Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

Status Recruiting

Clinical Trial Summary

This is a prospective, observational, open-label, pharmacokinetic study will evaluate PK of SOF/DAC in lactating HCV-infected females at weaning or women who voluntarily decided to forego breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.

Clinical Trial Description

Eligible women will be advised to arrange for initiation of treatment with their physician once they decide to stop breastfeeding. Treatment will be initiated once the women decide to wean their children and a warning will be given to abstain from any breast-feeding once treatment is started. This treatment is prescribed by the physician either the patients choose to participate in the study or not. In addition, effective contraceptive methods should be used. The treatment consists of SOF/DAC: 400 mg sofosbuvir and 60 mg daclatasvir administered with food for 12 weeks. All recruited patients will be screened for the following data at baseline: Serum creatinine, bilirubin, albumin, AST, ALT, prothrombin time (PT), CBC, and viral load by PCR. The patient's general and demographic information (age, gender, height, and weight), comorbidities, and concurrent medications will be assessed and recorded in a specially designed patient data sheet. The study will be conducted in the Faculty of Medicine Ain-Shams Research Institute Clinical Research Center (MASRI -CRC). After the first dose, women will be instructed to express their milk and discard it on the first two days and come to the research center on the third day for plasma and milk sampling. Patients will be instructed to take the dose on time especially the day before sampling. They will be asked to record the time of dose administration. They might be also followed up by telephone calls ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04852614
Study type	Observational
Source	Ain Shams University
Contact	Manal H El-Sayed, MD
Phone	01227461120
Email	manalhelsayed@yahoo.co.uk
Status	Recruiting
Phase
Start date	December 1, 2020
Completion date	December 1, 2023

View Details

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