Chappell, Catherine A.; Scarsi, Kimberly K.; Kirby, Brian J.; Suri, Vithika; Gaggar, Anuj; Bogen, Debra L.; Macio, Ingrid S.; Meyn, Leslie A.; Bunge, Katherine E.; Krans, Elizabeth E.; Hillier, Sharon L. published the artcile< Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study>, SDS of cas: 58-97-9, the main research area is .
Background Hepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiol. changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women. Methods This was an open-label, phase 1 study of pregnant women with genotype 1 HCV infection and their infants. A reference group of women who had participated in pharmacokinetic studies of ledipasvir-sofosbuvir during phase 2 and 3 trials was used. Participants were enrolled at Magee-Womens Hospital (Pittsburgh, PA, USA) between 23 and 24 wk’ gestation and had a 12-wk course of oral ledipasvir-sofosbuvir (daily 90 mg ledipasvir plus 400 mg sofosbuvir). Three 12-h intensive pharmacokinetic visits were done at 25-26, 29-30, and 33-34 wk’ gestation and individual pharmacokinetics were summarised by geometric mean across the three visits. The primary outcome, analyzed in all participants without suspected dosing errors, was the ledipasvir-sofosbuvir area under the concentration-time curve of the dosing interval (AUCtau) during pregnancy compared with the reference group by geometric mean ratio. This study is registered with ClinicalTrials.gov, NCT02683005. Findings From Oct 1, 2016, to Sept 30, 2018, 29 pregnant women were screened and nine (31%) were enrolled. Eight (89%) women were included in the primary anal. Ledipasvir and sofosbuvir exposures were similar in the pregnant women vs. the non-pregnant reference group (geometric mean ratio of AUCtau ledipasvir 89·3% [90% CI 68·7-116·1]; sofosbuvir 91·1% [78·0-106·3]). Interpretation Ledipasvir-sofosbuvir was safe and effective without clin. meaningful differences in drug exposure among pregnant vs. non-pregnant women.
Lancet Microbe published new progress about 58-97-9. 58-97-9 belongs to class tetrahydrofurans, and the molecular formula is C9H13N2O9P, SDS of cas: 58-97-9.
Referemce:
Tetrahydrofuran – Wikipedia,
Tetrahydrofuran | (CH2)3CH2O – PubChem