WHO directives. This strategy has virtually contributed to the eradication of the disease in infancy, in many countries

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1 A Retrospective Study of 63 infants born to HIV seropositive mothers in a Central Maternity Hospital of Greece, from 2011 to 2018 Eirini Koutsounaki Pediatrician Neonatologist Helena Venizelou NICU, Athens Polyxeni Bitouni 1, Anastasia Kapetanaki 1, Stephanos Pappas 2, Eirini Zorou 3, Margarita Tzaki 1 1. Neonatal Department, Helena Venizelou Maternity Hospital of Athens, Greece 2. Obstetrics; Gynecology Department, Helena Venizelou Maternity Hospital of Athens, Greece 3. Infectious disease Department, Helena Venizelou Maternity Hospital of Athens, Greece

2 WHO directives combined AntiRetroviral Treatment (cart) is recommended for all HIV seropositive women during pregnancy, according to the World Health Organization (WHO) directives This strategy has virtually contributed to the eradication of the disease in infancy, in many countries WHO. Global update on the health sector response to HIV, 2014

3 Introduction In Greece, as in many other countries, a significant proportion of the population is still infected with HIV near the reproductive age (horizontal transmission) Besides, the population map changes and there is an influx of new incidents, originating from regions with vertical or horizontal transmission (seropositive pregnant women diagnosed at the country s borderline admitted to hospitals) Pregnancy incidence and outcomes in women with perinatal HIV infection Laura Byrne, et al. AIDS doi:

4 Introduction Early detection of the infection and prompt inclusion in a therapeutic protocol is of paramount importance to the Public Health The administration of cart to the mother though, has been observed to result in neonatal complications such as IUGR, prematurity and lethal neonatal outcome Zash R, et al. JAMA Pediatr doi: Chetty T, et al. PLoS One doi: Snijdewind IJM, et al. PLoS One doi: Sania A, et al. J Pediatr doi:

5 Scope The purpose To study the clinical outcomes of the neonates born to HIV seropositive mothers in relation to cart

6 Method Study Design: Retrospective recording from the Patients Registry Archive, Elena Venizelou Maternity Hospital Inclusion criteria: each case born to HIV seropositive mother, in the period

7 Treatment During pregnancy, combined cart treatment was provided to all HIV seropositive pregnant women, who were attending the out patient department Before and during delivery, zidovudine was being administered intravenously to the mother Newborns according to risk parameters received single, double or triple treatment (zidovudine, ± nevirapine, ± lamivudine).

8 Table 1. Mothers Characteristics Mother s age (years) 30 (min, max) (17, 41) Origin (Greek) 31/ 63 47% Use of substanses 17/ 63 26% Co-infections (TORCH, other viruses) 22/ 63 34% HIV RNA Viral load at delivery (High) > 400 copies: 4 6,3% (Low) < 400 copies: 7 11,1% (Not detected) < 34 copies: 26 41% (Unknown) 26 41% anti HIV1/2 (mother at delivery) 49/63, mean: 491 (26, 890)(1Q, 3Q ) (neonate at birth) 32/63, mean: 383 (40, 794) Medical Follow Up 42/ 63 64,6% Compliance to cart 36/ 63 53% cart introduced at <6 months 10/ 63 16% cart introduced at >6 months 24/ 63 38%

9 Results (1) In our hospital 63 infants (38 males) were born to HIV seropositive mothers, from 2011 to March 2018 Low Birth Weight <2500gr or IntraUterine Growth Retardation IUGR presented 22/63 (35%) of newborns

10 Number of live births from HIV-positive mothers per year, "Elena Venizelou" Maternity Hospital Ν: 63 38/63 males

11 Results (2) SGA vs cart 50 SGA<2500gr (or IUGR) /63 (35%) of newborns There was shown a tendency to SGA in relation to antiretroviral treatment Pearson's chi-squared test p-value is not significant sga cart χωρίς δυ aga

12 Results (3) Prematurity < weeks: 22/63 (35%) Mean GA (min, max) w (30 + 4, ) Προωρότητα vs c ART no difference was noted in the rate of prematurity in relation to antiretroviral treatment Χ 2 p-value not significant 10 0 πρόωρα ΤΜΝ νεογνά χωρίς με cart ΔΥ

13 Results (4) Treatment/ zidovudine at delivery (caesarian section): all, without any exception Only 5 cases, those of vaginal delivery (upon arrival at the hospital, in the absence of time) did not receive zidovudine at delivery

14 Table 2. Mother s demographics and comparison of the duration of the disease Mother with acquired disease N: 43 Mother with origin/ vertical transmission N: 18, missing: 3 P- Maternal Age, years, median (min, max) 29 (17, 41) 30 (20, 39) NS Greek Origin, number (%) 28 (65%) 0 (0%) S Substance use, number (%) 15 (34%) 2 (11%) S Co-infections, number of patients (%) 17 (39%) 2 (11%)/ΔΥ: 4 (22%) S/NS HIV RNA Viral load at delivery (High) 4 (9%) /missing: 19 (44%) Medical Follow Up 1 (5,5%) /missing: 6 (33%) (Low) 3 (6.9%) 11 (61%) S p-value is<.001 (Not detected) 16 (37%) 8 (44%) NS anti -HIV (mother at delivery) 532,33 ( ) 400,72 ( ) NS 28 (65%) missing: 10 (23%) 10 (55%) missing: 8 (44%) Compliance to cart 25 (58%) 10 (55%) NS cart introduced at <6 μήνες 3 (6.9%) 7 (38%) S cart introduced at >6 μήνες 20 (46%) 4 (5,5%) S NS S/NS

15 Results (5) The mothers carrying the disease for a longer period due to their origin are more likely to maintain positive, low though, viral load in pregnancy and are more likely to have shorter follow-up period and shorter treatment duration closer to the perinatal period

16 Results (6) Our newborns received treatment for 40 days, initiating soon after birth: one drug, zidovudine 34/63 (52.3%) two drugs, zidovudine and nevirapine 12/63 (18.5%) and / or (depending on the presence of risk factors) triple treatment with zidovudine, nevirapine, lamivudine 18/63 (27.6%) Only one neonate 1/63 (1.5%) presented with positive HIV viral load at birth... This infant had shown good response to triple treatment, with undetected viral load at 6 months of life follow-up in the specific pediatric infectious department

17 Study Limitations Retrospective recording (eg missing data the mother's height, IUGR information?) Maternal monitoring by different infectious diseases departments, not in our hospital Compliance: according to mother s statement Absence of mothers data regarding behavioral idividualities Only cases of pregnancy which resulted in the birth of viable newborns were recorded

18 Conclusions (1) Maternal cart treatment tends to affect neonatal birth weight and possibly gestational age, although our results did not show statistically significant differences The time of origin of the mother's disease, particularly if she was infected by vertical transmission, is related to retaining low viral load during pregnancy and the late treatment compliance, at the perinatal period

19 Conclusions (2) the findings of the study are in line with the recent literature Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine Rough K, et al. N Engl J Med doi: /NEJMoa

20 Take home message A significant number of neonates are born to HIV seropositive mothers during the recent years. Compliance to the treatment is mandatory. Specialists observation is needed for the treated newborns growth and developmental follow up.

21 People of the study Anastasia Kapetanaki, Polyxeni Bitouni, Marianthi Liaska, Stefanos Pappas, Irini Zorou, Sofia Xydia, Eleni Zambeta, Athanasios Vlachogiannis, Irene Glynou, Neonatal Department Head Director: Margarita Tzaki "ELENA VENIZELOU Maternity Hospital

22 Thank you!