Injection Drug Use and Hepatitis C

1
Injection Drug Use and Hepatitis C

• Brian R. Edlin, MD
• Associate Adjunct Professor
• Director, Urban Health Study
• Institute for Health Policy Studies
• Dept. of Family and Community Medicine
• University of California, San Francisco

2
Why Does Injection Drug Use Matter?

• IDUs are largest group of infected persons in
  U.S.
• Approx. 1 million IDUs infected
• Highest prevalence (80-90)
• Highest incidence (10-20 per year)
• Source of most HCV transmission
• Will require developing, testing, and
  implementing treatment strategies effective with
  drug users.

3
Overview Key Questions

• Natural history in IDUs?
• Not well understood
• Which patients should be treated?
• Individual decisions by patients and physicians
• Balanced portrayal of risks and benefits
• Drug use not a criterion
• How should patients be treated?
• Interdisciplinary approach expertise in
  hepatitis and substance use

4
Overview Key Questions

• How should patients be monitored?
• Assess, monitor, and support adherence and mental
  health
• How can transmission be prevented?
• Teach safe injection
• Provide access to sterile syringes
• What research is needed?
• Effective treatment strategies for substance users

5
Recommendations

• Which patients with hepatitis C should be
  treated?
• 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 2001345211-4

6
Risk-Benefit Considerations

• for All Patients with Hepatitis C
• Limited benefit (SVR lt 50 in genotype 1)
• Side effects (physical and mental)
• Timing (future regimens)
• Need/urgency (disease stage)
• Clinical benefit not shown
• Personal values, feelings about infection, side
  effects
• Patients should receive a balanced portrayal of
  the risks and benefits of treatment.

7
Risk-Benefit Considerations

• for IDUs with Hepatitis C
• Adherence
• IDUs can adhere to medical regimens
• Physicians cannot predict patients adherence
• Psychological side effects
• No evidence to date of inordinate side effects in
  IDUs
• Timing
• HCV and substance use can be treated together
• No data on optimal sequence
• Reinfection
• Evidence suggests low risk

8
Adherence by IDUs to Medical Treatments
Author Year
N
Adherence
Regimen
IDU adh lt non-IDU?
Tulsky 2000
118
33
TB PT
N
Pablos-Mendez 1997
184
35
TB Rx
Y
Haubrich 1999
173
51
HAART
Y/N
Pilote 1996
244
53-84
TB appt
Y/N
Eldred 1998
244
60
HIV Rx
N
Moatti 2000
164
65
HAART

Singh 1999
123
76
ART
N
Bamberger 2000
68
76
HAART

Chaisson 2001
300
79
TB PT

Broers 1994
313
81
AZT
Y/N
Samet 1992
83
83
AZT
Y/N
Mezzelani 1991
79
85
hepatitis B vaccine

Marco 1998
62
86
TB Rx
N
N
 
9
HIV Treatment Guidelines on Adherence

• No patient should automatically be excluded.
• Assess readiness before prescribing.
• Monitor adherence during therapy.
• Provide adherence support.

Guidelines for Antiretroviral Agents
Recommendations of the Panel on Clinical
Practices for Treatment of HIV. MMWR 2002
51(RR-7)7 (http//www.cdc.gov/mmwr//mmwr_rr.html
)
10
HCV Rx in IDUs Entering Opiate Detoxification
(N50)

• Pts Active opiate injectors beginning opiate
  detoxification
• Rx IFN or IFN/RBV
• MDs expertise in both hepatitis and substance
  use
• Patients who relapsed to drug use
• received methadone maintenance
• continued receiving HCV medications despite drug
  use
• Patients were instructed how to avoid acquiring
  HCV when injecting drugs.

Backmund, Hepatol 200134188-93
11
HCV Rx in IDUs Entering Opiate Detoxification
(N50)
of Pts. with SVR
p .17
p .02
53
45
40
36
24
8
N50
10
25
15
38
12
Overall
None
Relapse
Rel.Rx
gtb
ltb
Drug Use
Appts. Kept
Backmund, Hepatol 200134188-93
12
Methadone Patients Treated for HCV (N66)

• Pts chronic methadone maintenance recipients
• Rx IFN?-2b RBV
• Patients selected by adherence to clinic visits
• 62 had psychiatric diagnoses
• 21 drank alcohol during HCV treatment
• 30 used illicit drugs during HCV treatment
• No serious psychological side effects during HCV
  treatment
• 85 required antidepressants
• 39 required increase in methadone dose (median
  10 mg)

