Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz.

Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz Alam, M.D. Medical Director, Austin Hepatitis Center Medical Director, HepCare Specialty Pharmacy Clinical Associate Professor of Medicine, Texas A & M University HIV Outreach Workers & HIV Early Intervention Case Management Conference

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

Number of HCV Cases (millions) HCV Cases Not Included in NHANES*
Over 5.2 Million People Living With Chronic HCV in the US Conservative estimate Upper limit of estimate 7.1 5.2 Number of HCV Cases (millions) 3.8 3.2 1.9 NHANES Estimate HCV Cases Not Included in NHANES* Estimated Total HCV Cases *Homeless (n=142, ,6100); incarcerated (n=372, ,826); veterans (n=1,237,461-2,452,006); active military (n=6805); healthcare workers (n=64, ,234); nursing home residents (n=63,609); chronic hemodialysis (n=20,578); hemophiliacs (n=12,971-17,000). Chak E, et al. Liver Int. 2011; 31:

Patients Should be Screened for HCV According to Birth Cohort and Risk Factors1,2
Patient Screening for HCV Birth Cohort Screening Risk Factor–Based Screening Persons Born Between 1945 and 19651,2 The birth cohort was selected on the basis of HCV prevalence and disease burden One-time screening for HCV infection in the birth cohort may identify infected patients at earlier stages of disease Important Risk Factors1,2 Past or current injection drug use Intranasal drug use Getting an unregulated tattoo Receiving a blood transfusion before 1992 Other percutaneous exposures Long-term hemodialysis Being born to an HCV- infected mother Incarceration Smith BD, et al. MMWR Recomm Rep. 2012;61:1-32. Moyer VA; US Preventive Services Task Force. Ann Intern Med. 2013;159:

Hepatitis C is an INFECTIOUS Virus Treatment as Prevention
People who inject drugs account for the majority of new cases of HCV in developed countries[4] Sex between men who are HIV-positive increases the risk of contracting HCV[3] Risk of transmission from mother to child is low[2] Infection in monogamous heterosexual couples is rare[1] 1. Terrault NA, et al. Hepatology. 2013;57: Thomas SL, et al. Int J Epidemiol. 1998;27: Larsen C, et al. PLoS One. 2011;6: Shepard CW, et al. Lancet Infect Dis. 2005;5: Slide credit: clinicaloptions.com

What Does the Term “PWIDs” Refer to?
“PWIDs” is a subjective term referring to any people who have ever injected drugs1 Once Regularly Occasionally No longer (ie, on stable OST) Previously (eg, ever in the past) PWID populations1,2: “Active” or “recent” PWIDs – injected drugs within 1 month to 1 year* and are at risk for transmitting/acquiring HCV infection “Former” PWIDs – ceased injecting drugs but may have existing HCV infection Lifetime PWIDs Active PWIDs OST NSP Due to the relapsing nature of drug dependence, active PWIDs often move between populations and may access harm reduction services at any time.1 Past or current injection drug use is the most important risk factor for HCV infection.3 − US Preventive Services Task Force *There are varying definitions in literature. 1. Larney S, et al. Int J Drug Policy. 2015;26(10): Grebely J, et al. Int J Drug Policy. 2015;26(10): Moyer VA. Ann Intern Med. 2013;159(5): NSP, needle/syringe program; OST, opioid substitution therapy.

Transmission Via Contact with Contaminated Blood: Needles and Syringes
Fixed Detachable Zibbell J, CDC, Presented as part of Hepatitis C Prevention Opportunities Among PWID, April 28, 2015.

Transmission Via Contact with Contaminated Blood: Preparation Equipment
Filters Cookers Water Surfaces Zibbell J, CDC, Presented as part of Hepatitis C Prevention Opportunities Among PWID, April 28, 2015.

Fingers on cooker and in solution
HCV Transmission Bloody fingers Fingers on cooker and in solution Zibbell J, CDC, Presented as part of Hepatitis C Prevention Opportunities Among PWID, April 28, 2015.

