CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

796 Viral Suppression and Retention 2-5 Years After ART Initiation in Pregnancy in Uganda

Catherine A. Koss 1 ; Paul Natureeba 2 ; Dalsone Kwarisiima 2 ; Mike Ogena 2 ;Tamara Clark 1 ; Deborah Cohan 1 ; Peter Olwoch 2 ; Edwin Charlebois 1 ; Moses R. Kamya 3 ; DianeV. Havlir 1 1 Univ of California San Francisco, San Francisco, CA, USA; 2 Makerere Univ-Univ of California San Francisco Rsr Collab, Kampala, Uganda; 3 Makerere Univ Coll of Hlth Scis, Kampala, Uganda Background: Recent studies have demonstrated that up to 40% of women are lost to follow-up after initiating antiretroviral therapy (ART) during pregnancy in Option B+ programs. Data are limited on long-term virologic outcomes and retention in care, particularly after cessation of breastfeeding. Methods: We evaluated retention in care and viral suppression (VS) 2-5 years postpartum among previously ART-naïve women who initiated ART during pregnancy (Option B+) at 12-28 weeks gestation in a study (PROMOTE, NCT00993031) in rural Uganda. Participants breastfed and were followed for up to 1 year postpartum, then referred to clinics in surrounding communities. A random sample (n=200) was invited to participate in a cross-sectional follow-up study after completing the trial, including a questionnaire and pregnancy and HIV viral load (VL) testing. Retention in care was defined as having attended an HIV clinic in the last 90 days. Logistic regression models were used to examine factors associated with VS (VL ≤400 copies/ml). Results: One hundred fifty women (75%) were successfully contacted for follow-up. Median months postpartumwas 46 (IQR 37-52) and median CD4 count was 664 cells/mm 3 (IQR 476-870). Of the 150 contacted, 131 (87.3%) were on ART (78 on EFV, 35 on NVP, 18 on LPV). Fifty-eight (38.7%) participants reported ≥1 pregnancy after initiating Option B+; 19 (12.7%) were pregnant at the time of follow-up and 23 (15.3%) were breastfeeding. Long-term retention in care following initiation of Option B+ was 90% (95% CI 84.0%- 94.3%), with 135/150 seen in the last 90 days. Assuming those we could not contact had fallen out of care (n=50), retention in care was 67.5% (95% CI 60.5%-73.9%). Among the 150 contacted, 121 (80.7%, 95% CI 73.4%-86.7%) had VS. Assuming those we could not contact had virologic failure, long-term retention in care with VS was 60.5% (95% CI 53.6%-67.3%). Factors associated with VS included disclosure of HIV status to primary partner (OR 5.24, 95% CI 1.21-22.6), no difficulty obtaining ART in the past 3 months (OR 4.16, 95% CI 1.50-11.5), and food security (OR 2.61, 95% CI 1.00-6.88). Conclusions: Following initiation of Option-B+, long-term (2-5 year) retention in care and viral suppression was observed in 90% and 80.7%, respectively. Women who had disclosed their HIV status to their primary partner were 5 times more likely to be virologically suppressed, indicating a significant need for facilitated disclosure interventions to maintain long-term retention in care with viral suppression. 797 HIV Resistance in Pregnant WomenWith Detectable HIV-1 RNA at Delivery in Mozambique Maria Ruperez 1 ; Marc Noguera-Julian 2 ; Raquel González 1 ; Rocio Bellido 2 ; AnifaVala 3 ; Cristina Rodríguez 2 ; Esperança Sevene 3 ; Eusebio Macete 3 ; Roger Paredes 2 ; Clara Menéndez 1 1 Barcelona Inst for Global Hlth, Barcelona, Spain; 2 IrsiCaixa Inst for AIDS Rsr, Badalona, Spain; 3 Manhiça Hlth Rsr Cntr (CISM), Manhiça, Mozambique Background: Few data on HIV resistance in pregnant women are available fromMozambique, one of the countries with the highest HIV toll in the world. The HIV resistance implications of reaching delivery with detectable HIV-1 RNA despite prevention of mother to child transmission of HIV (pMTCT) are not fully understood. Methods: We analyzed stored plasma samples from HIV-infected pregnant woman participating in a randomized controlled trial on intermittent preventive treatment of malaria in pregnancy (IPTp) at the Manhiça district hospital (MDH) in a semi-rural area in southern Mozambique. Women attending their 1 st antenatal (ANC) visit between 2009 and 2013 were followed prospectively through 1 month post-partum. Women with HIV-1 RNA levels>400 c/mL at delivery were included in our HIV resistance analysis. HIV drug resistance mutations (HIVDRM) were determined using MiSeq® (limit of detection 1%) at the first ANC visit and at the time of delivery. Results: Overall, 150 plasma samples from 113 pregnant women were analyzed. Ninety and 60 samples were available at the 1 st ANC and delivery visits, respectively. Women attended the first ANC visit with a mean of 25 years of age and a median gestational age of 22 weeks. Of them, 96% had HIV-1 RNA>400 c/mL, 39% had CD4+ counts <350 c/mm3 and 20%were on antiretroviral therapy (ART). Thirteen women (14%) had at least 1 HIVDRM at the 1 st ANC, of whom 2/3 were not on previous ART. The number of women with at least 1 HIVDRM to nucleoside reverse-transcriptase inhibitors (NRTI), non-nucleoside reverse-transcriptase inhibitors (NNRTI) and protease inhibitors (PIs) in the 1 st ANC visit was 8 (9%), 6 (7%) and 2 (2%), respectively. Eight women (13%) had at least 1 HIVDRM at delivery, 6 (10%), 5 (8.3%) and 0 (0%) to NRTI, NNRTIs and PIs, respectively. Table 1 summarizes the predicted susceptibility to the different antiretrovirals (HIVdb) in both visits. Of the 37 women with longitudinal data available from the two time points, 5 (13.5%) developed at least 1 new HIVDRM during pMTCT; 2 (5.4%) to NNRTI, 2 (5.4%) to NRTI and 1 (3%) to PI. Conclusions: Even with ultrasensitive HIV-1 genotyping, less than 15% of women with detectable viremia at delivery had HIVDRM before initiating pMTCT with 1 st line ARVs. This suggests that other factors beyond pre-existing resistance, such as lack of adherence or interruptions of the ANC chain, are relevant to explain lack of virological suppression in women receiving pMTCT at the time of delivery. 798 Maternal Vitamin D Deficiency Is AssociatedWith Preterm Birth in HIV-InfectedWomen Jennifer Jao 1 ; Laura Freimanis 2 ; Marissa Mussi-Pinhata 3 ; Rachel Cohen 2 ; Jacqueline P. Monteiro 3 ; Maria Leticia S. Cruz 4 ; Andrea Branch 1 ; Rhoda S. Sperling 1 ; George K. Siberry 5 ; for the National Institute of Child Health and Human Development (NICHD) International Site Development Initiative (NISDI) 1 Icahn Sch of Med at Mount Sinai, New York, NY, USA; 2 Westat, Inc., Rockville, MD, USA; 3 Univ of Sao Paulo, Sao Paulo, Brazil; 4 Hosp Fed dos Servidores do Estado, Rio de Janeiro, Brazil; 5 Eunice Kennedy Shriver NICHD, Bethesda, MD, USA

