of ARVs for treatment and prevention Getting to 15 million by 2015 and thinking beyond Gottfried Hirnschall MD MPH Department of HIVAIDS World Health Organization July 26 2012 Questions for today ID: 626853
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Expanding HIV testing and the use of ARVs for treatment and preventionGetting to 15 million by 2015… and thinking beyond
Gottfried Hirnschall MD, MPH
Department of HIV/AIDS, World Health Organization
July 26, 2012Slide2
Questions for todayCan we reach 15 million by 2015?Is 15 million enough to achieve optimal impact on treatment and prevention? What strategic choices can be made? What are the opportunities to enhance ART program effectiveness and reach? Slide3
8 million on ART by end 2011 …15 million is achievable !8 million15 millionSlide4
8 million on ART by end 2011 …15 million is achievable !8 million15 million
2002
15.0
12.5
10.0
7.5
5.0
2.5
0
.0Slide5
ART scale-up: three success stories
High-level
commitment and resources
P
roactive
approaches
to HIV
testing
Innovation in service delivery
Integration
Task-shifting
Community-based services
ART coverageSlide6
Disparities in ART coverage between regions and populationsART coverage* 2010 HIV case reporting (18 countries) Slide7
Scale-up of ART, number of AIDS deaths and new HIV infections in LMIC*, 2001–2011* LMIC = Low- and middle-income countriesSlide8
Effect of ART coverage on rate of new HIV infections in a rural South African populationSource: Tanser F et al. CROI 2012
For every 10% increase in coverage there is a 17% decrease in individual riskSlide9
Effect of ART coverage on rate of new HIV infections in a rural South African populationSource: Tanser F et al. CROI 2012
For every 10% increase in coverage there is a 17% decrease in individual risk
1.2
1.0
0
.8
0.6
0.4
0
.2
0.0Slide10
Balance of evidence favours earlier initiation of ART ↓ Drug toxicity↓ Resistance↓ Upfront costs
Preservation
of
Tx
options
↑
Clinical benefits (AIDS- and
non-AIDS related)
↓
HIV and TB
transmission
↑
Potency, durability, tolerability
↑
Treatment sequencing options
↑ Medium/long-term cost savings
Delayed ART
Earlier ARTSlide11
Relationship between transmitted resistance to NNRTI drugs and ART coverage in LMIC
Source: HIV drug resistance report, WHO, 2012Slide12
ART eligibility: 5 policy scenariosRecommended Since 2003
CD4
≤
200
Recommended
since 2010
CD4
≤
350
Incremental approach 2012
CD4
≤
350
+
TasP
Ongoing systematic review of evidence
(GRADE review)
CD4
≤
500
“
Test and treat
”
All HIV+
ART regardless of CD4
count for:
-
Serodiscordant
couples
- Pregnant women
- Key populations
(
SW, IDU, MSM)
Estimated
millions of people
eligible for
ART in LMIC in 2011
11
15
23
25
32
1
2
3
4
5Slide13
ART eligibility: 5 policy scenariosRecommended Since 2003
CD4
≤
200
Recommended
since 2010
CD4
≤
350
Incremental approach 2012
CD4
≤
350
+
TasP
Ongoing systematic review of evidence
(GRADE review)
CD4
≤
500
“
Test and treat
”
All HIV+
ART regardless of CD4
count for:
-
Serodiscordant
couples
- Pregnant women
- Key populations
(
SW, IDU, MSM)
Estimated
millions of people
eligible for ART
in LMIC in 2011
11
15
23
25
32
1
2
3
4
5Slide14
WHO’s ARV-related guidance in 2012Treatment as Prevention (TasP)Recommendation for TasP in sero-discordant couples
Consider lifelong ART for pregnant women (“B/B+”)
Explore use of
TasP
in key populations
(SW, IDU, MSM)
Pre-Exposure Prophylaxis (
PrEP
)
Recommendation for demonstration projects in
sero
-discordant couples and MSMSlide15
WHO’s consolidated ARV guidelines in 2013(children, adolescents, adults, pregnant women, key populations)WHAT TO DO?(when to start or switch,how to monitor, which regimen to use,c
o-morbidities)
HOW TO
DO IT?
(diagnostics,
s
ervice delivery)
HOW TO
DECIDE?
(scale-up,
e
quity and ethics,
M&E)
Clinical
Programmatic
OperationalSlide16
Significant variation in ART eligibility thresholds among countriesCD4 count for ART initiation
≤
200-350
≤
300
≤
350
≤
350 +
TasP
≤
500
≤
500 +
TasP
Number of countries
1
1
43
12
1
3
Results of a WHO
survey (2011
,
n= 61 countries)Slide17
17
Low-income
Lower middle-income
High-income
Upper middle-income
Year of starting ART
Mean CD count (cells/µL)
Estimates from random-effects
model adjusted for age, sex and
year of starting ART, 2002-2009
Mean
CD4 count at
ART initiation is below 200
in LMIC
Source:
Egger M.
