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      Safety and Tolerability of Antiretrovirals during Pregnancy

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          Abstract

          Combination antiretroviral therapy (CART) dramatically decreases mother-to-child HIV-1 transmission (MTCT), but maternal adverse events are not infrequent. A review of 117 locally followed pregnancies revealed 7 grade ≥3 AEs possibly related to antiretrovirals, including 2 hematologic, 3 hepatic, and 2 obstetric cholestasis cases. A fetal demise was attributed to obstetric cholestasis, but no maternal deaths occurred. The drugs possibly associated with these AE were zidovudine, nelfinavir, lopinavir/ritonavir, and indinavir. AE or intolerability required discontinuation/substitution of nevirapine in 16% of the users, zidovudine in 10%, nelfinavir in 9%, lopinavir/ritonavir in 1%, but epivir and stavudine in none. In conclusion, nevirapine, zidovudine, and nelfinavir had the highest frequency of AE and/or the lowest tolerability during pregnancy. Although nevirapine and nelfinavir are infrequently used in pregnancy at present, zidovudine is included in most MTCT preventative regimens. Our data emphasize the need to revise the treatment recommendations for pregnant women to include safer and better-tolerated drugs.

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          Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy.

          (2005)
          Very low rates of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) are achievable with use of highly active antiretroviral therapy (HAART). We examine risk factors for MTCT in the HAART era and describe infants who were vertically infected, despite exposure to prophylactic MTCT interventions. Of the 4525 mother-child pairs in this prospective cohort study, 1983 were enrolled during the period of January 1997 through May 2004. Factors examined included use of antiretroviral therapy during pregnancy, maternal CD4 cell count and HIV RNA level, mode of delivery, and gestational age in logistic regression analysis. Receipt of antenatal antiretroviral therapy increased from 5% at the start of the HAART era to 92% in 2001-2003. The overall MTCT rate in this period was 2.87% (95% confidence interval [CI], 2.11%-3.81%), but it was 0.99% (95% CI, 0.32%-2.30%) during 2001-2003. In logistic regression analysis that included 885 mother-child pairs, MTCT risk was associated with high maternal viral load (adjusted odds ratio [AOR], 12.1; P=.003) and elective Caesarean section (AOR, 0.33; P=.04). Detection of maternal HIV RNA was significantly associated with antenatal use of antiretroviral therapy, CD4 cell count, and mode of delivery. Among 560 women with undetectable HIV RNA levels, elective Caesarean section was associated with a 90% reduction in MTCT risk (odds ratio, 0.10; 95% CI, 0.03-0.33), compared with vaginal delivery or emergency Caesarean section. Our results suggest that offering an elective Caesarean section delivery to all HIV-infected women, even in areas where HAART is available, is appropriate clinical management, especially for persons with detectable viral loads. Our results also suggest that previously identified risk factors remain important.
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            Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir.

            C Mamotte, D Sayer, Christian F Christiansen … (2002)
            The use of abacavir--a potent HIV-1 nucleoside-analogue reverse-transcriptase inhibitor--is complicated by a potentially life-threatening hypersensitivity syndrome in about 5% of cases. Genetic factors influencing the immune response to abacavir might confer susceptibility. We aimed to find associations between MHC alleles and abacavir hypersensitivity in HIV-1-positive individuals treated with abacavir. MHC region typing was done in the first 200 Western Australian HIV Cohort Study participants exposed to abacavir. Definite abacavir hypersensitivity was identified in 18 cases, and was excluded in 167 individuals with more than 6 weeks' exposure to the drug (abacavir tolerant). 15 individuals experienced some symptoms but did not meet criteria for abacavir hypersensitivity. p values were corrected for comparisons of multiple HLA alleles (p(c)) by multiplication of the raw p value by the estimated number of HLA alleles present within the loci examined. HLA-B*5701 was present in 14 (78%) of the 18 patients with abacavir hypersensitivity, and in four (2%) of the 167 abacavir tolerant patients (odds ratio 117 [95% CI 29-481], p(c)<0.0001), and the HLA-DR7 and HLA-DQ3 combination was found in 13 (72%) of hypersensitive and five (3%) of tolerant patients (73 [20-268], p(c)<0.0001 ). HLA-B*5701, HLA-DR7, and HLA-DQ3 were present in combination in 13 (72%) hypersensitive patients and none of the tolerant patients (822 [43-15 675], p(c)<0.0001). Other MHC markers also present on the 57.1 ancestral haplotype to which the three markers above belong confirmed the presence of haplotype-specific linkage disequilibrium, and mapped potential susceptibility loci to a region bounded by C4A6 and HLA-C. Within the entire abacavir-exposed cohort (n=200), presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 had a positive predictive value for hypersensitivity of 100%, and a negative predictive value of 97%. Genetic susceptibility to abacavir hypersensitivity is carried on the 57.1 ancestral haplotype. In our population, withholding abacavir in those with HLA-B*5701, HLA-DR7, and HLA-DQ3 should reduce the prevalence of hypersensitivity from 9% to 2.5% without inappropriately denying abacavir to any patient.
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              Use of antiretroviral therapy in pregnant HIV-infected women and the risk of premature delivery: a meta-analysis.

