1. Treatment as prevention: policy and programmatic considerations
Dr Peter Cherutich, MD, MPH
Head, HIV Prevention, Kenya Ministry of Public Health

2. But then why policy makers are cautious
Outline
Why the excitement?
But then why policy makers are cautious
Who will pay? How sustainable is it
What implementation considerations
Prioritization
Adherence
Drug resistance
Measuring Impact
Accelerate access to viral load

3. Why are we excited? Elimination of vertical transmission
And potential for elimination of sexual transmission
Balance between public health and human rights
Demonstrated scale up

4. Significant contribution of early treatment

5. Accelerated Scale-Up Results in Annual Decline in New HIV Infections
Under the base-case scenario, incident HIV infections remain relatively constant at or above 120,000 new cases per year. With accelerated treatment scale-up, incident HIV infections could be driven down to ~86,500 by 2015.

6. But there is caution…..?cost? sustainability
Millions
Estimated costs to maintain current coverage levels in the Base Case and Accelerated Scale-Up Scenario. Flattened treatment costs in the accelerated scale-up scenario reflect effects of declining HIV incidence and additional implementation efficiency.

7. Prioritization....the ethical dilemna
To triage or not to triage
Risk-based? Co-morbidities? CD4 count?
Pregnant women
Triple Benefits of Option B Plus
Transmission benefits to baby
<5% transmission in breastfeeding populations
Transmission benefits to the sexual partners-linked or otherwise
Health/fertility benefits to mother
Preserves fertility
Would be eligible for HAART

8. CD4 threshold for maternal ART
Risk of transmission related to maternal CD4
Many women with CD will go below 350 by the time they would wean their infant (47% of women receiving short-course ARVs with baseline had CD4 < 350 by 24 months (Ekouevi K, CROI 2011)
Data support ART for prevention of sexual transmission or disease progression if CD4 < 500

9. Prioritization...contd
Sero-discordant couples
Dynamics of sexual partnerships
89% protective effect combined
Sex workers (including MSM)
High rates of partnerships/high HIV prevalence
Patients with TB
Reduction of TB mortality- ?a competing public health imperative

10. To PreP or to Treat...thats the question!
PrEP until ART at 350 favoured
Partners in Prevention Couples (2/100pyar)
“Alive and HIV Free at 50”
More Typical Couples (~9/100pyar)
Modelling prevention cost effectiveness of PrEP versus ART in serodiscordant couples by CD4 count at ART initiation: Result depends on:
Relative costs, PrEP effectiveness, and couple sexual behaviour
Use of PrEP can be more cost-effective that earlier initiation of ART at 350 cell/µL, if:
Cost<40% that of ART & Effectiveness>60%
Cost-effectiveness strongly influenced by couples behaviour: PrEP most likely to be cost-effective if used in couples that remain at high risk.
Broad range of PrEP characteristics coul make PrEP preferable to initiating treatment at CD4<500 cells/µL instead of <350 cells/µL.
ART at 500 favoured
Tim Hallett; UNAIDS/WHO PrEP modelling meeting March 2011 10

11. Implementation Considerations
Build on the current treatment programmes
Targets, pilot programmes
Optimize treatment options/outcomes for the current patients
E.g Those with lower cut-offs<250
HIV Testing will be critical-routine, regular
New technologies, task-shifting
Health system strengthening
Chronic disease model-cf diabetes, hypertension
Risk compensation-appropriate communication

12. The Treatment Cascade Decrease in HIV Transmission Wafaa El-Sadr Test
HIV Positive
Adopt safer behaviors
Enroll in Care
Treat
Maintain viral
suppression
Initiation
of ART
Testing
Adherence
to ART
Positive Prevention
Linkage to care
Decrease in HIV
Transmission
Wafaa El-Sadr 12 12

13. Adherence: Requires Innovation
Robust retention strategies
Regular adherence assessment and counselling
Accelerate Fixed Dose Combinations
Review current adherence theoretical models
A significant proportion of healthy ‘patients’
Technology
Phone based applications
This requires funding!

14. Drug resistance..is inevitable!
HIV Drug Resistance, a matter of Time
However, HIV drug resistance can be exacerbated by:
Patient
Poor treatment adherence
Drug
Poor absorption
Varying pharmacokinetics
Sub-optimal dosing
Supply chain
Irregular ARV supply
Strengthen health systems
Strong surveillance systems
Quality assurance mechanisms
Supply chain management
This requires funding!

15. Demonstrating Impact: Viral Load
Consider viral load
Undetectable viral load as a treatment/prevention outcome
PEPFAR indicators etc
Global access initiatives
Integrate into existing surveillance systems
Fast-track the point of care VL
Learn from Early Infant Diagnosis Programmes
Laboratory network
Facilities should be supported to transport samples
Quality assurance

16. …scaling up is possible
UNAIDS, 2010

17. Acknowledgements
John Blandford
Nancy Knight
Nicholas Muraguri
Wafaa El-Sadr
Fellow presenters