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      Antiretroviral Prescribing Practices Among Pregnant Women Living With HIV in the United States, 2008-2017

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          Key Points

          Question

          Do antiretroviral prescribing patterns in the United States reflect Department of Health and Human Services prescribing guidelines for pregnant women living with HIV?

          Findings

          In this cohort study of antiretroviral prescribing practices during 1867 pregnancies among women living with HIV, only 49.5% of antiretroviral prescriptions were classified as preferred or alternative according to Department of Health and Human Services guidelines.

          Meaning

          More than half of the pregnant women living with HIV studied were prescribed antiretroviral regimens categorized by Department of Health and Human Services guidelines as having insufficient evidence for use in pregnancy or for which evidence indicates that use is not recommended.

          Abstract

          Importance

          Since 1994, the US Department of Health and Human Services has published treatment guidelines for pregnant women living with HIV. Understanding how well prescribing patterns correspond with treatment guidelines could inform health policy and influence future clinical practice.

          Objectives

          To compare antiretroviral prescribing practices over time among pregnant women living with HIV with Department of Health and Human Services treatment guidelines and identify factors associated with receiving recommended regimens.

          Design, Setting, and Participants

          A prospective cohort study of 1582 pregnant women living with HIV were enrolled in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART (antiretroviral therapy) Toxicities study between January 1, 2008, and June 30, 2017. The study was conducted at 18 academic research hospitals in the United States.

          Exposures

          Antiretroviral medications (ARVs) prescribed during pregnancy.

          Main Outcomes and Measures

          Proportion of regimens prescribed to pregnant women living with HIV qualifying as preferred or alternative according to Department of Health and Human Services guidelines, stratified by timing of initiation.

          Results

          Of 1867 pregnancies (among 1582 pregnant women living with HIV with a mean [SD] age of 28.6 [6.1] years at conception), 1264 (67.7%) occurred among women self-identified as black, 480 (25.7%) self-identified as white, and 123 (6.6%) self-identified as other or unreported race/ethnicity. Antiretroviral medications were initiated prior to conception for 790 women (42.3%), resumed during pregnancy for 625 women (33.5%), and initiated during pregnancy for 452 women (24.2%). Only 925 pregnancies (49.5%) were associated with prescribed ARVs designated as preferred or alternative, while 492 (26.4%) involved ARVs with insufficient evidence for use during pregnancy and 136 (7.3%) involved ARVs that were not recommended during pregnancy. A higher proportion of treatment-naive pregnant women initiating ARVs were prescribed preferred or alternative ARVs compared with those resuming ARVs or those treated with ARVs before conception (316 of 452 [69.9%] vs 325 of 625 [52.0%] vs 284 of 790 [35.9%]; P < .001). A total of 91 of 452 women (20.1%) initiating ARVs during pregnancy were prescribed ARVs with insufficient evidence for use during pregnancy or not recommended during pregnancy. Among women resuming ARVs, those with a viral load greater than 1000 copies/mL early in pregnancy had higher odds of being prescribed guideline-recommended ARVs (adjusted odds ratio, 2.03 [95% CI, 1.33-3.10]) compared with those with a viral load of 400 copies/mL or less.

          Conclusions and Relevance

          This study suggests that US ARV prescribing practices for pregnant women living with HIV do not align well with national guidelines. This finding is particularly concerning when treatment is initiated during pregnancy. Further research is needed to understand disparities between prescribing practices and evidence-based guideline recommendations.

          Abstract

          This cohort study compares antiretroviral prescribing practices over time among pregnant women living with HIV with US Department of Health and Human Services treatment guidelines.

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          Most cited references12

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          Prevalence of transmitted drug resistance associated mutations and HIV-1 subtypes in new HIV-1 diagnoses, U.S.-2006.

