IMPLEMENTING CLINICAL RECOMMENDATIONS: ART STRATEGIES, TOOLS, AND HEALTHY SYSTEMS/SERVICE

DELIVERYRECOMMENDATIONS 11-14: ADHERENCE

John G. Bartlett

Johns Hopkins UniversitySchool of Medicine 

May 2012 www.iapac.org

THE CONTINUUM OF HIV CARE -- US

MMWR (60), 2011

Of all with HIV infection, 850,000 individuals do not have suppressed HIV RNA (72%)

100%

75%

50%

25%

80%

77%

66%89%

77%

• Among regimens of similar efficacy and tolerability, once-daily regimens are recommended for treatment-naive patients beginning ART (II B).

• Switching treatment-experienced patients receiving complex or poorly tolerated regimens to once-daily regimens is recommended, given regimens with equivalent efficacy (III B).

• Among regimens of equal efficacy and safety, fixed-dose combinations are recommended to decrease pill burden (III B).

ART STRATEGIES

• Reminder devices and use of communication technologies with an interactive component are recommended (I B).

• Education and counseling using specific adherence-related tools is recommended (I A).

ADHERENCE TOOLS FOR PATIENTS

EDUCATION AND COUNSELING INTERVENTIONS

• Individual one-on-one ART education is recommended (II A).

• Providing one-on-one adherence support to patients through 1 or more adherence counseling approaches is recommended (II A).

• Group education and group counseling are recommended; however, the type of group format, content, and implementation cannot be specified on the basis of the currently available evidence (II C).

• Multidisciplinary education and counseling intervention approaches are recommended (III B).

• Offering peer support may be considered (III C).

THE NON-VALUE OF PILL COUNTS: FEM-PrEP(Van Damme. NEJM 2012)

Trial: Randomized, double-blind placebo-controlled trial in 2,120 HIV negative women in South Africa.

Results Placebo TDF/FTC

n=1,058 n=1,062

Adherence report 95% 95%Pill counts 88%

88%TDF levels >10 ng/mL

Failure -----15%

No failure -----24%

WHAT TO START

Guideline Backbone 3rd Drug

DHHS, IAS-USA TDF/FTC EFV, RAL, British

ATV/r, DRV/rEuropean TDF/FTC EFV,

NVP ABC/3TC ATF/r DRV/r

LPV/r, RALWHO TDF/3TC

EFV, NVP AZT/3TC

ART REGIMEN: REGIMEN SELECTIONGoal: NDV, avoid resistance, ADRFactors in the decision: • Baseline resistance test• Co-morbidities: Core, Renal, HBC,

Pregnancy, Psychological issues• Potency: Undefeated regimens• Urgency: Pregnancy, HIVAN, AIDS, Primary

HIV• Resistance to resistance: FOTO (EFV) and

PI/r• Cost and coverage

WHAT TO START: PILL BURDEN

Regimen x/d Pills

EFV/TDF/FTC* 1 1ATV/r/2 NRTIs 1 3DRV/r/2 NRTIs 1 4RAL/2 NRTIs 2 3

*RPV/TDF/FTC

Study 236-102: ATRIPLA VS. QUAD IN TREATMENT-NAÏVE (N=700): HIV-1 RNA < 50 copies/mL

(Sax P. 2012 CROI. Abstr. 101)

+3.6%, 95% CI 3.6 (-1.6% to +8.8%)

CD4+ change: Quad +239 vs. EFV +206 c/mm3 (p=0.009)

Sax P, et al. 19th CROI; Seattle, WA; March 5-8, 2012. Abst. 101.

COST OF CAREContemporary costs/yr.(AIDS 2010;24:2705)• HAART $12,000 (72%)• Meds (other) $ 2,100• In-patient $ 600• Out-patient $ 400Total (Meds) $ 16,600Growth: 40,000/yr survival + T&T all:

$800 million

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US PATENT EXPIRATIONS

DLV

SQV RTVIDV

AZT ddI d4T ABC3TCddC TDF

AZT/3TCNVP AZT/3TC/ABC

ABC/3TC

NFV

05 0706 08 09 10 11 12 13 14 15 16 17 18

ATV

19 20 21 22 23

TDF/FTC VVC*(SP)

LPV/RTV tabs

MVC

TPVDRV

LPV/ RTV caps

ETR RPV

EFV RAL 2022-5

EVG

RTV boosting

GS7340 = 2025

CVC=2023+

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FREQUENCY OF RESISTANCE MUTATIONS WITH VIROLOGIC FAILURE

Class Trials Resistance mutationsPI/r 7 1/255 (0.4%)NNRTI 3 69/213 (32%)II 2 68/102 (67%)CCR5 1 113/29 (45%)

DHHS GUIDELINES 2012

VLCD4

Pre ART 3-6 mos. 3-6 mos.

Start BaselineBaseline

2-8 wks* -----------

On ART 3-6 mos. 3-12 mos.

*week VL (log 10 c/mL1 -0.75-14 1.5-2

8-16 <50024-48 <50

P4P4P: THE STATUS OF PAYING PATIENTS FOR SELF CARE

Practice: Widespread and internationalIncentives: Cash, groceries, lottery tickets, meal tickets.Conditions: Chronic – smoking, obesity , BP control,

diabetes, HIVHIV trial: HPTN 65 – Controlled trial, (unblinded) HIV test –

$25, Enroll in care – $70, NDV – $280/yr (1.7% of HIV care cost)

Status: Widely practiced, no one wants to talk about it.

A TEST OF FINANCIAL INCENTIVES TO IMPROVE WARFARIN ADHERENCE

(VOLPP KG. BMC HEALTH SYS RES 2008;8:272)

THE POWER OF HOPE(Harris J, De Angelis. JAMA 2012;300:2912)

“With a deeper understanding of the science of care, physicians will increasingly realize that a meaningful patient-physician relationship leaves each patient better able to adhere to the treatment plan.”

HEALTHCARE OUTCOMES IN HIV:REDUCING DISPARITIES

(MOORE R. CID; IN PRESS) Issue: Major issue in HIV care is retention in care

and adherenceMethod: Moore Clinic data 1995-2010

N=6,366 Pt/yrs 27,941Demographics: B – 77%, F – 34%Risk: IDU-45%; MSM – 30%Insurance: Private – 15%

Results: Calculated life expectancy at age 28 yrs = 73.4 yrs for all groups – race, gender and risk

HEALTHCARE OUTCOMES IN HIV:REDUCING DISPARITIES

(MOORE R. CID; IN PRESS) Issue: Major issue in HIV care is retention in care

and adherenceMethod: Moore Clinic data 1995-2010

N=6,366 Pt/yrs 27,941Demographics: B – 77%, F – 34%Risk: IDU-45%; MSM – 30%Insurance: Private – 15%

Results: Calculated life expectancy at age 28 yrs = 73.4 yrs for all groups – race, gender and risk

VL FOR 3 HIV RISK CATEGORIES OVER TIME(MOORE RD. CID 2012; IN PRESS)

ART ADHERENCEIAPAC GUIDANCE: Scientifically validated

systematic approachesRegimen selection:• Drugs that will work (science)• Drugs patients will take (art)Factors to consider:• Documentation metric: VL• Impact of patent expiration• Cost-support services• P4P4P• Clinic viral load