title: Adverse effects of antiretrovirals in HIV-infected pregnant women.
abstract: BACKGROUND
  Current guidelines for the use of antiretroviral (ARV) therapy during pregnancy recommend that women be offered treatment with combination ARV therapy used in nonpregnant HIV-infected individuals. It is unclear whether the risk of ARV-related adverse drug reactions (ADRs) is increased during pregnancy.
  
  
  OBJECTIVE
  To evaluate the frequency and severity of ADRs likely caused by ARV therapy in pregnant women who are HIV-positive.
  
  
  METHODS
  A retrospective analysis of HIV-infected women who received ARV therapy during pregnancy and delivered between January 1997 and February 2006 was conducted. Incidence of maternal ADRs was determined through evaluation of laboratory findings, documented physical examinations, and patient self-reports. An AIDS Clinical Trials Group severity grading scale was applied to the ADRs. Cause-effect relationship was adjudicated based on the Naranjo probability scale and, if causality was found, that information was included.
  
  
  RESULTS
  There were 103 women who accounted for 133 pregnancies that resulted in deliveries. Of the 111 pregnancies in which treatment was received, regimens included 26 nucleoside reverse transcriptase inhibitor monotherapy, 40 nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, 44 protease inhibitor (PI)-based, and 1 PI/NNRTI combination therapy. Ninety-eight ADRs were documented in 49 pregnancies. The most common ADRs were gastrointestinal (n = 48), followed by central nervous system symptoms (n = 15), anemia (n = 15), elevated liver/pancreatic enzyme levels (n = 11), and cutaneous reactions (n = 8). Severe ADRs included elevations in liver/pancreatic enzymes (n = 3), nausea and vomiting (n = 3), and anemia (n = 2). Seven women required a change in therapy due to an ADR.
  
  
  CONCLUSIONS
  Approximately 7 ADRs were reported for every 10 pregnancies in this cohort. Most ADRs were mild to moderate. Short exposure times in most women (second and third trimester) may have accounted for the lack of long-term toxicities. Although ADRs did not pose a major barrier to use of ARVs in pregnancy, close monitoring of pregnant women receiving ARV therapy continues to be warranted.
authors.affiliation: Regional Pharmacy Services, Capital Health, Edmonton, Alberta, Canada.
authors.forename: Dalyce M
authors.initials: DM
authors.lastname: Zuk
authors.forename: Christine A
authors.initials: CA
authors.lastname: Hughes
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Foisy
authors.forename: Joan L
authors.initials: JL
authors.lastname: Robinson
authors.forename: Ameeta E
authors.initials: AE
authors.lastname: Singh
authors.forename: Stan
authors.initials: S
authors.lastname: Houston
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011262:Pregnancy Trimester, Second; D011263:Pregnancy Trimester, Third; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents