CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

781 EARLY INFANT DIAGNOSIS OF HIV USING DNA PCR CT VALUE AND REPEAT TESTING ALGORITHM Gbolahan Ajibola 1 , Sikhulile Moyo 1 , Terence Mohammed 1 , Seretlogelwa Moseki 1 , Jack Disaro 1 , Maureen Sakoi-Mosetlhi 1 , Oganne Batlang 1 , Kenneth Maswabi 1 , Kara Bennett 2 , Michael D. Hughes 3 , Shahin Lockman 4 , Joseph Makhema 1 , Mathias Lichterfeld 4 , Daniel R. Kuritzkes 4 , Roger L. Shapiro 3 1 Botswana Harvard AIDS Institute Partnership, Gabarone, Botswana, 2 Bennett Statistical Consulting, Inc, New York, NY, USA, 3 Harvard University, Boston, MA, USA, 4 Brigham and Women’s Hospital, Boston, MA, USA Background: Early infant diagnosis (EID) of HIV immediately after birth allows for rapid initiation of treatment in HIV+ infants, limiting disease progression and restricting viral reservoir seeding. However, no standardized testing algorithm is currently recommended. Methods: From April 2015-July 2018, the Early Infant Treatment Study (EIT) screened HIV-exposed infants in Botswana < 96 hours from delivery by Roche TaqMan qualitative DNA PCR. A negative DNA PCR test was defined as no HIV DNA amplification (target not detected) at initial dried blood spot screening; a positive as two concordant spots from same sample with target detected at any cycle threshold (Ct) value; and indeterminate as discordant spots (target detected/target not detected) from same sample. Repeat blood draw occurred for initial positive and indeterminate results. Quantitative HIV-1 RNA testing occurred for those presumptively enrolled in the study. We compared Ct values by the ultimate HIV status of the child (as confirmed by subsequent HIV-1 DNA, and when possible DNA/RNA, testing). Results: Of 10622 HIV-exposed infants screened, 10549 (99.3%) tested negative, 42 (0.4%) tested positive, and 31 (0.3%) tested indeterminate at the first HIV screening test. On repeat testing, 40 (95.2%) of the initial 42 positive infants remained positive and 2 (4.8%) tested negative. Of the 31 indeterminates, repeat testing confirmed 29 (93.5%) as negative and 2 (6.5%) as positive. Confirmatory testing of all positives and indeterminates re-classified 4 (5.5%) infants in total; 1 (1.4%) of the indeterminates required further HIV RNA testing to become reclassified as positive. Median DNA PCR Ct value at screening was 28.1 (IQR 19.8, 34.8) for all positive results and 35.5 (IQR 32.8, 41.4) for indeterminates (p<0.0001). Only 6 (8.2%) infants with final HIV+ status had Ct value > 33 at first screen, and only 2 (6.5%) with indeterminate result and Ct value < 33 at first screen had a final negative HIV status. Conclusion: Using a standard cycle threshold of 33 and a confirmatory second blood draw for HIV DNA and RNA, our test algorithm appeared to eliminate the risk for false positive HIV results in the first week of life. Infants with Ct >33 should be re-tested with follow-up sampling, to minimize the risk for false positive testing.

machine errors (44: 42 Alere q, 2 GeneX) or cartridge stock-out (35: 14 Alere q, 21 GeneX). Conclusion: POC testing at birth and 6 wks requires collaboration among departments and cadres of personnel, yet is feasible in government hospitals in Kenya. Patient education and provider sensitization are needed to support POC at birth, repeat testing at 6 wks, and immediate ART initiation to realize the full benefit of POC technologies. 780 ROUTINE POINT-OF-CARE HIV TESTING AT BIRTH: RESULTS FROM A 1-YEAR PILOT IN ESWATINI Emma Sacks 1 , Caspian Chouraya 1 , Bonisile Nhlabatsi 2 , Philisiwe Khumalo 1 , Thembie Masuku 1 , Tandzile Zikalala 1 , Gcinile Nyoni 1 , Nobuhle Mthetwa 2 , Flavia Bianchi 1 , Jennifer Cohn 1 1 Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA, 2 Ministry of Health, Mbabane, Swaziland Background: In 2017, point of care (POC) birth testing was introduced into routine care at the 3 highest volume maternity sites in Eswatini. POC birth testing was offered to HIV-exposed infants born at, or presenting to, the maternities within 3 days of birth. Two of the POC platforms were used only for birth testing; one was shared with another hospital unit. National guidance states that infants testing negative at birth should return for a 6-week test; infants testing positive at birth should start nevirapine (NVP) immediately and return at 14 days of life to begin a lopinavir/ritonavir regimen (LPV/r). Methods: Prospective data were collected on tests occurring 1 Aug 2017-1 Aug 2018. Variables included number of infants eligible for birth testing, percentage of infants tested, turnaround time from sample collection to receipt of results, positivity, percentage of infected infants initiated on treatment, turnaround time from sample collection to treatment initiation, and percentage of infants testing negative at birth who received a subsequent test at 6 weeks. Results: Of 3385 eligible infants, 1999 (59.1%) received a birth test. Of those producing a positive or negative result (n=1928; 96.4%), 98.9% (n=1906) reached the caregiver. Median turnaround time from sample collection to caregiver receipt of results was 0 days (range 0-31; IQR 0-0). Testing uptake was lower, but turnaround time to result receipt was not longer for the shared platform. 12 HIV-infected infants were identified (yield = 0.6%) and 11 were initiated on treatment (91.7%); 3 on day 14 after diagnosis, 4 after 15 days, and 4 after 60 days. The median time from sample collection to initiation on treatment for positive infants was 32 days (range 14-124; IQR 16-65). One infant died after diagnosis but prior to initiation. Analysis of subsequent tests of infants who tested negative at birth is ongoing (and will be available to be presented at CROI). Conclusion: POC EID at birth is a feasible strategy in this setting. However, not all eligible infants were tested, possibly due to staff shortages or queues for platform use. In practice, infants received no treatment until they returned to begin LPV/r. Same-day pediatric treatment initiation is uncommon in Eswatini due to caregiver desire to consult with male family members. Policymakers may consider better promotion of NVP at birth, the introduction of new pediatric formulations that can be used at birth and beyond, and/or better linkage to care to ensure timely initiation on treatment.

Poster Abstracts

CROI 2019 302