Cost effective implementation of POC molecular testing and the impact on a priority population:

1. Cost effective implementation of POC molecular testing and the impact on a priority population: EID and beyond

2. HIV Infections Among Infants Is a Public Health Emergency Early infant diagnosis of HIV (EID) is vital to ensure HIV-infected infants begin lifesaving treatment as early as possible, thereby ensuring their survival The WHO recommends early testing of all HIV-exposed infants, rapid return of results, and prompt antiretroviral treatment (ART) initiation for those who are HIV-positive • All HIV-exposed infants should have a virological test at four to six weeks of age or at the earliest opportunity thereafter (strong recommendation)1 • The turnaround time (TAT) from specimen collection to results return to caregiver should never be longer than four weeks. (strong recommendation)2 • Positive test results should be fast-tracked to the mother-baby pair as soon as possible to enable prompt initiation of ART, if needed (strong recommendation)1 • Point-of-care early infant HIV diagnosis (POC EID) can be used for early infant HIV testing (conditional recommendation)2 • POC EID testing can be used to confirm positive test results3 • Consideration can now be given to replacing RDT at nine months with NAT (e.g. POC EID)3 1 World Health Organization (2016). Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Second edition. Geneva. 2 World Health Organization (2010). WHO recommendations on the diagnosis of HIV infection in infants and children. Geneva. 3 World Health Organization (2018). Technical report. HIV diagnosis and ARV use in HIV-exposed infants: A programmatic update. Geneva.

3. With laboratory-based EID testing, the number of steps from sample collection to return of results to caregiver and clinical action lead to persistent delays and a high proportion of lost results. Step 1 Specimen collection at health facility Step 2 Sample transport to laboratory Analysis at the laboratory Step 3 Result return to health facility Step 4 Step 5 Result return to caregiver Timeframe: 30-90 days

4. Why POC EID? Challenges with the Conventional EID Cascade Turnaround time from blood sample collection to return of results to caregiver: 30-90 days Source: On the Fast-Track to an AIDS-Free Generation, UNAIDS, 2016

5. With Conventional EID Testing Many Infants Never Get Results Based on a weighted average of nine studies and monitoring and evaluation (M&E) data, 42% of EID test results are not received by the patient • Wasted reagents • Wasted HR time • Unnecessary repeat testing • Infants LTFU before receiving results • Poor linkage between testing and care and treatment • High infant mortality

6. Results from Implementation Study in 9 Countries: Conventional vs. POC EID (Cameroon, Cote d’Ivoire, Eswatini, Kenya, Lesotho, Mozambique, Rwanda, Zambia, Zimbabwe)

7. Cost Per Test Result Returned • Current conventional reagents are approximately $10, while the price of POC EID cartridges range from $14.90 to $25. • BUT what truly matters is cost per test result returned so clinical action can be taken (and time and resources not wasted). *https://www.theglobalfund.org/media/5765/psm_viralloadearlyinfantdiagnosis_content_en.pdf

8. Cost-effectiveness modeling for Zimbabwe found POC EID improved survival by 6.8% in the first 3 months of life and was cost-effective compared to Conventional EID. ICER vs conventional for year of life saved: $630 USD Frank et al. LHIV 2019.

9. The incremental cost-effectiveness ratio (ICER) for POC EID is $630 per year of life saved. This is $740 less per year of life save than Option B+ for PMTCT, which is a widely accepted and used intervention. .

10. Integrated Diagnostics: Moving Closer to the Goal of Patient-Centered Care • Meeting the diagnostic needs of the patient • Where they present • Accurately • In a holistic way • With rapid clinical action • Integrated diagnostics adapted to the facility type, patient population and site set-up • Ensuring HCWs have the tools and training to support integrated testing • With fidelity • Safely for the patient and provider

11. Rapid Response to Viremia in Pregnancy: An opportunity to improve PMTCT DTG vs EFV When Starting ART in Late Pregnancy Viremia at Delivery by Regimen Khoo S et al. CROI 2019 Seattle, WA Abs. 40LB

12. Closer to EMTCT: Plans for POC VL in Lesotho

13. Conclusions: POC EID Is a Game-Changer • Early HIV testing, prompt return of test results, and rapid initiation of treatment reduce morbidity and mortality among HIV-infected infants. • HIV-exposed infants have a right to a timely and accurate diagnosis • POC resulted in significantly improved EID outcomes when compared with conventional EID: • Dramatically reduced turnaround time for test results (median of 50 days with conventional testing versus 0 days with POC) • Twice as likely for HIV+ infants to be initiated on treatment in 60 days • POC EID is cost-effective and saves lives • It is critical that diagnostics are valued in public health if we are to reach our goals • Diagnostic integration offers the opportunity to provide patient-centered care and also improve platform utilization, thus improving value for money

14. Thank you!