Patient Comprehension of Antiretroviral Drug

Resistance:Implications for Treatment

and Clinical Practice

Catherine Sarai RaceyMarch 19th 2009

MPH Capstone Defense

BC Centre for Excellence in HIV/AIDS

The B.C. Centre for Excellence in HIV/AIDS (CfE) is Canada’s largest HIV/AIDS research and treatment facility.

The Centre was founded by St. Paul’s Hospital and the provincial Ministry of Health and is dedicated to improving the health of British Columbians with HIV.

In B.C., all anti-HIV medications are distributed at no cost to eligible HIV-infected individuals through the Centre’s Drug Treatment Program.

As of the last update nearly 4,380 HIV-positive persons are accessing therapy in the province.

Approximately 54 new patients access therapy each month. (www.cfenet.ubc.ca)

Health Literacy

Vital component for chronic disease care

Encompasses: the capacity to act on knowledgeunderstand treatment and health risksability to utilize the health care system

A key element of self-management is health literacy

Poor health literacy is associated with poor health outcomes

A component of high health literacy is understanding treatment

HIV/AIDS Treatment

Dramatic reduced morbidity and mortality

High level of adherence in order to maximize benefits

Incomplete adherence is a key determinant in the development of drug resistance

Antiretroviral drug resistance is: a significant reduction of drug efficacy due to mutations

in the viral genome. Drug resistant quasi-species can emerge and be selected when the viral population is exposed to sub-optimal drug levels13

Antiviral drug resistance limits treatment options

Differential adherence and drug resistance have been associated with an increased risk of death

Importance of Health Care Providers

The health care provider plays an important role

The relationship is an important factor in treatment success, including better adherence

Positive relationships provide opportunities

Physician experience associated with improved survival and perception of care

Pharmacists play an important role in adherence counseling and daily treatment concerns

HIV/AIDS Health Literacy

Self-management strategies minimize symptoms in HIV patients

Knowledgeable about HIV/AIDS, as well as overall treatment plans

Key focus in treatment is preventing and prolonging development of HIV drug resistance

Patients need to understand fully the nature of their treatment, the implications of incomplete adherence and the consequences of developing drug resistance

Objective

To determine the current level of Knowledge of HIV drug resistance in a cohort of HIV+ people on HAART

Identify predictive factors for comprehension Identify areas of focus for improving comprehension

The LISA project is conducted through the Drug Treatment Program (DTP) at the CfE

LISA is a 3 – year prospective cohort, which aims to examine the effects of various supportive health services on the health status of HIV+ persons on meds

Eligibility: HIV+, 18+years and on medication after 1996

Participants were recruited through physician letters and advertisements at local HIV/AIDS service organizations

A 45 minute comprehensive interviewer-administered survey

On-going linkage with the DTP provided data on the clinical variables

Methods

Instrument – Variables Physician – patient relationship

length of time with physician, if they choose or were referred, ever switched physicians and if they are satisfied with care

Pharmacist involvement ever received one-to-one counseling by a pharmacist when beginning or switching medications

Quality of life using a 9-item HIV/AIDS – targeted quality of life scale18

Housing stability assessed with stable or non-stable housing

Food security 13-item Radimer/Cornell measurement scale19

Other socio-demographic variables ever or current illicit drug use, current employment, provincial income assistance and level of

education

Adherence refill adherence, measured as the number of days medication is dispensed divided by the number of

days medication is prescribed (<95% and ≥95% adherence)

Resistance knowledge variable

Knowledge of HIV drug resistance was conducted through a 2 – part question

A complete definition had to identify: Importance of adherence Presence of a viral mutation (or change) Drugs ceasing to work

Coding: Identify 3 factors – complete Identify 1 – 2 factors – partial Identify 0 factors – incorrect Responses of ‘unsure’, ‘don’t know’, or blank were

coded as no response

Statistical Analysis

In the multivariable analysis ‘complete’ and ‘partial’ definitions were pooled and ‘no response’ and ‘incorrect’ were pooled.

Three comparison groups

Bivariable analysis investigated associations using Fisher’s Exact test or the Chi-square test for categorical variables and the Wilcoxon rank sum test for continuous variables

Logistic regression was used for unadjusted bivariable and the adjusted multivariable analysis

ResultsAs of July 2008 there were 457 participants

90% are currently on HAART

The median age is 46, with 75% being male

At the time if interview 46% of participants had CD4 cell counts of ≥350 cells/mm3 and 58% were virologically suppressed

45% of the cohort was ≥95% adherent

23% reported gainful employment and 47% reported using illicit drugs (heroin, cocaine, crack, speedball, crystal meth)

94% reported being highly satisfied with their physician and over 80% reported high provider trust

Results – Bivariable AnalysisBased on Bivariable model participants who gave

partial or complete definitions more likely to:

VariableYounger (44.4 yrs vs. 45.9 yrs)High school education or greater (65.7% vs. 47.6%)Be employed (31.0% vs. 21.1%)Live in stable housing (73.1% vs. 12.1%)Discuss medications with their physician

(95.8% vs. 91.9%)

Received a one-to-one counseling session with a pharmacist

(66.8% vs. 53.2%)

Have higher provider trust (91.7% vs. 83.3%)Have CD4 cell count >350cells/mm3

(55.1% vs. 38.3%)

Results – Resistance KnowledgeBased on multivariable model participants who

gave partial or complete definitions more likely to:

OR (95% CI)Variable Unadjusted AdjustedYounger 0.98 (0.96-

0.99) 0.98 (0.96-0.99)

High school education or greater

1.84 (1.29-2.62)

1.64 (1.07-2.51)

Discuss medications with their physician

4.49 (2.43-8.29)

5.15 (2.60-10.18)

Received a one-to-one counseling session with a pharmacist

2.46 (1.72-3.53)

1.79 (1.19-2.69)

Results – Resistance KnowledgeBased on multivariable model participants who

gave partial or complete definitions more likely to:

OR (95% CI)Variable Unadjusted AdjustedYounger 0.98 (0.96-

0.99) 0.98 (0.96-0.99)

High school education or greater

1.84 (1.29-2.62)

1.64 (1.07-2.51)

Discuss medications with their physician

4.49 (2.43-8.29)

5.15 (2.60-10.18)

Received a one-to-one counseling session with a pharmacist

2.46 (1.72-3.53)

1.79 (1.19-2.69)

Results – Resistance KnowledgeBased on multivariable model participants who

gave partial or complete definitions more likely to:

OR (95% CI)Variable Unadjusted AdjustedYounger 0.98 (0.96-

0.99) 0.98 (0.96-0.99)

High school education or greater

1.84 (1.29-2.62)

1.64 (1.07-2.51)

Discuss medications with their physician

4.49 (2.43-8.29)

5.15 (2.60-10.18)

Received a one-to-one counseling session with a pharmacist

2.46 (1.72-3.53)

1.79 (1.19-2.69)

The probability of a complete or partial definition increased from 15.90% (without discussing medications with a physician or receiving one-to-one counseling by a pharmacist) to 63.90% (if a participant received both)

Limitations

Use of participant reported definitionsThe working definition is stringent with complete

definitions having to identify all 3 factorsSubsequently controlled for in the analysis by

pooling. Participants who were able to identify 1 to 3 of the factors were pooled.

Distribution of participants As of July 1st ½ the LISA cohort reported current illicit

drug use and over 45% of interviews were conducted at one site

As the number of interview sites increases the make-up of the cohort will become more representative of the HIV population in BC

Conclusions HIV drug resistance knowledge is low

Participants who were able to completely or partially define resistance had: higher provider trust, higher education, were on average younger, discussed medications with their physician and had one-to-one counseling session with a pharmacist.

Two areas of focus for interventions are: discussing medications with physicians and one-to-one counseling with a pharmacist

Health literacy has been demonstrated as an important factor in treating chronic diseases

Building health literacy capacity through increased knowledge of HIV drug resistance may help close the gap between adherence and improve clinical outcomes

Clinically relevant universal guidelines for patient education may help direct consistent discussions and information for patients

Future DirectionsThere are no provincial guidelines for patient

education

Devising a standardized patient education package which incorporates the major mechanisms for developing resistance, the implications for treatment and quality of life and the importance of adherence

A clinically relevant example: The IDC

The program will comprise of a series of workshops whose objectives tackle different areas of patient education

Including: access to special health care services and preventing and prolonging drug resistance

The workshops will be delivered over a period of time in hopes of engaging patients

Engaged patients, with better health literacy, will do better in self-management

Dissemination

Accepted Poster presentation at Ontario HIV Treatment Network (OHTN) 2008 Conference – November 13-14th 2008

Accepted Oral presentation at the Canadian Association for HIV Research (CAHR) 2009 Conference – April 23-26th 2009

To be submitted for peer review in the Journal - AIDS

Acknowledgements

I would like to acknowledge all of the LISA participants.

Forever grateful to Wendy Zhang, Kimberly Fernendes, Eirikka Brandson, Despina Tzemis, Richard Harrigan, Julio Montaner, Junine Toy, Rolando Barrios and Bob Hogg for their contributions and guidance.

Thank you to the LISA team:Alexis Palmer, Katie Duncan, Andy Mtambo, Oghenowede Eyawo, Despina Tzemis, Alexandra Borwein, Mark Philips and Elizabeth Pipes.

Special thank you to Eirikka Brandson, for her mentorship and encouragement, Rolando Barrios for his insight and support, and Bob Hogg for the wonderful opportunity to be a part of the LISA team and for providing excellent guidance and support throughout.

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