Antiretroviral Treatment (ART) For Injecting Drug Users: Module Objectives

Pelatihan Lanjutan Perawatan, Dukungan dan Pengobatan Bagi ODHA
Jakarta, 25 30 April 2005
Antiretroviral treatment (ART) for injecting drug users
Module objectives
At the end of the session, participants will:

Have a better understanding of substance abuse, the links between drug use and
HIV/AIDS and the benefits of harm reduction treatment approaches
Understand the problems of providing ART for IDUs
Become familiar with the potential interaction between ART and methadone
Assess the major barriers /difficulties that confront IDUs requiring ART
Time to complete the module
1 day (Four 2 hour sessions)
Training materials to be prepared

Hand outs
Case Studies
Power point to accompany the information in this module
Trainers: For the morning sessions a specialist in drug abuse is required. The afternoon
session requires experts on ART treatment who also have knowledge of IDUs and
methadone treatment
Content (to be completed

Annex 1 Drug use and HIV/AIDS in Indonesia
Annex 2 Side effects from ART
Annex - Assessment questionnaires for drug problems, screening questionnaire for
alcohol problems (CAGE), severity of alcohol dependence questionnaire (SADQ)
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NOTES FOR TRAINERS

Part one of this training module contains information for trainers and suggestions for
activities.
Part two contains slides which may be used during the training
This is module is designed for the training of

.
A. Doctors treating AIDS patients in hospitals or in Primary Health
Care facilities: It is assumed that these doctors will have undergone a
comprehensive training on ART. This module focuses specifically on
treatment for injecting drug user patients. It will present information
on how to recognise and diagnose substance abuse, the relationship
between substance abuse and HIV/AIDS, on the barriers to ART
experienced by IDUs and the problems of adherence and will suggest
ways to overcome these
B. Doctors working in Methadone clinics: It is assumed that doctors

working in methadone clinics will be familiar with issues relating to
drug abuse and will have also participated in the comprehensive
training for ARV treatment management. These participants need only
attend session x of this module where the potential interaction between
methadone and ART and with medication used to treat commonly
found medical conditions among IDUs are discussed.
Sections marked AB includes training material which is applicable to both groups of

trainees. Sections marked A are applicable to doctors working in AIDS clinics or in
primary health facilities. Sections marked B are applicable to doctors working in
methadone clinics.
Sessions 1-2 (half a day) contains information on drug abuse and concomitant
HIV/AIDS. (No information on high risk sexual behaviour by this group is included here
as it is discussed elsewhere).
Sessions 3-4 (half a day) focuses on ART for IDUs and explores the potential interactions
between ART and Methadone and other medicines used to treat some of the diseases
commonly experienced by drug users
Annex 1 Provides background country information on drug use and HIV

Annexes 2-3 provide reference information for practitioners and are simply a reminder of
the overall side effects from ART. This reminder should help when IDUs experience
adherence difficulties.
Annexe 4 - include standardized questionnaires that may be use to flag drug and alcohol
problems and may be used for that purpose in clinical practice
Draft country information for Indonesia on drug and HIV/AIDS are included in Annex x
but will need to be completed and updated before use.
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Sessions One and Two: The links between drug use and HIV/AIDS
At the end of these two sessions participants will:
Have a basic understanding of drug abuse and the links with HIV/AIDS
Become familiar with standardised clinical instrument used for the diagnosis of
drug or alcohol problems
Have a basic familiarity with the drug treatment options for drug abuse including
harm reduction approaches.
Understand the links between drug abuse and HIV/AIDS
(A) Introduction
An estimated 7, 4 million people in Asia are living with HIV/AIDS and of these xx are
estimated to be injecting drug users (IDUs). In some countries drug users constitute the
majority of those infected (e.g.), and even where IDUs are in the minority of those
infected (e.g.) there is a serious epidemic among them. It is therefore to be expected that
a large number of drug users will be requiring antiretroviral treatment. However, there is
a widespread view that drug users are poor candidates for ARV - based on the following
perceptions:
Drug users will be unable to adhere to ARV treatment

The drugs used by IDUs (including substitution drugs such as methadone) will
interact with ARV, either causing opiate withdrawal or conversely rendering the
ARV medication ineffective
Drug users who become abstinent in order to enter ART are at risk of relapsing
and leaving treatment.
However, extensive experience and research has found that HIV care for injection drug
users including ART can be highly successful and that drug users can adhere to treatment
and benefit from ART as much as other AIDS patients provided their special needs are
met. It is necessary therefore for physicians to understand drug abuse and learn to address
potential ARV treatment barriers.
It is important to remember that excluding IDUs from ART is medically and ethically
untenable
(a) Understanding drug abuse
Behaviours associated with drug abuse have major consequences for health. Injecting
drugs exposes the user to a number of blood borne diseases including hepatitis B and C,
and HIV/AIDS are now the major factor in the spread of HIVAIDS infection in
Indonesia. Using and sharing contaminated needles and syringes and other drug use
paraphernalia (e.g. cotton swabs, water, and cookers) leaves a drug user vulnerable to
contracting or transmitting HIV. Furthermore, drug users and those intoxicated from a
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variety of drugs (including alcohol) are in additional jeopardy because they also practice
unsafe sex while intoxicated.
(b) What are the major features of drug use?
Not all drug users are drug addicts, but as far as HIV/AIDS risks are concerned its the
behaviours associated with drug use that are the most critical.
Becoming addicted to a drug depends on the pharmacology of the drug itself as well as
on the frequency and quantity of use. Drug addiction is a complex behaviour, which has
been characterised as a chronic and relapsing disease
Drug abuse is manifested by the excessive and repeated use of a

drug for non-medical purposes. Repeated use of some drugs may
cause drug dependence or drug addiction when a person becomes
dependent/ addicted repeated substance use is necessary to avoid
unpleasant withdrawal symptoms
Withdrawal symptoms are the clinical manifestations that occur when the drug to which a
person is addicted is withdrawn. In the case of opiate users (including heroin injectors)
addicted individuals may experience the following symptoms if the supply of drug is
suddenly withheld: Anxiety and difficulty sleeping, sweating, runny nose, stomach
cramps or diarrhea, nausea and vomiting, increase in blood pressure, pulse and
temperature. Drug addicts seek a supply of drugs in order to avoid these symptoms.
Drug users may experience a number of serious health problems as a consequence of

