Treat To Prevent –Millennials, Drugs and Hepatitis C [HCV]

Strategies To Identify and Advance PWID HCV Patient Care

Imtiaz Alam, M.D.Medical Director, Austin Hepatitis Center

Medical Director, HepCare Specialty PharmacyClinical Associate Professor of Medicine, Texas A & M University

HIV Mantra:“Treatment as Prevention”

[TasP]

HCV Mantra:“Treat to Prevent”

Make a Change to Reduce HARM

When asked why he robbed banks Willie Sutton replied:“Because that is where the money is”

1. Yehia BR, et al. PLoS One. 2014;9:e101554.2. Litwin AH, et al. Clin Infect Dis. 2005;40:S339-S345.3. Grebely J, et al. Clin Infect Dis. 2013;57:1014-1020.4. CDC. Surveillance for Viral Hepatitis – United States, 2013. http://www.cdc.gov/hepatitis/Statistics/2013Surveillance/Commentary.htm. Accessed August 18,

2015.

Current or Former People Who Inject Drugs (PWIDs) Comprise More Than Half of the Chronic Hepatitis C Virus (HCV) Population in the US

are current or former PWIDs2,3

of new HCV infections occur among PWIDs3

~3.5 million people are living with HCV1

~29,000 new HCV infectionsin 2013a,4

aVerified active infection that is known not to be acute.

An Estimated 3.8 Million Persons in the US Have Injected Heroin at Least Once1

1. CDC. MMWR. 2012;61:1-43.2. SAMHSA. National Survey on Drug Use and Health Report. September 4, 2014.3. CDC. MMWR. 2015:64:1-7.

aUse within the year prior to data collection.bUse within the past month.

Activeheroin

use2

~289,000

~289,000persons actively use heroinb,2

~425,000persons injected heroin, cocaine, or stimulants within the last yeara,1

~63%increase in heroin use in the US from 2002-20133

It is estimated that ~60% of individuals with HCV are current or former PWIDs.4,5

4. Litwin AH, et al. Clin Infect Dis. 2005;40:S339-S345.5. Grebely J, et al. Clin Infect Dis. 2013;57:1014-1020.

A Surge in Injection Drug Use is Shifting the Epidemiology of HCV

364% Increase in Acute HCV Infections [2006-2012] for those aged <30 Years – Kentucky,

Tennessee, Virginia, and West Virginia

Jon E. Zibell, MDHealth Scientist, CDCMMWR 2015;64:1-6

Increased injection drug use is not unique to Massachusetts; these data may be indicative of emerging trends in HCV transmission in other regions of the US.

Increased Injection Drug Use in Adolescents and Young Adults Is Shifting the Demographics of HCV Infection in the US

CDC. MMWR. 2011;60:537-541.

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aExcludes 35 cases with missing age or sex information.bExcludes 346 cases with missing age or sex information.

Newly Reported Confirmed HCV Cases,Massachusetts, 2002-2009

Injection drug use was the most common risk factor for

HCV transmissionN=6281a N=3904b

“ Heroin was traditionally an inner-city drug, but that has changed. Heroin users are now white, with college education and high-paying jobs”

The Changing Face of Heroin Use in the United States: A Retrospective Analysis of the Past 50 YearsTheodore J. Cicero, PhDJAMA Psychiatry. 2014;71(7):821-826. doi:10.1001/jamapsychiatry.2014.366.

Acute HCV – 2,194 reported cases in 2014 –young whites with IDU [2x increase since 2010]

30,000 new HCV cases per year

19,659 HCV related deaths in 2014 – “HCV Leading Infectious Disease Killer in U.S.”

CDC ReportClinical Infectious Diseases May 2016

Increases in New HCV Infections• 50% increase in national

reporting• 200% increase in 17 states• Recent studies show• ~70% report IDU• Ages 18 to 29 years• Predominantly white • Equally female and male• Equally Non-urban and

urban• Antecedent prescription

opioid misuse

Source: CDC/hepatitis.gov; MMWR 2011; MMWR 2014; CDC unpublished data.

