epidemiology and management of hcv in injection drug users patricia perkins, ms, mph independent...
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Epidemiology and Epidemiology and Management of HCV in Management of HCV in
Injection Drug UsersInjection Drug Users
Patricia Perkins, MS, MPH
Independent Healthcare Consultant
San Francisco & Los Angeles, CA
Advisory Board, OASIS, Oakland
HCV Infection Prevalence by Frequency of HCV Infection Prevalence by Frequency of Selected Groups in the US PopulationSelected Groups in the US Population
Hemophiliapatients
0 5 10 15 20 80 90
100Percentage
IVDU patients
Dialysis patients
STDpatients
Healthcare workers
Generalpopulation
HCV
Group
Gro
up
Volunteer Blood
Donors
HCV PrevalenceHCV PrevalenceNHANES 1988-1994NHANES 1988-1994
01234567
10 20 30 40 50 60 70 >70
Age Group (yrs)
An
ti-H
CV
Po
siti
ve (
%)
AA
MA
CA
*Nosocomial, occupational, perinatal
Remote (>15 yrs ago)Remote (>15 yrs ago)
Transfusion
Sexual
Other*UnknownTransfusion
Injection Drug Use
Unknown
Other*Sexual
Injection Drug Use
Recent (=<15 yrs ago)Recent (=<15 yrs ago)
Relative Importance of Risk Factors Relative Importance of Risk Factors for Remote and Recent HCV Infectionfor Remote and Recent HCV Infection
Risk Factors for Transmission Risk Factors for Transmission of Hepatitis Viruses and HIVof Hepatitis Viruses and HIV
Transfusion Transfusion
No Identified Risk No Identified Risk
Occupational Occupational
Heterosexual partners Heterosexual partners
MSM MSM
Injection drug use Injection drug use
Risk Factor Risk Factor
rare rare
30%30%
5-7%5-7%
(past)(past)
40%40%
15%15%
14%14%
HBVHBV
PastPast
7- 20%7- 20%
10%10%
<<1%<<1%
20%20%
1%1%
60%60%
HCVHCV
9%9%
PastPast
2%2%
<<1%<<1%
10%10%
47%47%
31%31%
HIVHIV
Percentage of Infections
Natural History of HCVNatural History of HCV
45-year cohort study (VAMC) in young military recruits
8,570 samples from 1948-1954 VAMC follow-up includes HCFA records Results: -- Anti-HCV = 17 (0.2%) -- Symptomatic liver disease unusual -- Liver-related death: 1/17 (6%) vs. 1.4%Source: Seef et al Ann Intern Med 2000; 132:105-11
0 6 12 18 24 30 36 42 48 54 60 66 720
20
40
60
80
100
Ser
opre
vale
nce
(%)
Duration of Injecting (mo)
HCVHCV
HBVHBV
HIVHIV
Risk of HCV, HBV, and HIV Infection Among Injection Drug UsersBaltimore 1983–1988
Garfein RS. Am J Public Health. 1996;86:655.
Risk of HCV Infection Among IDUs
0
20
40
60
80
100
0 6 12 18 24 30 36 42 48 54 60 66 72 78 84
Duration of Injection (months)
Se
rop
rev
ale
nc
e (
%)
Garfein RS AJPH 1996; 86:655. Thorpe LE JID 2000;182:1588-94. Diaz T AJPH 2001; 91(1): 23-30.
Baltimore: 1983-1988
Chicago: 1997-99
NY - Harlem: 1997-99
NY – LES: 1997-99
Garfein Part IIGarfein Part II
CDC Risk Reduction for IDUsCDC Risk Reduction for IDUs
If continuing to inject:Never reuse or share syringes, needles, or
drug preparation equipment
Vaccinate against hep B and hep A
Refer to community-based risk reduction programs
The Issues of Hepatitis CThe Issues of Hepatitis CGlobal ConsiderationsGlobal Considerations
The epidemiology of the infection and co morbid conditions
Natural History variationsTreatment; when, who and comorbidityPrevention – needles, sex, babies,
adolescentsVaccines- delivery and effectiveness
Hepatitis C and Drug Use issues
• Drug interactions
• Virus species interactions
• How to treat out of treatment drug users
• Early Hepatitis C intervention (a set point?)