CROI 2012
2002 2009
2002 2009
2002 2009
2002 2009Slide18
HIVDR Early Warning Indicators, 2011Proportion of clinics achieving
WHO-recommended standards
Source: Bennett DE et al. CID
2012
Supp
4
pp
280-9
%Slide19
The test-treat-retain cascadeCreate demand for testing and treatment
Testing
+
Pre-ART
care and support
ART
Adherence
and viral
suppression
ART eligible
HIV+Slide20
Patient enrolment into HIV care and treatment, six studies in sub-Saharan Africa
%
Source:
Mugglin
C et al.
IeDEA
Southern Africa ( in press)
N = 58,779 personsSlide21
Key areas for optimization in the cascadeExpand, simplify and diversify HIV testingOffer concrete interventions in the pre-ART windowUse simple and better drugs for first- and second-lineProvide diagnostic tests and monitoring tools at point-of-careInnovate service delivery to enhance adherence and retentionSlide22
Provider-initiated testing and counselling (PITC) in Africa 42/53 countries in Africa have PITC policies
1
High PITC acceptance by ANC
2
& TB patients
3,4
Most clinical settings in generalized epidemics not routinely offering HIV testing
5
1
Baggaley (2012)
Bulletin WHO,
2
Etirbet
(2004)
AIDS Care
;
Byamugisha
(2010)
J
Int
AIDS
,
3WHO, Global TB control
(2011),4 Corneli (2008) IJTBLD, 5
MacPherson (
2012) Trop Med.
Date not identified
Adoption of a policy on PITC 2003-2010
Not adopted
Data not available
2009 - 2010
2003 - 2004
2005 - 2006
2007 - 2008Slide23
Scaling up HIV testing in the communityHome-based (door-to-door)CommunityIndex-case
Campaigns plus
HTC-plus –malaria, safe water
Non-communicable diseases
Mobile outreach
General populations
Key populations
Workplaces, schools Slide24
A potential new approach: self-testing Today Practiced 'informally' by many health workers1Included in Kenyan National Guidelines
Readily available over the internet and in pharmacies in some
countries
Approved by
FDA
in
USA
this month
Future potential
General population?
Marginalized groups?
PrEP
?
1
Napierala S, (2011). HIV self-testing among health workersSlide25
ART optimization approaches
Once daily FDC for 1
st
line (e.g
.,
TDF/3TC/EFV)
Heat stable once-daily boosted PI options for 2
nd
line (e.g
.,
ATV/r)
Solid pediatric formulations (sprinkles,
dispersible tablets)
Replacement of regimen components by new
drugs/classes
(e.g
.,
integrase
inhibitors
,
NRTI pro-drugs, entry blockers)
New therapeutic approaches (e.g
.,
induction/maintenance, co-therapies, anti-latency drugs)
SHORT TERM
Next 1-2 years
Improve currently available drugs and formulations
MEDIUM TERM
Next 2-5 years
Add new drugs/better sequencing
LONG TERM
Next 5-10 years
Use new strategiesSlide26
ARV drugOptimization
methods
Present cost in USD
(
per patient/year)
Expected cost in USD
(
per patient/year)
TDF
Process chemistry and dose optimization
87
63 (
28%)
AZT
Dose optimization
89
60 (
33
%)
EFV
Reformulation and dose optimization
63
31 (
51%)
ATV/r
Process chemistry and reformulation
355
125 (
6
5%)
DRV/r
Process chemistry dose optimization and reformulation
835
335
(
60%)
Potential cost benefits of optimizing ARVs
Adapted from
Crawford et al, 2012Slide27
Point-of-care CD4 is just emerging
3 products available and 1 prequalified
Point-of-care
testing
for VL and EID
is
imminent
Affordability is
key
Breakthroughs in diagnostic testing and patient monitoring at
point-of-care
Number of POC technology releases expected (cumulative numbers)Slide28
Retention rates for ART at 12, 24 and 60 months in selected countries, 2011
84%
78%
72%Slide29
Conclusions (1)Global progress on scale-up of ART has been extraordinary. Countries show the way! 15 million can be reachedFurther scale-up must address disparities and inequities (countries, key populations) With new evidence and new policies, the number of persons eligible for ART will increaseCountries face strategic choices and are already taking advantage of new opportunities (early ART, TasP, PrEP
)Slide30
Now is the moment to think and plan beyond the 15 million target This will require forward-looking policies, more effective and innovative approaches, together with further investments ARVs for treatment and prevention are a powerful
tool towards ending
the HIV epidemic
Conclusions (2)Slide31
AcknowledgementsRachel BaggaleyTony HarriesAndrew BallYing-Ru Lo
Michel Beusenberg
Jos Perriens
Txema
Garcia Calleja
Yves Souteyrand
Wafaa
El-Sadr
John Stover
Charles
Flexner
Frank
Tanser
Nathan Ford
Bernhard
Schwartländer
Reuben
Granich
Stefano
Vella
Ian Grubb
Marco Vitoria
Tim Hallett
Gundo
Weiler