NCT02175758 is a Phase 2 clinical trial of SOF in Hepatitis C Virus Infection, sponsored by Gilead Sciences.

Who is sponsoring NCT02175758?

NCT02175758 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02175758?

Interventions in NCT02175758: SOF, RBV.

What condition does NCT02175758 study?

NCT02175758 studies Hepatitis C Virus Infection.

Is NCT02175758 still recruiting?

NCT02175758 is currently completed. Last updated 30 April 2019.

Are results published for NCT02175758?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-30 · How we verify

NCT02175758

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 30 April 2019

What this trial tests

Phase 2 trial testing SOF in Hepatitis C Virus Infection in 106 participants. Completed in 13 September 2018.

Timeline

7 July 2014

Primary endpoint
21 June 2018

13 September 2018

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	7 July 2014
Primary completion	21 June 2018
Estimated completion	13 September 2018
Sites	37 locations across Italy, New Zealand, Russia, Belgium, United Kingdom, Germany, Australia, United States

Drugs / interventions tested

SOF — full drug profile →
RBV — full drug profile →

Conditions studied

Hepatitis C Virus Infection — all drugs for Hepatitis C Virus Infection →

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 3 to 17, any sex, with Hepatitis C Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) Primary · 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks	9106.0	± 2601.96
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks	7651.2	± 1723.32
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks	10293.7	± 1860.57

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase Primary · Up to 24 weeks

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	0
12 to < 18 Years Old - SOF+RBV 24 Weeks	0
6 to < 12 Years Old - SOF+RBV 12 Weeks	0
6 to < 12 Years Old - SOF+RBV 24 Weeks	0
3 to < 6 Years Old - SOF+RBV 12 Weeks	20.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	0

For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) Primary · Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Group	Value	95% CI
12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks	98.1	89.7 – 100.0
3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks	98.1	90.1 – 100.0
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	97.4	86.5 – 99.9
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks	80.0	28.4 – 99.5
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA Secondary · Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

Change at Week 1

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks	-3.98	± 1.056
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.23	± 0.765
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks	-3.82	± 0.447
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-3.78	± 1.234
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.12	± 0.632
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.53	± 0.347

Change at Week 2

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.84	± 0.743
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.92	± 0.674
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.56	± 1.553
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.31	± 0.846
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.94	± 0.422

Change at Week 4

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.84	± 0.743
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.92	± 0.674
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.60	± 1.686
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.42	± 1.006
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 8

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.84	± 0.743
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.92	± 0.674
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.61	± 1.700
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.52	± 1.177
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 12

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.84	± 0.743
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.92	± 0.674
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.61	± 1.700
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.52	± 1.177
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 16

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.61	± 1.700
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 20

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.61	± 1.700
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 24

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.34	± 0.758
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.61	± 1.700
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase Secondary · Up to Day 7

Group	Value	95% CI
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks	0
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks	0
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks	0

For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) Secondary · Posttreatment Week 4

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks	80.0	28.4 – 99.5
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) Secondary · Posttreatment Week 24

SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	97.4	86.5 – 99.9
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks	80.0	28.4 – 99.5
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough Secondary · Up to 24 weeks

Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment.

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	0
12 to < 18 Years Old - SOF+RBV 24 Weeks	0
6 to < 12 Years Old - SOF+RBV 12 Weeks	0
6 to < 12 Years Old - SOF+RBV 24 Weeks	0
3 to < 6 Years Old - SOF+RBV 12 Weeks	0
3 to < 6 Years Old - SOF+RBV 24 Weeks	0

For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse Secondary · Up to Posttreatment Week 24

Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	0
12 to < 18 Years Old - SOF+RBV 24 Weeks	0
6 to < 12 Years Old - SOF+RBV 12 Weeks	0
6 to < 12 Years Old - SOF+RBV 24 Weeks	0
3 to < 6 Years Old - SOF+RBV 12 Weeks	0
3 to < 6 Years Old - SOF+RBV 24 Weeks	0

