Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Drug: SOF/VEL

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Guwahati, India, 781006
    • Institute of Digestive and Liver Disease
  • Hyderabad, India, 500004
    • Global Hospitals
  • Kochi, India, 682040
    • Lakeshore Hospital
  • Ludhiana, India, 141001
    • Dayanand Medical College & Hospital
  • Surat, India, 395002
    • Nirmal Hospital
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Seth GS medical college and KEM Hospital
    • Nagpur, Maharashtra, India, 440003
      • Government Medical College & Super Speciality Hospital
  • New Delhi
    • Delhi, New Delhi, India, 110029
      • All India Institute of Medical Sciences
  • Parel
    • Mumbai, Parel, India, 400012
      • Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • Post Graduate Institute of Medical Education and Resesarch (PGIMER)
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600010
      • YRG Care
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641005
      • VGM Hospital - Institute of Gastroenterology
  • Telangana
    • Secunderabad, Telangana, India, 500003
      • Gandhi Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226014
      • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Department of Hepatology, School of Digestive and Liver Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Willing and able to provide written informed consent
• HCV RNA detected at screening
• Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
• Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
• Cirrhosis determination (approximately 20% may have cirrhosis)
• Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment.
• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
• Lactating females must agree to discontinue nursing before the study drug is administered
• Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

• Current or prior history of any of the following:

  • Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
  • Liver transplantation
  • Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol.
• Screening laboratory parameters outside of defined threshold
• Prior exposure to HCV NS5A inhibitor
• Pregnant or nursing female
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Use of any prohibited concomitant medications as described in study protocol
• Known hypersensitivity to VEL, SOF, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF/VEL; SOF/VEL for 12 weeks	Drug: SOF/VEL; 400/100 mg FDC tablet(s) administered orally once daily; Other Names: Epclusa®; GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Virologic Failure	Virologic failure was defined as the following: On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or; Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment.	Up to Posttreatment Week 12

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): February 7, 2018
• Study Completion (Actual): February 7, 2018

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: GS-US-342-1521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes