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

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

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

Significant contribution of early treatment

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.

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.

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

CD4 threshold for maternal ART Risk of transmission related to maternal CD4 Many women with CD4 350-500 will go below 350 by the time they would wean their infant (47% of women receiving short-course ARVs with baseline 400-500 had CD4 < 350 by 24 months (Ekouevi K, CROI 2011) Data support ART for prevention of sexual transmission or disease progression if CD4 < 500

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

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

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

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

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!

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!

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

…scaling up is possible UNAIDS, 2010

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