How Long Can HCV Survive on Inanimate Objects?
HCV-contaminated solution needs to be heated for almost 90 seconds and reach temperatures of 144°F for the virus to be at undetectable levels. Paintsil, et al. JID. 2010; Doerrbecker, et al. JID. 2011; Thibault, et al. JID. 2011; Doerrbecker, et al. JID. 2012; Paintsil, et al. JID

Anti-HCV Prevalence Among PWIDs (million)1,2,*
IDU Is the Most Important Risk Factor for HCV Infection Globally In most developed countries, IDU increased in the 1970s and 1980s and is now the main risk factor for HCV infection in these countries1 Anti-HCV Prevalence Among PWIDs (million)1,2,* No evidence of IDU No eligible report (74 countries) <40% (16 countries) 40%-<60% (24 countries) 60%-<80% (25 countries) ≥80% (12 countries) Prevalence of HCV in PWIDs IDU, injection drug use. *Data identified in a systematic literature search (up until May 2011) with wider input from relevant organizations; Regional data are PWIDs positive for HCV antibodies (midpoint estimates). 1. Midgard H, et al. J Hepatol. 2016;65(Suppl 1):S33-S Grebely J, Dore GJ. Antiviral Res. 2014;104:62-72.

10 67% ~80% Globally, Approximately Two-thirds of PWIDs Have HCV
MILLION PWIDs have HCV…1 10 …that is ~80% of new HCV infections result from IDU2 67% OF TOTAL PWIDs1 1. Grebely J, et al. Int J Drug Policy. 2015;26(10): Grebely J, et al. Clin Infect Dis. 2013;57(7):

are current or former PWIDs3
IDU Is the Primary Risk Factor for New HCV Infections in the United States1 ~3.5 million people living with chronic HCV in the United States2 ~60% With an estimated 34,000 new HCV infections in the United States in 2015, new infections have nearly tripled in the past 5 years, reaching a 15-year high.2,4,* are current or former PWIDs3 The greatest increases in new HCV infections, and the highest overall number of cases, were among young people aged years, with injection drug use as the primary route of transmission.4 *Estimated prevalence of acute HCV infections after adjusting for under-ascertainment and under-reporting. Latest available data. 1. Campbell CA, et al. MMWR Morb Mortal Wkly Rep. 2017;66(18): CDC. Hepatitis Surveillance Report – United States. Accessed May 11, Litwin AH, et al. Clin Infect Dis. 2005;40(Suppl 5):S339-S CDC. Hepatitis Surveillance Report – United States. Accessed May 11, 2017.

HCV Infection Incidence Rates Increasing in IDU and MSM
Wandeler G et al., CID 2012: Nov 15; 55(10):

Increased Prevalence in HIV [-] MSM in PrEP Program
Sexually transmitted HCV – HIV [+] MSM > HIV [-] MSM Recent studies have shown increased prevalence among HIV [-] MSM Kaiser Permanente San Francisco PrEP Program U.K. PROUD French Ipergay PrEP Study CROI Amsterdam Pre-Exposure Prophylaxis Project (AMPrEP): 4.8%, tested positive for either HCV antibodies or HCV RNA at baseline [n=18] 25% of MSM HCV Ab [+] (4 out of 18) reported injecting drugs during the 3 months before starting PrEP -- much higher than the 3% (11 out of 357) among HCV Ab [-] participants MSM HCV Ab [+]: were younger on average than those without HCV (median 33 vs 40 years) had more anal sex partners (median 20 vs 15) were more like to have been recently diagnosed with chlamydia, gonorrhea, or syphilis (61% vs 35% in the past 6 months) engaged in "chemsex," or use of certain recreational drugs during sex (83% vs 40% in the past 3 months) Routine testing for HCV in PrEP Programs

The average age at first heroin use is 25.4 years.
NSDUH Shows Increasing Trend in Heroin Use Among Youth Heroin use has doubled among people aged ≥26 years in the past decade In 2015, there were 136,000 new initiates of heroin use 11,000 adolescents (aged years) 57,000 young adults (aged years) 68,000 adults (aged ≥26 years) Past Year Heroin Initiates Among People Aged ≥12 Years, by Age Group (in Thousands): * 12 or older 18 to 25 12 to 17 26 or older Past Year Initiates (in thousands) 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2002 Year “+” = Difference between this estimate and the 2015 estimate is statistically significant at the 0.05 level. The average age at first heroin use is 25.4 years. *Caution is advised in interpreting the fluctuations in the numbers of heroin initiates in single years because the relatively small numbers of respondents aged ≥26 years who reported that they initiated heroin use in the past year can greatly influence estimates of initiates aged ≥26 years in a single year; these respondents aged ≥26 years often represent large numbers of people in that age group. Lipari R, et al NSDUH Survey. 2016;1-34. NSDUH, National Survey on Drug Use and Health.

