Bangkok September 4, 2009

Fransje van der Waals MD PhD

Health[e]Foundation

Adherence to Therapy

Adherence to Therapy

� Adherence is the term used to describe the patient’s

behavior of taking drugs correctly – in the right dose,

with the right frequency, and at the correct time

� A critical aspect of adherence is the patient’s

involvement in deciding whether or not to take the drugs

� Compliance means the patient does what he or she has

been told to do by the doctor/pharmacist

HIV[e]DUCATION

Adherence to Therapy

� One of the key determinants of treatment

success

� Poor adherence leads to failure of viral

suppression, evolution of drug resistance, and

subsequent immunologic and clinical failure

HIV[e]DUCATION

Importance of adherence in the therapeutic scheme. Potent drugs, well

taken will result in inhibition of viral replication and delay of disease

progression.

GH Friedland, MD19

HIV TherapeuticsDrug Efficacy

Systemic

concentration

Adherence

Intracellular

concentration

Inhibition of

viral

replication

Delay

disease

progression

Host factorsPotent drug

(Properly prescribed)

Viral resistance

Viral virulence

PharmacokineticsAbsorption

Metabolism

Excretion

HIV[e]DUCATION

Virologic suppression is predicted by levels of adherence.

Among those with reported 100% adherence, 65% achieved an HIV RNA

level of <50 copies at 12 months. Conversely, among those with less that

80% adherence, only 18% had suppression < 50 copies at 12 months. From Mannheimer, et al. Clinical Infectious Diseases 2002.

GH Friedland, MD30

Virologic Outcomes by Adherence Level % HIV RNA <50 copies/ml

0

10

20

30

40

50

60

70

80

100%

80-99%

0-79%

% HIV

RNA <50

copies/mL

) (n=922) (n=699) (n=531)Month 1 (n=1074)

Month 4 Month 8 Month 12

P<.005 at months 4,8,12

HIV[e]DUCATION

Adherence to Therapy� Important to counsel and educate patients carefully

before initiating ART.

� Clinicians, nurses, pharmacist, family etc should be

involved.

� ART should not be started on first clinic visit

� Adherence counseling is necessary to prepare the

patient in order to maximize adherence

� Once treatment has started, continued monitoring and

support for adherence is necessary

HIV[e]DUCATION

Incremental effect of excellent adherence on viral

suppression. DOT=directly observed therapy, SAT= self

administered therapy

HIV[e]DUCATION

GH Friedland, MD20

Directly Observed Therapy and RNA Decline Fischl et al 7th CROI 2000

0

10

20

30

40

50

60

70

80

90

100

wk 4 wk 8 wk 16 wk 24 wk 32 wk 40 wk 48

DOT

SAT

¥ Prisoners receiving antiretrovirals by direct

observation (DOT) or self administration (SAT)

HIV RNA

<50

Proportion <50 copies, p< . 001

Consistency of adherence over time is associated with the highest levels of

viral suppression. Among those with 100% adherence at all clinic visits,

viral suppression below 50 copies is 70%. Conversely, among those with

less than 100% adherence at all clinic visits, suppression is 12%

Mannheimer, et al. Clinical Infectious Diseases, 2002.

GH Friedland, MD34

Consistency of 100% adherence and virologic outcomes among patients with 12

mos follow-up (n=540)

Number of follow-up visits in which participants

reported 100% adherence, p <.001

0

10

20

30

40

50

60

70

80

% HIV RNA

< 50 at 12 mos

0

(n=46)

1

(n=77)

2

(n=80)

3

(n=125)

4

(n=197)

HIV[e]DUCATION

Factors affecting Adherence

1. Patient related Factors

2. Provider related Factors

3. Regimen related Factors

4. Other Factors

HIV[e]DUCATION

Factors affecting Adherence

Patient-related factors

� Patient readiness/ commitment

� Forgetfulness

� Travel away from home

� Lifestyle

� Depression

� Cultural

� Socioeconomic

� Etc

HIV[e]DUCATION

Adherence to therapy

1. Patient related Factors

2. Provider related Factors

3. Regimen related Factors

4. Other Factors

HIV[e]DUCATION

Factors affecting Adherence

Provider-related factors

� Provider readiness - knowledge, skills

� Counseling

� Patient education

� Medication alerts, e.g., charts, diaries, etc.

� Adherence team

� Provider support

� Etc.