          Benedict W Wheeler, Joseph Prejean, C Mahle … (2010)
          To determine the distribution of HIV-1 subtypes and the prevalence of transmitted drug resistance-associated mutations (TDRM) among persons newly diagnosed with HIV-1 infection in the United States. We used sequence data from Variant, Atypical, and Resistant HIV Surveillance (VARHS) collected from newly diagnosed persons in 10 states and 1 county health department in 2006. To evaluate TDRM, we used a mutation list for surveillance of TDRM appropriate for the primarily subtype B HIV epidemic in the United States. Sequences were obtained from 2030 of 10,860 persons newly diagnosed with HIV in 11 surveillance areas. Mutations associated with transmitted drug resistance occurred in 292 (14.6%) persons; TDRM associated with a specific drug class occurred in 156 (7.8%) for non-nucleoside reverse transcriptase inhibitors, 111 (5.6%) for nucleoside reverse transcriptase inhibitors and 90 (4.5%) for protease inhibitors. There were no significant differences in prevalence of TDRM by demographic characteristic. The HIV-1 subtype B was the most prevalent subtype occurring in 1922 (96.2%) persons; subtype C (1.3%) was the most prevalent non-B subtype. We presented a clade B-optimized mutation list for evaluating surveillance of TDRM in the United States and analyzed the largest collection of sequence data obtained from individuals newly diagnosed with HIV. The prevalence of TDRM in persons newly diagnosed with HIV is higher than in previous U.S. studies; however, this is not necessarily a significant trend. Continued reporting of sequence data for public health purposes from all sources will improve representativeness and accuracy in analyzing trends in transmitted drug resistance and genetic diversity.
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            The epidemiology of antiretroviral drug resistance among drug-naive HIV-1-infected persons in 10 US cities.

            M D Wendell, Maria G. Dickinson, Sindy Paul … (2004)
            The prevalence and characteristics of persons with newly diagnosed human immunodeficiency virus (HIV) infections with or without evidence of mutations associated with drug resistance have not been well described. Drug-naive persons in whom HIV had been diagnosed during the previous 12 months and who did not have acquired immune deficiency syndrome were sequentially enrolled from 39 clinics and testing sites in 10 US cities during 1997-2001. Genotyping was conducted from HIV-amplification products, by automated sequencing. For specimens identified as having mutations previously associated with reduced antiretroviral-drug susceptibility, phenotypic testing was performed. Of 1311 eligible participants, 1082 (83%) were enrolled and successfully tested; 8.3% had reverse transcriptase or major protease mutations associated with reduced antiretroviral-drug susceptibility. The prevalence of these mutations was 11.6% among men who had sex with men but was only 6.1% and 4.7% among women and heterosexual men, respectively. The prevalence was 5.4% and 7.9% among African American and Hispanic participants, respectively, and was 13.0% among whites. Among persons whose sexual partners reportedly took antiretroviral medications, the prevalence was 15.2%. Depending on the characteristics of the patients tested, HIV-genotype testing prior to the initiation of therapy would identify a substantial number of infected persons with mutations associated with reduced antiretroviral-drug susceptibility.
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              The PHACS SMARTT Study: Assessment of the Safety of In Utero Exposure to Antiretroviral Drugs

              Russell Van Dyke, Ellen Chadwick, Rohan Hazra … (2016)
              The Surveillance Monitoring for ART Toxicities (SMARTT) cohort of the Pediatric HIV/AIDS Cohort Study includes over 3,500 HIV-exposed but uninfected infants and children at 22 sites in the US, including Puerto Rico. The goal of the study is to determine the safety of in utero exposure to antiretrovirals (ARVs) and to estimate the incidence of adverse events. Domains being assessed include metabolic, growth and development, cardiac, neurological, neurodevelopmental (ND), behavior, language, and hearing. SMARTT employs an innovative trigger-based design as an efficient means to identify and evaluate adverse events. Participants who met a predefined clinical or laboratory threshold (trigger) undergo additional evaluations to define their case status. After adjusting for birth cohort and other factors, there was no significant increase in the likelihood of meeting overall case status (case in any domain) with exposure to combination ARVs (cARVs), any ARV class, or any specific ARV. However, several individual ARVs were significantly associated with case status in individual domains, including zidovudine for a metabolic case, first trimester stavudine for a language case, and didanosine plus stavudine for a ND case. We found an increased rate of preterm birth with first trimester exposure to protease inhibitor-based cARV. Although there was no overall increase in congenital anomalies with first trimester cARV, a significant increase was seen with exposure to atazanavir, ritonavir, and didanosine plus stavudine. Tenofovir exposure was associated with significantly lower mean whole-body bone mineral content in the newborn period and a lower length and head circumference at 1 year of age. With ND testing at 1 year of age, specific ARVs (atazanavir, ritonavir-boosted lopinavir, nelfinavir, and tenofovir) were associated with lower performance, although all groups were within the normal range. No ARVs or classes were associated with lower performance between 5 and 13 years of age. Atazanavir and saquinavir exposure were associated with late language emergence at 1 year, but not at 2 years of age. The results of the SMARTT study are generally reassuring, with little evidence for serious adverse events resulting from in utero ARV exposure. However, several findings of concern warrant further evaluation, and new ARVs used in pregnancy need to be evaluated.
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                Author and article information