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

Hepatitis C Infections Soaring Fueled by Prescription Painkiller Abuse
CDC May 11th 2017 Acute HCV infections x3 – age <30 years KY, TN, Virginia and WV New HCV cases 1.25 per 100,000 [2006] vs. 4 per 100,000 [2015] 2013 – KY – 5.1 cases per 100,000 2013 – DE & SC – NO reported cases First time heroin users 90,000 [2006] vs. 156,000 [2012]

Newly Reported Confirmed HCV Cases, Massachusetts, 2002-2009
Increased IDU in Adolescents and Young Adults Is Shifting the Demographics of HCV Infection in the United States Newly Reported Confirmed HCV Cases, Massachusetts, 5 4 3 2 1 10 20 30 40 50 60 70 80 90 Age (years) Percentage of Total Cases Reported for the Year Male Female 2002 2009 Male Female IDU was the most common risk factor for HCV transmission‡ N=6281* N=3904† Increased IDU is not unique to Massachusetts; these data may be indicative of emerging trends in HCV transmission in other regions of the United States. *Excludes 35 cases with missing age or sex information. †Excludes 346 cases with missing age or sex information. ‡Among persons aged 15–24 years. CDC. MMWR Morb Mortal Wkly Rep. 2011;60(17):

CDC, Centers for Disease Control and Prevention.
HCV Outbreaks Associated With IDU Are Occurring Throughout the United States CDC, Centers for Disease Control and Prevention.

Injection Networks Are Driving Hepatitis C Outbreaks
Higher incidence of HCV infection (especially among younger PWIDs) in 2012 than in 2006 in at least 30 states, with the largest increases occurring in nonurban counties east of the Mississippi River* Data indicate an emerging US epidemic of HCV infection among young nonurban persons (aged ≤30 years). *Based on data from national surveillance and supplemental case follow-up at selected jurisdictions describing the US epidemiology of HCV infection among young persons (aged ≤30 years). Suryaprasad AG, et al. Clin Infect Dis. 2014;59(10):

“ 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, MD Professor 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, PhD Professor NYU College of Nursing

HCV Is Underdiagnosed and Undertreated, Even More for PWIDs
Cascade of Care* ~3.5 Million1,† HCV disproportionately impacts PWIDs, but treatment rates are even lower relative to the overall HCV population 50% ~2.1 Million2,‡ ~1.75 Million1,† 49% 16% ~1 Million3,§ 1%-9% ~560,0001,† ≤~189,0003,§ Chronic HCV infection Diagnosed and aware Treated HCV in general US population HCV in PWID US population *All numbers are approximate. † ‡Estimated, 2005. §Estimated, 2014. 1. Yehia BR, et al. PLoS One. 2014;9(7):e Litwin AH, et al. Clin Infect Dis. 2005;40(Suppl 5):S339-S Coffin PO, Reynolds A. Hepat Med. 2014;6:79-87.

Perceived Barriers to HCV Care in the PWID Population
Mental illness Adherence REASON1-3 ? Reinfection Substance abuse In a single-center study in Denver, Colorado, individuals (born ) with substance abuse were less likely to be referred compared with those without substance abuse, but if referred were equally likely to attend an HCV specialty visit (n=250)4,* *Individuals born between were screened for HCV through a testing and linkage-to-care program in 2 community clinics in Denver, Colorado. HCV evaluation and treatment courses were followed prospectively from January 2013–March 2015. 1. Asher AK, et al. Subst Use Misuse. 2016;51(9): Rich ZC, et al. BMC Public Health. 2016;16: Aspinall EJ, et al. Clin Infect Dis. 2013;57(Suppl 2):S80-S89. 4. Muething L, et al. IDSA/ID Week Poster 1029.

Barriers to Care Identified by Pts in OST Clinics and Needle Exchange Programs
Survey of PWID in Philadelphia needle exchange program (N = 188) Self-Reported Barriers to Care Among HCV-Infected PWID (n = 117) 100 80 60 Pts (%) 40 20 No Insurance Can’t Afford Copay Can’t Afford Transport Treatment Will Make Me Sick Fear of Liver Biopsy Feel Fine Without Treatment Fear of Judgement by Doctor Slide credit: clinicaloptions.com Feller SC, et al. AASLD Abstract 274.

