Transcript Expanding HIV testing and the use of ARVs for treatment and prevention Getting to 15 million by 2015… and thinking beyond Gottfried Hirnschall MD,

Expanding HIV testing and the use
of ARVs for treatment and prevention
Getting to 15 million by 2015…
and thinking beyond
Gottfried Hirnschall MD, MPH
Department 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?
Millions
8 million on ART by end 2011
…15 million is achievable !
15.0
15.0
15 million
12.50
12.5
10.0
10.0
8 million
7.50
7.5
5.0
5.0
2.50
2.5
0.0
.0
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
• High-level commitment
and resources
• Proactive approaches
to HIV testing
• Innovation in service
delivery
• Integration
• Task-shifting
• Community-based
services
ART coverage
ART scale-up: three success stories
100%
Cambodia >90%
80%
60%
40%
67%
Malawi
66%
South
Africa
20%
0%
2003
2011
Disparities in ART coverage between
regions and populations
ART coverage
100%
Adults
90%
Children IDUs*
80%
70%
60%
50%
62%
70%
57%
40%
30%
46%
20%
23%
10%
28%
14%
<10%
0%
SubSaharan
Africa
Latin
America &
Caribbean
Asia
Eastern Middle-East
Europe & & North
Central Asia Africa
* 2010 HIV case reporting (18 countries)
All
All
Eastern
Europe &
Central Asia
Millions
Scale-up of ART, number of AIDS deaths and
new HIV infections in LMIC*, 2001–2011
9
8
People on ART
7
New HIV infections
6
AIDS-related deaths
5
4
3
2
1
0
2001
2002
2003
2004
2005
2006
2007
2008
* LMIC = Low- and middle-income countries
2009
2010
2011
Adjusted hazard ratio
Effect of ART coverage on rate of new HIV
infections in a rural South African population
01
1.2
01
1.0
01
0.8
01
0.6
0.4
00
For every 10% increase in
coverage there is a 17%
decrease in individual risk
00
0.2
00
0.0
<10%
10-20%
20-30%
30-40%
>40%
Proportion of all HIV-infected people receiving ART (CD4 ≤ 200)
Source: Tanser F et al. CROI 2012
Balance of evidence favours earlier
initiation of ART
Delayed ART
Earlier ART
↓ Drug toxicity
↓ Resistance
↓ Upfront costs
↑ Clinical benefits (AIDS- and
Preservation of Tx options
non-AIDS related)
↓ HIV and TB transmission
↑ Potency, durability, tolerability
↑ Treatment sequencing options
↑ Medium/long-term cost savings
Prevalence of NNRTI resistance
Relationship between transmitted resistance to
NNRTI drugs and ART coverage in LMIC
10%
5%
0%
0%
5%
10%
15%
20%
25%
30%
Proportion of HIV-infected people receiving ART
Source: HIV drug resistance report, WHO, 2012
35%
40%
ART eligibility: 5 policy scenarios
Estimated millions of people eligible for ART in LMIC in 2011
11
15
23
25
32
1
2
3
4
5
CD4 ≤ 200
CD4 ≤ 350
CD4 ≤ 350
+ TasP
CD4 ≤ 500
All HIV+
Ongoing systematic
review of evidence
(GRADE review)
“Test and
treat”
Recommended
Recommended
Since 2003
since 2010
Incremental
approach 2012
ART regardless of CD4 count for:
- Serodiscordant couples
- Pregnant women
- Key populations
(SW, IDU, MSM)
ART eligibility: 5 policy scenarios
Estimated millions of people eligible for ART in LMIC in 2011
11
15
23
25
32
1
2
3
4
5
CD4 ≤ 200
CD4 ≤ 350
CD4 ≤ 350
+ TasP
CD4 ≤ 500
All HIV+
Ongoing systematic
review of evidence
(GRADE review)
“Test and
treat”
Recommended
Recommended
Since 2003
since 2010
Incremental
approach 2012
ART regardless of CD4 count for:
- Serodiscordant couples
- Pregnant women
- Key populations
(SW, IDU, MSM)
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)
Clinical
Operational
HOW TO DO IT?
(diagnostics,
service delivery)
Programmatic
HOW TO DECIDE?
(scale-up,
equity and ethics,
M&E)
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)
Mean CD4 count at ART initiation is below 200
in LMIC
Mean CD count (cells/µL)
Low-income
2002
Lower middleincome
2009 2002
Upper middleincome
2009 2002
Year of starting ART
Source: Egger M. CROI 2012
High-income
2009 2002
2009
Estimates from random-effects
model adjusted for age, sex and
year of starting ART, 2002-2009
17
HIVDR Early Warning Indicators, 2011
Proportion of clinics achieving WHO-recommended standards
75%
Correct prescribing practices
69%
Loss to follow-up
67%
Retention on first-line ART
58%
On time appointment keeping
65%
Drug supply continuity
0
20
40
60
Source: Bennett DE et al. CID 2012
Supp 4 pp 280-9
80
100%
The test-treat-retain cascade
ART eligible
Create
demand for
testing and
treatment
Testing
+
HIV+
Pre-ART
care and
support
ART
Adherence
and viral
suppression
Patient enrolment into HIV care and treatment,
six studies in sub-Saharan Africa
%
100
100%
N = 58,779 persons
80
60
72%
40
40%
20
25%
0
Diagnosed
with HIV
CD4
measurement
Eligible for ART
Source: Mugglin C et al. IeDEA Southern Africa ( in press)
Start of ART
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 secondline
• 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
Adoption of a policy on PITC
 42/53 countries in Africa
have PITC policies1
2003-2010
 High PITC acceptance
by ANC2 & TB patients3,4
 Most clinical settings in
generalized epidemics
not routinely offering HIV
testing5
1Baggaley (2012)
2003 - 2004
2005 - 2006
2007 - 2008
2009 - 2010
Date not identified
Not adopted
Data not available
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.
Scaling up HIV testing in the community
Home-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
SHORT TERM
MEDIUM TERM
LONG TERM
Next 1-2 years
Next 2-5 years
Next 5-10 years
Improve currently
available drugs
and formulations
Add new
drugs/better
sequencing
Use new
strategies
•
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)
Potential cost benefits of optimizing ARVs
Adapted from Crawford et al, 2012
ARV drug
Optimization 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 (65%)
DRV/r
Process chemistry dose
optimization and reformulation
835
335 (60%)
Breakthroughs in diagnostic testing and patient
monitoring at point-of-care
• Point-of-care CD4 is
just emerging
16
14
• 3 products available
and 1 prequalified
• Point-of-care testing
for VL and EID is
imminent
12
10
Number of POC technology releases
expected (cumulative numbers)
CD4
Viral Load
Early Infant Diagnosis
8
6
4
2
• Affordability is key
0
2012
2013
2014
Later
Retention rates for ART at 12, 24 and 60 months
in selected countries, 2011
100 %
90
84%
Botswana
78%
72%
80
Brazil
Cambodia
Burundi
70
China
60
Guatemala
50
Namibia
40
Malawi
Central African Rep.
30
Kenya
20
DR Congo
10
Indonesia
Median
0
12 months
24 months
60 months
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)
Conclusions (2)
• 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
Acknowledgements
Rachel Baggaley
Andrew Ball
Michel Beusenberg
Txema Garcia Calleja
Wafaa El-Sadr
Charles Flexner
Nathan Ford
Reuben Granich
Ian Grubb
Tim Hallett
Tony Harries
Ying-Ru Lo
Jos Perriens
Yves Souteyrand
John Stover
Frank Tanser
Bernhard Schwartländer
Stefano Vella
Marco Vitoria
Gundo Weiler