For the Treatment Phase, Change From Baseline in HCV RNA Secondary · Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

Change at Week 1

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.25	± 0.986
12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.12	± 0.733
6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.12	± 0.692
6 to < 12 Years Old - SOF+RBV 24 Weeks	-3.88	± 0.928
3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.12	± 0.632
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.53	± 0.347

Change at Week 2

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.74	± 0.980
12 to < 18 Years Old - SOF+RBV 24 Weeks	-4.86	± 0.702
6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.55	± 0.812
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.51	± 1.102
3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.31	± 0.846
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.94	± 0.422

Change at Week 4

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.74	± 0.980
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.01	± 0.760
6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.68	± 0.843
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.56	± 1.171
3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.42	± 1.006
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 8

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.74	± 0.980
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.02	± 0.771
6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.68	± 0.843
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.54	± 1.191
3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.52	± 1.177
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 12

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	-4.74	± 0.980
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.02	± 0.771
6 to < 12 Years Old - SOF+RBV 12 Weeks	-4.68	± 0.843
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.57	± 1.178
3 to < 6 Years Old - SOF+RBV 12 Weeks	-4.52	± 1.177
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 16

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.02	± 0.771
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.57	± 1.178
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 20

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.02	± 0.771
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.57	± 1.178
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

Change at Week 24

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	-5.02	± 0.771
6 to < 12 Years Old - SOF+RBV 24 Weeks	-4.57	± 1.178
3 to < 6 Years Old - SOF+RBV 24 Weeks	-3.97	± 0.453

For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment Secondary · Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

Week 1

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	30.8	9.1 – 61.4
12 to < 18 Years Old - SOF+RBV 24 Weeks	30.8	17.0 – 47.6
6 to < 12 Years Old - SOF+RBV 12 Weeks	46.2	19.2 – 74.9
6 to < 12 Years Old - SOF+RBV 24 Weeks	39.3	21.5 – 59.4
3 to < 6 Years Old - SOF+RBV 12 Weeks	50.0	6.8 – 93.2
3 to < 6 Years Old - SOF+RBV 24 Weeks	37.5	8.5 – 75.5

Week 2

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	74.4	57.9 – 87.0
6 to < 12 Years Old - SOF+RBV 12 Weeks	76.9	46.2 – 95.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	78.6	59.0 – 91.7
3 to < 6 Years Old - SOF+RBV 12 Weeks	75.0	19.4 – 99.4
3 to < 6 Years Old - SOF+RBV 24 Weeks	87.5	47.3 – 99.7

Week 4

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	92.3	79.1 – 98.4
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	96.4	81.7 – 99.9
3 to < 6 Years Old - SOF+RBV 12 Weeks	75.0	19.4 – 99.4
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

Week 8

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	96.4	81.7 – 99.9
3 to < 6 Years Old - SOF+RBV 12 Weeks	100.0	39.8 – 100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

Week 12

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0	75.3 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks	100.0	39.8 – 100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

Week 16

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

Week 20

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

Week 24

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0	91.0 – 100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0	87.7 – 100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0	63.1 – 100.0

For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization Secondary · Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to \< 6 Years Old 12 Weeks group had ALT \> ULN at Baseline, but had no other available data.

Week 1

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	50.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	63.6
6 to < 12 Years Old - SOF+RBV 12 Weeks	25.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	75.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 2

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	90.9
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	93.3
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 4

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	95.5
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 8

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	95.5
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 12

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 12 Weeks	100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 16

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 20

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Week 24

Group	Value	95% CI
12 to < 18 Years Old - SOF+RBV 24 Weeks	100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks	100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks	100.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

12 to < 18 Years Old - SOF+RBV 12 Weeks

Serious: 0/13 (0%)

Deaths: 0/13

12 to < 18 Years Old - SOF+RBV 24 Weeks

Serious: 0/39 (0%)

Deaths: 0/39

6 to < 12 Years Old - SOF+RBV 12 Weeks

Serious: 0/13 (0%)