their drug use/addiction and these are compounded by inadequate substance abuse
treatment and a general lack of access to health care facilities, partly due to drug users
own reluctance to access such generic health services. These include: Hepatitis C, B, TB,
skin and soft tissue infections, recurrent bacterial pneumonia and endocarditis,
complicating drug interactions, medication side effect. Furthermore IDUs have a high
prevalence of psychiatric problems, which may antedates and /or be exacerbated by
substance misuse.
(c) Does the patient in the AIDS clinic have a drug or an alcohol problem?
diagnosing substance abuse?
Physicians in AIDS treatment facilities are likely to meet drug users or ex-drug users who
require treatment. It may not be immediately apparent to the physician that a patient has
or has had a substance abuse problem. In order to assess vulnerability and to pre-ampt
potential difficulties it is important for the physicians to be aware of the patients
substance use history.
In Annex 3 can be found are a number of recommended standardised assessment and

diagnostic tools that can be used to flag whether the patient has a drug or alcohol
problem and whether a further investigation is needed.
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(d) What treatments are available for drug users?
There are a number of treatments and interventions modalities focusing on substance

abuse. In a review of the effectiveness of drug dependence treatment WHO found that all
treatment modalities were found to have the potential for reducing the risk of HIV
transmission and that drug treatment was therefore an important component of all
HIV/AIDS prevention programmes for IDUs.
(1) Abstinence based approaches
These may vary considerably and may include residential hospital or therapeutic
community approaches, as well as outpatient, counselling and self help groups. These
approaches are based on the principle that drug users need to address underlying causes
of their drug use / addiction and learn how to change their behaviour and their life style
and find new social networks that do not support drug use. Evidence from abstinence
based programmes from around the world suggests that there is a high drop out rate at the
beginning of treatment but that for those who remain in treatment longer drop out rates
decline. However, the overall recovery rates for abstinent based treatment are frequently
disappointing.
(2) Harm reduction interventions
In the context of the HIV/AIDS epidemic, the overriding objectives of harm reduction is
to prevent drug users from becoming infected with HIV/AIDS, and other blood borne
diseases and from transmitting the virus to other drug injectors and to sexual partners.
Harm reduction is a comprehensive package of policies and programmes

which attempt primarily to reduce the adverse health, social and economic
consequences of mood altering substances to individuals, drug users, their
families and their communities.
Harm reduction strategies for IDUs are intermediate steps towards the
ultimate goal of abstinence and include peer counselling and education,
needle and syringe programmes and substitution treatment.
Resistance to widespread acceptance and implementation of harm reduction approaches

is rooted in the misconceptions that harm reduction is a covert attempt to legalise drugs
and that harm reduction approaches encourage rather than prevent drug abuse.
Additionally some believe erroneously that substitution treatment and needle and syringe
programmes contravene the UN Conventions on narcotic drugs.
However, although patients in substitution treatment are not drug free maintenance
therapy with methadone or buprenorphine offers stability and freedom from the
psychosocial stresses of opiate addiction.
5
ACTIVITY 1 (30-45 minutes discussion +15-20 minutes for reporting back)
Small group discussion (5-6):

Objectives:
For the groups to explore what participants know about the drug / HIV/AIDS
situation in their neighborhood/ district/ city (as appropriate)
Discuss experiences of encountering drug /alcohol abusers in clinical practice
Examine critically the questionnaires in annexes x and y (try them out) and
discuss their utility in your clinical practice
In the discussion address the following questions: Have you treated an IDU with ART? If
yes, what is your experience? If no what are the reasons, what treatment and support
services for IDUs exist in your area? What in your view is lacking?
Report back to the whole group.
This session to be followed up by country information about HIV/AIDS to be updated as

needed.
If possible invite a number of drug users being prescribed methadone to talk about their
experiences
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The IDUs HIV nexus: How is HIV/AIDS transmitted among IDUs?
o HIV infection spreads easily when people share contaminated equipment

to inject drugs. Sharing equipment also spreads hepatitis B, hepatitis C,
and other infectious diseases.
o Infected blood can be drawn up into a syringe and then gets injected
along with the drug by the next user of the syringe. This is the easiest way
to transmit HIV because infected blood is injected directly into the
bloodstream.
o Even small amounts of blood on cookers, filters, tourniquets, or in rinsing
water can be enough to infect another user.
o Research shows that HIV can survive in a used syringe for at least 4
weeks
As already noted above the concerns about IDUs ability to adhere to ART is focused on
their life style. It is not the drug consumption per se that is a risk for non adherence to
ART but it is the drug using life style and the behaviours associated with it Clearly an
abstinent drug user makes a better candidate for ART but abstinence is not always
achievable (at least not in the short-term). It is therefore recommended that ARV be
combined with substitution therapy wherever possible. The methadone maintenance
clinics to which drug users come daily is an ideal venue for ART Directly Observed
Therapy (DOT) thus eliminating the problem of adherence for at least part of the time.
(f) Options for offering ART to IDUs
There are a number of different ways of delivering antiretroviral medication to IDUs.

IDU attending an AIDS clinic in a general hospital
Establishing substance abuse treatment in AIDS clinics (e.g. substitution
treatment) thus combining methadone and ART
Providing ART in substance abuse treatment facilities.
Each of these models of care delivery has some advantages and some disadvantages and
the choice of delivery systems will depend on the country situation. For ex drug users the
AIDS clinic in a general hospital may be suitable but it is likely that active IDUs will
have some difficulties in attending an AIDS clinic in a general hospital and for them a
joint programme of methadone and ART is recommended.
(f.1) The advantages of combining ART with substitution treatment:
Where substitution therapy is available consideration should be given to offering HIV

care and dispensing HIV medication at the same site where substitution therapy is
delivered. This approach has an immense utility where AIDS treatment is needed. It
facilitates support and supervision of active drug users who require ART. Substitution
treatment helps injecting drug use organise their life, cease using street drugs, injecting
and sharing needles and syringes and enables them to return to work, improve relations
with family and friends and avoid breaking the law and face imprisonment. Continued
injecting drug use is associated with a range of high-risk behaviours that put users at risk
of becoming infected with HIV and of non-adherence to AIDS treatment when required.
It is therefore an indispensable adjunct to successful ART for IDUs.
7
Thus patients would be assessed and treatment initiated in designated hospitals, but the
day-to-day therapy (Directly observed therapy DOT) would be provided in Community
Primary Health facilities. This approach can achieve maximal levels of treatment
supervision, which should reduce the risks of non-adherence to ART and minimize the
risks of HIV drug resistance. While true DOT is desirable it is not always practical
because most of the regimen at this time require more than a once daily dosage so that
patients have to take at least one dose at home.
Both are long term treatments

