Adherence Preparing to start

ARVs
Dr. Kevin M Harvey
MBBS, MPH (UWI), Dip. ID (Lon.)
Treatment care and support
2006

What do we know?:HIV Treatment in 2004

Many regimens are active in people with no drug resistance
Measured as suppression of virus (lowering plasma viral load to
under detection) or other response to treatment (CD4, clinical,
weight etc)

But treatment after resistance develops is still a challenge

and usually requires more complicated and/or more
expensive regimens
In addition resistant virus can be transmitted
Failure carries a high price on an individual, financial and
public health
Finding the reasons and preventing failure is therefor critical

Why does antiretroviral therapy fail?

Not a cure
Efficacy
Drug toxicity
Drug interactions
Drug resistance
Adherence issues lifelong therapy
Cost

Failure of Therapy: Types of failure

Clinical failure
Progression of disease, new infections

Immunologic failure
Decline in CD4 count

Virologic failure
Persistent viral replication (usually associated with resistance)

Drug toxicity
Severe side effects

Infrastructure failure
Lack of drug supply, lack of money to pay for drugs

ART in the Real World

Many clinical trials show suppression of virus in
>80% of subjects
BUT, studies in a multitude of clinical settings have
shown only 50-70% success rates with multipledrug therapy at 1-2 years
WHY?
While baseline resistance and poor prescribing
contribute, poor adherence accounts for many of
these failures*
As HIV turns from a uniformly fatal illness to a
chronic disease, adherence grows even more
important
*Estimates from 40-80% report some non-adherence

Adherence

Adherence
Compliance
Concordance
Taking the medication/following the regimen as directed
(dose, timing, diet etc etc) with follow-up and care as
directed
WHO: 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.

Adherence in other diseases*

Poor adherence to treatment of chronic diseases is a worldwide

problem of striking magnitude
Average of 50% in most diseases
Ex. Non-adherence accounts for a significant percent of admissions in
patients with heart failure

The consequences of poor adherence to long-term therapies are

poor health outcomes and increased health care costs

Increasing the effectiveness of adherence interventions may have a

far greater impact on the health of the population than any
improvement in specific medical treatments
A multidisciplinary approach towards adherence is needed

*WHO. Adherence to long-term therapies: evidence for action,

2003.

WHO. Adherence to long-term therapies:

evidence for action
Adherence is simultaneously influenced by several factors
Factors include:
Medication
Ex. Dose frequency, side effects

Patient
ex. Readiness, substance use

Health care system/providers

Ex. Patient provider relationship

Treatment education
DOT
cost

Community/environment
Ex. Stigma, transport

Adherence is a dynamic process that needs to be followed up

Improving long-term adherence is complex and required continuous support and
monitoring

Health professionals need to be trained in adherence

Family, community and patients organizations: a key factor for success in

improving adherence

Why is HIV different

Excellent adherence in other diseases is
considered >60-70%
Adherence rates for HIV need to be higher
>95%

Non adherence with HIV carries very high risk of

virus developing drug resistance
Once resistance develops, that drug (and possibly
others) will never work as well or may not work at
all
Communicable disease

Adherence and viral suppression

Percentage of Medication Taken
<80%

80% to 95%

95% to 99%

100%

50

Percent
40
of
patients
with 30
viral
load
20
<500
copies
10

2 Months

6 Months
Haubrich RH, et al. AIDS 1999;13:1099-107.

HIV, adherence and clinical

significance
Better adherence is also linked with
decreased risk of getter sicker from HIV
infection, losing more CD4 cells, and dying
from HIV

Adherence in resource richer areas

Average rates of adherence vary widely, but generally fall
well short
Percentage of patients with treatment failure in clinical
practice reflect a combination of non adherence and
resistance:
USA
Amsterdam
Swiss

50%
40%

nave
experienced

38%
70%

Johns Hopkins
Cleveland

63%
53%

Adherence to ARVs treatment over time

100
90
80
70
Percent
reporting
100%
adherence

60
50
40
30
20
10
0
1 month

4 months

8 months

*p<0.01 for difference between months 1 & 4 and months 1 & 8

Mannheimer et al, CPCRA, 2000.

Adherence in Resource-limited
settings
In programs with self-pay, cost is not
always the major barrier to adherence
Innovative approaches to support adherence
before and during treatment are being used

Adherence to ARVs in resource-limited settings:*

Uganda: 88%
Cote dIvoire: 75%
Haiti: 88%
Senegal: 78%-88%
South Africa: 89%
Brazil: range: 57%-87%
Botswana: ~55%
Nigeria: 58%
Kenya: 59%

Adherence is as problematic in resource-limited settings as it

is in resource-rich settings. No evidence to show that it is
more problematic.
* NB: small studies, differing definitions of adherence

Adherence in resource limited

settings
African Countries
Strong pre treatment
education and screening,
counselors and treatment
buddy
High rates of adherence,
viral suppression
Need to determine critical
components for scale-up

100
90
80
70
60
50
40
30
20
10
0

Cootzee, AIDS 18 suppl 3, 2004

6
months

viralload
<400

24
months

Predictors of nonadherence: Medication

related
dosing frequency
side effects
Number of pills
?type of medication
?complexity of regimen