Deaths: 0/13

6 to < 12 Years Old - SOF+RBV 24 Weeks

Serious: 0/28 (0%)

Deaths: 0/28

3 to < 6 Years Old - SOF+RBV 12 Weeks

Serious: 0/5 (0%)

Deaths: 0/5

3 to < 6 Years Old - SOF+RBV 24 Weeks

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	12 to < 18 Years Old - SOF…	12 to < 18 Years Old - SOF…	6 to < 12 Years Old - SOF+…	6 to < 12 Years Old - SOF+…	3 to < 6 Years Old - SOF+R…	3 to < 6 Years Old - SOF+R…
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—	—	—

Other adverse events (79 terms — click to expand)

Reaction	System	12 to < 18 Years Old - SOF…	12 to < 18 Years Old - SOF…	6 to < 12 Years Old - SOF+…	6 to < 12 Years Old - SOF+…	3 to < 6 Years Old - SOF+R…	3 to < 6 Years Old - SOF+R…
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—
Mood swings	Psychiatric disorders	—	—	—	—	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—	—	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Skin exfoliation	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—
Motion sickness	Ear and labyrinth disorders	—	—	—	—	—	—
Anal pruritus	Gastrointestinal disorders	—	—	—	—	—	—
Epigastric discomfort	Gastrointestinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Accidental overdose.

Data from ClinicalTrials.gov NCT02175758 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection.
Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, et al · · 2017 · cited 65× · PMID 28543053 · DOI 10.1002/hep.29278
Hepatitis C virus infection in children and adolescents.
Squires JE, Balistreri WF. · · 2017 · cited 46× · PMID 29404447 · DOI 10.1002/hep4.1028
Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection.
Rosenthal P, Schwarz KB, Gonzalez-Peralta RP, Lin CH, et al · · 2020 · cited 39× · PMID 31222783 · DOI 10.1002/hep.30821
Hepatitis C genotype 4: The past, present, and future.
Abdel-Ghaffar TY, Sira MM, El Naghi S. · · 2015 · cited 31× · PMID 26668691 · DOI 10.4254/wjh.v7.i28.2792
New prospects for the treatment and prevention of hepatitis C in children.
Ohmer S, Honegger J. · · 2016 · cited 17× · PMID 26709684 · DOI 10.1097/mop.0000000000000313
Treating hepatitis C virus in children: time for a new paradigm.
Thorne C, Indolfi G, Turkova A, Giaquinto C, et al · · 2015 · cited 8× · PMID 27482412 · DOI 10.1016/s2055-6640(20)30500-8
The Role of Direct-acting Antivirals in the Treatment of Children with Chronic Hepatitis C.
Yang CHT, Yoo ER, Ahmed A. · · 2017 · cited 7× · PMID 28507928 · DOI 10.14218/jcth.2016.00053
[Use of sofosbuvir-based regimens in the treatment of adolescents and children with chronic hepatitis C].
He S, Wang XY, Han QY, Liu ZW. · · 2021 · PMID 33548971 · DOI 10.3760/cma.j.cn501113-20190606-00199

Verify or expand the search:

Other trials of SOF

Trials testing the same drug.

NCT03487107 — Phase 3 Study of Yimitasvir Phosphate Capsules · Phase 3 · completed
NCT03458481 — Phase 2 Study of Yimitasvir Phosphate Capsules · Phase 2 · completed
NCT02738333 — Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection · Phase 3 · completed
NCT02673489 — A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection · Phase 3 · completed
NCT02592057 — Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Inf · completed

Other recruiting trials for Hepatitis C Virus Infection

Currently open trials in the same condition.

NCT06870019 — Hepatitis C Tracker Study · NA · recruiting
NCT06463912 — Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia · recruiting
NCT06718530 — Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Canc · recruiting
NCT06155006 — Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia · recruiting
NCT06431945 — Early Detection of HCV in Injection Drug Users · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02175758 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 30 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02175758.

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