Decision Making in a Time of Uncertainty: Dolutegravir for Reproductive-Age Women
Authors: Risa M. Hoffman, Lynne M. Mofenson
Journal: Annals of Internal Medicine (2019)

Editorials7 May 2019Decision Making in a Time of Uncertainty: Dolutegravir for Reproductive-Age WomenRisa M. Hoffman, MD, MPH and Lynne M. Mofenson, MDRisa M. Hoffman, MD, MPHDavid Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (R.M.H.) and Lynne M. Mofenson, MDElizabeth Glaser Pediatric AIDS Foundation, Washington, DC (L.M.M.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-0641 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Plans for a global dolutegravir-based antiretroviral therapy (ART) rollout were unexpectedly disrupted in May 2018 by preliminary results from the Botswana Tsepamo birth surveillance study that showed a higher-than-expected rate of neural tube defects (NTDs) in infants born to women receiving dolutegravir-based ART (0.94%) than in those receiving efavirenz-based ART (0.05%) at conception (1). These data brought into sharp focus the complexity of decision-making regarding treatment for pregnant women, the lack of data on new drugs in pregnancy, and the need for improved pharmacovigilance systems to evaluate safety when broadly introducing new drugs into populations that include women of child-bearing ...References1. Zash R, Makhema J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception [Letter]. N Engl J Med. 2018;379:979-981. [PMID: 30037297] doi:10.1056/NEJMc1807653 CrossrefMedlineGoogle Scholar2. Hamers RL, Rinke de Wit TF, Holmes CB. HIV drug resistance in low-income and middle-income countries. Lancet HIV. 2018;5:e588-e596. [PMID: 30193863] doi:10.1016/S2352-3018(18)30173-5 CrossrefMedlineGoogle Scholar3. Dorward J, Lessells R, Drain PK, Naidoo K, de Oliveira T, Pillay Y, et al. Dolutegravir for first-line antiretroviral therapy in low-income and middle-income countries: uncertainties and opportunities for implementation and research. Lancet HIV. 2018;5:e400-e404. [PMID: 29884404] doi:10.1016/S2352-3018(18)30093-6 CrossrefMedlineGoogle Scholar4. World Health Organization. HIV/AIDS. Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV. Interim guidance. Accessed at www.who.int/hiv/pub/guidelines/ARV2018update/en/ on 19 February 2019. Google Scholar5. Nakkazi E. Changes to dolutegravir policy in several African countries. Lancet. 2018;392:199. [PMID: 30043745] doi:10.1016/S0140-6736(18)31641-6 CrossrefMedlineGoogle Scholar6. Dugdale CM, Ciaranello AL, Bekker LG, Stern ME, Myer L, Wood R, et al. Risks and benefits of dolutegravir- and efavirenz-based strategies for South African women with HIV of child-bearing potential. A modeling study. Ann Intern Med. 2019;170:614-25. doi:10.7326/M18-3358 LinkGoogle Scholar7. Zash R. Surveillance for neural tube defects following antiretroviral exposure from conception. Presented at 22nd International AIDS Conference, Amsterdam, the Netherlands, 23–27 July 2018. Google Scholar8. Cournil A, Kouanfack C, Eymard-Duvernay S, Lem S, Mpoudi-Ngole M, Omgba P, et al. Dolutegravir versus an efavirenz 400 mg-based regimen for the initial treatment of HIV-infected patients in Cameroon: 48 week efficacy of the NAMSAL ANRS 12312 trial. HIV Drug Therapy 2018 [Abstract]. J Int AIDS Soc. 2018;21 Suppl 8 16. Google Scholar9. Sherwood J, Sharp A, Honermann B, Horrigan C, Chatterjee M, Jones A, et al. Mapping the impact of the expanded Mexico City Policy for HIV/ family planning service integration in PEPFAR-supported countries: a risk index. BMC Public Health. 2018;18:1116. [PMID: 30208876] doi:10.1186/s12889-018-6008-2 CrossrefMedlineGoogle Scholar10. Chola L, McGee S, Tugendhaft A, Buchmann E, Hofman K. Scaling up family planning to reduce maternal and child mortality: the potential costs and benefits of modern contraceptive use in south africa. PLoS One. 2015;10:e0130077. [PMID: 26076482] doi:10.1371/journal.pone.0130077 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (R.M.H.)Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC (L.M.M.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0641.Corresponding Author: Risa M. Hoffman, MD, MPH, University of California, Los Angeles, 10833 Le Conte Avenue, 37-121 CHS, Los Angeles, CA 90095; e-mail, [email protected]ucla.edu.Current Author Addresses: Dr. Hoffman: University of California, Los Angeles, 10833 Le Conte Avenue, 37-121 CHS, Los Angeles, CA 90095.Dr. Mofenson: Elizabeth Glaser Pediatric AIDS Foundation, 1140 Connecticut Avenue NW, Washington, DC 20036.This article was published at Annals.org on 2 April 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoRisks and Benefits of Dolutegravir- and Efavirenz-Based Strategies for South African Women With HIV of Child-Bearing Potential Caitlin M. Dugdale , Andrea L. Ciaranello , Linda-Gail Bekker , Madeline E. Stern , Landon Myer , Robin Wood , Paul E. Sax , Elaine J. Abrams , Kenneth A. Freedberg , and Rochelle P. Walensky Metrics Cited bySafety of in-utero antiretroviral exposure: neurologic outcomes in children who are HIV-exposed but uninfectedNeural-Tube Defects and Antiretroviral Treatment Regimens in BotswanaDolutegravir, efavirenz: maternal & paediatric effects 7 May 2019Volume 170, Issue 9Page: 658-659KeywordsAIDSAntiretroviral therapyBirth ratesContraceptivesDrug safetyDrugsHIVNeural tube defectsPregnancySafety ePublished: 2 April 2019 Issue Published: 7 May 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...