                Journal
                Journal ID (nlm-ta): JAMA Netw Open
                Journal ID (iso-abbrev): JAMA Netw Open
                Journal ID (pmc): JAMA Netw Open
                Title: JAMA Network Open
                Publisher: American Medical Association
                ISSN (Electronic): 2574-3805
                Publication date (Electronic): 18 December 2019
                Publication date Collection: December 2019
                Publication date PMC-release: 18 December 2019
                Volume: 2
                Issue: 12
                Electronic Location Identifier: e1917669
                Affiliations
                [1 ]Department of Internal Medicine, Massachusetts General Hospital, Boston
                [2 ]Department of Pediatrics, Massachusetts General Hospital, Boston
                [3 ]Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
                [4 ]Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
                [5 ]Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
                [6 ]Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
                [7 ]Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
                [8 ]Division of Infectious Diseases, Department of Pediatrics, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois
                [9 ]Department of Pediatrics, Tulane University School of Medicine, New Orleans, Louisiana
                Author notes
                Article Information
                Accepted for Publication: October 27, 2019.
                Published: December 18, 2019. doi:10.1001/jamanetworkopen.2019.17669
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2019 Powis KM et al. JAMA Network Open.
                Corresponding Author: Kathleen M. Powis, MD, MBA, MPH, Department of Internal Medicine, Massachusetts General Hospital, 125 Nashua St, Office 8426, Boston, MA 02114 ( kpowis@ 123456mgh.harvard.edu ).
                Author Contributions: Ms Huo and Dr Williams had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Powis, Williams, Kacanek, Jao, Seage, Van Dyke, Chadwick.
                Acquisition, analysis, or interpretation of data: Powis, Huo, Williams, Kacanek, Patel, Seage, Van Dyke, Chadwick.
                Drafting of the manuscript: Powis, Huo, Williams, Chadwick.
                Critical revision of the manuscript for important intellectual content: Powis, Williams, Kacanek, Jao, Patel, Seage, Van Dyke, Chadwick.
                Statistical analysis: Huo, Williams.
                Obtained funding: Seage, Van Dyke.
                Administrative, technical, or material support: Powis, Seage, Van Dyke.
                Supervision: Powis, Seage, Chadwick.
                Conflict of Interest Disclosures: Dr Powis reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) during the conduct of the study. Ms Huo reported receiving grants from the Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research during the conduct of the study. Dr Williams reported receiving grants from the NICHD during the conduct of the study. Dr Kacanek reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study. Dr Jao reported receiving grants from the NIH outside the submitted work. Dr Patel reported receiving a grant from the NIH during the conduct of the study outside the submitted work. Dr Seage reported receiving grants from the NICHD during the conduct of the study. Dr Van Dyke reported receiving grants from the NIH during the conduct of the study. Dr Chadwick reported receiving grants from the NICHD during the conduct of the study; and reported that her spouse holds stock in AbbVie and Abbott Labs outside the submitted work.
                Funding/Support: This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with cofunding from the National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, the Office of AIDS Research, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute on Deafness and Other Communication Disorders, the National Institute of Dental and Craniofacial Research, and the National Institute on Alcohol Abuse and Alcoholism, through cooperative agreements with the Harvard T.H. Chan School of Public Health (HD052102) (principal investigator: Dr Seage) and the Tulane University School of Medicine (HD052104) (principal investigator: Dr Van Dyke; coprincipal investigator: Dr Chadwick). Data management services were provided by the Frontier Science and Technology Research Foundation, and regulatory services and logistical support were provided by Westat Inc.
                Role of the Funders/Sponsors: The NIH was involved in the design of the Pediatric HIV/AIDS Cohort Study, but the US Department of Health and Human Services were not involved in the design, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
                Group Information: The following institutions, clinical site investigators, and staff participated in conducting the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART Toxicities in 2018, in alphabetical order: Ann & Robert H. Lurie Children’s Hospital of Chicago: Jessica D’Angelo, Margaret Ann Sanders, Kathleen Malee, and Lynn Heald; Baylor College of Medicine: William Shearer, Mary Paul, Norma Cooper, and Lynnette Harris; Bronx Lebanon Hospital Center: Murli Purswani, Emma Stuard, Mahboobullah Mirza Baig, and Alma Villegas; Children’s Diagnostic & Treatment Center: Ana Puga, Dia Cooley, Patricia A. Garvie, and James Blood; New York University School of Medicine: William Borkowsky, Sandra Deygoo, and Marsha Vasserman; Rutgers–New Jersey Medical School: Arry Dieudonne, Linda Bettica, and Juliette Johnson; St Jude Children’s Research Hospital: Katherine Knapp, Kim Allison, Megan Wilkins, and Jamie Russell-Bell; San Juan Hospital/Department of Pediatrics: Nicolas Rosario, Lourdes Angeli-Nieves, and Vivian Olivera; SUNY Downstate Medical Center: Stephan Kohlhoff, Ava Dennie, and Ady Ben-Isreal; Tulane University School of Medicine: Russell Van Dyke, Karen Craig, and Patricia Sirois; University of Alabama at Birmingham: Marilyn Crain, Paige Hickman, and Dan Marullo; University of California, San Diego: Stephen A. Spector, Kim Norris, and Sharon Nichols; University of Colorado, Denver: Elizabeth McFarland, Christine Kwon, Kay Kinzie, and Robin McEvoy; University of Florida, Center for HIV/AIDS Research, Education and Service: Mobeen Rathore, Kristi Stowers, Saniyyah Mahmoudi, Ana Alvarez, and Sarah Dew-Reeves; University of Illinois at Chicago: Karen Hayani, Lourdes Richardson, Renee Smith, and Alina Miller; University of Miami: Gwendolyn Scott, Sady Dominguez, Jennifer Rodriguez, and Anai Cuadra; Keck Medicine of the University of Southern California: Toni Frederick, Mariam Davtyan, and Guadalupe Morales-Avendano; and University of Puerto Rico School of Medicine, Medical Science Campus: Zoe M. Rodriguez, Ibet Heyer, and Nydia Scalley Trifilio. All clinical site investigators and staff members were compensated for their study effort.
                Disclaimer: The conclusions and opinions expressed in this article are those of the authors and do not necessarily reflect those of the NIH or US Department of Health and Human Services.
                Meeting Presentation: This study was presented at the 10th Workshop on HIV and Pediatrics; July 21, 2018; Amsterdam, the Netherlands; and at the HIV & Women Workshop; March 2, 2019; Seattle, Washington.
                Additional Contributions: We thank the women for their participation in the Pediatric HIV/AIDS Cohort Study and the individuals and institutions involved in the conduct of the Pediatric HIV/AIDS Cohort Study.
                Article
                Publisher ID: zoi190670
                DOI: 10.1001/jamanetworkopen.2019.17669
                PMC ID: 6991210
                PubMed ID: 31851347
                SO-VID: 36893005-f1cc-4f50-9587-b39ae74b1c11
                Copyright © Copyright 2019 Powis KM et al. JAMA Network Open.
                License:

                This is an open access article distributed under the terms of the CC-BY License.

                History
                Date received : 23 July 2019
                Date accepted : 27 October 2019
                Categories
                Subject: Research
                Subject: Original Investigation
                Subject: Online Only
                Subject: Public Health

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