Ingrid T. Katz, MD, MHS; Erin Leister, MS; Deborah Kacanek, ScD; Michael D. Hughes, PhD; Arlene Bardeguez, MD; Elizabeth Livingston, MD; Alice Stek, MD; David E. Shapiro, PhD; Ruth Tuomala, MD
Presented in part at the 19th Conference on Retroviruses and Opportunistic Infections Meeting, Seattle, Washington, 5 to 8 March 2012.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, Harvard Catalyst, or Harvard University and its affiliated acade mic health care centers.
Acknowledgment: The authors thank the women and infants who participated in IMPAACT Protocol 1025.
Grant Support: By the National Institute of Allergy and Infectious Diseases (U01 AI068632); the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Mental Health (AI068632); and the Statistical and Data Analysis Center at Harvard School of Public Health (National Institute of Allergy and Infectious Diseases cooperative agreement 5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group and 1 U01 AI068616 with the IMPAACT Group). Support of the sites was provided by the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development International and Domestic Pediatric and Maternal HIV Clinical Trials Network (contract N01-DK-9-001/HHSN267200800001C). Dr. Katz received funding through the National Institute of Mental Health (K23MH097667-01), the Harvard University Center for AIDS Research (National Institute of Allergy and Infectious Diseases fund 5P30AI060354-08), the KL2 MeRIT program of Harvard Catalyst | The Harvard Clinical and Translational Science Center (award UL1 RR 025758), and financial contributions from Harvard University and its affiliated academic health care centers.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2005.
Reproducible Research Statement:Study protocol: Available from Dr. Tuomala (e-mail, RTuomala@partners.org). Statistical code: Available from Ms. Leister (e-mail, ELeister@sdac.harvard.edu). Data set: Available from Dr. Shapiro (e-mail, Shapiro@sdac.harvard.edu).
Requests for Single Reprints: Ingrid T. Katz, MD, MHS, Division of Women's Health, Brigham and Women's Hospital, 1620 Tremont Street, 3rd Floor, Boston, MA 02120; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Katz: Division of Women's Health, Brigham and Women's Hospital, 1620 Tremont Street, 3rd Floor, Boston, MA 02120.
Ms. Leister: Harvard School of Public Health, 651 Huntington Avenue, FXB 619, Boston, MA 02115.
Ms. Kacanek: Harvard School of Public Health, 651 Huntington Avenue, FXB 505, Boston, MA 02115.
Dr. Hughes: Harvard School of Public Health, 655 Huntington Avenue, Building II, Room 439A, Boston, MA 02115.
Dr. Bardeguez: Rutgers, New Jersey Medical School, MSB E-506,185 South Orange Avenue, Newark, NJ 07103.
Dr. Livingston: Duke University Medical Center, Box 3967, Durham, NC 27710.
Dr. Stek: University of Southern California, 1240 North Mission Road, Los Angeles, CA 90033.
Dr. Shapiro: Harvard School of Public Health, 651 Huntington Avenue, FXB 643B, Boston, MA 02115.
Dr. Tuomala: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.
Author Contributions: Conception and design: I.T. Katz, D. Kacanek, M.D. Hughes, A. Bardeguez, E. Livingston, A. Stek, D.E. Shapiro, R. Tuomala.
Analysis and interpretation of the data: I.T. Katz, E. Leister, D. Kacanek, M.D. Hughes, A. Bardeguez, E. Livingston, A. Stek, D.E. Shapiro, R. Tuomala.
Drafting of the article: I.T. Katz, E. Leister, D. Kacanek, E. Livingston, R. Tuomala.
Critical revision of the article for important intellectual content: D. Kacanek, M.D. Hughes, A. Bardeguez, E. Livingston, D.E. Shapiro, R. Tuomala.
Final approval of the article: I.T. Katz, E. Leister, D. Kacanek, M.D. Hughes, A. Bardeguez, E. Livingston, A. Stek, D.E. Shapiro, R. Tuomala.
Provision of study materials or patients: E. Livingston, A. Stek, R. Tuomala.
Statistical expertise: E. Leister, D. Kacanek, M.D. Hughes, D.E. Shapiro.
Obtaining of funding: D.E. Shapiro.
Collection and assembly of data: E. Livingston, A. Stek, R. Tuomala.
A high delivery maternal plasma HIV-1 RNA level (viral load [VL]) is a risk factor for mother-to-child transmission and poor maternal health.
To identify factors associated with detectable VL at delivery despite initiation of highly active antiretroviral therapy (HAART) during pregnancy.
Multicenter observational study. (ClinicalTrial.gov: NCT00028145)
67 U.S. AIDS clinical research sites.
Pregnant women with HIV who initiated HAART during pregnancy.
Descriptive summaries and associations among sociodemographic, HIV disease, and treatment characteristics; pregnancy-related risk factors; and detectable VL (>400 copies/mL) at delivery.
Between 2002 and 2011, 671 women met inclusion criteria and 13.1% had detectable VL at delivery. Factors associated with detectable VL included multiparity (16.4% vs. 8.0% nulliparity; P = 0.002), black ethnicity (17.6% vs. 6.6% Hispanic and 6.6% white; P < 0.001), 11th grade education or less (17.6% vs. 12.1% had a high school diploma; P = 0.013), initiation of HAART in the third trimester (23.9% vs. 12.3% and 8.6% in the second and trimesters, respectively; P = 0.003), having an HIV diagnosis before the current pregnancy (16.1% vs. 11.0% during the current pregnancy; P = 0.051), and having the first prenatal visit in the third trimester (33.3% vs. 14.3% and 10.5% in the second and third trimesters, respectively; P = 0.002). Women who had treatment interruptions or reported poor medication adherence were more likely to have detectable VL at delivery.
Data on many covariates were incomplete because women entered the study at varying times during pregnancy.
A total of 13.1% of women who initiated HAART during pregnancy had detectable VL at delivery. The timing of HAART initiation and prenatal care, along with medication adherence during pregnancy, were associated with detectable VL at delivery. Social factors, including ethnicity and education, may help identify women who could benefit from focused efforts to promote early HAART initiation and adherence.
U.S. Department of Health and Human Services.
Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, et al. Factors Associated With Lack of Viral Suppression at Delivery Among Highly Active Antiretroviral Therapy–Naive Women With HIV: A Cohort Study. Ann Intern Med. 2015;162:90–99. doi: 10.7326/M13-2005
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Published: Ann Intern Med. 2015;162(2):90-99.
HIV, Infectious Disease.
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