Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175758

GS-US-334-1112

2014-002283-32 (EudraCT Number)

Details and patient eligibility

About

This study will have two parts as follows:

The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.

Enrollment: 106 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 genotype 2 or 3
• Screening laboratory values within defined thresholds
• PK Lead-in only: all individuals must be treatment naive

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 HIV, acute hepatitis A virus, or hepatitis B virus
• Clinical hepatic decompensation (ie, ascites, encephalopathy 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: Parallel Assignment

Masking: None (Open label)

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106 participants in 6 patient groups

12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)

Experimental group

Description:

Participants between 12 to \< 18 years of age with genotype (GT) 2 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)

Experimental group

Description:

Participants between 12 to \< 18 years of age with genotype 3 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.

Treatment:

Drug: RBV

Drug: SOF

6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)

Experimental group

Description:

Participants between 6 to \< 12 years of age with genotype 2 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)

Experimental group

Description:

Participants between 6 to \< 12 years of age with genotype 3 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.

Treatment:

Drug: RBV

Drug: SOF

3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)

Experimental group

Description:

Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)

Experimental group

Description:

Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks.

Treatment:

Drug: RBV

Drug: SOF