Published Online, 2 June 2009, www.theannals.com, DOI 10.1345/aph.1L689.
The Annals of Pharmacotherapy: Vol. 43, No. 6, pp. 1028-1035. DOI 10.1345/aph.1L689
© 2009 Harvey Whitney Books Company.
Adverse Effects of Antiretrovirals in HIV-Infected Pregnant Women
Dalyce M Zuk, BScPharm ACPR PharmD
at time of study, Pharmacy Resident, Regional Pharmacy Services, Capital Health, Edmonton, Alberta, Canada; now, Post-Doctoral Clinical Pharmacotherapy Practice Fellow, Regional Pharmacy Services, Alberta Health Services, Edmonton
Christine A Hughes, PharmD
Associate Professor, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton; HIV Clinical Pharmacist, Regional Pharmacy Services, Alberta Health Services
Michelle M Foisy, PharmD
HIV Clinical Pharmacist, Regional Pharmacy Services, Alberta Health Services
Joan L Robinson, MD FRCPC
Professor of Pediatrics, Department of Pediatrics, Division of Infectious Diseases, University of Alberta
Ameeta E Singh, BMBS MSc FRCPC
Associate Professor, Department of Medicine, Division of Infectious Diseases, University of Alberta
Stan Houston, MD FRCPC
Professor of Medicine and Public Health, Department of Medicine, Division of Infectious Diseases, University of Alberta
Reprints: Dr. Hughes, Faculty of Pharmacy and Pharmaceutical Sciences, 3126 Dentistry/Pharmacy Centre, University of Alberta, Edmonton T6G 2N8, AB, Canada, fax 780/492-1217, firstname.lastname@example.org
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.
Key Words: adverse effects, antiretroviral therapy, HIV, pregnancy
Published Online, June 2, 2009. http://www.theannals.com, DOI 10.1345/aph.1L689
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