GSG Briefing
July 19, 2013
2013 WHO Consolidated
ARV Guidelines
Summary of Major Recommendations
and Estimated Impact
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
HIV+ pregnant women receiving ARVs for PMTCT
HIV+ pregnant women needing ARVs for PMTCT
1,600,000
1,570,000
1,470,000
1,400,000
1,200,000
1,000,000
56%
800,000
600,000
400,000
14%
200,000
0
2005
2006
2007
2008
2009
2010
2011
(WHO, Global Report 2013)
Number of children acquiring HIV infection in
low- and middle-income countries, 1996-2012
No ARV prophylaxis for PMTCT
Current ARV prophylaxis
coverage for PMTCT
800,000
pediatric
infections
averted
~290,000 new pediatric
infections 2012
2015 goal: 40,000 new
pediatric infections
2015
(WHO, Global Report 2013)
01 | Results: The gap between adult and child ART
coverage in 20 high burden countries is widening
Source: Global AIDS Response Progress Reporting (WHO/UNICEF/UNAIDS) and 2013 UNAIDS estimates.
30th June 2013
WHO 2013 Consolidated ARV Guidelines
HOW TO DO IT?
WHAT TO DO?
•Service delivery
•Diagnostics
•Drug supply
•When to start or switch
•Which regimen to use
•How to monitor
•Co-infections &
co-morbidities
Clinical
Operational
Simplification and consolidation across:
- Continuum of HIV care
- Ages and populations
- Clinical, operational and programmatic guidance
- Existing and new recommendations
Guidance for
Programme
Managers
HOW TO DECIDE?
•Prioritization
•Equity and ethics
•Monitoring & Evaluation
Treatment 2.0
Key New Recommendations
in 2013 WHO Guidelines
Clinically relevant
oEarlier initiation of ART (CD4 ≤ 500)
oImmediate ART for children < 5 years
oART initiation for all pregnant and
breastfeeding women (Option B/B+)
and lifelong ART (Option B+)
oHarmonization of ART across
populations (e.g., adults and pregnant
women) and age groups
oSimplified, fewer, and less toxic
1st-line regimens (TDF/XTC/EFV)
Operationally relevant
o Use of Fixed Dose Combinations as a
preferred approach
o Improved patient monitoring to
support better adherence and detect
earlier treatment failure (increased
use of VL)
o Recommend task shifting,
decentralization, and integration
o Community based testing to
complement broader HTC
Summary of Changes in Recommendations
When to Start in Adults
TARGET
POPULATION
(ARV-NAIVE)
2010 ART GUIDELINES
2013 ART GUIDELINES
CD4 ≤500 cells/mm3 (CD4
≤ 350 cells/mm3
as a priority)
HIV+
ASYMPTOMATIC
CD4 ≤350
HIV+
SYMPTOMATIC
WHO clinical stage 3 or 4
No change
regardless of CD4 cell count
PREGNANT AND
BREASTFEEDING
WOMEN WITH HIV
HIV/TB COINFECTION
HIV/HBV COINFECTION
cells/mm3
CD4 ≤350 cells/mm3
or
WHO clinical stage 3 or 4
Presence of active TB
disease, regardless of CD4
cell count
Evidence of chronic active
HBV disease, regardless of
CD4 cell count
HIV+ PARTNERS IN No recommendation
SD COUPLE
established
Regardless of CD4 cell
count or WHO clinical
stage
No change
Evidence of severe chronic
HBV liver disease,
regardless of CD4 cell
count
Regardless of CD4 cell
count or WHO clinical
stage
STRENGTH OF
RECOMMENDATION
& QUALITY OF
EVIDENCE
Strong, moderatequality evidence
Strong, moderatequality evidence
Strong, moderatequality evidence
Strong, low-quality
evidence
Strong, low-quality
evidence
Strong, high-quality
evidence
Recommendations: CD4 Independent
Conditions
INITIATE ART REGARDLESS OF CD4 COUNT OR CLINICAL
STAGE
ADULTS WITH
HIV…
RECOMMENDATION
…and active TB disease
Strong, low-quality
evidence
…and HBV co-infection with severe
liver disease
Strong, low-quality
evidence
…who are pregnant or breastfeeding
Strong, moderatequality of evidence
…in a HIV serodiscordant
partnership
Strong, high-quality
evidence
CHILDREN < 5
Infants diagnosed in the first year of
YEARS OLD WITH life
HIV
Children infected with HIV between
one and below five years of age
Strong, moderatequality of evidence
Conditional, very-lowquality evidence
Rationale: Shift from Option A to B+ or B
BENEFITS FOR MOTHER AND CHILD
BENEFITS FOR PROGRAM DELIVERY &
PUBLIC HEALTH
Ensures all ART eligible women initiate
treatment
Reduction in number of steps along PMTCT
cascade
Prevents MTCT in future pregnancies
Same regimen for all adults (including
pregnant women)
Potential health benefits of early ART for
non-eligible women
Simplification of services for all adults
Reduces potential risks from treatment
interruption
Simplification of messaging
Improves adherence with once daily, single
pill regimen
Protects against transmission in discordant
couples
Reduces sexual transmission of HIV
Cost effective
Major issue now is not “when to start” or “what to start” but “whether to stop”
2010
Estimated impact on ART eligibility of implementing
the new recommendations
= 16.7
2013
CD4 <350*
on ART
= 25.9
CD4 <500*
<5y
**
**
Number of people eligible for ART in low- and middle-income countries in million per WHO
2010 and 2013 ARV guidelines, based on end of 2012 epidemic situation
* incl. co-infected with TB or HBV
30th June 2013
** only CD4>500, others included in adults
Estimated impact on incidence and deaths of
implementing the new recommendations
WHO Global ART report, 2013
Estimated cost of implementing
the new recommendations
10% increase of the 22-24
billion USD annually for full HIV
response
WHO Global ART report, 2013
Global Update on HIV Treatment 2013: Key
Findings and Messages
9.7 million on ART,
1.6 more than in 2011
In high burden countries, ART
coverage varies from 30% to 90%
630 000 children on ART,
only 64 000 more than in 2011
ARVs saved 4.2 million lives and
prevented 800 000 child infections
Eligibility increase from 17 to 26 m
Mortality/ incidence decline by 1/3
30th June 2013
15 by 15 is within reach
Many countries do well, but some
need intensified support
Child – adult coverage gap is widening,
other key populations lag behind
HIV treatment scale-up is paying off
Switching from 2010 to 2013 guidelines
will enhance impact on lives & epidemic
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 dissemination workshops
• All regions planned for the next 3-6 months
• UN and implementing partners support
• Country level
– Country adaptation
• Policy and national guidelines updates
• Implementation roll out
09/04/2015
16
Find the New 2013 WHO Consolidated ARV
Guidelines on www.who.int/hiv
30th June 2013