Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL/VOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT03820258

2018-000480-87 (EudraCT Number)

GS-US-367-1175

Details and patient eligibility

About

The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.

Full description

Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.

Enrollment: 21 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Consent of parent or legal guardian required

• Chronic HCV infection

• Screening laboratory values within defined thresholds

• Individuals must have a determination of prior treatment status:

  • DAA-naive is defined as either:

    • Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA
    • Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA

  • DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)
• Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)
• Pregnant or nursing females
• Known hypersensitivity to study medication
• Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 6 patient groups

Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks

Experimental group

Description:

Direct-acting antiviral (DAA)-naive participants without cirrhosis in Cohort 1 (12 to \< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 8 weeks.

Treatment:

Drug: SOF/VEL/VOX

Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks

Experimental group

Description:

DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 1 (12 to \< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 12 weeks.

Treatment:

Drug: SOF/VEL/VOX

Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks

Experimental group

Description:

DAA-naive participants without cirrhosis in Cohort 2 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.

Treatment:

Drug: SOF/VEL/VOX

Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks

Experimental group

Description:

DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 2 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 12 weeks.

Treatment:

Drug: SOF/VEL/VOX

Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks

Experimental group

Description:

DAA-naive participants without cirrhosis in Cohort 3 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.

Treatment:

Drug: SOF/VEL/VOX

Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks

Experimental group

Description:

DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 3 (3 to \< 6 years old) will receive SOF/VEL/VOX FDC for 12 weeks.

Treatment:

Drug: SOF/VEL/VOX