Background:

1. 226 treated pregnancies 76 women continued ART 150 women discontinued ART 15 (10%) never returned to clinic 56 (37.3%) Remained off ART 4 New OI events CD4 at OI 25 (19-31) cells/mm3 44 (29.3%) Reinitiated ART, clinical reasons 14 New OI events CD4 at OI 32 (11-78) cells/mm3 17 (22.4%) Still remain on ART 0 New OI events 59 (77.6%) Stopped ART 4 New OI events CD4 at OI 27 (5-149) cells/mm3 35 (23.3%) Reinitiated ART, further pregnancy 0 New OI events 32 (54.2%) Reinitiated therapy 34 (97.1%) Discontinued medication again 28 (63.6%) Discontinued medication again Contact Information Nur F. Önen Division of Infectious Diseases Washington University School of Medicine660 S. Euclid Ave.Campus Box 8051St. Louis, MO 63110-1093 Email: nonen@im.wustl.edu HIV Treatment Interruption After Pregnancy. Are We Treating Women SMARTly?Nur F. Önen1, Diana Nurutdinova2, Somnuek Sungkanuparph3, Debra Gase1, Kristin Mondy1 and E. Turner Overton1Washington University, St. Louis, MO, USA1, St. Louis, VA Medical Center, St. Louis, MO, USA2 ,Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand3 Abstract # 937 Abstract Methods Results Results Table 1. Socio-demographic, clinical, pregnancy and delivery outcome characteristics of HIV-infected women, based on postpartum continuation of ART. Background: Long term maternal outcomes after postpartum discontinuation of antiretroviral therapy (ART) remain an important clinical issue. Methods: Retrospective review of pregnancies in HIV-infected women seen at a Midwestern university HIV clinic between 1997 and 2005 to assess factors associated with ART discontinuation and long term outcomes. Women were grouped by ART use after delivery and followed until new opportunistic infection (OI) or last clinic visit. Multivariate logistic regression identified independent predictors of ART discontinuation among factors significant by univariate analysis. Results: There were 226 pregnancies in this period. 191 (85%) received >3 antiretrovirals during pregnancy. Median CD4 cell count at delivery was 506 cells/mm3 and HIV RNA was <1000 copies/mL in 81%. Transmission rate was 0.9%. Mean follow-up was 36 months post delivery. Postpartum ART discontinuation occurred after 150 (66%) pregnancies. In multivariate analyses, less need for preconception ART or OI prophylaxis and higher HIV RNA at delivery were associated with ART discontinuation (p<0.05). Those who discontinued ART were less likely to remain in HIV care (p<0.001). Forty-four (29%) of the women who discontinued ART postpartum subsequently restarted therapy due to disease progression. There were 22 OIs and 2 deaths in the follow-up period; 18 OIs occurred in women who discontinued ART (incidence rate of 3.65 OIs per 100 women-years) vs. 4 OIs in the continued group (1.63 OIs per 100 women-years). Both deaths occurred in women who discontinued ART. Conclusion: Postpartum ART discontinuation is common, especially among women with less advanced HIV disease. However, with discontinuation, women are at increased risk of long term adverse outcomes. This study highlights the need for larger longitudinal studies to determine appropriate recommendations for postpartum ART administration. • A retrospective cohort study of all treated pregnancies in HIV-infected women between January 1997 and December 2005. Women were grouped into those who continued or discontinued ART after delivery and followed to first, new opportunistic infection (OI) or last clinic visit. • Data collection: Maternal socio-demographic, clinical, medication, CD4+ count and HIV-RNA history plus neonatal gestational age, birth-weight, ART history and HIV testing results. • Statistical Analysis: Data analyzed using SPSS version 14.0. Student’s t-test or Mann-Whitney U test used for continuous variables. Chi-square or Fisher’s exact tests used for categorical variables. All p values were two-tailed and significant at p<0.05. • Multivariate logistic regression analyses determined factors associated with ART discontinuation. • Kaplan-Meir method stratified by continuation and discontinuation groups, and compared by the log rank test, estimated the distribution of the probability of first, new OI. • Baseline was from delivery and women were censored when lost to follow-up, at death or at study termination. • There were 22 new OIs during follow up: 4 (5.3%) occurred in the continued group (incidence rate 1.63 OIs per 100 person years) and 18 (12.0%) occurred in the discontinued group (3.65 OIs per 100 women years). • All new OIs in the continued group occurred in women who subsequently stopped (3) or were poorly adherent to (1) therapy. • The median (IQR) time to the first new OI was 65.0 months (13.8-80.3) in the continued group and 40.0 months (22.0-65.0) in the discontinued group. This trend between groups was not significant (p=0.13 by the log rank test). • There were two deaths in the study. Both occurred in the discontinued group and were attributable to a new OI event. Figure 2. Probability of having a new OI event for patients who continued or discontinued antiretroviral therapy after delivery. Results • There were 226 treated pregnancies in 173 HIV-infected women (79.8% African American, 19.1% Caucasian and 1.2% Hispanic). • Highly active antiretroviral therapy (HAART) was administered in 84.5% pregnancies, 114 as a nevirapine based regimen. • Zidovudine monotherapy or dual nucleoside therapy was administered in 15.5% pregnancies before May 1999. • 99.0% of live born neonates received ART prophylaxis after delivery and the mother to child transmission rate of HIV infection during this study was 0.9%. Figure 1. Clinical events and treatment changes after the delivery. Conclusions • Postpartum ART discontinuation was common, especially among women with adverse social circumstances (no partner present during pregnancy and ongoing substance use), and was independently associated with less advanced HIV disease. • During follow-up, over 50% of all women became lost to clinic care. • Of those who remained in care, two mothers died and 22 developed an OI at a rate of 1 case per 33 person years. • These adverse outcomes were more frequent among women who discontinued ART after delivery but did not reach statistical significance. • Our results suggest that long-term postpartum ART discontinuation may be particularly deleterious among vulnerable, high risk HIV-infected women and may not be safe even among women with asymptomatic HIV-disease. Background • The use of antiretroviral therapy (ART) during pregnancy is firmly established as standard of care. • Treatment options in HIV-infected mothers after delivery are dependent on the stage of HIV infection, bias of the medical practitioner and the individual’s ability to adhere to therapy. • Findings from the Strategies for Management of Antiretroviral Therapy study, have shown that structured treatment interruption in HIV-infected patients not only accelerates HIV disease progression, but also increases serious complications such as myocardial infarction. • To date, few studies have examined the long term maternal outcomes after postpartum ART discontinuation. Mean=mean ± standard error of the mean (S.E.M), median includes interquartile range (IQR). STI=sexually transmitted infection, (defined as infection with gonorrhea, chlamydia, syphilis and genital herpes). HTN=hypertension, DM=diabetes mellitus, ZDV=zidovudine. * Women who initiated ART after pregnancy diagnosis. Table 2. Longitudinal follow up of women based on postpartum continuation of ART.