Globally 10 million people with HCV are injecting drugs

Int J Drug Policy 2015:26[10]:1014-1019

“ It is estimated that within the first 5 years of injection practices, about 50% of the people who inject drugs will become infected by HCV”

Julie Bruneau, MDProfessor of Family Medicine, University of Montreal

“Currently only 1-2% of People Who Inject Drugs [PWID] with chronic HCV infection are treated each year”!!

Holly Hagan, PhDProfessor NYU College of Nursing

“Permanent implementation of needle exchange programs are needed to reduce the spread of HIV, HCV and other infections spread through the use of injection drugs”

Strathdee, SA et al.NEJM 2015;doi:10.1056/NEJMp1507252Director of the Institute of Global Health at UCSD

“HCV treatment alone will not control HCV infection in PWID”

“Combined HCV prevention –syringe access and Opioid Substitution Therapy [OST] –must be continued (and expanded)”

Holly Hagan, PhDProfessor NYU College of Nursing

• Substance abuse treatment• HARM Reduction• HCV Testing• Linkage to HCV Care• Monitoring Adherence to HCV Therapy• Post-therapy Cure Surveillance – Prevent Re-

infection

“Treat to Prevent”“One-Stop” Shopping

Collaborative Care Model

Evidence-Based Care Without Stigma

50%

Cascade of Carea

HCV Disproportionately Impacts PWIDs, but Treatment Rates Are Even Lower Relative to the Overall HCV Population

Chronic HCV infection Diagnosed and aware Treated

aAll numbers are approximate.b2003-2013.cEstimated, 2005.dEstimated, 2014.1. Yehia BR, et al. PLoS One. 2014;9:e101554.2. Litwin AH, et al. Clin Infect Dis. 2005;40(suppl 5):s339-s345.3. Coffin PO, Reynolds A. Hepat Med. 2014;6:79-87.

HCV in general US population

3.5Millionb,1

16%

1.75 Millionb,1

560,000b,1

HCV in US PWID population

50%2.1

Millionc,2

1%-9%1

Milliond,3

≤189,000d,3

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Martin, et al. Hepatology. 2013.

Can Treatment as Prevention be Applied For HCV Among PWID (Modeling DAAs)?

PWID = [People Who Inject Drugs]

Treatment as Prevention• HCV prevalence can be reduced by 70% at 30 years if 25 in 1,000

PWID are treated annually– Hellard ME et al. Med J Aust 2012– Martin N et al. Hepatology 2013

• Treating PWIDs and all their contacts in the network was most effective in reducing the incidence rates of reinfection and combined infection– Rolls D et al. PLoS One 2013

• “Treat Your Friends” strategy – where an individual is chosen at random for treatment and all their infected neighbors are treated vs. treat randomly– Over 10 years of treating 25 per 1000 PWID, the prevalence drops

from 50% to 33% [treat your friend] vs. 40% [random strategy]– Hellard M et al. Hepatology 2014

NORTH-C Trial• EASL 2015• Prospective cohort study – Norway, Sweden &

Denmark [n=161]• High Incidence of HCV Reinfection Following SVR

Among Patients Who Relapse to Injection Drug Use• 39% of PWID had relapse to IDU after HCV treatment

– Short term or sporadic IDU (<100 injections): 51% – Dependent or frequent IDU (≥ 100 injections): 49%

• Baseline variables associated with IDU relapse – Younger than 40 years of age– Low education level

• HCV RNA recurrence rate 13% (n = 12) among IDU vs 0% among non-IDU

Cascade of Care for Suburban Heroin Users 17-35 years age, New Jersey Oct 2014-June 2015

020406080

100120

Patients [%]

Princeton House – Psychiatric Facility with an Active Opioid Detoxification Program

N = 861 were HCV Ab testedN = 16 patients returned for in-office F/U visitsN = 2 started treatment Akyar E et al. Emerg Infect Dis; 22 [5]; May 2016