Patient-related

Active substance abuse

Depression
HIV knowledge and knowledge and belief in
medications
Literacy (?more of a system problem)
Non-adherence to care
Stage of readiness
?Distance from site
?age
?disclosure

System-related

Cost of care/treatment
Access to care and medications
provider/patient relationship
Stock-outs
?employment out of the home
?transportation
?stigma

Non-predictors
Non-predictors include
Race
gender
prior substance abuse
social status or income
education

Other reasons people do not take

their ART

Pill fatigue
Forgot
Pills not with them
Transportation
Fear of disclosure
Concern with drug interactions (prescribed or
other)
And others

Preparing for Adherence

More sustainable response to ARVs if
adherence is optimized within the first three
to six months
Must therefore prepare individuals to
adhere prior to the start of ARVS
Must also have a strategy to sustain
adherence throughout life

Preparing for ARVs

Culture
Access +Knowledge + Motivation+Cues to Action
Stigma & Discrimination

ADHERENCE

Access
Potential Barriers

Distance from Clinic

Appointment system
User Fees
Availability of Service
Confidentiality
Stigma & Discrimination
Cost for CD4,Viral Loads +
other labs
Cost of other Medicines
Cultural Practices

Possible Solutions
Telephone Appointments
Waiver from User Fees
(free does not =Access)
Waiver from General fees
& lab cost via assessment
Process
Refer closest acceptable
Treatment site
Assistant with Bus Fares
Register with the NHF
Family support

Knowledge
Potential Barriers

Believes
Culture
Myths
Low literacy
Lack of Exposure to
Specific HIV Education
Educational Material
inappropriate

Possible Solutions
Appropriate Literacy
Material for Individual
HIV Basic Facts
Condom Negotiation
Skills
Name etc of Specific
Meds

Motivation

Potential Barriers

Depression
Number of pills
Frequency of doses per day
No Family support
No disclosure /fear disclosure
Negligence/ forgetfulness
Unemployment
Lack of privacy

Possible Solutions
Refer to Social Worker
Mental Health Professional
Reduce the number of pills If
possible link meds to
something the patient does that
they enjoy
Refer to support groups

Encourage disclosure,
provide temporary support
encourage buddy system
Channel to income generating
projects

Cues to Action
Barriers
Non Disclosure and
lack of support
Drug addiction
Stigma and
Discrimination
Attention drawn by
Reminders
Pill boxes can be too
big
Late refills
Cognitive function

Possible Solutions

Family Support
Media
Pill Boxes
Text Messages
Alarms
Link to Favourite radio
and TV programmes
Support at workplace

Culture
Barriers
Patients only listen to
doctor
Alternative Medicine
Can provide a Cure
Role of the Church
Myths

Solutions
Patients will listen to
Doctors
Alternative(Herbal
Medicines) can be
immune boosters
Education of Clergy

Stigma & Discrimination

Potential Barriers
Fear Discrimination
Lack of or Low Public
education
Remove Labels
Fail to take meds in
Public
Move away from
district
Do not want to attend
Clinic in Own district
Visible side effects

Possible Solutions
Confidentiality at the
work place is key
Reduced stigma and
discrimination at work
place
Refer to acceptable
treatment site or
facilitate easier access

Supportive Environment
Knowledge

Motivation

Positive Behaviour Change

Increased Adherence

Family-Focused Adherence
Support

It may take several weeks and several visits to ready the family
for treatment.

Before prescribing
Family is part of and agrees with treatment plan
Assess family life-style, priorities, beliefs
Ask about prior medication experience: build on success
and work on problems
Educate about the disease, purpose of ARV, importance of
adherence
Repeat information as many times as necessary

Family-Focused Adherence Support

Planning for a good start:

Develop a simple schedule that fits the familys daily
activities. Consider differences between weekdays and
weekends.
Clarify who will be responsible for giving or
supervising each dose, each day of the week
Make the schedule visual. Use pictures of pills. Colorcode everything. Consider literacy level of family
members

Family-Focused Adherence Support

Planning for a good start:

Demonstrate medication preparation:
measuring volumes of liquids
crushing or dissolving tablets
opening capsules
using foods or liquids to mask task

Do a trial run with dummy pills or liquid

Observe medication administration in the office. If possible, start
the first dose under supervision
Follow-up with a phone call and/or home visit
in the first few days

General lessons we have learned

Adherence is hard for everyone and long term
treatment present the most difficult challenges
Adherence is critical to the successful care of
patients with HIV/AIDS
On an individual level, adherence to care and treatment
can mean the difference between life and death
On a population level, adherence to treatment can
minimize the emergence of viral resistance and prevent
therapeutic failure

Adherence needs to be to medications and care.

More lessons
Every HIV/AIDS treatment program should
include processes to assess and support adherence
Adherence promotion must be multifaceted and
multidisciplinary and adapt to changing needs and
realities
Many models/approaches in use
Many also need to be evaluated and adapted for local
needs

Simpler and more tolerable regimens which

preserve efficacy are still needed

Acknowledgements
Sources for some of the slides or materials
included:
KITSO AIDS Training Program (Botswana)
MTCT-Plus training (Columbia University)
Vietnam-CDC-Harvard Medical School AIDS
Partnership (VCHAP)
Colleagues and most importantly,people living
with HIV