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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

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ClinicalTrials.gov Identifier: NCT03820258
Recruitment Status : Terminated (SOF/VEL/VOX will not be evaluated in younger age groups.)
First Posted : January 29, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL/VOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children With Chronic HCV Infection
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : February 19, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks
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 or a lower dose smaller tablet based on swallowability assessment) for 8 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Experimental: Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks
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 or a lower dose smaller tablet based on swallowability assessment) for 12 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Experimental: Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks
DAA-naive participants without cirrhosis in Cohort 2 (6 to < 12 years old) will receive SOF/VEL/VOX FDC (400/100/100 mg or a lower dose smaller tablet based on swallowability assessment) for 8 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Experimental: Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks
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 (400/100/100 mg or lower dose smaller tablet based on swallowability assessment) for 12 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Experimental: Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks
DAA-naive participants without cirrhosis in Cohort 3 (6 to < 12 years old) will receive SOF/VEL/VOX FDC (a lower dose smaller tablet or a non-tablet formulation based on swallowability assessment) for 8 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®
Experimental: Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks
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 (a lower dose smaller tablet or a non-tablet formulation based on swallowability assessment) for 12 weeks.
 Drug: SOF/VEL/VOX
Administered once daily with food.
Other Name: Vosevi ®


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: AUCtau of SOF, its Major Metabolite (GS-331007), VEL and VOX. [ Time Frame: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose at Week 2 or 4; Cohort 3 (3 to < 6 years of age): predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose at Week 2 or 4 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).


Secondary Outcome Measures :
  1. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to End of Treatment (Week 8 or Week 12) plus 30 days ]
  2. Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

  3. Proportion of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < the LLOQ at 4 weeks after stopping study treatment.

  4. Proportion of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]
    SVR24 is defined as HCV RNA < the LLOQ at 24 weeks after stopping study treatment.

  5. Proportion of Participants With Overall Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure is defined as:

    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
      • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
      • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

    • Virologic relapse:

      • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

  6. Proportion of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  7. Proportion of Participants Who Develop Resistance to SOF, VEL, and/or VOX During Treatment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  8. Proportion of Participants Who Develop Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued [ Time Frame: Up to Posttreatment Week 24 ]
  9. Change in HCV RNA From Day 1 [ Time Frame: Day 1 and up to End of Treatment (Week 8 or Week 12) ]
  10. Growth and Development as Measured by Height Percentiles [ Time Frame: Up to Posttreatment Week 24 ]
  11. Growth and Development as Measured by Weight Percentiles [ Time Frame: Up to Posttreatment Week 24 ]
  12. Growth and Development as Measured by Tanner Stage Assessment [ Time Frame: Up to Posttreatment Week 24 ]
  13. Growth and Development as Measured by Radiographic Bone Age Assessment [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  14. Growth and Development as Measured by C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker [ Time Frame: Up to Posttreatment Week 24 ]
  15. Growth and Development as Measured by Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker [ Time Frame: Up to Posttreatment Week 24 ]
  16. Swallowability of SOF/VEL/VOX Tablets as Assessed by the Participant's Ability to Swallow the Solid Dosage Tablet Formulation [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  17. Acceptability of SOF/VEL/VOX Tablets as Measured by a Questionnaire to Assess Acceptability, Including Palatability [ Time Frame: Up to End of Treatment (Week 8 or Week 12) ]
  18. Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric Quality of Life survey [ Time Frame: Up to Posttreatment Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820258


Locations
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Italy
SOS-intraSOC Epatologia
Firenze, Italy, 50139
US Infettivologia Pediatrica-Polo Universitario
Milano, Italy, 20157
Servizio di Epatologia e Nutrizione Pediatrica
Milan, Italy, 20122
UOS Epatologia Pediatrica
Napoli, Italy, 80131
UOSD Epatologia
San Giovanni Rotondo, Italy, 71013
Poland
Wojewodzki Szpital
Bydgoszcz, Poland, 85-030
Med Polonia
Poznan, Poland, 60-693
Uniwersytecki Szpital Kliniczny im.
Wroclaw, Poland, 50-368
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH
Kings Healthcare NHS Trust Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03820258    
Other Study ID Numbers: GS-US-367-1175
2018-000480-87 ( EudraCT Number )
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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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
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections