HCV Coinfection: Expanding Access through the RWCA

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HCV CoinfectionExpanding Access through the RWCA

• Laura W. Cheever, MD, ScM
• Chief Medical Officer, Deputy Associate
  Administrator
• U.S. Department of Health and Human Services
• Health Resources and Services Administration
• HIV/AIDS Bureau

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Overview

• Pretest
• Overview of viral hepatitis
• Basics of Hepatitis C and coinfection with HIV
• Increasing access to treatment through the RWCA

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Hepatitis

• Inflammation of the liver
• Acute symptoms nausea, vomiting, jaundice,
  abdominal pain, fever, fatigue
• Causes are diverse
• Viruses (Hep A, B, C, D, G, Epstein Barr, etc)
• Toxins (Including alcohol, drugs)
• Chronic hepatitis can lead to scarring
  (fibrosis?cirrhosis) and liver cancer

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Healthy Liver

Cirrhotic Liver
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End Stage Liver Disease Liver Cancer

Source Beri Hull, National HIV/HCV
Co-infection Coalition
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What Is Hepatitis C and How Does It Differ From
Other Forms of Hepatitis?
Adapted from CommonHealth Alcohol and Drug
Addiction Counseling for HCV Patients
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What Is Hepatitis C and How Does It Differ From
Other Forms of Hepatitis?
Adapted from CommonHealth Alcohol and Drug
Addiction Counseling for HCV Patients
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Hepatitis C The Basics

• 4 million have been infected in the US
• Leading cause of liver transplant
• Four genotypes (1-4)
• Genotype 1 most common among IDUs in US
• Genotype 1 and 4 least likely to respond to
  treatment

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Hepatitis C and HIV Coinfection

• 30 of PLWHA in the US are co-infected
• Up to 90 among PLWHA infected through IDU
• HIV makes HCV worse
• Less likely to clear new infections of HCV
• More likely to have perinatal transmission
• Develop fibrosis more quickly
• Less likely to respond to treatment of HCV

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Liver disease is a major cause of death in the
HAART era
Bica et al. Clin Infect Dis 2001
32492497Puoti et al. JAIDS 2000
24211217Soriano et al. Eur J Epidemiol 1999
1514Soriano et al. PRN Notebook 2002
71015Martin-Carbonero et al. AIDS Res Human
Retrovirus 2001 1714671471
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HCV Treatment

• Standard of care is Pegylated interferon (inject
  every week) and Ribavirin (daily pill) for 6-12
  months
• Most centers do liver biopsies to assess fibrosis
  prior to treatment
• Treatment response is relatively low in
  co-infected
• Especially for Genotype 1, 4
• Response rates lower in African Americans
• Treatment has many side effects

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Frequent Side Effects of HCV Treatment (PEG-IFN
RBV Combination Therapy)

• Fatigue 64
• Muscle Aches 56
• Shaking chills 48
• Depression 31
• Joint aches 34
• Insomnia 40

• Headache 62
• Inj. site reaction 58
• Nausea 43
• Irritability 35
• Loss of appetite 32
• Hair loss 36

Manns MP et al. Lancet. 2001358958-965.
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Treatment Response in Co-infection (Combination
PEG-IFN/RBV)
40
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Abstracted from 11th CROI
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HCV Treatment

• Many patients with absolute () and relative
  contraindications to treatment
• Untreated mental illness
• Severe anemia
• Decompensated liver disease
• Pregnancy
• Advanced HIV disease
• Nonadherence/ nonengagement
• Refuse liver biopsy
• Active drug use
• Active alcohol use
• Many patients decide against treatment

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Impact of Alcohol Use and CD4 on Progression to
Cirrhosis
Benhamou Y. Hepatology 1999301054
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Weighing Treatment Decisions
HCV Progression
Adverse Effects Overlapping toxicities
Treatment response? Cure Drug use
issues Virologic Histologic
Competing Mortality (HIV disease other OIs)
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Access to Treatment

• Urban Co-infection Clinic
• 30 of 149 pts eligible for HCV treated
• 56 gt 1 criterion
• 36 of eligible pts agreed to treatment
• 53 if genotype 2,3

Fleming, CID, 2005
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Access to Treatment1

• VA Multisite study
• 33 active alcohol users counseled to stop
• 18 patients eligible for treatment biopsied
• 3 eligible patients received interferon
  treatment
• Bottom line Funding is necessary but not
  sufficient - other barriers

1 Fultz, CID 2003
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Treatment in Title III Programs1

• HCV antibody screening 99
• Treating HCV 70
• Treating in house 43
• Referral out 32
• Combination 24

1Title III survey 10/04, 40 response rate
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Barriers to Treatment1