TAP Study – HCV Treatment and Prevention Using a Flexible Nurse-Led Model of Care

• Active PWID with their injecting partners from outreach sites throughout Melbourne, Australia

• Immediate vs deferred Rx – Harvoni [G1] or Harvoni + RBV [G2-6]• Study Nurses:

– Conduct interviews– Clinical assessment– Liver stiffness assessment– Labs

• TAP Study Outreach Van• Funded by investigator – initiated research grant from Gilead Sciences• Results:

– 172 HCV Ab [+]• 52 individuals not participating• 56% - ineligible due to comorbidities• 33% uncontactable since screening• 6% incarcerated

• Recruitment Challenges:– Limited understanding of new HCV therapies– Unstable housing– Feelings of stigmatization and marginalization– Inadequate income support Von Bibra, S et al. ILC 2016

To truly impact HCV transmission in PWID, treatment programs need to be aggressive in

treating large numbers of PWID almost immediately after HCV acquisition and

comprehensive by integrating harm reduction

Mier-y-Teran-Romero, L et al.HCV Cure: Moving the needle from the Patient to the Population CROI, Abstract 535, Feb 2016

Various Clinical Models Have Demonstrated Improved Linkages to HCV Care for PWIDs

1. AASLD/IDSA. Recommendations for Testing, Managing, and Treating Hepatitis C. http://www.hcvguidelines.org. Accessed August 18, 2015. 2. University of New Mexico. Project ECHO Model. http://echo.unm.edu/about-echo/model/. Accessed August 18, 2015.3. Arora S, et al. N Engl J Med. 2011;364:2199-2207.4. Rossaro L, et al. Dig Dis Sci. 2013;58:3620-3625.

“Evaluation by a practitioner who is prepared to provide comprehensive management, including consideration of antiviral therapy, is recommended for all persons with current (active) HCV infection.”

— AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C1

Colocated or Integrated Care

• Designed to impact loss to follow-up1

• Potentially affects access to treatment1

Telehealth

• Delivers service to underserved populations2

• Links specialists to communities2

• Has shown similar safety and efficacy to non-telehealth settings for HCV patients3,4

Referral

• Referral for HCV infection to an experienced HCV clinician1

• Multidisciplinary approach to treatment has the potential to mitigate barriers to HCV care1

Prevent new infections[HARM REDUCTION]

Detect and care for existing infections

[LINKAGE TO C CARE]

Reduce chronic infections[TREAT TO PREVENT]

HCV Prevention Activities• Access to syringes & other

equipment

• Opioid Substitution Treatment [OST] –Buprenorphine/Methadone

• Safe injection education

• Outreach to those not engaged

• Short & Long Term Residential Treatment Centers

• Outpatient - Sober Living Homes

Screening and Diagnosis• Antibody screening• HCV RNA test to

confirm infection• Clinical evaluation to

determine disease stage• Monitoring disease

progression• Reduce alcohol use

HCV care and Treatment• Treat to cure infection [DAA’s

Rx] – Pharmacy

• Mobile Medical Provider

• Telemedicine – Project ECHO HCV

• Support adherenceto treatment & evaluate PRO’s [Patient Related Outcomes]

• Support post-cure to prevent reinfection

Co-locating these services increases their impact on HCV control

Framework of a Model HCV Control Strategy For PWID“Treat to Prevent”

Collaborative Care Model

What Are The Barriers To HCV Linkage To Care?

– Fragmentation of HCV services– Denial or lack of understanding about the importance of care– Concerns about costs of care– Conditions that make it harder for patients to enter care, like

substance abuse and mental health issues– Difficulties arranging transportation, childcare, time away

from work, or other logistics related to keeping appointments– Fear of stigma

GOALS OF LINKAGE TO C CARE• Identifying persons infected with HCV early in the course of their disease

• Earlier diagnosis and improvements along the entire continuum of care can lead to reductions in the incidence of cirrhosis, liver cancer and liver transplantations

• Link and refer persons infected with HCV to care and treatment• List of medical providers treating HCV in every state

