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

For treatment-naive adult patients infected with HIV, the first-line antiretroviral regimen consists of 2 nucleoside reverse transcriptase inhibitors in combination with an integrase inhibitor or a boosted darunavir regimen.1 As of April 2015, the US Department of Health and Human Services replaced atazanavir with an alternative protease inhibitor regimen in its guidelines for adults and adolescents.1 However, the most recent update (in August 2015) of the same organization’s perinatal guidelines confirmed that during pregnancy, ritonavir-boosted atazanavir is still considered a first-line protease inhibitor option, because there has been extensive experience in this clinical setting with no adverse infant outcomes.2 Atazanavir has been associated, in both adult and pediatric populations, with unconjugated hyperbilirubinemia, a phenomenon that usually occurs without clinical complications.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.3 However, recent postmarketing reports have suggested a potential association between this regimen and cholelithiasis. Here, we describe a case of cholelithiasis in a pregnant woman who was taking ritonavir-boosted atazanavir. To our knowledge, this is the first reported case of this form of toxicity during pregnancy.