Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV

To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. Ongoing, nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and infants....

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Published in:	AIDS (London) Vol. 32; no. 6; p. 729
Main Authors:	Mulligan, Nikki, Best, Brookie M, Wang, Jiajia, Capparelli, Edmund V, Stek, Alice, Barr, Emily, Buschur, Shelley L, Acosta, Edward P, Smith, Elizabeth, Chakhtoura, Nahida, Burchett, Sandra, Mirochnick, Mark
Format:	Journal Article
Language:	English
Published:	England 27.03.2018
Subjects:	Adult Chromatography, Liquid Female Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - pharmacokinetics HIV - isolation & purification HIV Infections - drug therapy HIV Integrase Inhibitors - administration & dosage HIV Integrase Inhibitors - pharmacokinetics Humans Infant, Newborn Male Oxazines Piperazines Plasma - chemistry Postpartum Period Pregnancy Pregnancy Complications, Infectious - drug therapy Prospective Studies Pyridones Tandem Mass Spectrometry Viral Load Young Adult
ISSN:	1473-5571, 1473-5571
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Abstract	To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. Ongoing, nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and infants. Intensive steady-state 24 h pharmacokinetic profiles after dolutegravir 50 mg once-daily were performed during the second trimester (2T), third trimester (3T) and postpartum. Maternal delivery and postnatal infant samples were collected after birth. Dolutegravir was measured by validated LC-MS/MS; quantitation limit was 0.005 μg/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-subject comparisons. Twenty-nine enrolled participants had a median age of 32 years (range 21-42). Pharmacokinetic data were available for 15 (2T), 28 (3T) and 23 (postpartum) women. Median dolutegravir AUC0-24,Cmax and C24 were 25-51% lower in the 2T and 3T compared with postpartum. The median cord blood/maternal plasma concentration ratio was 1.25 (n = 18). In 21 infants, median elimination half-life was 32.8 h after in utero exposure. Viral load at delivery was less than 50 copies/ml for 27/29 women (93%). Twenty-nine infants were HIV-negative. Renal abnormalities noted on ultrasound in two infants were deemed possibly related to dolutegravir. Dolutegravir exposure is lower in pregnancy compared with postpartum in the same women on once-daily dosing. Median AUC0-24 during pregnancy was similar to, whereas trough concentrations were lower than, those seen in nonpregnant adults. Trough concentrations in pregnancy were well above dolutegravir EC90 (0.064 μg/ml). Dolutegravir readily crosses the placenta. Infant elimination is prolonged, with half-life over twice that of historical adult controls.
AbstractList	To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. Ongoing, nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and infants. Intensive steady-state 24 h pharmacokinetic profiles after dolutegravir 50 mg once-daily were performed during the second trimester (2T), third trimester (3T) and postpartum. Maternal delivery and postnatal infant samples were collected after birth. Dolutegravir was measured by validated LC-MS/MS; quantitation limit was 0.005 μg/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-subject comparisons. Twenty-nine enrolled participants had a median age of 32 years (range 21-42). Pharmacokinetic data were available for 15 (2T), 28 (3T) and 23 (postpartum) women. Median dolutegravir AUC0-24,Cmax and C24 were 25-51% lower in the 2T and 3T compared with postpartum. The median cord blood/maternal plasma concentration ratio was 1.25 (n = 18). In 21 infants, median elimination half-life was 32.8 h after in utero exposure. Viral load at delivery was less than 50 copies/ml for 27/29 women (93%). Twenty-nine infants were HIV-negative. Renal abnormalities noted on ultrasound in two infants were deemed possibly related to dolutegravir. Dolutegravir exposure is lower in pregnancy compared with postpartum in the same women on once-daily dosing. Median AUC0-24 during pregnancy was similar to, whereas trough concentrations were lower than, those seen in nonpregnant adults. Trough concentrations in pregnancy were well above dolutegravir EC90 (0.064 μg/ml). Dolutegravir readily crosses the placenta. Infant elimination is prolonged, with half-life over twice that of historical adult controls. To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.OBJECTIVETo evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.Ongoing, nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and infants.DESIGNOngoing, nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and infants.Intensive steady-state 24 h pharmacokinetic profiles after dolutegravir 50 mg once-daily were performed during the second trimester (2T), third trimester (3T) and postpartum. Maternal delivery and postnatal infant samples were collected after birth. Dolutegravir was measured by validated LC-MS/MS; quantitation limit was 0.005 μg/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-subject comparisons.METHODSIntensive steady-state 24 h pharmacokinetic profiles after dolutegravir 50 mg once-daily were performed during the second trimester (2T), third trimester (3T) and postpartum. Maternal delivery and postnatal infant samples were collected after birth. Dolutegravir was measured by validated LC-MS/MS; quantitation limit was 0.005 μg/ml. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-subject comparisons.Twenty-nine enrolled participants had a median age of 32 years (range 21-42). Pharmacokinetic data were available for 15 (2T), 28 (3T) and 23 (postpartum) women. Median dolutegravir AUC0-24,Cmax and C24 were 25-51% lower in the 2T and 3T compared with postpartum. The median cord blood/maternal plasma concentration ratio was 1.25 (n = 18). In 21 infants, median elimination half-life was 32.8 h after in utero exposure. Viral load at delivery was less than 50 copies/ml for 27/29 women (93%). Twenty-nine infants were HIV-negative. Renal abnormalities noted on ultrasound in two infants were deemed possibly related to dolutegravir.RESULTSTwenty-nine enrolled participants had a median age of 32 years (range 21-42). Pharmacokinetic data were available for 15 (2T), 28 (3T) and 23 (postpartum) women. Median dolutegravir AUC0-24,Cmax and C24 were 25-51% lower in the 2T and 3T compared with postpartum. The median cord blood/maternal plasma concentration ratio was 1.25 (n = 18). In 21 infants, median elimination half-life was 32.8 h after in utero exposure. Viral load at delivery was less than 50 copies/ml for 27/29 women (93%). Twenty-nine infants were HIV-negative. Renal abnormalities noted on ultrasound in two infants were deemed possibly related to dolutegravir.Dolutegravir exposure is lower in pregnancy compared with postpartum in the same women on once-daily dosing. Median AUC0-24 during pregnancy was similar to, whereas trough concentrations were lower than, those seen in nonpregnant adults. Trough concentrations in pregnancy were well above dolutegravir EC90 (0.064 μg/ml). Dolutegravir readily crosses the placenta. Infant elimination is prolonged, with half-life over twice that of historical adult controls.CONCLUSIONDolutegravir exposure is lower in pregnancy compared with postpartum in the same women on once-daily dosing. Median AUC0-24 during pregnancy was similar to, whereas trough concentrations were lower than, those seen in nonpregnant adults. Trough concentrations in pregnancy were well above dolutegravir EC90 (0.064 μg/ml). Dolutegravir readily crosses the placenta. Infant elimination is prolonged, with half-life over twice that of historical adult controls.
Author	Mulligan, Nikki Smith, Elizabeth Burchett, Sandra Wang, Jiajia Acosta, Edward P Best, Brookie M Capparelli, Edmund V Buschur, Shelley L Chakhtoura, Nahida Stek, Alice Mirochnick, Mark Barr, Emily
Author_xml	– sequence: 1 givenname: Nikki surname: Mulligan fullname: Mulligan, Nikki organization: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, California – sequence: 2 givenname: Brookie M surname: Best fullname: Best, Brookie M organization: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, California – sequence: 3 givenname: Jiajia surname: Wang fullname: Wang, Jiajia organization: Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts – sequence: 4 givenname: Edmund V surname: Capparelli fullname: Capparelli, Edmund V organization: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, California – sequence: 5 givenname: Alice surname: Stek fullname: Stek, Alice organization: University of Southern California School of Medicine, Los Angeles, California – sequence: 6 givenname: Emily surname: Barr fullname: Barr, Emily organization: University of Colorado, Children's Hospital Colorado, Aurora, Colorado – sequence: 7 givenname: Shelley L surname: Buschur fullname: Buschur, Shelley L organization: Baylor College of Medicine-Texas Children's Hospital – sequence: 8 givenname: Edward P surname: Acosta fullname: Acosta, Edward P organization: University of Alabama at Birmingham, Birmingham, Alabama – sequence: 9 givenname: Elizabeth surname: Smith fullname: Smith, Elizabeth organization: Maternal, Adolescent, and Pediatric Research Branch, National Institute of Allergy and Infectious Diseases – sequence: 10 givenname: Nahida surname: Chakhtoura fullname: Chakhtoura, Nahida organization: Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland – sequence: 11 givenname: Sandra surname: Burchett fullname: Burchett, Sandra organization: Children's Hospital Boston – sequence: 12 givenname: Mark surname: Mirochnick fullname: Mirochnick, Mark organization: Boston University School of Medicine, Boston, Massachusetts, USA
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Snippet	To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. Ongoing, nonrandomized,... To evaluate dolutegravir pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.OBJECTIVETo evaluate...
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SubjectTerms	Adult Chromatography, Liquid Female Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - pharmacokinetics HIV - isolation & purification HIV Infections - drug therapy HIV Integrase Inhibitors - administration & dosage HIV Integrase Inhibitors - pharmacokinetics Humans Infant, Newborn Male Oxazines Piperazines Plasma - chemistry Postpartum Period Pregnancy Pregnancy Complications, Infectious - drug therapy Prospective Studies Pyridones Tandem Mass Spectrometry Viral Load Young Adult
Title	Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV
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