Both require peer and family support and an enabling environment
Both require commitment and motivation
Daily attendance makes the methadone clinics good venues for DOT
Daily attendance facilitates adherence monitoring and support.
Whichever model of care for IDUs living with HIV/AIDS is chosen the services must
ensure that a continuity of care is offered by instituting care managers whose task is to
oversee and coordinate the different aspects of the patients care; Thus treatment must be
Accessible
Comprehensive and managed and if possible co-located.
Allow patients to participate in the design and delivery of the service
Include active outreach and peer support system.
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ACTIVITY 2 (30-45 minutes+ and half an hour for reporting back and discussion)
Work in small groups of 5-6.
Try to figure out a harm reduction advocacy strategy directed at your district/ provincial
authorities. You should assume that overall the country is willing to entertain harm
reduction approaches, but that as of now none (or too few) exist in your
neighbourhood /city /district /province. As a physician preparing to treat IDUs with ART
what would you say to policy makers and funding agencies? What do you see as the
major gaps in services? What can you /and your clinic do to improve the situation
9
(A)(B) Session three: Treatment of IDUs with ART
At the end of the session participants will
Be familiar with antiretroviral drugs and their side effects

Understand the potential interactions between ARV /methadone and other drugs
used in the treatment of diseases commonly found among IDUs
Using case studies, practice diagnosing and treating IDUS with ARV
a. Methadone and ARV
Methadone is an orally administered long-acting opiate agonist and is the most common
pharmacologic treatment for opiate addiction. Its use is associated with decreased heroin
use, improved quality of life, and decreased needle sharing. Pharmacologic effects and
interactions with antiretroviral medication occur and these may diminish the effectiveness
of either or both therapies by causing opiate withdrawal or overdose and/or increase in
toxicity or decrease in efficacy of ART. Pharmacologic interactions may produce either
changes in methadone concentrations, or changes in concentrations of the antiretroviral
agents being used. To meet these difficulties certain antiretroviral drugs are recommended
as more suitable for MMT patients because they cause less cross-tolerance and thus
undesired side effects. Careful monitoring of the situation and adjusting the drugs
accordingly can solve these difficulties.
(See table below for details about interactions)
Methadone is readily absorbed and then metabolized by several cytochrome P450

(CYP) enzymes and the methadone level may decrease when methadone is used
together with cytochrome inducers such as carbamazepine and rifampin --
necessitating higher doses.
Conversely, cytochrome inhibitors could raise methadone levels. In turn,
methadone inhibits the metabolism of zidovudine (AZT) and can elevate AZT
levels.
Alterations in antiretroviral concentrations, especially NRTIs, may result when
administered with methadone. At present 2 potentially relevant interactions have
been described. First, zidovudine concentrations are increased approximately
40% when administered with methadone. No empiric dose reduction is currently
recommended, but signs of zidovudine toxicity should be closely monitored.
Second, didanosine concentrations have been found to be reduced approximately
60% when administered with methadone. This may lead to didanosine
underexposure, incomplete viral suppression, and the development of resistance.
(These pharmacologic data are based on the buffered-tablet formulation of
didanosine, given twice daily. There are no data on the powder or enteric-coated
capsule formulations. Until more information is available use of the buffered
tablet didanosine formulations in methadone recipients should be avoided if other
options exist).
10
Studies suggest that nevirapine, efavirenz, and ritonavir decrease methadone

concentrations through induction of the cytochrome P450 system (principally CYP 3A4),
and produce clinically significant opiate withdrawal in some patients.
Signs and symptoms of methadone withdrawal typically occur 4-8 days after
starting a new drug and include chills, sweating, piloerection, nausea, diarrhoea,
abdominal cramping, rhinorrhea and lacrimation, myalgias, tremulousness, and
anxiety.
Precipitating opiate withdrawal may trigger relapse to heroin use, stopping

methadone treatment and leaving the methadone clinic. Furthermore this
discomfort may jeopardise distrust of medical providers, and lead to
unwillingness to take antiretroviral therapy.
Usually an immediate and a substantial increase in methadone dose is not

appropriate because the increase in methadone dose required is not as great as
might be expected from the pharmacokinetic data. Medical assessments should be
done frequently for such patients to monitor withdrawal symptoms, increasing
methadone dose in increments of 10 mgs from day 8-10 onwards.
Interactions between Antiretroviral medication and Methadone
ANTIRETROVIRAL EFFECT ON EFFECT ON COMMENT

AGENT METHADONE ANTIRETROVIRAL
AGENT
NRTIs
Zidovudine None AUC* by 40% Watch for nausea, vomiting,
asthenia, headache, and bone
marrow suppression in
recipients. If methadone trough
levels are normal, suspect that
problem is zidovudine toxicity
rather than methadone
withdrawal.
Didanosine None AUC by 60% This has only been studied with
twice-daily administration of the
buffered tablets and was
hypothesized to be due to
reduced bioavailability of
didanosine in the setting of
slower transit through the acidic
environment of the stomach in
patients taking methadone.
Additionally, there was great
interindivinjecting drug useal
variability in didanosine
pharmacokinetic data. The
effects of methadone on
didanosine powder or enteric-
coated tablet formulations are
unknown.
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Zalcitabine Unknown Unknown

Stavudine None AUC by 18% Decreased Stavudine
concentrations probably not
clinically significant.
Lamivudine None None No known interactions.
Abacavir clearance by 23% peak by 34% Data sparse, risk of opiate
withdrawal low.
time to peak
NNRTIs
Nevirapine AUC 46%, Unknown In a case series of chronic
withdrawal methadone recipients initiating
reported nevirapine, 50%-100% increases
in the daily methadone doses
were required to treat opiate
withdrawal. Withdrawal
symptoms generally occurred
between 4 and 8 days after
starting Nevirapine.
Efavirenz Levels Unknown See nevirapine.
Protease Inhibitors
Indinavir None None Studies limited, but no reported
interactions.
Ritonavir levels 35%-50% None Studies limited. Observe closely
for signs of methadone
withdrawal.
Saquinavir None None Studies limited, but no reported
interactions.
Nelfinavir levels 29%-47% None reported Clinical withdrawal was not
reported in studies in which
decreased methadone
concentrations were reported.
Amprenavir Unknown Unknown
Lopinavir/ritonavir Unknown Unknown Methadone withdrawal possible
from low-dose ritonavir.
b. Buprenorphine and ARV
Buprenorphine, is increasingly being used for opiate abuse treatment. Only limited
information is currently available about interactions between buprenorphine and
antiretroviral agents. In contrast to methadone, buprenorphine does not appear to raise
zidovudine levels. Pilot data indicate that buprenorphine levels do not appear to be
reduced and opiate withdrawal does not occur during co-administration with efavirenz.
c. ARV medication for methadone patients with chronic liver disease