Sylvestre, DDW (AASLD 118), Gastroenterology
2002122(4 Suppl 1)A630
13
Methadone Patients Treated for HCV (N66)
of Pts. with SVR
p .15
p .44
Overall
6 m
lt6 m
None
Interm
Daily
gt1y
None
Rare
Pre-Rx Abstinence
Drug Use During Rx
Sylvestre, DDW (AASLD 118), Gastroenterology
2002122(4 Suppl 1)A630
14
Methadone Patients Treated for HCV (N66)
of Pts. with SVR
p .52
p .001
p .31
No
Yes
No
Yes
No
Yes
Overall
Alcohol
Marijuana
Psych Dx
Sylvestre, DDW (AASLD 118), Gastroenterology
2002122(4 Suppl 1)A630
15
Reinfection in IDUs Successfully Treated for HCV

• Backmund, Hepatol 200134188-93
• 12 patients injected drugs during the 24 weeks
  after having an ETR.
• 10 of the 12 (83) achieved SVR.
• Patients were instructed how to avoid acquiring
  HCV when injecting drugs.
• Dalgard, Eur Addict Res 2002845-9
• 27 IDUs were retested 5 years after clearing HCV
  on Rx.
• 9 of the 27 relapsed to drug use (45 person-years
  at risk).
• One reinfection observed ( 2.2/100 person-years)

16
Recommendations

• What is the best approach to the patient with
  HCV?
• Screen for substance use.
• Provide treatment for substance use!
• Expertise working with drug users
• Coordinate medical care and substance abuse
  treatment.
• Assess, monitor, and support adherence and mental
  health

• Harm reduction workers
• HIV providers
• Substance abuse treatment professionals

• Substance abuse researchers
• Drug users

17
Recommendations

• Approach to Caring for Injection Drug Users
• Education, counseling, and support to avoid
• Sharing syringes
• Sharing other injection equipment (cookers,
  cottons)
• Any blood contact (eg, giving and receiving
  injections)
• Access to sterile syringes
• Referral to syringe exchange programs
• Syringe prescription

US PHS medical advice (http//www.cdc.gov/idu/pubs
/hiv_prev.htm)
CDC fact sheet (http//www.cdc.gov/idu/facts/phys
ician.htm)
18
Recommendations

• Policy Recommendations
• HCV prevention and care in correctional
  facilities
• Federal funding of HCV care (like Ryan White Care
  Act)
• Clarify that methadone is not a contraindication
  to HCV Rx

19
Recommendations

• What recommendations can be made
• to patients to prevent transmission of hepatitis
  C?
• Avoid injecting drugs
• or
• Practice safe injection.

20
Recommendations

• What research is needed?
• Epidemiology
• How many IDUs infected
• How many new infections/yr
• Natural history of hepatitis C in IDUs
• Effective treatment strategies for IDUs

21
Acknowledgement
Scott A. Allen Frederick L. Altice Tomas
Aragon Markus Backmund Joshua D. Bamberger David
R. Bangsberg Robert E. Booth Scott Burris Charles
C. J. Carpenter Margaret A. Chesney Allan
Clear James W. Curran Don C. Des Jarlais Maria L.
Ekstrand Neil Flynn Gerald H. Friedland Samuel R.
Friedman
Kim Page-Shafer Allan Rosenfield Josiah D.
Rich Ellie E. Schoenbaum Peter A. Selwyn James L.
Sorensen Sharon L. Stancliff Steffanie A.
Strathdee Diana L. Sylvestre David L.
Thomas David Vlahov Paul A. Volberding Robert M.
Weinrieb Ian T. Williams Alex D. Wodak Teresa L.
Wright Barry Zevin
Cynthia A. Gomez Lawrence O. Gostin Marc N.
Gourevitch Marilyn Hollinquest Peter
Hauser Robert Heimer James G. Kahn Mitchell H.
Katz Susan M. Kegeles Robert S. Klein Stewart
Leavitt Bernard Lo David S. Metzger Stephen F.
Morin Nancy Moss Phillip I. Nieburg Thomas R.
OBrien
22
USPHS Medical Advice For Persons Who Inject
Illicit Drugs

• Dont use drugs.
• Receive substance abuse treatment.
• Never use syringes previously used by another
  person.
• Never use other injection equipment previously
  used by another person.
• Use a new, sterile syringe to prepare and inject
  drugs.
• Use a new or disinfected container ("cooker") and
  a new filter ("cotton") to prepare drugs.
• Wash hands and clean the injection site before
  injection.
• Safely dispose of syringes after one use.
• Wash hands before and after giving injections.

