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Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02074514
Enrollment
117
Registered
2014-02-28
Start date
2014-03-31
Completion date
2015-11-30
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HCV Infection

Brief summary

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.

Interventions

DRUGSofosbuvir

400 mg tablet administered orally once daily

DRUGRBV

200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HCV RNA ≥10\^4 IU/mL at screening * Confirmed chronic HCV genotype 1 or 3 infection * HCV treatment naive * Approximately 30% of individuals may have compensated cirrhosis at screening

Exclusion criteria

* Any other chronic liver disease * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) * Current or prior history of clinical hepatic de-compensation * Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia). * Chronic use of systemically administered immunosuppressive agents * History of solid organ transplantation

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse EventUp to 24 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)Posttreatment Weeks 4 and 24SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure and Viral RelapseUp to Posttreatment Week 24Virologic failure was 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.

Countries

India

Participant flow

Recruitment details

Participants were enrolled at study sites in India. The first participant was screened on 31 March 2014. The last study visit occurred on 30 November 2015.

Participants by arm

ArmCount
SOF + RBV 16 Weeks GT1
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
30
SOF + RBV 24 Weeks GT1
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
28
SOF + RBV 16 Weeks GT3
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
29
SOF + RBV 24 Weeks GT3
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
30
Total117

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy32
Overall StudyLost to Follow-up01
Overall StudyWithdrew Consent01

Baseline characteristics

CharacteristicSOF + RBV 24 Weeks GT1SOF + RBV 16 Weeks GT1SOF + RBV 16 Weeks GT3SOF + RBV 24 Weeks GT3Total
Age, Continuous46 Years
STANDARD_DEVIATION 12.6
45 Years
STANDARD_DEVIATION 11.7
40 Years
STANDARD_DEVIATION 12.7
37 Years
STANDARD_DEVIATION 10.8
42 Years
STANDARD_DEVIATION 12.4
Cirrhosis Status
Absence
19 participants20 participants22 participants23 participants84 participants
Cirrhosis Status
Presence
9 participants10 participants7 participants7 participants33 participants
HCV genotype
Genotype 1a
5 participants5 participants0 participants0 participants10 participants
HCV genotype
Genotype 1b
23 participants25 participants0 participants0 participants48 participants
HCV genotype
Genotype 3
0 participants0 participants29 participants30 participants59 participants
HCV RNA5.9 log10 IU/mL
STANDARD_DEVIATION 0.72
6.5 log10 IU/mL
STANDARD_DEVIATION 0.44
6.2 log10 IU/mL
STANDARD_DEVIATION 0.68
6.5 log10 IU/mL
STANDARD_DEVIATION 0.7
6.3 log10 IU/mL
STANDARD_DEVIATION 0.67
HCV RNA Category
< 800,000 IU/mL
14 participants5 participants10 participants6 participants35 participants
HCV RNA Category
≥ 800,000 IU/mL
14 participants25 participants19 participants24 participants82 participants
IL28b Status
CC
15 participants14 participants17 participants23 participants69 participants
IL28b Status
CT
8 participants13 participants11 participants7 participants39 participants
IL28b Status
TT
5 participants3 participants1 participants0 participants9 participants
Race/Ethnicity, Customized
Asian
28 participants30 participants29 participants30 participants117 participants
Race/Ethnicity, Customized
Not Hispanic or Latino
24 participants28 participants26 participants28 participants106 participants
Race/Ethnicity, Customized
Not Permitted
4 participants2 participants3 participants2 participants11 participants
Sex: Female, Male
Female
14 Participants11 Participants12 Participants5 Participants42 Participants
Sex: Female, Male
Male
14 Participants19 Participants17 Participants25 Participants75 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
32 / 5927 / 58
serious
Total, serious adverse events
1 / 591 / 58

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 24 weeks

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
SOF + RBV 16 Weeks GT1Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event3.4 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Population: Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
SOF + RBV 16 Weeks GT1Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)90 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)96.4 percentage of participants
SOF + RBV 16 Weeks GT3Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
SOF + RBV 24 Weeks GT3Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)93.3 percentage of participants
Secondary

Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF + RBV 16 Weeks GT1Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR490.0 percentage of participants
SOF + RBV 16 Weeks GT1Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2490.0 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2496.4 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR496.4 percentage of participants
SOF + RBV 16 Weeks GT3Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
SOF + RBV 16 Weeks GT3Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
SOF + RBV 24 Weeks GT3Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR496.7 percentage of participants
SOF + RBV 24 Weeks GT3Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2493.3 percentage of participants
Secondary

Percentage of Participants With Virologic Failure and Viral Relapse

Virologic failure was 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.

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF + RBV 16 Weeks GT1Percentage of Participants With Virologic Failure and Viral RelapseRelapse10.0 percentage of participants
SOF + RBV 16 Weeks GT1Percentage of Participants With Virologic Failure and Viral RelapseOverall Virologic Failure10.0 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants With Virologic Failure and Viral RelapseRelapse3.6 percentage of participants
SOF + RBV 24 Weeks GT1Percentage of Participants With Virologic Failure and Viral RelapseOverall Virologic Failure3.6 percentage of participants
SOF + RBV 16 Weeks GT3Percentage of Participants With Virologic Failure and Viral RelapseOverall Virologic Failure0 percentage of participants
SOF + RBV 16 Weeks GT3Percentage of Participants With Virologic Failure and Viral RelapseRelapse0 percentage of participants
SOF + RBV 24 Weeks GT3Percentage of Participants With Virologic Failure and Viral RelapseOverall Virologic Failure3.3 percentage of participants
SOF + RBV 24 Weeks GT3Percentage of Participants With Virologic Failure and Viral RelapseRelapse3.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026