HIV Point of Care tests in Babies Study (BABY) Operational evaluation of HIV Point of Care tests for very early infant HIV diagnostics in infants born.

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HIV Point of Care tests in Babies Study (BABY) Operational evaluation of HIV Point of Care tests for very early infant HIV diagnostics in infants born from HIV infected mothers in Mbeya, Tanzania Arne Kroidl

Baby Study Study design: Non-invasive in-vitro diagnostic study Study population: N=600 HIV+ mothers & exposed neonates from Mbeya, Tanzania HIV PoC Test: - Cepheid Xpert HIV-1 Qual PoC (neonates) - Cepheid Xpert HIV-1 Qual PoC from DBS (neonates) - Cepheid Xpert HIV-1 VL (mothers at delivery) Confirmatory HIV diagnostics: DBS HIV-DNA (Roche COBAS TaqMan) plasma HIV-RNA viral load (Roche COBAS TaqMan) End of Study Week 6 Delivery/Birth Week 1 Week 2 Week 3 PoC Neonatal Xpert HIV-1 Qual Martenal Xpert HIV-1 VL

Baby Study Primary objective Secondary objectives Operational specificity, sensitivity and predictive values of the Xpert Qual HIV-1 to identify vertical HIV newborn transmission Secondary objectives Assessments of neonatal HIV transmission rates and at different time points (intra-uterine, peri-/postnatal) and define the optimal time point to detect the highest number of peripartal transmissions at the earliest possible occasion. Evaluation of the Xpert Qual HIV-1 from dry blood samples (DBS) Evaluation of the Xpert HIV-1 Viral load test in mothers at delivery Practical feasibility of implementing early newborn diagnostics in de-centralized African Health Care settings

Maternal Characteristics N=614 neonates born from 606 HIV-infected women included (8 twin pairs) included Variable N=614 Age, median (range) 29 (18-44) Mode of delivery Vaginal, at hospital 498 (81.1%) Vaginal, at home 25 (4.1%) Caesarean section 89 (14.5%) Not on ART at delivery 51 (8.3%) CD4 count categories <200 cells/µL 97 (15.8%) 200 to 350 cells/µL 156 (25.4%) >350 cells/µL 353 (57.5%) Plasma HIV-RNA* >1000 copies/mL 133 (21.7%) Plasma HIV-RNA* >1000 copies/mL on ART 89 (15.9%) * Measure by Roche TaqMan

Maternal HIV-RNA at delivery (N=574) Comparison of SoC plasma VL (Roche TaqMan) versus PoC plasma VL (Cepheid HIV-1 Xpert Quant) N=11 Xpert >1000 c/mL TaqMan <1000 c/mL Log HIV-RNA (Xpert) N=6 Xpert <1000 c/mL TaqMan >1000 c/mL Log HIV-RNA (TaqMan) Good agreement between VL results HIV-1 Xpert VL overall higher than TaqMan VL

Maternal HIV-RNA at delivery Comparison of SoC plasma VL (Roche TaqMan) versus PoC plasma VL (Xpert HIV-1 VL) Bland Altman Analysis → only quantifiable HIV-RNA results included lower limit: - 0.5 log mean difference: 0.3 log higher limit: 1.2 log

Vertical HIV transmission – infected neonates N=15 neonatal HIV transmissions detected by Xpert Qual HIV-1 PoC correctly confirmed by DBS HIV-DNA and/or plasma VL (Roche TaqMan) Neonatal HIV Status until Week 6 post-partum N=614 HIV-infected neonates 15 (2.4%) At birth 10 (66.7%) Week 1 post-partum 2 (13.3%) Week 2 post-partum 1 (6.7%) Week 3 post-partum Week 6 post-partum The majority on HIV infected infant had evidence for intra-uterine HIV transmission

Vertical HIV transmission – infected neonates Maternal risk-factors associated with vertical HIV transmission (n=infected infants/N=mothers with factor) Maternal risk factor n/N (%) RR (95% CI) p-value Not on ART at delivery 4/51 (7.8%) 4.0 (1.3-12.1) 0.014 VL >1000 copies/mL 14/133 (10.5%) 50.4 (6.7-380.1) <0.001 On ART at delivery but VL >1000 copies/mL 10/89 (11.2%) 53.7 (7.0-414.0) CD4 count <200 cells/µL 9/97 (9.3%) 7.8 (2.8-21.5) Non-adjusted Poisson regression, RR=risk factor

Cepheid Xpert Qual HIV-1 PoC Baby Diagnostic All whole blood Xpert Qual PoC results correctly identified neonatal HIV infection (no false negative test result) Confirmed by positive DBS qualitative HIV-DNA and/or plasma VL at the time of test positivity correctly identified HIV negativity (no false positive test result) Confirmed by negative DBS qualitative HIV-DNA at Week 6 but….