AASLD/IDSA INHSU WHO EASL
Major Global Organizations Recommend HCV Treatment for PWIDs1-4 AASLD/IDSA American Association for the Study of Liver Diseases/ Infectious Diseases Society of America WHO World Health Organization INHSU International Network for Hepatitis in Substance Users PWIDs HCV MANAGEMENT EASL European Association for the Study of the Liver 1. AASLD/IDSA HCV Guidance. Accessed April 23, European Association for Study of Liver. J Hepatol. 2017;66(1): 3. WHO guidelines approved by the guidelines review committee. Geneva: World Health Organization Grebely J, et al. Int J Drug Policy. 2015;26(10):

Decompensated cirrhosis Cirrhosis (within the first 20 years)
Chronic HCV Infection Can Result in Cirrhosis and Can Increase the Risk for Hepatocellular Carcinoma (HCC)* if Not Treated HCC per year 1%-4% Decompensated cirrhosis Up to 30% at 10 years Clearance of HCV RNA 15%-25% Potential extrahepatic manifestations Acute infection† Chronic infection 75%-85% Cirrhosis (within the first 20 years) 10%-20% *All percentages are approximate. †20%-30% of individuals are symptomatic. Adapted from Chen SL, Morgan TR. Int J Med Sci. 2006;3(2):47-52. RNA, ribonucleic acid.

Ascites: Most Common Complication of Cirrhosis
Estimated that 10 years after a diagnosis of compensated cirrhosis 50-70% will develop ascites

Factors Associated With Accelerated Fibrosis Progression
Host Viral Modifiable Alcohol consumption Nonalcoholic fatty liver disease Obesity Insulin resistance Non-modifiable Fibrosis stage Inflammation grade Older age at time of infection Male sex Organ transplant Genotype 3 Coinfection with HBV or HIV AASLD, IDSA, IAS–USA. Recommendations for testing, managing, and treating hepatitis C. Accessed July 15, 2015.

More People Die From HCV Than Other Infectious Diseases (Including HIV)
The HCV mortality rate surpassed that of HIV in 2007 and continued to rise1,2,* More people die from HCV than from 60 other infectious diseases combined2-4,† Annual number of HCV-related deaths vs other nationally notifiable infectious conditions in the United States, In 2007, patients with HCV died at a median age of 57 years. This is 20 years shorter than the average US lifespan.5 *Extended from: Ly KN et al. Ann Intern Med. 2012;156(4): †Including HIV, pneumococcal disease, and tuberculosis. 1. Ly KN, et al. Ann Intern Med. 2012;156(4): Holmberg S, Ly KN, Xing J, Moorman AC. Rising mortality from hepatitis C virus in the United States, Paper presented at: American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course; October 16-21, 2015; Honolulu, HI. 3. Ly KN, et al. Clin Infect Dis. 2016;62(10): CDC. Annual number of HCV related deaths vs. other nationally notifiable infectious conditions in the United States, Smith BD, et al. MMWR Recomm Rep. 2012;61(RR-4):1-32.

HCV Has an Impact Beyond the Liver1,2
Strongly Associated Extrahepatic Manifestations 1 Mixed cryoglobulinemia vasculitis Lymphoproliferative disorders Peripheral neuropathy* Membranoproliferative glomerulonephritis* Insulin resistance Cutaneous manifestations (eg, lichen planus, porphyria cutanea tarda, palpable purpura*) 2 2 5 4 3 4 3 5 6 6 1 3 *Secondary to mixed cryoglobulinemia vasculitis. 1. AASLD/IDSA HCV Guidance. Recommendations for testing, managing, and treating hepatitis C. Accessed April 23, Jacobson IM, et al. Clin Gastroenterol Hepatol. 2010;8(12):

