Epidemiology and Management of HCV in Injection Drug Users Patricia Perkins, MS, MPH Independent Healthcare Consultant San Francisco & Los Angeles, CA.

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