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CompletedNCT02480712ASTRAL-5Updated Nov 16, 2018Results posted

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

A Phase 3 interventional study of SOF/VEL in Hepatitis C Virus Infection, sponsored by Gilead Sciences. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.

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

Phase
Phase 3
Study type
Interventional
Enrollment
107
Allocation
Not applicable
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/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

02

Conditions studied

  • Hepatitis C Virus Infection
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 107 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

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:

  • HCV RNA ≥ 10\^4 IU/mL at screening
  • HCV genotype 1, 2, 3, 4, 5, 6
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • HIV-1 infection
  • Use of protocol specified method(s) of contraception
  • Screening laboratory values within defined thresholds

Key Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
  • Screening ECG with clinically significant abnormalities
  • Pregnant or nursing female or male with pregnant female partner
  • Infection with hepatitis B virus (HBV)
  • Use of any prohibited concomitant medications as described in the protocol
  • Chronic use of systemically administered immunosuppressive agents

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    SOF/VEL

    Participants will receive SOF/VEL for 12 weeks

    Drug: SOF/VEL

Interventions

  • DrugSOF/VEL

    400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

    Also known as: GS-7977/GS-5816, Epclusa®

06

What researchers measure

Primary outcomes

  1. 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) 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 12 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 were 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 HCV RNA < LLOQ on Treatment

    Time frame: Up to 12 Weeks

  3. HCV RNA Change From Baseline/Day 1

    Time frame: Baseline to Week 12

  4. Percentage of Participants With Virologic Failure

    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

  5. Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

    Time frame: Up to 12 Weeks

  6. Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12

    Time frame: Week 12; Posttreatment Week 12

07

Results

Posted Jun 1, 2017

Participant flow

Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.

Participant flow — Overall Study
MilestoneSOF/VEL 12 Weeks
Started107
Completed96
Not completed11
Withdrew: Enrolled but never treated1
Withdrew: Lost to follow-up5
Withdrew: Withdrew consent3
Withdrew: Death1
Withdrew: Lack of efficacy1

Outcome measures

PrimaryPercentage 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) 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/VEL 12 Weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)95.3 (89.3 to 98.5)
PrimaryPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame:
Up to 12 weeks
Reported as:
Number · percentage of participants
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
percentage of participantsSOF/VEL 12 Weeks
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event1.9
SecondaryPercentage of Participants With Sustained Virologic Response 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 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/VEL 12 Weeks
SVR495.3 (89.3 to 98.5)
SVR2495.3 (89.3 to 98.5)
SecondaryPercentage of Participants With HCV RNA < LLOQ on Treatment
Time frame:
Up to 12 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ on Treatment
percentage of participantsSOF/VEL 12 Weeks
Week 125.7 (17.7 to 35.2)
Week 268.0 (58.0 to 76.8)
Week 492.2 (85.3 to 96.6)
Week 699.0 (94.7 to 100.0)
Week 8100.0 (96.4 to 100.0)
Week 10100.0 (96.4 to 100.0)
Week 12100.0 (96.4 to 100.0)
SecondaryHCV RNA Change From Baseline/Day 1
Time frame:
Baseline to Week 12
Reported as:
Mean · log10 IU/mL
HCV RNA Change From Baseline/Day 1
log10 IU/mLSOF/VEL 12 Weeks
Change at Week 1-4.47 ± 0.606
Change at Week 2-4.97 ± 0.577
Change at Week 4-5.15 ± 0.560
Change at Week 6-5.18 ± 0.572
Change at Week 8-5.17 ± 0.575
Change at Week 10-5.17 ± 0.575
Change at Week 12-5.17 ± 0.575
SecondaryPercentage of Participants With Virologic Failure

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
Reported as:
Number · percentage of participants
Percentage of Participants With Virologic Failure
percentage of participantsSOF/VEL 12 Weeks
Percentage of Participants With Virologic Failure1.9
SecondaryPercentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Time frame:
Up to 12 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
percentage of participantsSOF/VEL 12 Weeks (Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non TDF Containing Regimens)
Week 494.497.1100
Week 896.397.1100
Week 1296.210092.9
SecondarySerum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
Time frame:
Week 12; Posttreatment Week 12
Reported as:
Mean · mg/dL
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
mg/dLSOF/VEL 12 Weeks (Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non TDF Containing Regimens)
Change at Week 120.09 ± 0.1960.04 ± 0.1070.00 ± 0.083
Change at Posttreatment Week 120.04 ± 0.1530.02 ± 0.142-0.06 ± 0.204

Adverse events

Collected over Up to 12 Weeks Plus 30 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)—2/56 (3.6%)34/56 (60.7%)
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)—0/35 (0%)19/35 (54.3%)
SOF/VEL 12 Weeks (Non TDF Containing Regimens)—0/15 (0%)9/15 (60%)
Most frequent serious events
Most frequent serious events
EventSOF/VEL 12 Weeks (Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non TDF Containing Regimens)
Localised infectionInfections and infestations1/560/350/15
SepsisInfections and infestations1/560/350/15
Urinary tract infection bacterialInfections and infestations1/560/350/15
Radial nerve palsyNervous system disorders1/560/350/15
Most frequent other events
Showing 10 of 29
Most frequent other events
EventSOF/VEL 12 Weeks (Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)SOF/VEL 12 Weeks (Non TDF Containing Regimens)
FatigueGeneral disorders16/567/353/15
HeadacheNervous system disorders7/566/351/15
Upper respiratory tract infectionInfections and infestations8/561/350/15
Urinary tract infectionInfections and infestations2/560/352/15
DiarrhoeaGastrointestinal disorders6/562/350/15
ArthralgiaMusculoskeletal and connective tissue disorders6/561/351/15
InsomniaPsychiatric disorders4/563/350/15
NauseaGastrointestinal disorders4/562/351/15
ToothacheGastrointestinal disorders0/560/351/15
VomitingGastrointestinal disorders1/561/351/15

Baseline characteristics

Safety Analysis Set: Participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)SOF/VEL 12 Weeks
Mean54 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)SOF/VEL 12 Weeks
Female15
Male91
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SOF/VEL 12 Weeks
Black or African American48
White54
Asian3
Other1
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SOF/VEL 12 Weeks
Hispanic or Latino15
Not Hispanic or Latino91
IL28b Status
IL28b Status(Participants)SOF/VEL 12 Weeks
CC24
CT52
TT30
HCV RNA
HCV RNA(log10 IU/mL)SOF/VEL 12 Weeks
Mean6.3 ± 0.57
HCV RNA Category
HCV RNA Category(Participants)SOF/VEL 12 Weeks
< 800,000 IU/mL28
≥ 800,000 IU/mL78
HIV RNA category
HIV RNA category(Participants)SOF/VEL 12 Weeks
Boosted TDF Containing Regimens — HIV RNA < 50 copies/mL55
Boosted TDF Containing Regimens — HIV RNA ≥ 50 copies/mL1
Non-Boosted TDF Containing Regimens — HIV RNA < 50 copies/mL35
Non-Boosted TDF Containing Regimens — HIV RNA ≥ 50 copies/mL0
Non TDF Containing Regimens — HIV RNA < 50 copies/mL14
Non TDF Containing Regimens — HIV RNA ≥ 50 copies/mL1

1 further baseline measures are reported on the registry.

08

Study locations

15 sites
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Torrance, California, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Lutherville, Maryland, United States
  • Boston, Massachusetts, United States
  • Bronx, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Richmond, Virginia, United States
09

References and documents

Publications

  • Wyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain.
  • Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260. PubMed 28369210 ↗

Individual participant data

Plan to share: Yes — Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02480712
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
Jul 1, 2015
Primary completion
Apr 29, 2016
Completion
Jun 22, 2016
Results posted
Jun 1, 2017
Last update
Nov 16, 2018

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

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

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