• Provider
• Knowledge, skills (managing pts with
  contraindications), attitudes
• System
• Availability of multidisciplinary team, labs,
  meds, biopsies, patient support
• Referral out of HIV system (stigma)
• Patient
• Knowledge, fears (bx, tx), contraindications

1Adapted Badem and Clanon, RWCA AGM, 2004
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Barriers to HCV Treatment
Title III survey 10/04, 40 response rate
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HCV Care Room for Improvement

• Even if RWCA programs cannot provide TREATMENT,
  they need to provide CARE
• Screening
• Education
• Progression, treatment
• Alcohol
• Vaccination

Source Tedaldi, CID, 2004
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USPHS/IDSA Guidelines for the Prevention of OIs
- CARE

• All HIV persons should be screened for HCV
  antibody
• HCV viral load testing if suspect false negative
  antibody
• Advise no alcohol
• Vaccinate hepatitis A and B
• Monitor liver enzymes after initiation of ART
• Patients should be evaluated for liver disease
  and possible need for treatment

MMWR Vol. 48 / No. RR10 (http//www.cdc.gov)
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RWCA Funding Care and Treatment

• Funding medical services
• Medical visits, specialty referral, counseling,
  lab monitoring, biopsies, vaccination
• AIDS Drug Assistance Program (ADAP)
• 17 states cover IF/RBV
• Total number of patients treated is small
• Claims are low
• Patient Assistance Programs
• Approx. 5000 patients treated per 2005 CADR

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ADAP HCV Treatment Claims (9/01)

• NY 0.2- 0.3 of costs
• California 0.0023
• Massachusetts 0.03
• New Jersey 0.07
• 2002 Mass and NJ Little increase in utilization
  since adding PEG

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Building Capacity

• AIDS Education and Training Centers Center of
  Excellence in HCV
• www.uchsc.edu/mpaetc/coe.htm
• Technical Assistance
• Individual
• New HCV document

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Hepatitis C and HIV Coinfection Expanding Access
Through the RWCA

• Basic information on HCV and HIV coinfection, HCV
  treatment
• Rationale for care and treatment
• Establishing a clinic
• Addressing barriers
• Resources

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Models for Care

• Referral for specialty care
• Co-located care
• Integrated care

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Case Study HIV ACCESS

• HIV Alameda County Coordinated Early Services
  System (East Bay)
• Program to address barriers to HCV care
• Funding
• Education and support to staff and clients
• Access to biopsy
• Increased capacity

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HIV ACCESS HCV Program

• Funding Title III funds
• Approx. 50,000 yr (RN time)
• Education and support of clinicians
• Education both to HIV specialists and
  hepatologists
• Hepatologist in clinic to transfer skills
• Hepatologist follow up ½ day/week

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HIV ACCESS HCV Program

• Patient education and capacity expansion Hired
  one dedicated RN
• 11 Patient education and counseling
• Support group 2x/week
• Direct support of treated patients
• Teaching other nurses
• Community education
• Access to biopsies Do biopsies in clinic
• Portable ultrasound
• Training of hepatologists to use this

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HIV ACCESS HCV Program

• Results
• 1800 HIV infected patients
• 254 co-infected
• 50 of these actively using (IDU, heavy alcohol)
• 10 treated at any time
• 25 treated to date
• Those agreeing to treatment have participated in
  support group
• 30 drop out rate1

1 Clanon, Topics in HIV Medicine, March/April 2003
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Overcoming Barriers

• Reauthorization of the RWCA
• Current legislation with authority to treat HCV
• Learning from other Federal agencies (VA)
• Technical assistance to grantees
• Highlighting importance of HCV in morbidity and
  mortality
• Assessing impact of adding IFV/RBV to ADAP costs
• Disseminating treatment guidelines and best
  practices
• Replicating models that work
• Education and support
• Clinicians, patients

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Select Hepatitis Resources

• Care and Treatment for Hepatitis C
• Expanding Access Through the RWCA
• http//hab.hrsa.gov/tools/coinfection/index.html
• http//careacttarget.org/Library/HIVHCV.pdf
• HIV/Hepatitis C Center of Excellence (HRSA/AETC)
• http//www.aids-ed.org/aidsetc?pageab-01-11
• VA National Hepatitis C Program
• http//hepatitis.va.gov/
• Hepatitis Links on the HRSA/HAB Web Site
• http//hab.hrsa.gov/links.htmhepatitis

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Laura W. Cheever, MD, ScMChief Medical
OfficerDeputy Associate AdministratorHIV/AIDS
BureauHealth Resources and Services
AdministrationLcheever_at_hrsa.gov301-443-3067