1. 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

2. 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?

3. 8 million on ART by end 2011 …15 million is achievable !

4. 8 million on ART by end 2011 …15 million is achievable !
15.0
12.5
10.0
7.5
5.0
2.5
15 million
8 million
0.0
2002

5. 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 services
ART coverage

6. Disparities in ART coverage between regions and populations
* 2010 HIV case reporting (18 countries)

7. Scale-up of ART, number of AIDS deaths and new HIV infections in LMIC
* LMIC = Low- and middle-income countries

8. Effect of ART coverage on rate of new HIV infections in a rural South African population
For every 10% increase in coverage there is a 17% decrease in individual risk
Source: Tanser F et al. CROI 2012

9. Effect of ART coverage on rate of new HIV infections in a rural South African population
1.2
1.0
0.8
0.6
0.4
0.2
0.0
For every 10% increase in coverage there is a 17% decrease in individual risk
Source: Tanser F et al. CROI 2012

10. Balance of evidence favours earlier initiation of ART
Delayed ART
Earlier 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

11. Relationship between transmitted resistance to NNRTI drugs and ART coverage in LMIC
Source: HIV drug resistance report, WHO, 2012

12. ART eligibility: 5 policy scenarios
Estimated millions of people eligible for ART in LMIC in 2011
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+ 1 2 3 4 5
ART regardless of CD4 count for:
- Serodiscordant couples
- Pregnant women
- Key populations
(SW, IDU, MSM)

13. ART eligibility: 5 policy scenarios
Estimated millions of people eligible for ART in LMIC in 2011
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+ 1 2 3 4 5
ART regardless of CD4 count for:
- Serodiscordant couples
- Pregnant women
- Key populations
(SW, IDU, MSM)

14. 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

15. 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
HOW TO DECIDE?
(scale-up,
equity and ethics,
M&E)
Operational
Programmatic
HOW TO DO IT?
(diagnostics,
service delivery)

16. Significant variation in ART eligibility thresholds among countries
CD4 count
for ART
initiation ≤
≤300
≤350
≤350 + TasP
≤500
≤500 + TasP
Number of countries 1 43 12 3
Results of a WHO survey (2011, n= 61 countries)

17. Mean CD4 count at ART initiation is below 200 in LMIC
Low-income
Lower middle-income
Upper middle-income
High-income
Mean CD count (cells/µL)
Year of starting ART
Estimates from random-effects
model adjusted for age, sex and
year of starting ART,
Source: Egger M. CROI 2012

18. HIVDR Early Warning Indicators, 2011
Proportion of clinics achieving WHO-recommended standards %
Source: Bennett DE et al. CID 2012 Supp 4 pp 280-9

19. The test-treat-retain cascade
ART eligible
Create demand for testing and treatment
Testing +
Pre-ART
care and support
ART
Adherence
and viral
suppression
HIV+

20. Patient enrolment into HIV care and treatment, six studies in sub-Saharan Africa%
N = 58,779 persons
Source: Mugglin C et al. IeDEA Southern Africa ( in press)

21. Key areas for optimization in the cascade
World Health Organization
Key areas for optimization in the cascade
5 April 2017
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

22. Provider-initiated testing and counselling (PITC) in Africa
World Health Organization
5 April 2017
Provider-initiated testing and counselling (PITC) in Africa
Adoption of a policy on PITC
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
Date not identified
Not adopted
Data not available
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.

23. Scaling up HIV testing in the community
World Health Organization
5 April 2017
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

24. A potential new approach: self-testing
World Health Organization
5 April 2017
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

25. Add new drugs/better sequencing
ART optimization approaches
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 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)

26. 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
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%)

27. Breakthroughs in diagnostic testing and patient monitoring at point-of-care
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
Number of POC technology releases expected (cumulative numbers)

28. Retention rates for ART at 12, 24 and 60 months in selected countries, 2011
84%
78%
72%

29. 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)

30. 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

31. Acknowledgements Rachel Baggaley Tony Harries Andrew Ball Ying-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