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CompletedNCT02021643Updated Feb 20, 2018Results posted

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

A Phase 3 interventional study of Sofosbuvir and RBV in Chronic HCV Infection, sponsored by Gilead Sciences. Completed at 35 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
687
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

02

Conditions studied

  • Chronic HCV Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 687 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10\^4 IU/mL at screening
  • HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key Exclusion Criteria:

  • Current or prior history of any clinically-significant illness (other than HCV)
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
687 participants (actual)

Study arms

  • Experimental
    Sofosbuvir+RBV+PEG 12 weeks

    Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.

    Drug: Sofosbuvir · Drug: RBV · Drug: PEG

  • Experimental
    Sofosbuvir+RBV 12 weeks

    Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.

    Drug: Sofosbuvir · Drug: RBV

  • Experimental
    Sofosbuvir+RBV 16 weeks

    Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.

    Drug: Sofosbuvir · Drug: RBV

  • Experimental
    Sofosbuvir+RBV 24 Weeks

    Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.

    Drug: Sofosbuvir · Drug: RBV

Interventions

  • DrugSofosbuvir

    Sofosbuvir 400 mg tablet administered orally once daily

    Also known as: Sovaldi®, GS-7977, PSI-7977

  • DrugRBV

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

    Also known as: Ribasphere®

  • DrugPEG

    Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

    Also known as: Pegasys®

06

What researchers measure

Primary outcomes

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

    SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.

    Time frame: Posttreatment Week 12

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

    Time frame: Up to 24 weeks

Secondary outcomes

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

    SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    Time frame: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With On-Treatment Virologic Failure

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

    Time frame: Up to 24 weeks

  3. Percentage of Participants With Viral Relapse

    Viral relapse was 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.

    Time frame: Up to Posttreatment Week 24

  4. Change From Baseline in HCV RNA (log10 IU/mL)

    Time frame: Up to 24 weeks

07

Results

Posted Feb 20, 2018

Participant flow

Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.

Participant flow — Overall Study
MilestoneSOF+PEG+RBV 12 WeeksSOF+RBV 12 WeeksSOF+RBV 16 WeeksSOF+RBV 24 Weeks
Started15629011230
Completed14728011218
Not completed910012
Withdrew: Enrolled but never treated1000
Withdrew: Adverse event0100
Withdrew: Death0100
Withdrew: Investigator's discretion1000
Withdrew: Lack of efficacy76012
Withdrew: Lost to follow-up0100
Withdrew: Withdrew consent0100

Outcome measures

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

SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.

Time frame:
Posttreatment Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
percentage of participantsSOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)95.5 (90.9 to 98.2)100 (69.2 to 100)100 (71.5 to 100)94.2 (87.9 to 97.9)96.8 (94.0 to 98.5)95.2 (89.9 to 98.2)
PrimaryPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame:
Up to 24 weeks
Reported as:
Count of participants · Participants
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
ParticipantsSOF+PEG+RBV 12 WeeksSOF+RBV 12 WeeksSOF+RBV 16 WeeksSOF+RBV 24 Weeks
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event1102
SecondaryPercentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Time frame:
Posttreatment Weeks 4 and 24
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
percentage of participantsSOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)
SVR496.8 (92.6 to 98.9)100 (69.2 to 100.0)100 (71.5 to 100.0)94.2 (87.9 to 97.9)97.5 (94.9 to 99.0)97.6 (93.2 to 99.5)
SVR2495.5 (90.9 to 98.2)100 (69.2 to 100.0)90.9 (58.7 to 99.8)94.2 (87.9 to 97.9)96.8 (94.0 to 98.5)95.2 (89.9 to 98.2)
SecondaryPercentage of Participants With On-Treatment Virologic Failure

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

Time frame:
Up to 24 weeks
Reported as:
Count of participants · Participants
Percentage of Participants With On-Treatment Virologic Failure
ParticipantsSOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)
Percentage of Participants With On-Treatment Virologic Failure000010
SecondaryPercentage of Participants With Viral Relapse

Viral relapse was 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.