CDC/NIDA/SAMHSA/HRSA (http//www.cdc.gov/idu/pubs
/hiv_prev.htm)
23
Principles for Managing Health Care Relationships
With Substance-Using Patients

• Establish a climate of mutual respect.
• Maintain a professional approach focused on the
  aim of enhancing patients well-being.
• Avoid moralizing, blaming, and judging.
• Educate patients about their medical condition,
  proposed treatments and side effects.
• Include patients in decision making.

24
Principles for Managing Health Care Relationships
With Substance-Using Patients

• Have staff who are familiar with substance use
  and comfortable with users.
• Have staff who are knowledgeable about substance
  use, mental health, AIDS, and hepatitis.
• Assess and address unmet needs such as hunger,
  housing, and untreated mental health conditions.
• Minimize barriers to participation (penalties for
  missed visits, etc.).
• Individualized counseling addressing barriers to
  and facilitators of adherence.

25
Principles for Managing Health Care Relationships
With Substance-Using Patients

• Set appropriate limits and respond consistently
  to behavior that violates those limits.
• Recognizing that patients must set their own
  goals for behavior change, work with patients to
  achieve commitment to realistic goals for
  healthier behaviors.
• Acknowledging that abstinence is not always a
  realistic goal, emphasize risk reduction measures
  for patients who continue to use drugs.
• Acknowledge that sustaining abstinence is
  difficult and that success may require several
  attempts.

26
Principles for Managing Health Care Relationships
With Substance-Using Patients

• Pitfalls to Avoid
• Unrealistic expectations
• Frustration
• Anger
• Moralizing
• Blame
• Withholding therapy

27
Effective Strategies for Improving Adherence

• Information about intended effects and side
  effects of medication
• Attention to perceived side effects
• Counseling addressing barriers to and
  facilitators of adherence
• Respectful and nurturing provider-patient
  relationship
• Treatment of depression if patient is depressed
• Directly observed therapy
• Cash incentives
• Devices (pager reminders, pill organizer boxes,
  etc.)

28
HIV Treatment Guidelines Statement on Adherence
"Regarding adherence, no patient should
automatically be excluded from consideration for
antiretroviral therapy simply because he or she
exhibits a behavior or other characteristic
judged by the clinician to lend itself to
nonadherence. Rather, the likelihood of patient
adherence to a long-term, complex drug regimen
should be discussed and determined by the patient
and clinician before therapy is initiated. To
achieve the level of adherence necessary for
effective therapy, providers are encouraged to
use strategies for assessing and assisting
adherence intensive patient education and
support regarding the critical need for adherence
should be provided specific goals of therapy
should be established and mutually agreed upon
and a long-term treatment plan should be
developed with the patient."
Guidelines for Antiretroviral Agents
Recommendations of the Panel on Clinical
Practices for Treatment of HIV. MMWR
200251(RR-7)7
29
Prevention and Treatment of Infectious Diseases
With Substance-Using Patients
A Harm Reduction Approach

• Assess patients interest and readiness to adopt
  various risk reduction strategies, including
• reduction or cessation of substance use
• use of sterile syringes and safer injection
  techniques
• safer sex practices
• Instruct patients in safer sex and safer
  injection methods. Assess patients access to
  sterile syringes and provide referrals to
  appropriate sources or, if necessary and where
  legal, prescribe syringes.

30
Prevention and Treatment of Infectious Diseases
With Substance-Using Patients
A Harm Reduction Approach

• Assess and address patients mental health status
  and needs.
• Assess and address patients housing and
  subsistence needs.
• Offer confidential testing and counseling for
  HIV, HBV, HCV, STDs, and TB.
• Provide vaccination for hepatitis A and B to
  patients without serologic evidence of prior
  infection.

31
Prevention and Treatment of Infectious Diseases
With Substance-Using Patients
A Harm Reduction Approach

• For patients with HIV, HBV, HCV, or TB, discuss
  treatment options, including risks, benefits,
  adverse effects, the need for adherence, and the
  risk of reinfection.
• For patients considering treatment, assess the
  likelihood of difficulty with adherence and offer
  adherence support.