1. The clinical impact and cost-effectiveness of incorporating point-of-care (POC) assays into early infant HIV diagnosis (EID) programs at 6 weeks of age in Zimbabwe
Simone C. Frank, BA
Jennifer Cohn, MD, MPH
Lorna Dunning, MBiochem
Emma Sacks, PhD
Rochelle P. Walensky, MD, MPH
Sushant Mukherjee, MBA
Esther Turunga, MBA
Kenneth A. Freedberg, MD, MSc
Andrea L. Ciaranello, MD, MPH
Supported by Unitaid, the Elizabeth Glaser Pediatric AIDS Foundation, NICHD, NIAID, the World Health Organization, amfAR, and the Charles Hood Foundation

2. Disclosures
I have no conflicts of interest to declare

3. Early Infant Diagnosis (EID)
Nearly 1.4 million children were born to HIV-infected mothers worldwide in 2015
150,000 children became newly infected
WHO recommends EID testing at 6 weeks for all infants born to women living with HIV:
<50% accessed EID testing by 2 months of age (2015)
Conventional EID: laboratory-based PCR assays
Long times for transporting specimens to lab; returning results to clinics, caregivers, and patients
Substantial loss to follow-up before result-return

4. Point-of-Care (POC) Assays for EID POC EID testing may lead to:
Increase in access to testing
Quick, on-site screening
Reduced result-return times & increased percentage of result-return to patients/caregivers
Rapid linkage to ART
Elizabeth Glaser Pediatric AIDS Foundation & Unitaid: pilot project in Zimbabwe

5. Objective
To project the clinical impact, cost, and cost-effectiveness of integrating POC assays into Zimbabwe’s national EID network

6. Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric Model
Widely-published mathematical model of pediatric HIV disease, infant HIV transmission, and EID testing
Simulates individual-level clinical events – HIV detection via EID or opportunistic infection, disease progression (CD4, VL), treatment response
Uses existing data to project longer-term clinical and economic outcomes

7. Methods: strategies
Modeled cohort of HIV-exposed infants undergoing EID testing in Zimbabwe
Conventional EID
Point-of-care (POC) EID

8. Methods: outcomes Outcomes projected separately for:
HIV-infected infants
Entire birth cohort (including both HIV-infected and HIV-exposed, uninfected)
Projected outcomes:
1-year survival
Life expectancy (LE)
Per-person HIV-related health care costs

9. Cost-effectiveness analysis
Used cost-effectiveness analysis to assess the comparative value of POC EID vs. Conventional EID
Incremental CE ratio (ICER):
“Cost-effective” = additional health benefit worth the additional cost
Compare to Zimbabwe per-capita GDP ($930)
We defined an ICER <1x GDP/YLS as “cost-effective”
Ongoing research to identify appropriate thresholds
∆ cost ($POC – $Conventional)
∆ health benefit
(POC LE – Conventional LE) $
Year of life saved (YLS) in

10. Inputs: EID assay and cascade
EID assay inputs
Conventional
POC
Sensitivity
100%
96.9%
Specificity
99.6%
Cost
$14.50
$21.00
EID cascade inputs
Result-return time
1 month
Immediate
Probability of receiving result and linking to care
71%
97%
Sources: EID Consortium 2016, GFATM 2017, Hsiao 2016, WHO 2013

11. Results: survival POC result-return and linkage to ART
Conventional result-return and linkage to ART
76.5
71.5
1 year

12. Results: lifetime projections
Lifetime projections (undiscounted)
Strategy
HIV-infected life expectancy (years)
Birth cohort life expectancy (years)
Lifetime costs (2014 USD per person)
Conventional
23.8
60.1
$860
POC
25.5
60.2
$930
Using birth cohort costs and life expectancy values discounted at
3%/year, the ICER of POC EID vs. Conventional EID was $750/YLS
POC EID was cost-effective compared to Conventional EID

13. Sensitivity analyses
Extensive sensitivity analyses on all key parameters
Specific to each strategy (i.e. assay cost, sensitivity, and specificity)
Applying to both strategies (i.e. care costs, PMTCT)
POC EID was no longer cost-effective if:
<75% of infants undergoing POC testing or >96% undergoing conventional testing received test results
<80% of infants linked to ART after receiving POC results
POC assay sensitivity: <85%
POC assay specificity: <92%
POC assay cost: >$40

14. Conventional result-return vs. POC sensitivity
POC assay sensitivity (%) 88 89 90 91 92 93 94 95 96 97 98 99
100 70 72 74 76 78 80 82 84 86
ICER ≤ $930/life-year saved
POC is more expensive and less effective
ICER $930 - $2,790/life-year saved
POC is less expensive and less effective
ICER ≥ $2,790/life-year saved
Lowest POC sensitivity point-estimate in published literature
Base case
Conventional result-return probability (%)
Highest conventional result-return probability in published literature

15. Limitations Only examines EID testing at 6 weeks of age
Limited data about resources required to implement or expand POC EID programs and how POC will affect EID cascade outcomes
Multiple factors may further decrease POC costs, making it more cost-effective
Clinical outcomes may be generalizable across sub-Saharan Africa; costs and cost-effectiveness outcomes specific to Zimbabwe

16. Conclusions
Timely return of EID test results is critical to averting infant mortality in the early months of life
Incorporating POC assays into EID programs at 6 weeks of age in Zimbabwe will improve survival and life expectancy and will be cost-effective compared to conventional EID

17. Acknowledgements
CEPAC-Pediatric Team: Elaine Abrams, Ingrid Bassett, Alex Bulteel,
Andrea Ciaranello, Sophie Desmonde, Caitlin Dugdale, Lorna Dunning, Simone Frank, Emily Hyle, Taige Hou, Valeriane Leroy, Landon Myer,
Anne Neilan, Robert Parker, Kunjal Patel,
Martina Penazzato, George Seage, Djora Soeteman,
Milton Weinstein, Rochelle Walensky, Kenneth Freedberg
Supported by: Unitaid, the Elizabeth Glaser Pediatric AIDS Foundation, NICHD (R01 HD079214), NIAID, the World Health Organization,
the IMPAACT Network, and amfAR, with prior support from
March of Dimes, Mass General Hospital, and the Charles Hood Foundation