• Co morbid infections in pregnancy
• Liver under fire– Hep B & C, alcoholic hepatitis, stigma
Why Does Injection Drug Use Why Does Injection Drug Use Matter so Much with HCV?Matter so Much with HCV?
IDUs are largest group of infected persons in US and most of the West
App. 1 million IDUs infected (mainly MMT and long-term IDU cohorts)
Highest prevalence (85%+): both Coasts; ChiHighest incidence (10%-20%/annum: UFO
Study (SF) & Seattle (RAVEN)
Natural History of Chronic Natural History of Chronic HCVHCV
SummarySummary Aging of HCV+ pt pool peaks in 10-20 yrs.* Decompensated cirrhosis * HCC (liver cancer) * Potential liver transplant candidates * Liver-related deaths Future healthcare cost burden is very high Treatment impact
– Reduced liver decompensation and health costs– Best effect by treating more advanced disease (Fibrosis II+?)– Little societal public health effect from treating mild disease
Why Does Injection Drug Use Why Does Injection Drug Use Matter in HCV Transmission?Matter in HCV Transmission?
Source of Most HCV transmission All drug use paraphernalia are implicated in its
transmission: cookers, cottons, tie-ups Higher rate of transmission than HIV requires
different type of risk reduction educ. Will require developing, testing, and implementing
treatment strategies effective with drug users: (O.A.S.I.S. model)
Recommendations/Q'sRecommendations/Q's 6/02 NIH Consensus Dev't 6/02 NIH Consensus Dev't
ConferenceConferenceNatural History of HCV in IDU's?
– Not well understood (Thomas et al; JAMA 2000; Nov 22; 284 (20); 2592
Which patients should be treated?– Individual decisions by patients and clinicians– Balanced portrayal of risks and benefits– Drug use NOT a criterion for HCV treatment
Add'l Questions for Treatment Add'l Questions for Treatment of HCV+ Drug Usersof HCV+ Drug Users
How should patients be treated?– Interdisciplinary approach: expertise in HCV &
substance abuse; harm reduction modelsHow should patients be monitored?
– Assess; monitor, and support adherence and mental health (replicate HIV & TB successes)
How can transmission be prevented?– Teach safer injection; e.g. CRC (Chi) & PHP
(NYC) – use “safety kits”
What research is still needed What research is still needed for HCV+ IDUs/DUs?for HCV+ IDUs/DUs?
Effective treatment strategies for drug users in substance abuse treatment
Developing tools for HCV recovery readiness for drug users NOT in drug treatment
Behavioral modification and risk reduction around alcohol consumption
Recommendations by Recommendations by IDU/Infectious Disease ExpertsIDU/Infectious Disease ExpertsWhich patients with HCV should be treated or
even evaluated to point of treatment?
– “HCV treatment decisions should be made by patients and their physicians on a case-by-case basis, factoring in risks, benefits, and personal values for each individual patient.”
Edlin et al; NEJM 2001; 345: 211-4
Risk-Benefit ConsiderationsRisk-Benefit Considerations
For all Patients with HCV:Limited benefit (SVR < 50% in genotype 1)Side effects (physical & mental)Timing (future regimens)Need/urgency (disease stage, best on
histology/biopsy
Risk Benefit cont.Risk Benefit cont.
Clinical benefit not shown in IDUs in long-term follow-up studies
Patients' personal values, feelings about infection/side effects
– “Patients should receive a balanced portrayal of the risks and benefits of treatment”
Risk Benefit ConsiderationsRisk Benefit Considerations
For IDUs with HCV:Adherence
– IDUs CAN adhere to medical regimens (HIV/TB)
– Physicians CANNOT predict patients' adherencePsychological side effects
– No evidence to date of inordinate side effects in IDUs; driven more by previous hx of psych issues/depression
Risk Benefit, cont.Risk Benefit, cont.