              Joseph Lau, Athena Kourtis, Christopher H Schmid … (2007)
              The use of antiretroviral agents in pregnant HIV-infected women has been reported to increase the risk of premature delivery in some studies. We performed a meta-analysis on relevant studies to address this question. We searched Medline, Embase and the Cochrane Controlled Clinical Trials Register for English language articles. Studies that reported premature delivery for HIV-infected women treated with antiretroviral regimens during pregnancy were selected. Meta-analyses were performed using a random effects model. Thirteen prospective cohorts and one retrospective study met the inclusion criteria. Antiretroviral therapy during pregnancy did not increase the risk of premature delivery overall [odds ratio (OR) 1.01, 95% confidence interval (CI) 0.76-1.34]. In subgroup analyses, compared with no therapy, monotherapy (mostly zidovudine) conferred an OR of 0.86 (95% CI 0.73-1.01), whereas combination therapy conferred an OR of 1.13 (95% CI 0.79-1.63). The use of protease inhibitor (PI)-containing combinations resulted in an OR for premature delivery of 1.24 (95% CI 0.76-2.02), compared with combinations without PI. The initiation of combination therapy before pregnancy or in the first trimester resulted in an OR of 1.71 (95% CI 1.09-2.67) compared with therapy initiation in the second trimester and beyond. There was a large degree of heterogeneity between studies. Evidence indicates that antiretroviral therapy during pregnancy is not associated with an overall increased risk of premature delivery. The use of combination regimens before or early in pregnancy may slightly increase the risk of prematurity. Continued surveillance will be necessary to quantify such a risk accurately.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Infect Dis Obstet Gynecol
                Journal ID (publisher-id): IDOG
                Title: Infectious Diseases in Obstetrics and Gynecology
                Publisher: Hindawi Publishing Corporation
                ISSN (Print): 1064-7449
                ISSN (Electronic): 1098-0997
                Publication date (Print): 2011
                Publication date (Electronic): 11 April 2011
                Volume: 2011
                Electronic Location Identifier: 867674
                Affiliations
                1School of Medicine University of Colorado Denver, Research Complex 2, Mail Stop 8604, 12700 E. 19th Avenue, Aurora, CO 80045, USA
                2Department of Obstetrics and Gynecology, University of Colorado Hospital, Aurora, CO 80045, USA
                3Pediatric Infectious Diseases, The Children's Hospital, Aurora, CO, USA
                Author notes

                Academic Editor: Michael G. Gravett

                Article
                DOI: 10.1155/2011/867674
                PMC ID: 3094700
                PubMed ID: 21603231
                SO-VID: 5fe11be4-ae5b-4c43-bac2-2e0279a115de
                Copyright © Copyright © 2011 Adriana Weinberg et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 8 December 2010
                Date revision received : 3 February 2011
                Date accepted : 17 February 2011
                Categories
                Subject: Clinical Study

                ScienceOpen disciplines: Obstetrics & Gynecology
                Data availability:
                ScienceOpen disciplines: Obstetrics & Gynecology

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