Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

NCT04852614 | Unknown DMC

• 1 other identifier: CL 2489
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C Virus Infection

Keywords

Egypt; Sofosbuvir/daclatasvir; Pharmacokinetics; Lactating Women

Outcome Measures

Primary Outcomes (2)

• Plasma and milk concentrations of sofosbuvir

  Determination of plasma and milk concentrations of sofosbuvir and its metabolite GS-331007 in plasma and milk of HCV infected lactating women.

  Time prior to first dose till 24 hours post first dose of sofosbuvir

• Plasma and milk concentrations of daclatasvir

  Determination of plasma and milk concentrations of daclatasvir in plasma and milk of HCV infected lactating women

  Time prior to first dose till 24 hours post first dose

Interventions

Pharmacokinetic test DIAGNOSTIC_TEST

Blood samples will be collected 48 hours after the first dose on day 3 of the observed intake of the study medication at the following time points: t=0 (pre-dose), 1, 2, 3, 4, 8 and 12 hours post ingestion (7 samples) (3 mL each), Breast milk samples will be collected by emptying both breasts at 0, 2, 4, 8 and 12 hours (5 samples).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Lactating Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lactating HCV infected female patients

You may qualify if:

• Patient is at least 18 years of age at the day of screening.
• Confirmed HCV infection by PCR and known genotype (GT) 1, 4, 5, or 6.
• Female lactating patient, who will wean their children on starting treatment and ensure not to breastfeed after start treatment.
• Patients with an indication for SOF/DAC treatment for the treatment of chronic HCV.
• Patient is able and willing to sign the Informed Consent Form.
• Patient is able and willing to follow protocol requirements.

You may not qualify if:

• Need for co-treatment with ribavirin.
• HepBSAg positive test at screening.
• Treatment with rosuvastatin.
• Medicinal products that are potent P-glycoprotein (P-gp) and or CYP3A4 inducers in the intestine (rifampicin, rifabutin, St. John's wort \[Hypericum perforatum\], carbamazepine, phenobarbital and phenytoin).
• HIV co-infected patients using antiretroviral agents possibly interacting with SOF/DAC.
• Drugs associated with bradycardia including amiodarone.
• History of heart block.
• eGFR \< 30 ml/min/1.73 m2.
• Compensated cirrhosis, based on historical data, evidence of decompensated cirrhosis by ascites, encephalopathy, or variceal hemorrhage and/or abnormal ALT/AST/INR/thrombocytes indicating cirrhosis.
• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion except for conditions related to HCV.
• Clinically relevant low hemoglobin concentration at screening.
• Pregnancy
• Refusal to use proper contraception during treatment

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Manal SE El-Sayed, M.D

  Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal H El-Sayed, MD

CONTACT

01227461120; manalhelsayed@yahoo.co.uk

Fatma Soliman E Ebeid, MD

CONTACT

01095569596; dr.fatma_ebeid@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Faculty of Medicine Ain Shams University Research Institute

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 21, 2021
• Study Start: December 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

EG (1)