Case 1 The Xpert Qual HIV-1 PoC demonstrated greater sensitivity to detect early HIV transmission (week 1) as compared to the DBS HIV-DNA and plasma HIV-RNA. Birth Week 1 Week 2 Week 3 Week 6 Xpert HIV-1 Qual POC (whole blood) negative positive DBS Soc HIV-DNA (Roche TaqMan) Plasma HIV-RNA SoC - < 34 116.000 Xpert HIV-1 Qual POC (DBS) Infant ARV’s NVP Plasma HIV-RNA Soc VL (mother) (Roche TaqMan) 41.900

Case 2 Negative HIV tests at week 6 → possibly due to infant NVP prophylaxis Routine HEID procedures at week 6 would have missed HIV infection Birth Week 1 Week 2 Week 3 Week 6 Week 10 Xpert HIV-1 Qual POC (whole blood) positive negative DBS Soc HIV-DNA (Roche TaqMan) Plasma HIV-RNA SoC 53.100 - <34 292 Xpert HIV-1 Qual POC (DBS) Infant ARV’s NVP ZDV+3TC+NVP Plasma HIV-RNA Soc VL (mother) (Roche TaqMan) 15.100

Case 3 Negative HIV tests at week 6 → possibly due to infant NVP prophylaxis Routine HEID procedures at week 6 would have missed HIV infection Birth Week 1 Week 2 Week 3 Week 6 Week 10 Xpert HIV-1 Qual POC (whole blood) positive negative DBS Soc HIV-DNA (Roche TaqMan) Plasma HIV-RNA SoC 1.570 - 75 Xpert HIV-1 Qual POC (DBS) Infant ARV’s NVP ZDV+3TC+LPV/r Plasma HIV-RNA Soc VL (mother) (Roche TaqMan) 181.000

Cepheid Xpert Qual HIV-1 PoC - Operational performance - Birth testing HIV-PoC testing at birth N=614 Time between birth and testing, median (range) 16 hours (0.5-58) Test performed <12 hours after birth 233 (38.0%) 12 to 24 hours after birth 222 (36.2%) 24 to 48 hours after birth 129 (21.0%) >48 hours after birth 9 (1.5%) Missing information 21 (3.4%)

Cepheid Xpert Qual HIV-1 PoC - Operational performance - Test performance at the health facilities PoC test performed N=2736 Valid test result obtained 2673 (97.7%) Time between sample collection and result communication to the mother of valid test results, median (range) 110 minutes (94 minutes to tab 7 days) No valid test result obtained 63 (2.3%) PoC test problem reported by nurses 183 (6.7%) Early terminated analysis because of power cut 106 (57.9%) Error/invalid result message 61 (33.3%) Problem with computer or analyser handling 4 (2.2%) Clotted blood 2 (1.1%) No reason indicated 10 (5.5%) PoC testing had to be repeated 132 (4.8%) PoC testing performed at other site (sample transferred) 210 (7.7%)

Cepheid Xpert Qual HIV-1 PoC - Operational performance - Opinions by nurses (N=24)

Conclusion 100% sensitivity & specificity of the whole blood Xpert Qual HIV-1 PoC to detect neonatal HIV infection Requirement for neonatal test & immediate antiretroviral treat approaches In some cases: Whole blood Xpert with greater sensitivity as compared to DBS testing False negative EID-HIV results for all tests at week 6 Good operational feasibility and acceptance among nurses/midwives Greatest challenge: power-cuts The greatest risk for vertical transmission is high maternal viral load at delivery Need for maternal PoC HIV-RNA monitoring for potential treatment adjustment or extended neonatal prophylactic regimens Good agreement seen between maternal Xpert HIV-1 VL and TaqMan

Acknowledgment Mbeya Medical Research Center & Mbeya Referral Hospital Clinic Issa Sabi (PI) Hellen Mahiga (cordinator) Debora Kikaro (nurse) Sarah Mlelwa (nurse) John France (HoD Obs & Gyn MRH) Data Management Peter Agrea Willyhelmina Olomi Lab Abidai Kisinda LMU Munich Arne Kroidl Otto Geisenberger (monitoring) Sabine Kastner (monitoring) Fidelina Zekoll (data managment) Conny Luer (local lab management) Michael Hoelscher Cepheid South Africa Dipti Lallubhai Gwynn Stevens Funder: All nurses and midwives at the Mbeya study sites ! Supported by: