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Expanding HIV testing and the use of ARVs for treatment and prevention
Getting to 15 million by 2015… and thinking beyond
Gottfried Hirnschall MD, MPHDepartment of HIV/AIDS, World Health Organization
July 26, 2012
Questions for today
• Can 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?
8 million on ART by end 2011 …15 million is achievable !
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015.000
2500.000
5000.000
7500.000
10000.000
12500.000
15000.000
8 million
15 million15.0
12.5
10.0
7.5
5.0
2.5
0.0
ART scale-up: three success stories
• High-level commitment and resources
• Proactive approaches to HIV testing
• Innovation in service delivery
• Integration• Task-shifting• Community-based
services0%
20%
40%
60%
80%
100%
66%
67%
Cambodia >90%
South Africa
Malawi
2003 2011
ART
cove
rage
Disparities in ART coverage between regions and populations
Sub-Sa
haran Afri
ca
Latin Ameri
ca &
Caribbea
nAsia
Easte
rn Eu
rope &
Centra
l Asia
Middle-
East
& North Afri
ca All All
Easte
rn Eu
rope &
Centra
l Asia
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100% Adults Children
70%57%
23%
62%
<10%
46%
14%
IDUs*
28%
AR
T c
ove
rag
e
* 2010 HIV case reporting (18 countries)
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110
1000000
2000000
3000000
4000000
5000000
6000000
7000000
8000000
9000000
People on ART
New HIV infections
AIDS-related deaths
Scale-up of ART, number of AIDS deaths and new HIV infections in LMIC*, 2001–2011
* LMIC = Low- and middle-income countries
Effect of ART coverage on rate of new HIV infections in a rural South African population
<10% 10-20% 20-30% 30-40% >40%00
01
02
Proportion of all HIV-infected people receiving ART (CD4 ≤ 200)
Adju
sted
haz
ard
ratio
Source: 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
0.0
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 ART
0% 5% 10% 15% 20% 25% 30% 35% 40%0%
5%
10%
Proportion of HIV-infected people receiving ART
Prev
alen
ce o
f NN
RTI r
esis
tanc
eRelationship between transmitted resistance to
NNRTI drugs and ART coverage in LMIC
Source: HIV drug resistance report, WHO, 2012
ART eligibility: 5 policy scenarios
Recommended 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 5
ART eligibility: 5 policy scenarios
Recommended 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 5
WHO’s ARV-related guidance in 2012
Treatment 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 MSM
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,co-morbidities)
HOW TO DO IT?(diagnostics,service delivery)
HOW TO DECIDE? (scale-up,equity and ethics,M&E)
Clinical
ProgrammaticOperational
Significant variation in ART eligibility thresholds among countries
CD4 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)
17
Low-income Lower middle-income
High-incomeUpper middle-income
Year of starting ART
Mea
n C
D c
ount
(ce
lls/µ
L)
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 2009
HIVDR Early Warning Indicators, 2011Proportion of clinics achieving WHO-recommended standards
Source: Bennett DE et al. CID 2012 Supp 4 pp 280-9
Drug supply continuity
On time appointment keeping
Retention on first-line ART
Loss to follow-up
Correct prescribing practices
0 20 40 60 80 100
65%
58%
67%
69%
75%
%
The test-treat-retain cascade
Create demand for testing and treatment
Testing
+
Pre-ART care and support
ART Adherence and viral
suppression
ART eligible
HIV+
Patient enrolment into HIV care and treatment, six studies in sub-Saharan Africa
Diagnosed with HIV
CD4 measurement
Eligible for ART Start of ART0
102030405060708090
100 100%
72%
40%
25%
%
Source: Mugglin C et al. IeDEA Southern Africa ( in press)
N = 58,779 persons
Key areas for optimization in the cascade
• Expand, simplify and diversify HIV testing• Offer concrete interventions in the pre-ART window• Use simple and better drugs for first- and second-
line• Provide diagnostic tests and monitoring tools at
point-of-care• Innovate service delivery to enhance adherence
and retention
Provider-initiated testing and counselling (PITC) in Africa
42/53 countries in Africa have PITC policies1
High PITC acceptance by ANC2 & TB patients3,4
Most clinical settings in generalized epidemics not routinely offering HIV testing5
1Baggaley (2012) Bulletin WHO, 2 Etirbet (2004) AIDS Care; Byamugisha (2010) J Int AIDS, 3WHO, Global TB control (2011),4 Corneli (2008) IJTBLD, 5MacPherson (2012) Trop Med.
Date not identified
Adoption of a policy on PITC 2003-2010
Not adopted Data not available
2009 - 2010
2003 - 20042005 - 20062007 - 2008
Scaling up HIV testing in the communityHome-based (door-to-door)
Community Index-case
Campaigns plus HTC-plus –malaria, safe water Non-communicable diseases
Mobile outreach General populations Key populations
Workplaces, schools
A potential new approach: self-testing
Today Practiced 'informally' by many health workers1
Included 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?
1Napierala S, (2011). HIV self-testing among health workers
ART optimization approaches
• Once daily FDC for 1st line (e.g., TDF/3TC/EFV)
• Heat stable once-daily boosted PI options for 2nd 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 TERMNext 1-2 years
Improve currently available drugs
and formulations
MEDIUM TERMNext 2-5 years
Add new drugs/better sequencing
LONG TERMNext 5-10 years
Use new strategies
ARV drug Optimization methodsPresent 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 (65%)
DRV/r Process chemistry dose optimization and reformulation 835 335 (60%)
Potential cost benefits of optimizing ARVsAdapted from Crawford et al, 2012
• 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
2012 2013 2014 Later0
2
4
6
8
10
12
14
16CD4Viral LoadEarly Infant Diagnosis
Number of POC technology releases expected (cumulative numbers)
Retention rates for ART at 12, 24 and 60 months in selected countries, 2011
12 months 24 months 60 months 0
10
20
30
40
50
60
70
80
90
100Botswana
Brazil
Cambodia
Burundi
China
Guatemala
Namibia
Malawi
Central African Rep.
Kenya
DR Congo
Indonesia
Median
%84%
78%72%
Conclusions (1)• Global progress on scale-up of ART has been
extraordinary. Countries show the way! 15 million can be reached
• Further scale-up must address disparities and inequities (countries, key populations)
• With new evidence and new policies, the number of persons eligible for ART will increase
• Countries face strategic choices and are already taking advantage of new opportunities (early ART, TasP, PrEP)
• 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)
Acknowledgements
Rachel Baggaley Tony HarriesAndrew Ball Ying-Ru LoMichel Beusenberg Jos PerriensTxema Garcia Calleja Yves SouteyrandWafaa El-Sadr John StoverCharles Flexner Frank TanserNathan Ford Bernhard SchwartländerReuben Granich Stefano VellaIan Grubb Marco VitoriaTim Hallett Gundo Weiler
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