To describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated in pregnancy in women with current hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV) and describe safety for their infants

Who can Participate

Pregnant women with HCV, age 16-45 and pregnant between 14-32 weeks gestation, Inclusion Criteria Of legal age or circumstance to provide independent informed consent Willing and able to provide written informed consent for their own and their infant study participation At entry, 16-45 years of age (inclusive) At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry At screening has normal, grade 1, grade 2, or grade 3 results for the following: Aspartate aminotransferase (AST) (<10.0 x ULN) Alanine aminotransferase (ALT) (<10.0 x ULN) At screening has normal, grade 1, or grade 2 results for the following, Hemoglobin (>;8.5 g/dL) Creatinine (<1.8 x ULN) At screening has normal or grade 1 results for the following International normalized ratio (INR) (<1.5 x ULN) Platelet count (>100,000 cells/mm3) Total bilirubin (<1.6 x ULN) HIV status For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report Exclusion Criteria Previous treatment for hepatitis C with a DAA regimen High risk of preterm delivery, defined as either of the following: History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records Any of the following liver-related conditions: Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT >2.5 x ULN Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives

Study ID

More information available at ClinicalTrials.gov: NCT07040319