HCV Infection Increases the Risk for Depression, Diabetes, and Other Conditions1-14
9 1 Possibly Associated Extrahepatic Conditions 10 INCREASED RISK FOR Depression Carotid atherosclerosis/atherothrombosis Type 2 diabetes mellitus Hypertension Congestive heart failure Chronic kidney disease End-stage renal disease Kidney cancer Other renal manifestations (eg, glomerulonephritis, proteinuria)* Low bone mineral density Rheumatologic manifestations (eg, polyarthralgia, polyarthritis)* Fatigue 2 1 3 4 5 6 7 8 9 POSSIBLE INCREASED RISK FOR† Neurologic impairment/disorders Stroke Coronary artery disease/ischemic heart disease 2 10 5 4 11 11 3 6 7 8 *Secondary to mixed cryoglobulinemia vasculitis. †Conflicting or equivocal data from studies. 1. Adinolfi LE, et al. World J Gastroenterol. 2015;21(8): Younossi ZM, et al. Aliment Pharmacol Ther. 2013;37(6): Younossi ZM, et al. Aliment Pharmacol Ther. 2014;39(5): Park H, et al. J Viral Hepat. 2015;22(11): Molnar MZ, et al. Hepatology. 2015;61(5): Gonzalez HC, et al. Dig Dis Sci. 2015;60(6): Huang H, et al. PLoS One. 2013;8(11):e Huang H, et al. PLoS One. 2014;9(9):e Thames AD, et al. Neurol Neuroimmunol Neuroinflamm. 2015;2(1):e Wong RJ, et al. Dig Dis Sci. 2014;59(7): Pothineni NV, et al. Am J Cardiol. 2014;114(12): Lai JC, et al. Dig Dis Sci. 2015;60(6): White DL, et al. J Hepatol. 2008;49(5): Clifford DB, et al. Neurology. 2015;84(3):

Although other chronic conditions‡ require lifelong management,
Unlike Some Chronic Conditions, HCV Can Be Cured The possibility of eliminating the virus and achieving a cure may be due to the manner in which the virus infects the host cells1 HCV does not integrate into the nuclei of infected cells, whereas HBV and HIV DNA are incorporated into the nucleus of the cell1 HCV1 HBV1 HIV1 Although other chronic conditions‡ require lifelong management, HCV is curable, with an average treatment duration of 12 weeks with highly effective all-oral treatments.1-4 *HBV cccDNA: accumulates in hepatocyte nuclei, acting as a template for viral messenger RNA transcription. †HIV proviral DNA: integrates into the chromatin of infected cells, acting as the template for the transcription of viral genes. ‡Including diabetes, hypertension, and hyperlipidemia. 1. Soriano V, et al. J Antimicrob Chemother. 2008;62(1): Last AR, et al. Am Fam Physician. 2011;84(5): World Health Organization. Advocacy Brief. May AASLD/IDSA HCV Guidance. Recommendations for testing, managing, and treating hepatitis C. Accessed April 23, 2017. cccDNA, covalently closed circular DNA; DNA, deoxyribonucleic acid.

Decreased transmission[1] Improved clinical outcomes[1,2]
Benefits of Achieving SVR Cure Decreased transmission[1] Improved clinical outcomes[1,2] Hepatic Extrahepatic ↓ Cirrhosis ↓ Decompensation ↓ HCC ↓ Transplantation ↓ All-cause mortality Improved QoL Malignancy Diabetes CVD Renal Neurocognitive 1. Smith-Palmer J, et al. BMC Infect Dis. 2015;15:19. 2. Negro F, et al. Gastroenterology. 2015;149: 3. George SL, et al. Hepatology. 2009;49: Slide credit: clinicaloptions.com

Treatment for HCV Has Evolved
Interferon Era Before 2011, HCV treatment could last as long as a year, with cure rates* (SVR) of 40%-50% for the most common genotype in the United States1 Since that time, scientific advances have made HCV treatment shorter (as few as 12 weeks) and more effective2 Interferon-free treatment options are available that have shown cure rates of approximately 95% in clinical studies2,3,* Cure rates: 40%-50% Direct-Acting Antiviral Era Cure rates: ~95% *Cure, also known as SVR, is defined as no detectable HCV in the blood at least 12 weeks after completion of therapy. 1. Ghany MG, et al. Hepatology. 2011;54(4): AASLD/IDSA HCV Guidance. Recommendations for testing, managing, and treating hepatitis C. Accessed April 23, US DHHS, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. May 2016.