Time frame:
Up to Posttreatment Week 24
Reported as:
Count of participants · Participants
Percentage of Participants With Viral Relapse
ParticipantsSOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)
Percentage of Participants With Viral Relapse700666
SecondaryChange From Baseline in HCV RNA (log10 IU/mL)
Time frame:
Up to 24 weeks
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA (log10 IU/mL)
log10 IU/mLSOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)
Change at Week 1-4.81 ± 0.653-4.59 ± 0.359-4.36 ± 0.560-4.61 ± 0.607-4.46 ± 0.815-4.52 ± 0.695
Change at Week 2-5.11 ± 0.734-4.89 ± 0.488-4.79 ± 0.858-5.04 ± 0.682-4.78 ± 1.008-4.86 ± 0.706
Change at Week 4-5.12 ± 0.738-4.89 ± 0.488-4.82 ± 0.880-5.12 ± 0.710-4.81 ± 1.025-4.87 ± 0.713
Change at Week 6-5.12 ± 0.738-4.89 ± 0.488-4.82 ± 0.880-5.12 ± 0.710-4.80 ± 1.038-4.87 ± 0.713
Change at Week 8-5.12 ± 0.738-4.89 ± 0.488-4.82 ± 0.880-5.12 ± 0.708-4.83 ± 0.966-4.87 ± 0.713
Change at Week 10-5.12 ± 0.738-4.89 ± 0.488-4.82 ± 0.880-5.12 ± 0.708-4.83 ± 0.966-4.87 ± 0.713
Change at Week 12-5.12 ± 0.739-4.89 ± 0.488-4.82 ± 0.880-5.12 ± 0.708-4.83 ± 0.966-4.84 ± 0.779
Change at Week 16——-4.82 ± 0.880-5.12 ± 0.708—-4.87 ± 0.713
Change at Week 20———-5.14 ± 0.701—-4.87 ± 0.713
Change at Week 24———-5.14 ± 0.701—-4.87 ± 0.713

Adverse events

Collected over Up to 24 Weeks Plus 30 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOF+PEG+RBV 12 Weeks—5/155 (3.2%)145/155 (93.5%)
SOF+RBV 12 Weeks—7/290 (2.4%)215/290 (74.1%)
SOF+RBV 16 Weeks—0/11 (0%)5/11 (45.5%)
SOF+RBV 24 Weeks—4/230 (1.7%)177/230 (77%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventSOF+PEG+RBV 12 WeeksSOF+RBV 12 WeeksSOF+RBV 16 WeeksSOF+RBV 24 Weeks
Angle closure glaucomaEye disorders1/1550/2900/110/230
GastritisGastrointestinal disorders1/1550/2900/110/230
BronchitisInfections and infestations1/1550/2900/110/230
HypocalcaemiaMetabolism and nutrition disorders1/1550/2900/110/230
Cerebral infarctionNervous system disorders1/1550/2900/110/230
Gingival bleedingGastrointestinal disorders0/1550/2900/111/230
PancreatitisGastrointestinal disorders0/1550/2900/111/230
Cholecystitis acuteHepatobiliary disorders0/1551/2900/111/230
CholelithiasisHepatobiliary disorders0/1550/2900/111/230
Hepatic lesionHepatobiliary disorders0/1550/2900/111/230
Most frequent other events
Showing 10 of 38
Most frequent other events
EventSOF+PEG+RBV 12 WeeksSOF+RBV 12 WeeksSOF+RBV 16 WeeksSOF+RBV 24 Weeks
PyrexiaGeneral disorders56/1554/2900/1110/230
Neutrophil count decreasedInvestigations38/1551/2900/111/230
Platelet count decreasedInvestigations37/1551/2900/112/230
White blood cell count decreasedInvestigations33/1551/2900/110/230
AnaemiaBlood and lymphatic system disorders30/15522/2901/1127/230
LeukopeniaBlood and lymphatic system disorders30/1552/2900/116/230
MalaiseGeneral disorders0/1553/2902/111/230
Upper respiratory tract infectionInfections and infestations11/15530/2902/1127/230
NeutropeniaBlood and lymphatic system disorders27/1550/2900/113/230
FatigueGeneral disorders24/15521/2900/1120/230

