2013 WHO Consolidated ARV Guidelines

Summary of Major Recommendations and Estimated Impact

GSG Briefing July 19, 2013

Gottfried Hirnschall, Director HIV Department, WHO

ART Scale up : Progress Towards Global Targets

WHO Global ART report, 2013

Number of pregnant women living with HIV needing and receiving ARVs for PMTCT, 2005-2011

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

2005 2006 2007 2008 2009 2010 2011

14%

56%

1,570,000 1,470,000

HIV+ pregnant women receiving ARVs for PMTCT HIV+ pregnant women needing ARVs for PMTCT

(WHO, Global Report 2013)

Number of children acquiring HIV infecSon in low- and middle-income countries, 1996-2012

No ARV prophylaxis for PMTCT

Current ARV prophylaxis coverage for PMTCT

800,000 pediatric infecSons averted

~290,000 new pediatric infecSons 2012

(WHO, Global Report 2013)

2015

2015 goal: 40,000 new pediatric infecSons

30th June 2013

01 | Results: The gap between adult and child ART coverage in 20 high burden

countries is widening

Source: Global AIDS Response Progress ReporGng (WHO/UNICEF/UNAIDS) and 2013 UNAIDS esGmates.

Clinical

Guidance for Programme Managers

HOW TO DO IT? Service delivery DiagnosScs Drug supply

HOW TO DECIDE? PrioriSzaSon Equity and ethics Monitoring & EvaluaSon

WHAT TO DO? When to start or switch Which regimen to use How to monitor Co-infecSons & co-morbidiSes

Operational

WHO 2013 Consolidated ARV Guidelines

Simplification and consolidation across:

- Continuum of HIV care

- Ages and populations

- Clinical, operational and programmatic guidance

- Existing and new recommendations

Treatment 2.0

Clinically relevant oEarlier iniSaSon of ART (CD4 500) oImmediate ART for children < 5 years oART iniSaSon for all pregnant and breas`eeding women (OpSon B/B+) and lifelong ART (OpSon B+) oHarmonizaSon of ART across populaSons (e.g., adults and pregnant women) and age groups oSimplied, fewer, and less toxic 1st-line regimens (TDF/XTC/EFV)

Key New RecommendaSons in 2013 WHO Guidelines

OperaSonally relevant o Use of Fixed Dose CombinaSons as a

preferred approach o Improved paSent monitoring to

support bejer adherence and detect earlier treatment failure (increased use of VL)

o Recommend task shiming, decentralizaSon, and integraSon

o Community based tesSng to complement broader HTC

Summary of Changes in RecommendaSons When to Start in Adults

TARGET POPULATION (ARV-NAIVE) 2010 ART GUIDELINES 2013 ART GUIDELINES

STRENGTH OF RECOMMENDATION

& QUALITY OF EVIDENCE

HIV+ ASYMPTOMATIC CD4 350 cells/mm3

CD4 500 cells/mm3 (CD4 350 cells/mm3 as a priority)

Strong, moderate-quality evidence

HIV+ SYMPTOMATIC

WHO clinical stage 3 or 4 regardless of CD4 cell count No change

Strong, moderate-quality evidence

PREGNANT AND BREASTFEEDING WOMEN WITH HIV

CD4 350 cells/mm3 or WHO clinical stage 3 or 4

Regardless of CD4 cell count or WHO clinical stage

Strong, moderate-quality evidence

HIV/TB CO-INFECTION

Presence of acGve TB disease, regardless of CD4 cell count

No change Strong, low-quality evidence

HIV/HBV CO-INFECTION

Evidence of chronic acGve HBV disease, regardless of CD4 cell count

Evidence of severe chronic HBV liver disease, regardless of CD4 cell count

Strong, low-quality evidence

HIV+ PARTNERS IN SD COUPLE

No recommendaGon established

Regardless of CD4 cell count or WHO clinical stage

Strong, high-quality evidence

RecommendaSons: CD4 Independent CondiSons

INITIATE ART REGARDLESS OF CD4 COUNT OR CLINICAL STAGE

RECOMMENDATION

ADULTS WITH HIV

and acGve TB disease Strong, low-quality evidence

and HBV co-infecGon with severe liver disease

Strong, low-quality evidence

who are pregnant or breas^eeding Strong, moderate-quality of evidence

in a HIV serodiscordant partnership

Strong, high-quality evidence

CHILDREN < 5 YEARS OLD WITH HIV

Infants diagnosed in the rst year of life

Strong, moderate-quality of evidence

Children infected with HIV between one and below ve years of age

CondiKonal, very-low-quality evidence

RaSonale: Shim from OpSon A to B+ or B

Major issue now is not when to start or what to start but whether to stop

BENEFITS FOR MOTHER AND CHILD BENEFITS FOR PROGRAM DELIVERY & PUBLIC HEALTH

Ensures all ART eligible women iniGate treatment

ReducGon in number of steps along PMTCT cascade

Prevents MTCT in future pregnancies Same regimen for all adults (including pregnant women)

PotenGal health benets of early ART for non-eligible women

SimplicaGon of services for all adults

Reduces potenGal risks from treatment interrupGon

SimplicaGon of messaging

Improves adherence with once daily, single pill regimen

Protects against transmission in discordant couples

Reduces sexual transmission of HIV Cost eecGve

30th June 2013

CD4

EsSmated impact on incidence and deaths of implemenSng the new recommendaSons

WHO Global ART report, 2013

EsSmated cost of implemenSng the new recommendaSons

WHO Global ART report, 2013

10% increase of the 22-24 billion USD annually for full HIV response

30th June 2013

Child adult coverage gap is widening, other key populaSons lag behind

Switching from 2010 to 2013 guidelines will enhance impact on lives & epidemic

15 by 15 is within reach

Global Update on HIV Treatment 2013: Key Findings and Messages

9.7 million on ART, 1.6 more than in 2011

630 000 children on ART, only 64 000 more than in 2011

Eligibility increase from 17 to 26 m Mortality/ incidence decline by 1/3

HIV treatment scale-up is paying o ARVs saved 4.2 million lives and

prevented 800 000 child infecSons

Many countries do well, but some need intensied support

In high burden countries, ART coverage varies from 30% to 90%

Next Steps Global level

Launch of guidelines at IAS KL (30 June 2013) Full guidelines Short summaries in 6 UN languages + Portuguese

Regional level Regional disseminaGon workshops

All regions planned for the next 3-6 months UN and implemenGng partners support

Country level Country adaptaGon

Policy and naGonal guidelines updates ImplementaGon roll out

7/26/13 16

30th June 2013

Find the New 2013 WHO Consolidated ARV Guidelines on www.who.int/hiv