IFN-Free DAA Therapy: OST vs Non-OST in Phase II/III Trials
No OST OST n/N = 60 80 40 20 100 49/ 51 966/ 984 98 96 455/ 473 54/ 56 37/ 38 269/ 296 299/ 316 66/ 70 1822/ 1882 OBV/PTV/RTV + DSV + RBV[1,2] 97 95 91 SVR12 (%) 94 OBV/PTV/RTV + DSV + RBV[3] LDV/SOF + RBV[4] SOF/VEL[5] EBR/GZR[6,7] 1. Feld JJ, et al. N Engl J Med. 2014;370: Puoti M, et al. AASLD Abstract Lalezari J, et al. J Hepatol. 2015;63: Grebely J, et al. Clin Infect Dis. 2016;[Epub ahead of print]. 5. Grebely J, et al. Clin Infect Dis. 2016;[Epub ahead of print]. 6. Zeuzem S, et al. Ann Intern Med. 2015;163: Dore GJ, et al. Ann Intern Med. 2016;165: Slide credit: clinicaloptions.com

Opioid Agonist Therapy
PWIDs Across the Spectrum Can Be Treated for HCV Active Injectors Opioid Agonist Therapy Former Injectors Among active injectors, frequent drug use (daily/every other day) has an impact on adherence, treatment completion, or treatment efficacy; occasional drug use does not1,* Among patients on opioid agonist therapy, HCV treatment outcomes improved among those treated for opioid addiction compared with nonaddiction-treated drug users2,* Among former injectors, successful HCV outcomes are more likely to be achieved if PWIDs are stabilized for addiction and then undergo HCV therapy3,* *Studies utilized IFN/RBV as the treatment arm. 1. Robaeys G, et al. Clin Infect Dis. 2013;57(Suppl 2):s129-s Dimova RB, et al. Clin Infect Dis. 2013;56(6): 3. Zeremski M, et al. World J Gastroenterol. 2013;19(44): IFN, interferon.

Non-PWIDs who initiated treatment PWIDs who initiated treatment
IFN Era: Adherence Among PWIDs Has Historically Been Comparable to the Overall HCV Population ( )1 Non-PWIDs who initiated treatment 79% completed treatment PWIDs who initiated treatment 71% completed treatment (N=655) (N=844) Adherence in PWIDs has been shown to be similar using newer IFN-free regimens.2 1. Hellard M, et al. Clin Infect Dis. 2009;49: Litwin A, et al. INHSU Oral presentation.

North American and European Reinfection Rates for PWIDs
Reinfection Is Rare, Even Among High-Risk Groups A global meta-analysis of 14 articles that assessed HCV recurrence in high-risk patients; 12 evaluated the risk in PWIDs* Reinfection rate among high-risk populations (PWIDs and Prisons) 19.06/1000 PYFU† North American and European Reinfection Rates for PWIDs Re-infections/1000 PYFU Total PWIDs studied Re-infections North American Studies European Studies TOTAL *Studies included adults (aged ≥18 years) who achieved SVR12 or SVR24 post-treatment with IFN-based therapies. †Includes 2 studies conducted in prisons and was not specific to PWIDs. Simmons B, et al. Clin Infect Dis. 2016;62(6): PYFU, person-years of follow-up.

HCV Reinfection Over 5 Yrs by Study Population
16 15 14 12 10 10 HCV Recurrence at 5 Yrs (%) 8 6 4 2 1 Low Risk PWID/Prisoner HIV Coinfected 43 studies (n = 7969; avg. FU: 3.9 yrs) 14 studies (n = 771; avg. FU: 2.8 yrs) 4 studies (n = 309; avg. FU: 3.3 yrs) Slide credit: clinicaloptions.com Simmons B, et al. Clin Infect Dis. 2016:62:

Specific Issues Related to HCV Reinfection
Acknowledgement: There will be cases of HCV reinfection Harm reduction access (NEP, OST): To reduce risk of reinfection Individual-level strategies: Treatment of injecting partners Rapid scale-up: Initial increase in reinfections, then control Access to retreatment: Without stigma and discrimination Slide credit: clinicaloptions.com

Pts With Minimal Liver Disease Denied HCV Treatment Access in Many Settings
Medicaid reimbursement criteria for DAAs based on documented liver fibrosis stage required for reimbursement Slide credit: clinicaloptions.com Greenwald R, et al. AASLD

Yrs From Biopsy to Death
HCV Cure Associated With Improved 15-Yr Survival in Pts With F0/F1 Disease Single-center cohort of consecutive pts since 1992 (N = 1381) Progression to F3/F4 was observed in 15.3% of F0/F1 pts with available liver biopsy (n = 157) 1.0 0.8 0.6 Survival F0/F1 Fibrosis Treated pts without SVR Untreated pts Treated pts with SVR 0.4 0.2 P = .003 5 10 15 20 Yrs From Biopsy to Death Slide credit: clinicaloptions.com Jézéquel C, et al. EASL Abstract P0709.