• Improve access to and quality of care for persons with HCV• Develop networks to support specialty providers who are uniquely

positioned and equipped to treat HCV – resulting in expanded capacity for HCV services across several systems

• Achieve “Real World” SVR >90% for ALL infected with HCV• Advance research to enhance care and treatment of persons infected with

HCV• Research and analyses that describe the continuum of care in various settings can illuminate

health disparities and guide resource allocation, program planning, and implementation • Reduce overall cost of achieving HCV cure• Reduce stigma of treating PWID [People Who Inject Drugs] HCV patients

Linkage to C Carewww.linkagetocare.com

Hub and Spoke Model – Centralizes Multi-Site Communication

PWID HCV PATIENT IDENTIFIED

Patient Information Sent to Linkage to Care ProgramWeb-Based Program[HIPPA Compliant]

NAVIGATOR CARE COORDINATOR

Community Clinic

Project ECHO HCV

UninsuredPatient

Local Private ProviderNetwork

• GI/Hepatology• Addiction Medicine• Primary Care

InsuredPatient HARM Reduction

Adherence To Clinical Program

Post Therapy IDU Relapse & HCV Reinfection

501.c.3 Linkage to Health, Inc.

MEDICAL – Residential Treatment CentersPWID HCV PATIENT ADMITTED

HCV Antibody [Phlebotomy or OraSure] HCV RNA PCR QUANT & GENOTYPE

INPATIENT TREATMENT

Project ECHO HCV

Medical Provider HCV Education

OUTPATIENT TREATMENT

Sober Living Home

Addiction Medicine Clinic

Primary Care

GI/Hepatology Clinic

Community Clinic Project ECHO HCV

Project ECHO HCV

Project ECHO HCV

Linkage To C Care

FibroscanLaboratory

Urine Drug ToxicologyPharmacy

NON-MEDICAL – Sober Living Homes & OST ClinicsPWID HCV PATIENT ADMITTED

OraSure HCV Antibody

Medical Provider HCV Education

Linkage To C Care

Telemedicine

Addiction Medicine Clinic

Primary Care

GI/Hepatology Clinic

Community Clinic Project ECHO HCV

Project ECHO HCV

Mobile Medical Provider

FibroscanLaboratory

Urine Drug ToxicologyPharmacy

www.linkagetocare.com

“ Effective care of substance users benefits both the individual and the community and is consistent with medical, public health and economic priorities”

Bruce Schackman, PhDProfessor of Health Care Policy and ResearchProfessor of Psychiatry and Public Health at Weill Cornel Medical College, NYDirector of CHERISH [The Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV[www.cherishresearch.org]

Treat to Prevent: Strategies To Identify and Advance PWID HCV Patient Care

36

PATIENT IDENTIFICATION

MEDICAL PROVIDERREFERRAL

MANAGEMENT

Outreach & Awareness: First Contact:• Recovery Treatment

Center – Short & Long Term Residential Treatment Centers

• Sober Living Homes

Diagnosis:• HCV Testing - Antibody• HCV Confirmation – PCR RNA

Quantification• HCV Genotyping• Fibrosis Determination - FibroScan• Urine Drug Toxicology Testing• HAV and HBV Testing –

Vaccination• Liver Cancer Screening –

Abdominal U/S

Clinical Care Coordination:Appropriate link to quality care – “Linkage To C Care”• Navigator• Care Coordinator• Website Portal - To submit

and communicate information

• Improved information sharing & communication between treatment center & medical provider

HCV Therapy:• Medication – Pharmacy• Care – Face-to-Face [Mobile

Provider or in office] +/-Telemedicine

• Support Adherence to therapy

• Monitor Patient Related Outcome to Therapy

• Prevent Post-Cure Reinfection

HARM Reduction:• Opioid substitution therapy

[OST] –Buprenorphine/Methadone

• Needle Exchange Programs• Behavioral Health Therapy• Relapse Prevention –

Naltrexone

Integrated and Sustainable Care of PWID HCV

Make a Change to Reduce HARM