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Braz J Infect Dis. 2014 Jul-Aug;18(4):372-8. doi: 10.1016/j.bjid.2013.11.008. Epub 2014 Mar 22.

Incidence of antiretroviral adverse drug reactions in pregnant women in two referral centers for HIV prevention of mother-to-child-transmission care and research in Rio de Janeiro, Brazil.

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  • 1Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil. Electronic address: marilia.santini@ipec.fiocruz.br.
  • 2Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
  • 3Fundação Oswaldo Cruz, Instituto Oswaldo Cruz, Laboratório de AIDS e Imunologia Molecular, Rio de Janeiro, RJ, Brazil; Hospital Geral de Nova Iguaçu, Departamento de DST/AIDS, Rio de Janeiro, RJ, Brazil.
  • 4Hospital Federal dos Servidores do Estado, Serviço de Doenças Infecciosas e Parasitárias, Rio de Janeiro, RJ, Brazil.


Mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) infection remains an important cause of new HIV infections worldwide, especially in low and middle-resource limited countries. Safety data from studies involving pregnant women and prenatal antiretroviral (ARV) exposure are still needed once these studies are often small and with a limited duration to assess adverse drug reactions (ADR). The aim of this study was to estimate the incidence of ADR related to the use of antiretroviral therapy (ART) in pregnant women in two referral centers in Rio de Janeiro State. A prospective study was carried out from February 2005 to May 2006. Women were classified according to their ART status during pregnancy diagnosis: ARV-experienced (ARTexp) or ARV-naïve (ARTn). Two hundred fourteen HIV-infected pregnant women were included: 36 ARTexp and 178 ARTn. ARTexp women have not experienced ADR. Among ARTn, 20.2% presented ADR. Incidence rate of ADR was 70.8 per 1000 person-months and the most common ADRs observed were: gastrointestinal (belly or abdominal cramps, diarrhea, nausea and vomit) in 16.3%, cutaneous (pruritus and rash) in 6.2%, anemia (2.2%) and hepatitis (1.7%). The frequency of obstetrical complications, pre-term delivery, low birth weight and birth abnormalities was low in this population. ADRs ranged from mild to moderate intensity, none of them being potentially fatal. Only in a few cases it was necessary to discontinue ART. In conclusion, the high effectiveness of ARV for HIV prevention of MTCT (PMTCT) overcomes the risk of ADR.

Copyright © 2014 Elsevier Editora Ltda. All rights reserved.


Adverse drug reaction; Antiretroviral; HIV; Prevention of mother-to-child transmission; Toxicity

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