Timing:– HCV and substance abuse CAN be treated
together– No data on optimal sequence; current practice is
for six months of MMT or abstinence-based treatment
Re-infection:– Evidence suggests low risk, limited data
Models for Treatment Models for Treatment Adherence: HIV GuidelinesAdherence: HIV Guidelines
Assess readiness BEFORE prescribingMonitor adherence during therapyNo patient should automatically be excludedProvide adherence support
Source:Guidelines for Antiretroviral Agents: Recomm of the
Panel on Clinical Practices for Treatment of HIV.
MMWR 2002; 51 (RR-7)7:
(http://www.cdc.gov/mmwr/mmwr_rr.html)
HCV Rx in IDUs Entering Opiate HCV Rx in IDUs Entering Opiate Detox (N = 50)Detox (N = 50)
Backmund, Hepatol 2001; 34: 188-93Backmund, Hepatol 2001; 34: 188-93 Pts: Active opiate injectors beginning opiate detox RX: IFN or IFN/RBV MD's: expertise in HCV & substance abuse Patients who relaped:
– Received MMT– Continued HCV meds despite drug use
Instruction on HCV risk reduction while injecting drugs
Results for this Detox StudyResults for this Detox Study
Overall SVR of 36%This is prior to use of Peg IFN productsOnly statistically significant predictor of
greater SVR was among patients who kept greater than 67% of medical appointments
Authors suggested role for social engagement with clinic as factor in adherence
MMT Patients treated for HCV MMT Patients treated for HCV in US: OASIS (n = 66)in US: OASIS (n = 66)
Pts: chronic MMT recipients – 6 centersRx: IFN-alpha-2b + RBVPatients selected by adherence to clinic visits
and support groups62% pre-existing psychiatric disorder21% drank alcohol during HCV treatment
MMT OASIS Study, cont.MMT OASIS Study, cont.
30% used illicit drugs during HCV treatmentNo serious psychological side effects during
HCV treatment85% required antidepressants during tx.39% required increase in methadone dose
(minimum of 10 mg/day)
Sylvestre, DDW (AASLD #118); Gastroenterology 2002; 122 (4 Suppl 1): A630
RecommendationsRecommendations
Approach to Caring for IDUs & DU's– Education, counseling, support to avoid:
Sharing syringes or disinfection?? Sharing other paraphernalia (cookers, cottons, etc) Any blood contact (e.g. giving/receiving injections)
Access to sterile syringes:– Referral to SEPs, as applicable/where possible– Syringe Rx (now possible in NYS & Texas)
Source: CDC fact sheet: (http://www.cdc.gov/idu/facts/physician.htm)
(
Final NIH Consensus Statements Final NIH Consensus Statements Recommendations: 6/02Recommendations: 6/02
With Greatest Public Health Impact With Greatest Public Health Impact
“Institute measures to reduce transmission of HCV among IDUs, including providing access to sterile syringes through needle exchange, physician prescription, and pharmacy sales; and expanding the Nation's capacity to provide treatment for substance abuse...”
Consensus, cont.Consensus, cont.
...”Physicians and pharmacists should be educated to recognize that providing IDUs with access to sterile syringes and education in safe injection practices may be lifesaving.”
Consensus Recomm, cont.Consensus Recomm, cont.
“Encourage a comprehensive approach to promote the collaboration among health professionals concerned with management of addiction, primary care physicians, and specialists involved in various aspects of HCV to deal with the complex societal, medical, and psychiatric issues of IDUs afflicted by the disease.”
AcknowledgementsAcknowledgements
Drs. Brian Edlin & Alex Kral, UCSF Urban Health Study
Dr. Ian Williams, Hepatitis Branch, US CDCDr. Richard Garfein, HIV Branch, US CDCDr. Robert Gish & Dr. Ed Wakil, CPMC, SF