Poster Abstracts

Background: Several studies in pregnant women have shown an association between lowmaternal vitamin D and preterm birth. HIV and antiretrovirals (ARVs) can affect vitamin D levels. Few studies have assessed the relationship between maternal vitamin D and preterm birth in HIV+ pregnant women. Methods: We evaluated data from Latin American HIV+ pregnant women enrolled in the National Institute of Child Health and Human Development (NICHD) International Site Development Initiative (NISDI) cohort from 2002-2009. Preterm birth was defined as delivery at <37 weeks (wks) gestational age (GA). Maternal plasma 25-hydroxyvitamin D (25OHD) levels were measured using the Abbott Architect® immunoassay on stored samples collected at 12-34 wks GA. Severe vitamin D deficiency was defined as 25OHD <10 ng/mL, deficiency as 10-20 ng/mL, insufficiency as 21–29 ng/mL, and sufficiency as >30 ng/mL. Logistic regression modeling was used to evaluate the effect of maternal vitamin D on preterm birth.

Results: Of 715 HIV+ women, 13 (1.8%) were severely vitamin D deficient, 224 (31.3%) deficient, and 233 (32.6%) insufficient. Severely deficient women had lower rates of no ARV use for >28 days prior to the date of vitamin D testing compared to deficient, insufficient, and sufficient women (15.4% vs. 55.4%, 49.4%, and 39.2% respectively) and higher rates of non-nucleoside reverse transcriptase inhibitor use (46.2% vs. 17.4%, 17.6%, and 16.7% respectively, p <0.01). Overall, 23.2% (166/715) of pregnancies resulted in preterm birth [median GA of preterm births=36 wks (Interquartile Range: 34-36)]. After adjusting for age, substance use in pregnancy, CD4 count, HIV RNA level, body mass index (BMI), ARV use in pregnancy, pre-eclampsia/eclampsia, and prior preterm birth, severe vitamin D deficiency was associated with preterm birth [adjusted Odds Ratio (aOR)=4.7, 95% Confidence Interval (CI): 1.3-16.8)]. In stratified analyses, these results remained the same amongst women with vitamin D testing at <22 wks GA (aOR=2.7, 95%CI: 1.1-6.7) and those with vitamin D testing at >22 wks GA (aOR=7.0, 95%CI: 1.6-30.9). In addition, pre-eclampsia/eclampsia (aOR=5.8, 95%CI: 2.3-14.7), underweight maternal BMI (aOR=1.8, 95%CI: 1.1-3.0), and prior preterm birth (aOR=2.7, 95%CI: 1.6-4.6) were also associated with preterm birth. Conclusions: HIV+ women with severe vitamin D deficiency may be at risk for preterm delivery. Further studies may be warranted to determine if vitamin D supplementation in HIV+ women may impact risk of preterm birth.

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CROI 2016