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.
Bibliography Wood E, Montaner JSG, Yip B, Tyndall MW, Schechter MT, O'Shaughnessy MV, et al. Adherence and plasma HIV RNA responses to highly
active antiretroviral therapy among HIV-1 infected injection drug users. CMAJ 2003; 169:656-661.
Stone VE. Strategies for Optimizing Adherence to Highly Active Antiretroviral Therapy: Lessons from Research and Clinical Practice. CID 2001; 33:865-872.
Moore DM, Hogg RS, Yip B, Craib K, Wood E, Montaner JSG. CD4 percentage is an independent predictor of survival in patients starting antiretroviral therapy with absolute CD4 cell counts between 200 and 350 cells/microL. HIV Med 2006; 7:383-388.
Montaner JS, Hogg RS, Heath KV, Phillips P, Craib KJ, Schechter MT, et al. Heterogeneity of physician agreement with recommended therapeutic guidelines for the management of HIV-associated disease. Antivir Ther 1996; 1:157-166.
Moore DM, Hogg RS, Yip B, Craib K, Wood E, Montaner JSG. CD4 percentage is an independent predictor of survival in patients starting antiretroviral therapy with absolute CD4 cell counts between 200 and 350 cells/microL. HIV Med 2006; 7:383-388.
Stone VE, Hogan JW, Schuman P, Rompalo AM, Howard AA, Korkontzelou C, et al. Antiretroviral Regimen Complexity, Self-Reported Adherence, and HIV Patients' Understanding of Their Regimens: Survey of Women in the HER Study. JAIDS: Journal of Acquired Immune Deficiency Syndromes 2001; 28:124.
Sungkanuparph S, Groger RK, Overton ET, Fraser VJ, Powderly WG. Persistent low-level viraemia and virological failure in HIV-1-infected patients treated with highly active antiretroviral therapy. HIV Medicine 2006; 7:437-441.
Tuldrà A, Wu AW. Interventions to improve adherence to antiretroviral therapy. J Acquir Immune Defic Syndr 2002; 31 Suppl 3:S154-7.
Battaglioli-DeNero AM. Strategies for improving patient adherence to therapy and long-term patient outcomes. J Assoc Nurses AIDS Care 2007; 18:S17-22.
March K, Mak M, Louie SG. Effects of pharmacists' interventions on patient outcomes in an HIV primary care clinic. American Journal of Health-System Pharmacy 2007; 64:2574-2578.