Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

NCT05140941 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY21080043
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 9

Brief Summary

This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second or third trimester in approximately 100 pregnant people. Maternal participants will take one SOF/VEL tablet once daily for 12 weeks (84 days) and followed until 12 weeks after treatment completion (postpartum). Infants will be followed from birth until one year of age. The primary objectives are to evaluate the sustained virologic response 12 weeks after completion of SOF/VEL treatment (SVR12) in participants treated during pregnancy and to evaluate impact of antenatal treatment with SOF/VEL on the gestational age at delivery.

Conditions

Hepatitis C, Chronic; Pregnancy; Infection

Outcome Measures

Primary Outcomes (2)

• Number of maternal participants with sustained virologic response after completion of SOF/VEL treatment (SVR12)

  Number of maternal participants with plasma level of HCV RNA PCR that is below the lower limit of quantification after completion of SOF/VEL treatment

  Approximately 12 weeks

• Number of maternal participants that deliver prior to 37 weeks' gestation

  Number of maternal participants that deliver (spontaneous and iatrogenic) prior to 37 weeks' gestation

  Approximately 28 weeks

Secondary Outcomes (31)

• Number of maternal participants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir

  Approximately six months

• Number of infants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir

  Approximately six months

• Number of maternal participants whose pregnancy results in a stillbirth or intrauterine fetal demise

  Approximately 28 weeks

• Number of maternal participants that experience intrapartum hemorrhage

  Approximately 28 weeks

• Number of maternal participants that experience postpartum hemorrhage

  Approximately 28 weeks

Study Arms (1)

Sofosbuvir/Velpatasvir

EXPERIMENTAL

Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet, one tablet taken once daily for 84 days

Drug: Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet

Interventions

Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet DRUG

One Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet taken once daily for 84 days.

Also known as: Epclusa

Sofosbuvir/Velpatasvir

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 through 45 years (inclusive) at screening
• Able and willing to provide written informed consent and take part in the study procedures
• Able and willing to provide adequate locator information, defined as at least two other alternate contacts
• HCV antibody seropositivity with detectable HCV RNA viral load at screening
• Chronic HCV infection of at least 6 months by laboratory report or participant reported medical history as determined by the site PI, or if duration of HCV cannot be determined then the participant can be enrolled if there is no clinical evidence of acute hepatitis C infection (defined by CDC as presence of jaundice or total bilirubin \>/= 3.0 mg/dL or ALT \>200IU/L)
• Singleton pregnancy at 20 + 0 to 30 + 0 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
• Having a comprehensive anatomy scan with no evidence of major structural abnormalities as defined by the CDC birth surveillance toolkit (https://www.cdc.gov/ncbddd/birthdefects/surveillancemanual/chapters/chapter-4/chapter4-1.html) or an anomaly that would significantly impact delivery timing or neonatal outcomes as determined by the Protocol Safety Review Team (PSRT) prior to enrollment
• Documented negative Hepatitis B testing for current infection (negative HBsAg test) prior to enrollment
• If living with HIV, must be on antiretroviral therapy with HIV viral load \<50 copies/mL on the most recent HIV viral load test within 30 days before enrollment and agree to continue antiretroviral therapy throughout study participation
• If taking acid-suppressant medication(s), willing and able to either discontinue administration during the 12-week period of study treatment or to follow specific dosing instructions for concomitant use with SOF/VEL
• Per participant report at screening and enrollment, agrees not to participate in other research studies involving investigational medications or investigational medical devices for the duration of study participation (does not include duration of infant participation). Note: maternal participants can participate in research studies that include standard of care medications.

You may not qualify if:

• Participant report of any of the following at screening or enrollment:
• Previous DAA treatment for HCV (prior interferon-based treatment is acceptable) without documentation of SVR12 (HCV RNA below the lower limit of quantification at least 24 weeks after DAA initiation)
• Use of any medications contraindicated with concurrent use of velpatasvir or sofosbuvir according to the most current EPCLUSA® package insert30
• Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits
• History of cirrhosis documented or reported by previous liver biopsy, imaging tests or on at least 2 noninvasive laboratory tests of fibrosis, including compensated cirrhosis
• Reports participating in any other research study involving investigational medications or investigational medical devices within 60 days or less prior to enrollment (does not include research studies involving standard of care medications)
• Known fetal chromosomal abnormality prior to enrollment (confirmed by chorionic villus sampling or amniocentesis)
• Clinically significant and habitual non-therapeutic drug use, not including marijuana, as determined by site PI at screening and enrollment
• At screening and enrollment, as determined by site PI, any significant, uncontrolled, active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease other than HCV (or HIV as outlined in eligibility criteria)
• Any of the following laboratory abnormalities at screening:
• Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limit of normal
• Hemoglobin less than 9 g/dL
• Platelet count less than 90,000 per mm3
• International normalized ratio (INR) \> 1.5
• Creatinine greater than 1.4

Sponsors & Collaborators

• Catherine Anne Chappell: lead
• Gilead Sciences: collaborator

Study Sites (9)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh, Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Marshall University

Huntington, West Virginia, 25755, United States

Location

Victoria Hospital, London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

University Health Toronto, St Michaels Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Pregnancy Complications, Infectious

Interventions

Sofosbuvir; velpatasvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Catherine Chappell, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 2, 2021
• Study Start: April 4, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately after the primary manuscript for the study is published for five years.
• Access Criteria: Data requests submitted by email will be reviewed by the Principal Investigator.

Locations

US (6); CA (3)