title: 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.
abstract: 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.
authors.affiliation: Fundação 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.
authors.forename: Marilia
authors.initials: M
authors.lastname: Santini-Oliveira
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Ruth Khalili
authors.initials: RK
authors.lastname: Friedman
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Valdilea Gonçalves
authors.initials: VG
authors.lastname: Veloso
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Cynthia Braga
authors.initials: CB
authors.lastname: Cunha
authors.affiliation: Fundação 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.
authors.forename: José Henrique
authors.initials: JH
authors.lastname: Pilotto
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Luana Monteiro Spindola
authors.initials: LM
authors.lastname: Marins
authors.affiliation: Hospital Federal dos Servidores do Estado, Serviço de Doenças Infecciosas e Parasitárias, Rio de Janeiro, RJ, Brazil.
authors.forename: Esaú Custódio
authors.initials: EC
authors.lastname: João
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Thiago Silva
authors.initials: TS
authors.lastname: Torres
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, RJ, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Grinsztejn
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001938:Brazil / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D015994:Incidence; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index
chemical_list: D019380:Anti-HIV Agents
keywords: Adverse drug reaction; Antiretroviral; HIV; Prevention of mother-to-child transmission; Toxicity