PWP Recommendations:Treatment As Prevention

John T. Brooks, MD

2011 National HIV Prevention Conference

August 14-17, 2011 – Atlanta, GA

National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention

Division of HIV/AIDS Prevention

Outline

� Methods

� Review data

� Review US existing recommendations

� Proposed PwP recommendation

Methods

� Recommendations based on:

� Epidemiologic data

• Reduction in HIV transmission risk associated with ART1

� HIV treatment recommendations

• U.S. Department of Health and Human Services (2009)

• International AIDS Society–USA Panel (IAS-USA – 2010) • International AIDS Society–USA Panel (IAS-USA – 2010)

� Consultation and narrative review for other aspects

Data Review: History of Research

� Observational cohort data

� Suggested association � low viral load (cause) reduce risk (effect)

� Modeling studies

� Suggested intervention (treating HIV infection) could reduce epidemic

� Ecological analyses (community-based observations)

� Treating a population associated with reduction in new infections� Treating a population associated with reduction in new infections

� Biomedical research

� Established mechanism and biological plausibility of intervention

� Randomized clinical trial

� Demonstrated intervention was effective

Low plasma viral load in sexual partner associated

with significantly decrease risk of HIV transmission

Quinn et al. NEJM 2000, 342:921

Meta-analysis indicated ART’s reduces sexual

transmission of HIV in serodiscordant couples11 cohort studies

92% reduction in HIV transmission risk: from 5.64 to 0.46 events/100 py

Attia et al. AIDS 2009, 23(11): 1397-1404

Mathematical modeling suggested universal

“test and treat” strategy could control the epidemic

Incidence

Granich et al. Lancet 2009, 373:48-57

20001980 2020 2040

20001980 2020 2040

Prevalence

Decreasing “community viral load” and

HIV diagnoses in San Francisco

Das et al. PLoS ONE 2010, 6(5):e11068

Period of

“HAART expansion”

Decreasing “community viral load” and

HIV diagnoses in British Columbia…

Maybe folks in BC are simply reducing number of partners and

using condoms more consistently and correctly?

Montaner et al. Lancet 2010, 376:532--539

using condoms more consistently and correctly?

Infectious Syphilis, 1999-2008

• BC

x Canada

Gonorrhea, 1999-2008

x Canada

…despite increasing rates of syphilis and gonorrhea

x Canada • BC

Modified from http://www.phac-aspc.gc.ca/std-mts/report/sti-its2008/index-eng.php

Viral load in plasma and genital secretions correlated, and each are correlated with risk of transmission

2,521 serodiscordant African couples

: 73 men seroconverted in 1,805 couples

Women

CVL

Women

plasma

Baeten et al., Sci Trans Med 2011, 3(77): 1

: 40 women seroconverted in 716 couples

Men

semen

Men

plasma

1,763 heterosexual couples

HIV discordant

CD4 count 350-500 cells/mm3

886 couples: “early therapy” 887 couples: “delayed therapy”

HPTN 052: Prevention of HIV-1 Infection with Early Antiretroviral Therapy

886 couples: “early therapy”

Infected partner initiates at:

CD4 count 350-500 cells/mm3

887 couples: “delayed therapy”

Infected partner initiates at:

CD4 count < 250 cells/mm3

or AIDS-related illness

Primary Outcomes:

• HIV incidence in HIV-uninfected partners

• HIV-associated clinical events

Cohen et al., N Engl J Med 2011, 365: 493-505

HPTN 052: Prevention of HIV-1 Infection with Early Antiretroviral Therapy

“The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1

and clinical events, indicating both personal and public health benefits from such therapy”

Early: 1

Delayed: 27

Early: 40

Delayed: 65

96% reduction 41% reduction

Cohen et al., N Engl J Med 2011, 365: 493-505

Existing US Recommendations

� DHHS (last updated January 2011):

� CD4 350-500 cells/mm3 – Recommend use

� CD4 >500 cells/mm3 – Optional use, not contraindicated

� ART for prevention – “Use of effective ART regardless of CD4

count is likely to reduce transmission to the uninfected sexual count is likely to reduce transmission to the uninfected sexual

partner”

Caveats and Considerations to PwP Recommendations

� Existing data limited mostly to heterosexuals

� Feasibility: limited capacity and financing

� Ethics of individual vs. population health:

→ Treating the patient for her/his own health → Treating the patient for her/his own health

must always be the first priority

Recommendations

Clinical care and community settings:

� HIV-infected persons should be made aware of individual health benefits and risks of ART, benefit of ART in reducing the risk of HIV transmission, and the need to continue other prevention measures while taking ART (see Risk Reduction section).

� HIV-infected persons with ongoing HIV transmission risk behavior despite risk-reduction measures should be offered ART regardless of despite risk-reduction measures should be offered ART regardless of CD4 lymphocyte count for the potential reduction in HIV transmission risk as well as potential individual health benefit. (HIV transmission risk behavior is defined in the Risk Screening section.)

� HIV-infected persons initiating or continuing ART should be made aware of the need to continue other prevention measures while on ART (see Risk Reduction section) and the importance of adherence (see Adherence section).

Recommendations

Clinical care settings:

� ART should be initiated for those individuals willing and able to commit to long-term ART.

� ART regimen selection should be guided by current ART recommendations for the optimal health of the HIV-infected individual and with greatest success of suppressing plasma viremia.

John T. Brooks

zud4@cdc.govzud4@cdc.gov