Co-infection with Hepatitis B and C is common in among IDUs who are
HIV/AIDS infected. Chronic active infection with Hepatitis B and
alcoholic liver disease are also frequent. The resultant hepatopathy
may increase the risk of liver toxicity and impair the metabolism of
some anti-retroviral agents. However, despite the common association
between hepatotoxicity and antiretroviral agents, almost 90% of HIV+
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patients, regardless of whether they are co-infected by hepatitis

viruses, will tolerate ARV treatment without severe liver toxicity.
- Among the nucleoside analogues, hepatotoxicity has been more

commonly reported with AZT, ddI or d4T in the form of liver
enlargement, liver enzyme abnormalities and/or lactic acidosis.
Abacavir or 3TC have also been involved but at a lesser degree.
- Among the non-nucleoside reverse transcriptase inhibitors

(NNRTI) hepatic toxicity has been associated with efavirenz but
appears more frequent and severe with nevirapine.
- The protease inhibitors are often associated with mild

hepatotoxicity. Ritonavir, especially if administered at full doses as
a single PI is significantly more hepatotoxic than the others. Unlike
the hepatotoxicity associated with NNRTIs which turns up during the
first weeks of therapy in most cases, that associated with PIs can
appear at any time during the treatment.
In managing these patients it is helpful to classify them according to

the degree of liver damage:
d. ARV treatment for methadone patients with tuberculosis (TB)
Rifampin plays a fundamental role in the treatment of patients with active TB and is the
one medication crucial for ensuring success of short-course (6 months) chemotherapy.
Rifampin and rifabutin both interact with both methadone and with ARV and therefore an
IDU at a methadone clinic who needs both ARV and TB treatment should be referred to a
specialist TB clinic for assessment
Methadone interaction: Rifampin accelerates the clearance of methadone by the liver.

Therefore, patients on methadone who take rifampin will need on average a 50% increase
in their methadone dose to prevent opiate withdrawal. However, it must be noted that
when patients receive this increased dose of methadone, they risk overdosing on
methadone if they fail to take the rifampin. Therefore, directly observed therapy (DOT) to
ensure adherence to TB treatment is essential for all patients who take methadone and
rifampin together
Interactions with ARV: There are numerous drug interactions between antiretroviral
drugs and rifampin and rifabutin (some are listed below). For information on the
management of both TB and ARV see module xx.
However, because patients attend the methadone clinics daily TB DOT as well as ARV
DOT are both feasible and recommended.
Summing up: it is should be noted that
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Just because certain drugs/substances can interact does not mean that they will or how
severe the side-effects may be.
Methadone works best at adequate therapeutic doses: however, due to individual
variability in methadone absorption and metabolism it becomes difficult to predict in
advance the effects of drug combinations and what adjustments might be necessary
If a patient is responding unexpectedly or unfavourably to methadone or to ARV a
search for other drug combinations would be appropriate. A comprehensive history
from the patients is important.
It must be noted that additional analgesics may be needed to treat acute or chronic pain in
the HIV-infected drug users who are on methadone maintenance treatment, because often
these patients do not obtain adequate pain relief from their usual daily dose of
methadone, to which they have become tolerant.
14
ACTIVITY 3: Clinical role play drug users on ARV

To be added in Indonesia
Suggest that these cases be discussed in pairs (give the same cases to a number of pairs)
Ask one person to be the doctor and the other the patient and then to switch around.
Apply knowledge on prescribing and dosing of ARV to methadone patients using case
studies
Try to determine what questions need to be asked to make sure that things are going
well, how to diagnose when there is a problem, and what action (if any) should be
taken.
Cases to be illustrative of
a. Mild side effects from ARV
b. Methadone/ARV interaction
c. A case of an IDU with Hep C with evidence of liver toxicity
d. A case of an IDU in TB treatment
e. A case of a pregnant IDUs
For each case illustration chose an ARV drug regimen to help illustrate the point some
should indicate that a change should be made, and others, that reassurance and
explanations are sufficient (e.g. for the mild side effects)
Discuss cases with colleagues, trainers and invited guests from the local AIDS
clinic/hospital ward. Use real cases where available.
To assist in deciding what should be done use:

Information on expected side effects from ARV regimens
The table on methadone/ARV interactions
The table on regimen changes
The information on which drugs are indicated or counter-indicated for IDUs with
liver disease and TB
15
Session Four: Identifying and overcoming barriers to adherence,
At the end of the session participants will be able to

Assess the potential barriers to adherence to ART
Work with patients to enhance adherence
What is meant by adherence and why is it important?
As the human immunodeficiency virus cannot be fully eradicated by antiretroviral

medication, the goal of ARV treatment is too achieve maximal and sustained virus
replication. This can only be achieved if the patient adheres to the treatment.
Definition
The extent to which a persons behaviour taking medication, following a diet

and/or executing lifestyle changes, corresponds with agreed
recommendations from a health care provider.
WHO (2003) Adherence to Long Term therapies: Evidence for Action
Adherence to ART is very important:
Adherence of >95% is needed

Treatment failure rate increase sharply as adherence decreases
The consequences of poor adherence include:
Incomplete viral suppression

Continued destruction of the immune system
AIDS Disease progression
The emergence of medication resistant viral strains.
Treatment failure rate increase sharply as adherence decreases
Note: There are many forms of non-adherence and the counsellor needs to be aware
of them. (e.g. missing one dose / multiple doses/ days), not observing the intervals
between doses).
It is important to assess the patients readiness for ARV treatment in order to ascertain
whether the patient understands his/her disease, whether s/he is able to make a
commitment to life long treatment and in order to determine what are the problems that
may prevent the patient from regularly adhering to treatment. This task will be
undertaken in the AIDS clinic by the doctor, the counsellor of both working together.
It is important to remember that:

Drug abuse/ drug addiction is a complex health condition and behaviour that frequently
requires long term interventions. There is no one formula for ensuring either abstinence
of adherence
What are the major treatment barriers experienced by IDUs
16
Need to be abstinent from drugs

Difficulty in maintaining abstinence
Difficulty in finding suitable treatment such as substitution
treatment
Experience of stigma and discrimination from health care staff
Side effects from ARV (See annex 2 for details of mild and major
side effects for 4 of the commonly used treatment regimens).
What are the potential systemic shortcomings that may hinder adherence?
Lack of comprehensive drug treatment that includes harm

reduction services such as substitution treatment and needle and
syringe programmes for those unable to sustain abstinence
Non-existence or insufficient adherence support systems in the
community including counselling, outreach, peer support groups
etc
A lack of user-friendly primary health care for IDUs
Negative attitudes of health care providers and patients
experiences of stigma and discrimination
It should be noted that there is a tendency to focus on patient-related factors as the causes
of problems with adherence to the relative neglect of providers and health system related
factors. However, the treatment environment has a considerable effect on patients, thus
both individual patients and systemic issues must be addressed.
Below is recommended checklist of the areas, which the physician and patient (with the
help of a counsellor/nurse /peers and family) need to explore prior to the initiation of
ART
Assessment of potential barriers to adherence
Social and economic circumstances including environmental factors including age, sex,
Social and economic factors such as living conditions, family/ dependents, support from
family/friends, NGO, employment housing, income, family understanding and support
Health system factors including health care professional knowledge, training and attitude,
accessibility of service, knowledge about adherence, case management
Severity of the HIV disease, co-morbidities, symptoms and OIs, rate of progression of the illness
Therapy related factors such as complexity of the treatment regimen, diet, side effects, and the
availability of medical staff to deal with these issues
Patient related factors are the resources, knowledge, attitudes, health beliefs, perception of
HIV/AIDS and of the usefulness treatment. Patients attitudes to their drug use. Patients
adherence may be affected by psychosocial factors, forgetfulness, anxieties about side-effects,
low motivation, inadequate knowledge on how to manage treatment, misunderstanding and non-
acceptance of the disease, hopelessness and negative feelings,
Factors related to the HIV disease and to drug dependence. These may include both physical and
psychological factors, the: Attitude and motivation for treatment (including mental
state/depression, commitment)
Logistic factors including accessibility to treatment facility, ability to pay treatment and travel cost.
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Having identified the major areas of vulnerability and concern it is the task of the health
care staff to identify strategies to overcome these difficulties. Interventions to promote
adherence need to address all dimensions and it is recommended that physicians avoid
focusing on just one or two prominent factors to the exclusion of the others and consider
the logistics needed to ensure the patient is able to adhere to treatment.
Some of the strategies that may be explored include

Social and economic interventions The main issues here concern poverty, access to
health care facilities and medication and sometimes illiteracy linking
patients with potential resources in the community e.g. AIDS support
groups and with others receiving the same treatment (i.e. peer support
groups).
Health system interventions many health providers are nave and ill informed about
adherence, and lack the knowledge to evaluate and intervene when
adherence difficulties occur hence the need for trained counsellors
Patient-related interventions these barriers are especially significant if the treatment
necessitates changes in behaviours and lifestyle. IDUs now in methadone have to attend a
clinic daily, and try to relinquish their drug using friends and contacts. When using drugs
much of their time was spent in securing, buying and using drugs, now they may find
themselves with time to spare and no work to go to. Patients need to be helped to manage
their disease and their medication. More specifically,
Patients should be given education and information about their treatment
Working on motivation for treatment and the development of skills to cope with
the demands of treatment.
Assisting patient to integrate ART into daily routine
Encouraging and ensuring family involvement
Linking patient with a buddy system and providing regular peer group support,
outreach and transport as indicated.
Providing adherence reminder cues: e.g. pill boxes, medication diaries
Directly observed therapy DOT where practical
Combining ART with MMT wherever possible
Adherence monitoring and counselling should be done at each clinical encounter whether
with the physician or the nurse/counsellor. Early detection of non-adherence and
appropriate intervention may reduce treatment failure. As already indicated clients have
to be clear and committed to the agreed treatment and understand that on the whole the
first drug regimen started if followed appropriately, allows for the best chances of
success. It is important for the physicians to understand that if the treatment environment
is set up properly than patients who experience difficulties with adherence will feel able
to contact the treatment team without too much delay.
Clinical adherence monitoring has been discussed elsewhere in this training. However it
is well to be reminded of a number of basic guidelines: Physicians should endeavour to
be non-judgmental towards their patients. Where things are not going well physicians
18
may wish to discuss adherence difficulties with patients. It is helpful in such a situation to
use
Prompts to help recall e.g. include asking about daily routines and
determining whether anything has changed (which may effect adherence)
Using pill count and asking about missing doses.
Examining medication diaries and pill boxes and encouraging clients to
keep those up-to-date.
Checking that the agreed medication regimen is still suitable to the client
life style (e.g. if client started work daily schedule may change and it
may be possible to adjust the medication schedule)
Factors that may impact on continued adherence thus include many variables not all of
which can be predicted at the onset of treatment. These might include
The level and progression of the HIV disease

Unexpected unpleasant side effects
Interaction with methadone
Methadone prescribed at too low a dose leading to relapse into injecting drug
use
Fro those not in substitution treatment - relapse from abstinence
An unexpected breakdown of peer or family support
The difficulties in achieving the necessary behaviour change that is required for
successful adherence and the extent to which normal life is disrupted by the
treatment.
A number of strategies can be recommended to IDUs: These include:
Informing clients and anticipating side effects

Carefully monitoring side effects
Adjusting medication if necessary
For abstinent drug user in AIDS clinics - alerting family/ and support personnel if
relapse occurs
Ensuring for IDUs on methadone that the dose is appropriate to the regimen and
that drug users do not experience withdrawal symptoms
Ensuring that IDUs feel able to discuss their concerns with the treatment
personnel
Helping clients to establish a regular time to take the medication and learning to
make forward plans for any change of routine.
Summing up: Lessons learnt about Adherence
Clients need to be supported not blamed

