18 and older, any sex, with Hepatitis C. 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.
Percentage of Participants With Sustained Virologic Response (SVR) 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
SOF+RBV 16 Weeks
71.9
SOF+RBV 24 Weeks
85.4
SOF+RBV+Peg-IFN 12 Weeks
92.9
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse EventPrimary· Up to 24 weeks
Group
Value
95% CI
SOF+RBV 16 Weeks
1.5
SOF+RBV 24 Weeks
1.5
SOF+RBV+Peg-IFN 12 Weeks
1.5
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)Secondary· Posttreatment Weeks 4 and 24
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
SVR4
Group
Value
95% CI
SOF+RBV 16 Weeks
73.0
SOF+RBV 24 Weeks
85.9
SOF+RBV+Peg-IFN 12 Weeks
95.9
SVR24
Group
Value
95% CI
SOF+RBV 16 Weeks
71.9
SOF+RBV 24 Weeks
84.4
SOF+RBV+Peg-IFN 12 Weeks
93.4
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24Secondary· Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 1
Group
Value
95% CI
SOF+RBV 16 Weeks
14.8
SOF+RBV 24 Weeks
20.1
SOF+RBV+Peg-IFN 12 Weeks
25.9
Week 2
Group
Value
95% CI
SOF+RBV 16 Weeks
53.3
SOF+RBV 24 Weeks
53.5
SOF+RBV+Peg-IFN 12 Weeks
67.0
Week 4
Group
Value
95% CI
SOF+RBV 16 Weeks
86.6
SOF+RBV 24 Weeks
91.9
SOF+RBV+Peg-IFN 12 Weeks
97.4
Week 8
Group
Value
95% CI
SOF+RBV 16 Weeks
99.5
SOF+RBV 24 Weeks
99.5
SOF+RBV+Peg-IFN 12 Weeks
99.5
Week 12
Group
Value
95% CI
SOF+RBV 16 Weeks
100.0
SOF+RBV 24 Weeks
98.5
SOF+RBV+Peg-IFN 12 Weeks
100.0
Week 16
Group
Value
95% CI
SOF+RBV 16 Weeks
99.0
SOF+RBV 24 Weeks
99.5
Week 20
Group
Value
95% CI
SOF+RBV 24 Weeks
99.5
Week 24
Group
Value
95% CI
SOF+RBV 24 Weeks
100.0
HCV RNA at Weeks 1, 2, 4, 8, and 12Secondary· Weeks 1, 2, 4, 8, and 12
Week 1
Group
Value
95% CI
SOF+RBV 16 Weeks
2.13
± 0.658
SOF+RBV 24 Weeks
2.08
± 0.749
SOF+RBV+Peg-IFN 12 Weeks
1.81
± 0.576
Week 2
Group
Value
95% CI
SOF+RBV 16 Weeks
1.44
± 0.436
SOF+RBV 24 Weeks
1.45
± 0.487
SOF+RBV+Peg-IFN 12 Weeks
1.32
± 0.342
Week 4
Group
Value
95% CI
SOF+RBV 16 Weeks
1.19
± 0.156
SOF+RBV 24 Weeks
1.21
± 0.287
SOF+RBV+Peg-IFN 12 Weeks
1.16
± 0.085
Week 8
Group
Value
95% CI
SOF+RBV 16 Weeks
1.15
± 0.021
SOF+RBV 24 Weeks
1.15
± 0.100
SOF+RBV+Peg-IFN 12 Weeks
1.15
± 0.000
Week 12
Group
Value
95% CI
SOF+RBV 16 Weeks
1.15
± 0.000
SOF+RBV 24 Weeks
1.17
± 0.318
SOF+RBV+Peg-IFN 12 Weeks
1.15
± 0.000
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Secondary· Baseline; Weeks 1, 2, 4, 8, and 12
Week 1
Group
Value
95% CI
SOF+RBV 16 Weeks
-4.18
± 0.559
SOF+RBV 24 Weeks
-4.15
± 0.664
SOF+RBV+Peg-IFN 12 Weeks
-4.46
± 0.556
Week 2
Group
Value
95% CI
SOF+RBV 16 Weeks
-4.86
± 0.661
SOF+RBV 24 Weeks
-4.78
± 0.714
SOF+RBV+Peg-IFN 12 Weeks
-4.96
± 0.661
Week 4
Group
Value
95% CI
SOF+RBV 16 Weeks
-5.11
± 0.671
SOF+RBV 24 Weeks
-5.02
± 0.735
SOF+RBV+Peg-IFN 12 Weeks
-5.12
± 0.699
Week 8
Group
Value
95% CI
SOF+RBV 16 Weeks
-5.16
± 0.684
SOF+RBV 24 Weeks
-5.08
± 0.708
SOF+RBV+Peg-IFN 12 Weeks
-5.12
± 0.691
Week 12
Group
Value
95% CI
SOF+RBV 16 Weeks
-5.15
± 0.686
SOF+RBV 24 Weeks
-5.05
± 0.788
SOF+RBV+Peg-IFN 12 Weeks
-5.12
± 0.691
Percentage of Participants Experiencing On-Treatment Virologic FailureSecondary· Up to 24 weeks
On-treatment virologic failure was defined as:
* 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)
Group
Value
95% CI
SOF+RBV 16 Weeks
0
SOF+RBV 24 Weeks
1.5
SOF+RBV+Peg-IFN 12 Weeks
0
Percentage of Participants Experiencing Viral RelapseSecondary· Up to Posttreatment Week 24
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Group
Value
95% CI
SOF+RBV 16 Weeks
26.7
SOF+RBV 24 Weeks
12.3
SOF+RBV+Peg-IFN 12 Weeks
4.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Randomized Period: SOF+RBV 16 Weeks
Serious: 8/196 (4%)
Deaths: 0/196
Randomized Period: SOF+RBV 24 Weeks
Serious: 10/199 (5%)
Deaths: 0/199
Randomized Period: SOF+RBV+Peg-IFN 12 Weeks
Serious: 12/197 (6%)
Deaths: 0/197
Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Serious: 1/30 (3%)
Deaths: 0/30
Serious adverse events (31 terms)
Reaction
System
Randomized Period: SOF+RBV…
Randomized Period: SOF+RBV…
Randomized Period: SOF+RBV…
Retreatment Period: SOF+RB…
Acute coronary syndrome
Cardiac disorders
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
Pancreatitis
Gastrointestinal disorders
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
Chest pain
General disorders
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
—
Subcutaneous abscess
Infections and infestations
—
—
—
—
Overdose
Injury, poisoning and procedural complications
—
—
—
—
Snake bite
Injury, poisoning and procedural complications
—
—
—
—
Haemoglobin decreased
Investigations
—
—
—
—
Arthritis
Musculoskeletal and connective tissue disorders
—
—
—
—
Flank pain
Musculoskeletal and connective tissue disorders
—
—
—
—
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
—
—
—
—
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
—
—
—
—
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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
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Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
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· 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
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: 20 June 2017
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/NCT01962441.