HIV[e]DUCATION

Adherence to therapy

1. Patient related Factors

2. Provider related Factors

3. Regimen related Factors

4. Other Factors

HIV[e]DUCATION

Factors affecting Adherence

Regimen/Drug-related factors

� Pill burden

� Frequency

� Side effects

� Food restrictions

� Drug interactions

� Storage

� Etc

HIV[e]DUCATION

Adherence to therapy

1. Patient related Factors

2. Provider related Factors

3. Regimen related Factors

4. Other Factors

HIV[e]DUCATION

Factors affecting Adherence

Other Factors

� Cost

� Culture

� Infrastructure

� Health Care System

HIV[e]DUCATION

Adherence Support

� Educate and motivate: basic drug info, importance

of adherence, timing of medications, drug

interactions, etc

� Simplify regimen

� Tailor treatment to patient’s lifestyle

� Prepare for and manage side effects

� Employ an adherence team

HIV[e]DUCATION

Adherence Intervention Support

� Address patient related issues

� Recruit an adherence monitor

� Provide adherence promoting devices

� Use home-based care staff to promote adherence

� Use adaptation of directly observed therapy for

time to be determined

HIV[e]DUCATION

Key barriers to Adherence

� Busy with others things or forgot

� Away from home

� Change in daily routine

� Depressed or overwhelmed

� Drug holiday or break from meds

� Ran out

� Too many medications

� Worried about becoming immune to meds

� Drugs too toxic

HIV[e]DUCATION

Key barriers to Adherence

� Avoid side effects

� Don’t want others to notice

� Taking drugs is reminder of HIV

� Slept through dosing time

� Recently eaten food

� No food available to take with medicine

� Size of pills

� Taste

� Medication does not work well

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

� Information

� Motivation

� Skills

� Maintenance

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

� Information

� Motivation

� Skills

� Maintenance

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

• Assess stage of readiness, including levels of

information, motivation and behavioral skills

• Do not prescribe antiretroviral therapy until the

patient is ready

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

� Information

� Motivation

� Skills

� Maintenance

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Information

• Provide information about HIV treatment: measures of efficacy; and need for adherence using clear, explicit, and patient-appropriate language

• Assess comprehension of information given -ask patient to explain dosing

• Use visual aids such as pictures of pills and simplified viral life cycle

• Provide written materials on information given

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

� Information

� Motivation

� Skills

� Maintenance

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence� Motivation

• Identify cultural and health beliefs that might influence therapy

• Identify perceptions of treatment, including fears of side effects

• Assess patient’s self- efficacy and their belief in ability to adhere to treatment

• Assess patient in their home environment when possible

• Provide treatment for depression or substance abuse or refer for treatment

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence� Motivation

• Identify vulnerable times for non-adherent behavior

• Identify support systems, involve loved ones in the treatment and adherence

• Set realistic goals

• Provide a non-judgmental environment, invite questions

• Link adherence to treatment goals (clinical improvement, viral load, CD4)

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Readiness

� Information

� Motivation

� Skills

� Maintenance

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence� Skills

• Simplify regimens, eliminate unnecessary medications

• Have patient develop own plan for achieving adherence

• Coordinate treatment to daily activities to enhance

convenience, acceptability of regimen and maintain

confidentiality

• Teach patient to identify cues for dosing

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence� Skills

• Insure a continual medication supply

• Budget financial resources to enable continual medication supply

• Provide medication organizers and reminders; educate on use

• Have patient demonstrate and practice pill organization

• Identify and recommend regular time for weekly pill organizer refills

• Provide treatment support, ie.transportation, child care

HIV[e]DUCATION

Clinician Strategies to

Improve Adherence

� Physician and Health Care Worker related

• Establish good relationship and trust

• Utilize allied health care workers to re-inforce adherence– Involve Nurses & pharmacist

– Peer educators, experienced patients

• Consider new diagnoses on adherence – Depression, wasting, oral/ esophageal candida

HIV[e]DUCATION

Conclusion

� Adherence to therapy is uniquely challenging, few other medical conditions require regimens that are as complex or as demanding.

� Adherence is as essential as it is difficult.

� At least 95% (at least for ART which includes PI’s) is required to keep the virus under control

� Every patient encounter provides an opportunity to encourage, support and reinforce the importance of adherence

HIV[e]DUCATION