The consequences of poor adherence to long term therapies are poor health
outcome and increased health care costs
Ensuring adherence helps sustain health gains from ART
19
Health and social support systems must develop and evolve to enable it to meet
the new challenges in health care.
A multidisciplinary approach to health care is needed.
(Adapted from WHO, 2003)
PROVIDE PATIENTS
Take home information about their HIV/AIDS disease, about Hepatitis B and C and TB
and about OIs
Take home information about ARV medication
Take home information about sources of support (NGOs, peer support groups etc)
PROVIDE FAMILIES
Take home information about HIV/AIDS and about ARV medication
Take home information about drug treatment (especially methadone if available).
20
ACTIVITY 4: Group work- Overcoming adherence difficulties
Four Case Studies

Questions to consider by small groups suggest that one member of the group takes the
patient role and one is the doctor. Group to observe and then offer suggestions and
recommendations (and criticism if indicated):
Suggest case scenarios to be developed in Indonesia
- case one methadone patient experiencing mild side effects from ART
- case two Abstinent patient in AIDS clinic reporting that s/he has been using heroin
occasionally, support system fallen by the wayside
- Case three IDU in methadone suffering from liver disease and feeling too sick to
come to methadone clinic
- Case four drug user feeling OK no symptoms and wanting to stop ART and
methadone and move to another town to get married
Groups to consider:
Is the presenting problem the real problem? What else may be going on in the patients
life?
How serious is the problem? Has the patient been well informed about treatment? What
support systems have been established? How are they working?
What efforts have already been made to ensure adherence?
What actions should be taken by the doctor?
21
Annex 1: DRUG USE AND HIV/AIDS IN INDONESIA

(To be completed and updated as necessary)
a. Who are the drug users in Indonesia?
Profile: numbers, age, demography

It is important to remember that drug use is a chronic relapsing disease.
b. HIV/AIDS in Indonesia
HIV infection has been reported in 27/30 provinces in Indonesia

However, the HIV/AIDS epidemic is a concentrated epidemic, with certain
locations have extremely high rates of HIV/AIDS
In July 2004 there was an estimated between 53,000 - 189,000 PLWHA in
Indonesia.
Two main routes of transmission in Indonesia are sexual (low condom use among
high-risk population) and IDUs who engage in high rates of needle sharing in
addition to practising unsafe sex.
c. IDUs living with HIV/AIDS in Indonesia
Indonesia has between 124,000- 196,000 injecting drug users of whom an

estimated 58% are HIV infected.
Data from prisons, rehabilitation and outreach centres show an HIV incidence of
between 24-90% among young and sexually active IDUs
xx% of all HIV/AIDS infections are injecting drug users (IDUs)
The National HIV/AIDS strategy 2003-7 states that harm reduction activities
should be employed to reduce HIV infection among injecting drug users.
The Sentani Commitment signed on the 19th January 2004 by 6 priority
provinces. Agreement was reached to- reduce the harm of intravenous narcotics
injection
WHO estimates (Dec 2004) that 11,500 need antiretroviral treatment
It is likely than many patients presenting for AIDS treatment are likely to be drug
users.
d. Current services for drug users in Indonesia in including harm reduction services
Detoxification services are provided by many state and private general and
mental hospitals
Rehabilitation is provided by state social rehabilitation centres and in the private
sector and by NGOs. Police rehabilitation is also available in Jakarta.
Therapeutic communities are available and run by NGOs.
Religious approach rehabilitation centres are run by Muslim, Catholic and
Protestant groups.
Methadone treatment currently available in two sites (Jakarta Drug Dependence
Hospital and Sanglah General Hospital in Denpasar Bali) and will hopefully be
extended to other provinces/ regions and prisons
22
xx needle and syringe programmes ? ..

Buprenorphine substitution is available and can be purchased in the pharmacy
with a doctors prescription
NGO services that focus on abstinence (e.g. T.C, drug rehabilitation services)
INGO and NGOs outreach, peer education, case management
e. HIV/AIDS treatment for IDUs
Antiretroviral treatment is available from x designated hospitals and are planned to

increase to xx in 2005. Despite the preponderance of IDUs infected with HIV/AIDS it is
not clear how many are now receiving ART. It is estimated as many as half of the
patients receiving ART are former drug users. It is unclear whether any active drug
users are among those prescribed ARV.
f. The development of Harm Reduction approaches in Indonesia
These have been now accepted in Indonesia since xxxx and pilot substitution treatment
and needle and syringe programmes? are ongoing. The government is planning a major
scale up of these facilities.
23
Annex 2: ANTIRETROVIRAL MEDICATION SIDE EFFECTS
It is important for counsellors to be aware of the potential side effects of ARV and of the
interactions between methadone and ART. Counsellors are likely to see clients more
frequently than physicians and to be in close touch with the case manager for the client
(or sometimes be the case manager) they should be able therefore to help the client
recognize and deal with these drug interactions and to alert the physicians when they
occur.
Below is a summary of some of the major side-effects that may occur with 4
antiretroviral drug combinations that may be used in Indonesia (WHO recommended
combinations).
a. AZT (ZDV)-3TC-NVP
Common minor side effects Major toxic effects

Severe anaemia ((ZDV)
Nausea Muscle tenderness or inflammation
Diarrhoea Liver toxicity
Headache Lactic acidosis (ZDV) can present as
Fatigue fatigue or shortness of breath
Mild rash Severe rash (NVP)
b. d4T-3TC-NVP
Common minor side effects: Major toxic effects:

Neuropathy (d4T) (usually after weeks or
Insomnia months)
Nausea Fat changes arms, legs, buttocks and cheeks
Diarrhoea become thin; breasts, belly, back of neck gain
Headache fat (d4T)
Fatigue Pancreatitis presents as abdominal pain (d4T)
Abdominal discomfort Liver toxicity: jaundice or liver tenderness (NVP)
Mild rash Severe rash (NVP)
Lactic acidosis (d4T) can present as fatigue or
shortness of breath
Fever (NVP)
c. ZDV- 3TC-EFV

Nausea
Diarrhoea Severe anaemia (ZDV)
Headache Muscle tenderness or inflammation (ZSV)
Fatigue Liver toxicity
Somnolence Lactic acidosis (ZDV)
Insomnia Severe rash (EFV)
Confusion Severe confusion, psychosis, depression (EFV)
Nightmares
Dizziness
24
d. d4T-3TC-EFV

