National HIV Prevention ConferenceAugust 16, 2011

Antiretroviral Medication Adherence

Division of HIV/AIDS PreventionNational Center for HIV/AIDS, Viral Hepatitis, STD , and TB Prevention

Cindy Lyles, PhDPrevention Research Branch,

Division of HIV/AIDS Prevention, CDC

Thanks toAdherence Writing Group

CDC: Linda Beer, Nicole Crepaz, Linda Koenig,

Cindy Lyles, Khiya Marshall, Rebecca Morgan,

David Purcell, Paul Weidle

HRSA: Brian Feit, Anna Huang

Outline

RationaleMethods Evidence Recommendations

Rationale for ART Adherence ART reduces viral burden, prolongs survival

and quality of life ART is now key for treatment & prevention health benefits for the PLWH Preventing sexual transmission of HIV

Adherence is critical for treatment success Positively associated with longer survival, lower

HIV viral load, greater viral suppression Declines/slips associated with treatment failure Suboptimal adherence can lead to viral resistance

& limited future trt options

Rationale for ART Adherence Success of HPTN 052 trial RCT: efficacy of early treatment (vs trt as usual) Both arms received couples risk reduction

counseling Early initiation of ART led to a 96% reduction in

risk of transmitting HIV to uninfected sexual partners

In combination w/ ART, regular, intense adherence counseling & support was provided

• Regular monthly visits

• Provided to both the index patient and the partner

• Provided by both the physician and an adherence counselor

Context for Promoting ART Adherence

Critical to help achieve NHAS goals Key activity in DHAPs strategic plan & in the

new Enhanced Comprehensive HIV Prevention Plan (ECHPP) Project

Expanded testing & early treatment more critical to focus on adherence

Methods (page 1)

Recommendations based on: Reviewed existing published recommendations Review of Reviews – Previously published

literature reviews, systematic reviews, and meta-analyses

Two types of reviews:

• Efficacy of HIV medication adherence interventions

• Correlates of HIV medication adherence

Published cost-effectiveness literature

Methods (page 2)

Recommendations based on: Results of CDC’s Prevention Research Synthesis

(PRS) Efficacy Review• Systematic review of all U.S.-based intervention evaluation

studies

• Identify specific interventions shown to be efficacious in improving adherence or reducing viral load

• Compendium of Evidence-based HIV Prevention Interventions (http://www.cdc.gov/hiv/topics/research/prs/)

Methods (page 3)

Recommendations based on: Other published literature, with emphasis on

specific topics:• Measurement & monitoring

• Current adherence levels & status of adherence interventions

• Barriers to implementation

• Special considerations & special populations

Evidence – What are Current Adherence Levels?

Adherence levels tend to be sub-optimal; tend to decrease over time

Estimates vary; 20% - 80% Data sources/methods vary greatly Study design (e.g. drug trials, cohort studies, surveys)

Study sample (e.g. target, eligibility)

How to measure/calculate adherence• Method of measurement (e.g. EDM, S-R, pharmacy)• Recall or time periods• Calculation (mean #; mean %; cutoff >90%)

Evidence – What are Current Adherence Levels?

Percent of individuals w/ >90% adherence to ART (n=84 studies)

50 55 60 65 70 75 80

Worldwide

North America

Meta-analysis (Ortego, 2011)

62%

59%

Evidence – Correlates of Adherence

Treatment regimen factors

Individual-level factors Patient-Provider factors

Evidence – Correlates of Adherence

Treatment regimen factors: Complexity of regimen – Pill burden, dosing frequency,

dietary restrictions

Frequency and severity of side effects

Evidence – Correlates of Adherence

Individual-level factors: Co-morbidity factors –substance abuse, alcohol abuse;

mental health issues, including depression, anxiety, other psychological symptoms

Psycho-social factors – Attitudes, beliefs, fear, stigma, & denial related to HIV disease; quality of life/life satisfaction; social support

Evidence – Correlates of Adherence

Individual-level factors: Adherence cognitions/competencies – Understanding

of ART regimen, ART benefits; Attitudes & beliefs about ART efficacy; Self-efficacy of adherence; poor self-management/adherence skills

Other – daily schedule issues; homelessness; income/financial issues

Evidence – Correlates of Adherence

Patient-Provider factors: Quality of relationship; provider support; shared

decision-making

Evidence – Adherence Interventions

Interventions are efficacious in improving adherence Several rigorous meta-analyses

Moderate magnitude of effects

Slightly weaker findings, in general, for clinical outcomes (viral suppression; CD4 cell count)

Stronger effects during the intervention or short follow-up; weaker effects over time

Evidence – Adherence Interventions

Interventions are cost-effective & beneficial to long-term survival of the individual No systematic reviews; handful of studies

Varied by study design, type of intervention, etc.

Evidence – Adherence Interventions

Key Intervention Elements Improving knowledge about treatment

Discussing/addressing cognitive barriers

Providing patient-centered or individual-level approach

Targeting medication management skills

Providing support (provider, group, peer, family)

Longer intervention duration

Robust findings with regards to: Deliverer; Setting; Delivery unit; Risk group; ART

naïve/exp

Adherence Recommendations –Patient Issues

Assess patient’s readinessEducate on importance of adherence to ARTAddress misconceptions or other concernsAddress barriers by linking patients to appropriate services Structural: homelessness, transportation, insurance Co-morbidities: depression, mental health,

drug/alcohol abuse

Adherence Recommendations –Regimen Issues

Simplify treatment regimen: reduce pill burden, dosing frequency, and dietary restrictions Involve the patient in decision makingTailoring schedule to the patient’s lifestyle, linking activities to “cues” as reminders, clarify instructions using a personal treatment plan Encouraging pill sorting and storage devices to fit with daily routinePrepare for, assess, and manage side effects at each visit

Recommendations – Maintaining Adherence

Provide adherence reminder devices or memory aides –alarms, diaries, pill boxes, beepersEmploy an adherence team to provide ongoing support -nurse practitioner, case manager, social worker, pharmacist, counselor, peer support person, family memberAssess adherence at each visit, in a non-judgmental way with open-ended questions to allow patient to disclose problems or barriersInvolve patient in problem-solving activities

Summary

We need to focus on every element in the care continuum, including adherence, in order to maximize TRT benefits

Expanding testing

Initiating ART

Linking to care

Adherence to ART

The findings & conclusions in this report are those of the authors & do not necessarily represent the official position of the Centers for Disease Control and Prevention

Thank You!

Cindy Lylesclyles@cdc.gov