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Pharmacovigilance data on 328 pregnancies exposed to glecaprevir/pibrentasvir presented at AASLD 2026 showed no vertical transmission and no pattern of congenital anomalies.
Pharmacovigilance data on more than 300 pregnancies exposed to glecaprevir/pibrentasvir showed no cases of vertical transmission of hepatitis C virus (HCV) and no pattern of congenital anomalies, according to an analysis presented by Tatyana Kushner, MD, MSCE, at The Liver Meeting 2026 in Denver, Colorado.
“From the data that we do see, overall it looks reassuring,” Kushner, associate professor of medicine in the Department of Gastroenterology at Weill Cornell Medicine in New York, New York, told HCPLive.
Universal HCV screening during each pregnancy has been recommended in the US since 2020, and Kushner notes that more people are now diagnosed during pregnancy.1 AASLD/IDSA guidance states that treatment can be considered on an individual basis after discussing risks and benefits, but she says many clinicians remain hesitant without clearer safety data.2
Investigators reviewed 328 pregnancies with reported glecaprevir/pibrentasvir (Mavyret) exposure in AbbVie’s global pharmacovigilance database from July 2017 to March 2026. Among the 87 pregnancies with documented outcomes, 51.7% resulted in live births, 19.5% in elective abortions, and 28.7% in spontaneous abortions. Three live births were preterm, and 2 had congenital anomalies with no recurring pattern. Investigators reported that rates of spontaneous abortion and preterm birth were lower than those reported among pregnant individuals with HCV not exposed to direct-acting antivirals.2
Kushner cautions that most exposures lacked outcome data and that adverse outcomes are more likely to be reported, which may skew results. Treatment was discontinued in 146 of 223 cases with available status, which investigators suggest may reflect a lack of shared decision-making.2
Watch the full interview to hear Kushner discuss how conversations about treatment differ by trimester, when pausing therapy during the first trimester may be considered, and what prospective data are still needed.
Editors’ note: Kushner has relevant disclosures with Gilead, GSK, Madrigal, Ipsen, Mirum, and Eiger Biopharmaceuticals.
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