Somnolence Neuropathy
Insomnia Fat changes arms, legs, buttocks and cheeks become
Confusion thin; breasts, belly, back of neck gain fat (d4T)
Nightmares Pancreatitis (presents as abdominal pain) (d4T)
Dizziness Lactic acidosis (4dT) can present as fatigue or cough
Nausea after months of treatment
Diarrhoea Liver toxicity (EFV)
Headache Severe rash (EFV)
Fatigue Severe confusion, psychosis, depression (EFV)
Rash
(Source: WHO Guidelines on Chronic HIV Care with ARV therapy -2004)
25
Annex 3: Dealing WITH DRUG SIDE EFFECTS: changing the medication1
As already indicated many of the ARV drugs have minor or major side effects. When this
happens physicians are advised to treat the symptoms if possible and to advise and
counsel the patients if it is expected that the side effects are short-term and expected to
disappear after a few weeks. However it may sometimes be necessary to change the
medication. The table below provides suggestions of how ARV drugs may be substituted
if needed.
If cross tolerance becomes a problem the physician can change ART in the following
recommended way:
Regimen Toxicity Drug substitution
D4t/3TC/NVP D4T- related neuropathy or pancreatitis D4T to ZDV
D4T-related lipoatropy Switch d4T TDF or
ABC
NEV-related severe hepatotoxicity Switch NVP EFV
(except in pregnancy)
NVP related severe rash (but not life Switch NVP to EFV
threatening)
NVP related life threatening rash (Stevens- Switch NVP to PI
Johnson syndrome)
ZDV/3TC/NVP ZDV-related persistent GI intolerance or Switch ZDV d4T
severe haematological toxicity
NVP severe hepatotoxicity Switch NVP EFV
(except in pregnancy
in that situation switch
to NFV, LPV/r or ABC
NVP related (but not life threatening) severe Switch NVP to EFV
rash
NVP related life threatening severe rash Switch NVP to PI
d4T/3TC/EFV d4T related neuropathy or pancreatitis Switch d4T ZDV
d4T related lipoactrophy Switch d4T TDF or
ABC
EFV related persistent CNS toxicity Switch EFV to NVP
ZDV/3TC/EFV ZDV related persistent GI intolerance or Switch ZDV to d4T
severe haematological toxicity
EFV persistent CNS toxicity Switch EFV to NVP
Note:
Switching off d4T typically does not reverse lipoatrophy but may slow its progression.
TDF and ABC can be considered as alternatives but availability is currently limited in
resource- constrained settings. In the absence of TDF or ABC availability ddl or ZDV are
additional alternatives to consider.
PI can be LPV or SQV/r. IDV/r pr NFV can be considered as alternatives
It is important to note that additional analgesics may be needed to treat acute / chronic
pain in HIV infected drug users who are on methadone maintenance.
1
See annex 2 for details of mild and major side effects from 4 ART regimens
26
Annex 4: SCREENING FOR DRUG /ALCOHOL PROBLEMS
Screening: If the physicians suspects or knows that the patient has or has had a drug
problem a quick screening questionnaire will help determine whether the matter is a
problem that requires further investigation.
The questionnaire below will indicate in broad terms whether the patient has a drug
problem and indicate whether the physician needs to explore the issue further.
Please answer every question.
These questions refer to the previous 12 Months
Yes No
1 Have you used drugs other than those prescribed to you for the
treatment of a medical condition
2 If yes, did/do you inject drugs?
3 Are you able to stop using drugs when you want to?
4 Have you in the last year needed medical treatment because of
your drug use? (e.g. overdosed. Had abscess, hepatitis C etc)
5 Do you ever feel guilty about your drug use?
6 Does your family complain about your drugs use?
7 Have you had any problems with the law (the police) because of
your drug use?
8 Have you experienced withdrawal symptoms (felt sick) when you
stopped taking drugs?
9 Have you neglected your family because of your drug use?
10 In the last year you had medical problems as a result of your drug
use (e.g. memory loss, hepatitis, convulsion, bleeding)?
Interpretation: ("Yes" response = 1, No = 0)
Score indicates the Degree of Problems Related to Drug Abuse
Suggested Action
0 No Problems Reported None needed
1-2 Low Level Monitor, Reassess at a later date
3-5 Moderate Level Further investigation are indicated
6-10 Substantial Level Intensive assessment is indicated
Adapted from: Drug Abuse Screening Test (DAST-10)
If further investigations are indicated a full drug history should be taken to determine
patients drug use past and present. The areas to be included are:
Drug use, including onset of use of each drug, frequency (number of days using per last
27
30 days), and route of administration, major drug (s) of abuse

Drug treatment history, (when and where, type of treatment e.g. TC/ hospital,
Emergency), and reason for admission for treatment, periods of abstinence
Sharing needles/syringes, cookers, or other drug use paraphernalia
Problems related to drug use, such as blackouts; withdrawal symptoms; overdose;
familial, employment, or legal complications (trouble with the police, arrests,
imprisonment, time spent in prison; suicide attempts
Known medical problem(s) due to drug use, including accidents, psychiatric admissions,
and suicide attempts
Role of drugs in daily functioning, including how money is raised to purchase drugs
Please note: it is useful to ask about
- Lifetime drug use (overall)
- Last 12 months (more detail)
- Last 4 weeks (as detailed as possible)
If patients are diagnosed to be still using drugs the following matters should be explored:
Drug related risk behaviours:
Is patient continuing to inject now that HIV/AIDS diagnosis has been confirmed
How many injections does the patient need on an average day?
Is patient sharing needles and syringes?
If yes, are they cleaned? If yes, how?
Has the patient thought about drug treatment? Has a drug treatment programme been
approached?
If a methadone clinic is available enquire whether MMT has been considered.
However, it is important to remember that as drug use is an illegal activity and

therefore in order to ensure truthful answers doctors should be non-judgmental and
re-assure patients that any disclosure of past or present drug use to the doctor is
confidential and will not put the patient at risk of arrest.
28
CAGE alcohol problems questionnaire
Yes No
Have you ever felt you should cut down on your drinking?
Have people annoyed you by criticizing your drinking?
Have you ever felt bad or guilty about your drinking?
Have you ever had a drink first thing in the morning to steady your
nerves or to get rid of a hangover?
Scoring: Item scoring on the CAGE is one or Zero with a higher score an indication
of alcohol problems. A total score of 2+ is considered clinically significant.
Source: American Psychiatric Association & NIAAA
If indicated the physician may wish to use a further questionnaire to determine whether
the patient is actually alcohol dependent. For this see the SADQ questionnaire in Annex x
29
Annex
SEVERITY OF ALCOHOL DEPENDENCE (SADQ) self completion
questionnaire
Name:
Sex: M/F DOB: Age:
Have you drunk any alcohol in the past six months? YES / NO
If YES, please answer the following questions by ticking the most appropriate response.
SECTION A During the past six months have you:
Never/Almost Sometimes Often Nearly

