Antenatal Atazanavir: A Retrospective Analysis of Pregnancies Exposed to Atazanavir

Abstract

Introduction. There are few data regarding the tolerability, safety, or efficacy of antenatal atazanavir. We report our clinical experience of atazanavir use in pregnancy. Methods. A retrospective medical records review of atazanavir-exposed pregnancies in 12 London centres between 2004 and 2010. Results. There were 145 pregnancies in 135 women: 89 conceived whilst taking atazanavir-based combination antiretroviral therapy (cART), “preconception” atazanavir exposure; 27 started atazanavir-based cART as “first-line” during the pregnancy; and 29 “switched” to an atazanavir-based regimen from another cART regimen during pregnancy. Gastrointestinal intolerance requiring atazanavir cessation occurred in five pregnancies. Self-limiting, new-onset transaminitis was most common in first-line use, occurring in 11.0%. Atazanavir was commenced in five switch pregnancies in the presence of transaminitis, two of which discontinued atazanavir with persistent transaminitis. HIV-VL < 50 copies/mL was achieved in 89.3% preconception, 56.5% first-line, and 72.0% switch exposures. Singleton preterm delivery (<37 weeks) occurred in 11.7% preconception, 9.1% first-line, and 7.7% switch exposures. Four infants required phototherapy. There was one mother-to-child transmission in a poorly adherent woman. Conclusions. These data suggest that atazanavir is well tolerated and can be safely prescribed as a component of combination antiretroviral therapy in pregnancy.

Adverse perinatal outcomes associated with timing of initiation of antiretroviral therapy: Systematic review and meta‐analysis

“…For each included study, the type of ART and comparisons of timings of ART initiation, along with perinatal outcomes analysed, are displayed in Table 2 2). Only four studies had uniform ART regimens for all timing of ART initiation categories [41,43,45,50]. In all remaining studies, either mixtures of regimens were used across the different ART initiation categories or details were only given for the regimen(s) used in the study as a whole (Appendix 3.1).…”

“…The perinatal outcomes reported were preterm birth (18 studies), very preterm birth (six), low birthweight (11), very low birthweight (four), small for gestational age (12), very small for gestational age (three), and neonatal death (two) (Figure 1). The studies, countries, country income status, recruitment periods, number of women analysed, population characteristics, methods to estimate gestational age and correct for confounding, and quality assessments are summarized in Table 1 [6, 16, 18, 30–51].…”

“…In total, 24 (96%) studies compared preconception and antenatal ART initiation, seven (28%) studies compared different trimesters of antenatal ART initiation, and six (24%) studies compared both preconception and antenatal trimesters (Table 2). Only four studies had uniform ART regimens for all timing of ART initiation categories [41, 43, 45, 50]. In all remaining studies, either mixtures of regimens were used across the different ART initiation categories or details were only given for the regimen(s) used in the study as a whole (Appendix 3.1).…”

Possible Atazanavir-Induced Cholelithiasis in a Pregnant Woman: A Case Report

“…3 In one retrospective study involving 155 pregnant women who were exposed to atazanavir, the drug was reported to be generally well tolerated, with 63.2% of the patients reporting no side effects. 4 Nausea was the most commonly observed adverse event (in 34.2% of patients), and about 2% of the women stopped treatment because of side effects. 4 Cholelithiasis was not reported in phase III clinical trials of ritonavir-boosted atazanavir.…”

“…4 Nausea was the most commonly observed adverse event (in 34.2% of patients), and about 2% of the women stopped treatment because of side effects. 4 Cholelithiasis was not reported in phase III clinical trials of ritonavir-boosted atazanavir. 3 However, recent postmarketing reports have suggested a potential association between this regimen and cholelithiasis.…”