drug users in 10 sites in India 10% had ever been tested for hepatitis C 50% said they had not been tested because they had never heard of hepatitis C

16 Lessons from HIV ChallengeLessons from HIVAction points for HCV Decrease cost of care Mechanism for overcoming patent barriers and increasing market competition Mechanism for monitoring quality of generics Prioritize policies to reduce prices of drugs Establish quality assurance program to monitor quality of drugs Simplify model of care Frequently updated treatment guidelines Fixed dose combinations Point-of-care laboratory testing Monitoring integrated into national program International guidelines Fixed-dose combinations POC lab tests Non-invasive disease strategies Task shifting (maximize resources) WHO guidelines on task shifting to nonphysician clinicians Operational resource to assess effectiveness Decentralized HCV care (e.g., telemedicine) to provide care at the community level Ongoing operational research for monitoring Service integration HIV integrated into other services (TB, STIs, antenatal care) Decentralization to primary care Integrate HCV care into other services (HIV, prison health, NEP, OST) Models for integrating with primary care Surveillance, evaluation & research Epidemiologic data available globally Monitoring integrated into national programs Collect epidemiologic data at the outset Integrate monitoring into existing systems Patient & community engagement Treatment literacy integrated into programs Community health workers Build treatment literacy materials Engage community health workers to promote engagement and retention in care Human rights (vulnerable groups) Monitoring of outcomes in vulnerable groups Dedicated funding to fulnerable groups Ensure reporting among vulnerable groups Encourage funding from AIDS donors (e.g., GFATM) Financial & political commitment New funding mechanisms for funding HIV/AIDS in resource limited settings Political & financial support at national level New funding to kick start HCV treatment programs Political commitment from governments Ford N, Clin Infect Dis 2012

17 Cannot wait 10 years for HCV treatment to get to the developing world 1 - UNAIDS Global HIV/AIDS Report 2013; 2 - Adapted from Thomas et al J Int AIDS Soc 2011 Saquinavir Indinavir Ritonavir Nevirapine Nelfinavir Delaviridine Efavirenz Abacavir Amprenavir Tenofivir Enfurvirtide Emtricitabine Fosamprenavir Tipranavir Darunavir Maraviroc Raltegravir Etravirine Rilpilvirine Lopinavir/Ritonavir Daclatasvir Ledipasvir Simeprevir Faldaprevir

18 Acknowledgements Collaborators – Johns Hopkins Bloomberg School of Public Health David Celentano Gregory Kirk – Johns Hopkins School of Medicine Gregory Lucas Richard Moore Sunil Solomon Mark Sulkowski David Thomas – YR Gaitonde Centre for AIDS Research and Education M Suresh Kumar Suniti Solomon AK Srikrishnan Funding – National Institute on Drug Abuse Kuala Lumpur, Malaysia, 30 June - 3 July 2013


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