Never Always
1 After having just one or two drinks, I
felt like having a few more
2 After having two or three drinks, I
could stop drinking if I had other
things to do
3 When I started drinking alcohol, I
found it hard to stop until I was fairly
drunk
4 When I went drinking, I planned to
have at least six drinks
5 When I went drinking, I planned to
have no more than two or three
drinks
SECTION B SADQ Form C During the past six months:

never always
1 The day after drinking alcohol, I
woke up feeling sweaty
2 The day after drinking alcohol, my
hands shook first thing in the
morning
woke up absolutely drenched in
sweat
4 The day after drinking alcohol, my
whole body shook violently first thing
in the morning if I didnt have a drink
dread waking up in the morning
6 The day after drinking alcohol, I was
frightened of meeting people first
thing in the morning
7 The day after drinking alcohol, I felt
at the edge of despair when I awoke
8 The day after drinking alcohol, I felt
very frightened when I awoke
9 The day after drinking alcohol, I liked
30
to have a morning drink

never always
10 The day after drinking alcohol, in the
morning I always gulped my first few
alcoholic drinks down as quickly as
possible
drank more alcohol in the morning to
get rid of the shakes
12 The day after drinking alcohol, I had
a very strong craving for an alcoholic
drink when I awoke
13 I drank more than a quarter of a
bottle of spirits in a day (or 1 bottle of
wine or 7 middies of beer)
14 I drank more than half a bottle of
spirits in a day (or 2 bottles of wine
or 15 middies of beer)
15 I drank more than one bottle of
spirits per day (or 4 bottles of wine or
30 middies of beer)
16 I drank more than two bottles of
spirits per day (or 8 bottles of wine or
60 middies of beer)
SECTION C SADQ Form C Imagine the following situation:
1. You have hardly drunk any alcohol for a few weeks.

2. You then drink very heavily for two days.
How would you feel the morning after those two days of heavy drinking?
Not at all Slightly Moderately Quite a
lot
1 I would start to sweat
2 My hands would shake
3 My body would shake
4 I would be craving for a drink
Scoring:
Items 1,3 and 4 of the Section A is scored on a 4 point scale ranging from 0 (never or almost
never) to 3 (nearly always). Items 2 and 5 are scored in reverse with a score of 0 (nearly always)
to a score of 3 (never or almost never).
The 20 items of the SADQ are all scored as follows:

0 = never or almost never; not at all
1 = sometimes; slightly
2 = often; moderately
3 = nearly always; quite a lot
Scores from 1 20 can be considered indicative of mild alcohol dependence

Scores from 21 40 can be considered indicative of moderate alcohol dependence
Scores of over 40 indicate severe alcohol dependence
Sources: Hodgson, Stockwell and Taylor (1979)
31

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Pelatihan Lanjutan Perawatan, Dukungan dan Pengobatan Bagi ODHA

Jakarta, 25 30 April 2005

Antiretroviral treatment (ART) for injecting drug users

At the end of the session, participants will:

Time to complete the module

1 day (Four 2 hour sessions)

Training materials to be prepared

Content (to be completed

NOTES FOR TRAINERS

This is module is designed for the training of

B. Doctors working in Methadone clinics: It is assumed that doctors

Sections marked AB includes training material which is applicable to both groups of

Annex 1 Provides background country information on drug use and HIV

At the end of these two sessions participants will:

Drug users will be unable to adhere to ARV treatment

(a) Understanding drug abuse

(b) What are the major features of drug use?

Drug abuse is manifested by the excessive and repeated use of a

Drug users may experience a number of serious health problems as a consequence of

In Annex 3 can be found are a number of recommended standardised assessment and

(d) What treatments are available for drug users?

There are a number of treatments and interventions modalities focusing on substance

(1) Abstinence based approaches

(2) Harm reduction interventions

Harm reduction is a comprehensive package of policies and programmes

Resistance to widespread acceptance and implementation of harm reduction approaches

ACTIVITY 1 (30-45 minutes discussion +15-20 minutes for reporting back)

Small group discussion (5-6):

This session to be followed up by country information about HIV/AIDS to be updated as

The IDUs HIV nexus: How is HIV/AIDS transmitted among IDUs?

o HIV infection spreads easily when people share contaminated equipment

(f) Options for offering ART to IDUs

There are a number of different ways of delivering antiretroviral medication to IDUs.

(f.1) The advantages of combining ART with substitution treatment:

Where substitution therapy is available consideration should be given to offering HIV

Both are long term treatments

Work in small groups of 5-6.

(A)(B) Session three: Treatment of IDUs with ART

At the end of the session participants will

Be familiar with antiretroviral drugs and their side effects

a. Methadone and ARV

(See table below for details about interactions)

Methadone is readily absorbed and then metabolized by several cytochrome P450

Studies suggest that nevirapine, efavirenz, and ritonavir decrease methadone

Precipitating opiate withdrawal may trigger relapse to heroin use, stopping

Usually an immediate and a substantial increase in methadone dose is not

Interactions between Antiretroviral medication and Methadone

ANTIRETROVIRAL EFFECT ON EFFECT ON COMMENT

Zalcitabine Unknown Unknown

b. Buprenorphine and ARV

c. ARV medication for methadone patients with chronic liver disease

patients, regardless of whether they are co-infected by hepatitis

- Among the nucleoside analogues, hepatotoxicity has been more

- Among the non-nucleoside reverse transcriptase inhibitors

- The protease inhibitors are often associated with mild

In managing these patients it is helpful to classify them according to

d. ARV treatment for methadone patients with tuberculosis (TB)

Methadone interaction: Rifampin accelerates the clearance of methadone by the liver.

Summing up: it is should be noted that

ACTIVITY 3: Clinical role play drug users on ARV

To assist in deciding what should be done use:

Session Four: Identifying and overcoming barriers to adherence,

At the end of the session participants will be able to