Baseline characteristics

Safety Analysis Set: participants who were enrolled and received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Mean41 ± 12.843 ± 17.243 ± 17.649 ± 13.353 ± 12.340 ± 8.147 ± 13.3
Sex: Female, Male
Sex: Female, Male(Participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Female67526116056351
Male88594312070335
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Asian1551011104280126686
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Hispanic or Latino0000000
Not Hispanic or Latino151101198280126676
Not Disclosed40060010
Region of Enrollment
Region of Enrollment(participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
China130006964126389
Hong Kong01011100031
South Korea00001290129
Taiwan000087087
Vietnam2500250050
HCV Genotype
HCV Genotype(Participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Genotype 1108778100203
Genotype 200002800280
Genotype 300000126126
Genotype 64734230077
IL28b Status
IL28b Status(Participants)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
CC11481174237102546
CT4020294223136
TT1001114
HCV RNA
HCV RNA(log10 IU/mL)SOF+PEG+RBV 12 Weeks (GT 1 and GT6)SOF+RBV 12 Weeks (GT1 and GT6)SOF+RBV 16 Weeks (GT1 and GT6)SOF+RBV 24 Weeks (GT1 and GT6)SOF+RBV 12 Weeks (GT2)SOF+RBV 24 Weeks (GT3)Total
Mean6.5 ± 0.746.3 ± 0.496.2 ± 0.886.5 ± 0.716.2 ± 0.966.2 ± 0.716.3 ± 0.84

1 further baseline measures are reported on the registry.

08

Study locations

35 sites
  • Beijing, China
  • Chongqing, China
  • Fujian, China
  • Guangdong, China
  • Guangxi, China
  • Hainan, China
  • Hebei, China
  • Hubei, China
  • Hunan, China
  • Jiangxi, China
  • Jilin, China
  • Jin'an, China
  • Liaoyang, China
  • Shanghai, China
  • Sichuan, China
  • Yunnan, China
  • Zhejiang, China
  • Hong Kong, Hong Kong
  • Sha Tin, Hong Kong
  • Incheon, Gyeonggi-do, Korea, Republic of
  • Seongnam-si, Gyeonggi-do, Korea, Republic of
  • Ansan-si, Korea, Republic of
  • Bucheon-si, Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Seoul, Korea, Republic of
  • Chang-hua, Taiwan
  • Kaohsiung, Taiwan
  • Keelung, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan
  • Hanoi, Vietnam
  • Ho Chi Minh City, Vietnam
09

References and documents

Publications

  • Lai CL, Wong VW, Yuen MF, Yang JC, Knox SJ, Mo H, Han LL, Brainard DM, Chan HL. Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong. Aliment Pharmacol Ther. 2016 Jan;43(1):96-101. doi: 10.1111/apt.13429. Epub 2015 Oct 26. PubMed 26503414 ↗
  • Ahn SH, Lim YS, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Mathias A, Han L, Knox SJ, Brainard DM, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. J Viral Hepat. 2016 May;23(5):358-65. doi: 10.1111/jvh.12499. Epub 2016 Feb 10. PubMed 26864153 ↗
  • Kao JH, Chien RN, Chang TT, Peng CY, Hu TH, Lo GH, Wang HY, Chen JJ, Yang JC, Knox SJ, Han L, Mo H, Mathias A, Brainard DM, Sheen IS, Hsu YC, Chu CJ, Chuang WL. A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver Int. 2016 Aug;36(8):1101-7. doi: 10.1111/liv.13082. Epub 2016 Mar 23. PubMed 26835876 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02021643
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Dec 27, 2013
Start date
Dec 10, 2013
Primary completion
Aug 12, 2016
Completion
Nov 3, 2016
Results posted
Feb 20, 2018
Last update
Feb 20, 2018

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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