“Treat to Prevent” “One-Stop” Shopping Collaborative Care Model
Substance abuse treatment HARM Reduction HCV Testing Linkage to HCV Care Monitoring Adherence to HCV Therapy Post-therapy Cure Surveillance – Prevent Re-infection

Screening and Linkage to Care Can Help Lead to Curing HCV for Our HCV-Positive PWID Patients
Diagnose Refer Patients to HCV Care Follow Up With Patients and HCV Care Provider High-risk patients should be screened whether or not symptoms are present Explain to your patient what a diagnosis of HCV means and that HCV is curable Assist with scheduling the appointment Call to check that your patient followed through

Harm Reduction Facilities Use By PWIDs Can Increase Adoption of Lower-risk Alternative Injection Practices1 Needle- Exchange Programs1 Opioid Substitution Therapy1 Risk Counseling2 Street/Peer Outreach Programs1 Supervised Injection Sites1 1. Beirness DJ, et al. Canadian Centre on Substance Abuse Logan DE, Marlatt GA. J Clin Psychol. 2010:66(2):

Comprehensiveness of State Laws Pertinent to Prevention of HCV Infection Among PWIDs*
Most comprehensive More comprehensive Moderate Less comprehensive Least comprehensive Assessment of whether a state had established Authorization of syringe exchange statewide or in selected jurisdictions Exemption of needles or syringes from the definition of drug paraphernalia Decriminalization of possession and distribution of syringes or needles for participants of a legally authorized syringe service program Avoidance of criminal prosecution for possession of drug paraphernalia by disclosing possession of a needle or sharp object to an arresting officer Allowance for the retail sale of syringes without a prescription to PWIDs *United States, 2016. Campbell CA, et al. MMWR Morb Mortal Wkly Rep. 2017;66(18):

You Are the First Line of Communication for Patients With Addiction
Give your patients a chance to be cured with 3 simple steps. Screen for HCV antibodies Test at-risk patients with a blood test to detect the presence of HCV antibodies* Diagnose with an HCV RNA test A blood test for the presence of HCV RNA will confirm an HCV diagnosis in patients who test positive for HCV antibodies Refer to an experienced HCV clinician Refer your patients with HCV to an experienced HCV clinician for treatment evaluation, regardless of symptoms *Screening for HCV antibodies does not have to be with a blood test. It can be via oral swab, or an even simpler approach, asking the patient questions about injecting drugs even once then proceed to the blood test for HCV RNA.

Cascade of Care for Suburban Heroin Users 17-35 years age, New Jersey Oct 2014-June 2015
N = 861 were HCV Ab tested N = 16 patients returned for in-office F/U visits N = 2 started treatment Akyar E et al. Emerg Infect Dis; 22 [5]; May 2016

Various Clinical Models Have Demonstrated Improved Linkages to HCV Care for PWIDs
“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 AASLD/IDSA. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed August 18, 2015. University of New Mexico. Project ECHO Model. Accessed August 18, 2015. Arora S, et al. N Engl J Med. 2011;364: Rossaro L, et al. Dig Dis Sci. 2013;58:

“Treat to Prevent” Framework of a Model HCV Control Strategy For PWID
Collaborative Care Model 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 adherence to treatment & evaluate PRO’s [Patient Related Outcomes] Support post-cure to prevent reinfection Co-locating these services increases their impact on HCV control

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 Care www.linkagetocare.com
Hub and Spoke Model – Centralizes Multi-Site Communication PWID HCV PATIENT IDENTIFIED HCV Antibody [Phlebotomy or OraSure] HCV RNA PCR QUANT & GENOTYPE Patient Information Sent to Linkage to Care Program Web-Based Program [HIPPA Compliant] Linkage to Care Specialist/Navigator Uninsured Patient Insured Patient HARM Reduction Community Clinic Project ECHO HCV Local Private Provider Network GI/Hepatology Addiction Medicine Primary Care Adherence To Clinical Program Post Therapy IDU Relapse & HCV Reinfection

https://youtu.be/i3Ruycukn60

What is Linkage To C Care?
Linkage to C care is a web based platform that assists people with HCV to enter into HCV medical care. Newly HCV-diagnosed persons need to connect quickly with a HCV provider and remain in care Why Enroll In It? Increases likelihood of newly HCV-diagnosed people accessing HCV treatment and remaining in HCV care What Are The Benefits? Provides patients the opportunity to get cured of HCV, thereby experiencing better health outcomes and significantly reduce the risk of transmitting HCV

Linkage to Care Referrals

Linkage to C Care March 2017 Stats
Users - MTD 21 Users - YTD 71 Users - Start 82 Counselors - MTD 7 Counselors - YTD 26 Counselors - Start 48 Referrals - MTD 59 Referrals - YTD 166 Referrals - Start 207 Questions - MTD 2 Questions - YTD 4 Questions - Start Logins - MTD 411 Logins - YTD 1015 Logins - Start 1767 Appt Sch - MTD Appt Sch - YTD 50 Appt Sch - Start 60 Telemed - MTD Telemed - YTD 9 Telemed - Start Link2Lab - MTD 1 Link2Lab - YTD 3 Link2Lab - Start Avg Response (Hours) - MTD 75 Avg Response (Hours) - YTD 64 Avg Response (Hours) - Start 84 Linkage to C Care March 2017 Stats

Linkage to c care program [LTC]
Jan – May 2017 289 HCV RNA [+] patients referred 31% self-referred 69% referred from 24 facilities in 15 states 66% uninsured Median age 41 years [19-77] 58% males 70% Sober Living Homes 85% [n=246] were contacted by LTC specialist [LTCS] 70% [n=173] were referred to a medical provider 49% [n=120] HCV patients made it to first appointment 25% [n=30] HCV patients initiated DAA therapy 30% [n=9] finished HCV DAA therapy 71% seen in office vs. 14% telemedicine vs. 15% by telephone Majority contacted within 2 days by LTCS INHSU September 2017

PATIENT IDENTIFICATION Integrated and Sustainable Care of PWID HCV
Treat to Prevent: Strategies To Identify and Advance PWID HCV Patient Care PATIENT IDENTIFICATION MEDICAL PROVIDER REFERRAL MANAGEMENT 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 Outreach & Awareness: First Contact: Recovery Treatment Center – Short & Long Term Residential Treatment Centers Sober Living Homes Clinical Care Coordination: Appropriate link to quality care – “Linkage To C Care” Care Specialist/Navigator Research Specialist Website Portal - To submit and communicate information Improved information sharing & communication between treatment center & medical provider 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 HARM Reduction: Opioid substitution therapy [OST] – Buprenorphine/Methadone Needle Exchange Programs Behavioral Health Therapy Relapse Prevention – Naltrexone Integrated and Sustainable Care of PWID HCV

Global Call for HCV Elimination
Vision: “A world where viral hepatitis transmission is stopped and everyone has access to safe, affordable, and effective treatment and care” 2020 target: 3 million HCV infections treated Feasible by scaling up 6 key interventions to high coverage: Hepatitis B vaccination (including birth dose) Safe injection practices and safe blood Harm reduction for injecting drug users Safer sex (including condom promotion) Hepatitis B treatment Hepatitis C cure 2030 Targets 90% Diagnosed 80% Treated 65% Reduced Mortality WHO. Towards the elimination of hepatitis B and C by Draft WHO Global Hepatitis Strategy, Slide credit: clinicaloptions.com

ERADICATING HCV Is Everyone’s Job in the Community
Identify undiagnosed HCV HCV rapid testing PWID – “Next Wave” Age cohort Preventing infection and reinfection Outreach and education Safer injection counseling Reinfection prevention counseling Treatment access and delivery Linkage to HCV care Access to HCV drugs Primary care–based therapy Methadone-based directly observed therapy Access to specialty care Telemedicine

Make a Change to Reduce HARM

Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz.

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Presentation on theme: "Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz."— Presentation transcript:

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Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz.

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Presentation on theme: "Treat To Prevent – Millennials, Drugs and Hepatitis C [HCV] Strategies To Identify and Advance PWID HCV Patient Care Linkage to C Care Program Imtiaz."— Presentation transcript:

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