NCT02480712 (ASTRAL-5) is a Phase 3 clinical trial of SOF/VEL in Hepatitis C Virus Infection, sponsored by Gilead Sciences.

Who is sponsoring NCT02480712?

NCT02480712 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02480712?

Interventions in NCT02480712: SOF/VEL.

What condition does NCT02480712 study?

NCT02480712 studies Hepatitis C Virus Infection.

Is NCT02480712 still recruiting?

NCT02480712 is currently completed. Last updated 16 November 2018.

Are results published for NCT02480712?

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

Last reviewed 2018-11-16 · How we verify

NCT02480712: ASTRAL-5

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

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

Completed Phase 3 Results posted Last updated 16 November 2018

What this trial tests

Phase 3 trial testing SOF/VEL in Hepatitis C Virus Infection in 107 participants. Completed in 22 June 2016.

Timeline

1 July 2015

Primary endpoint
29 April 2016

22 June 2016

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	1 July 2015
Primary completion	29 April 2016
Estimated completion	22 June 2016
Sites	15 locations across United States

Drugs / interventions tested

SOF/VEL — 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

18 and older, 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.

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Primary · Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Group	Value	95% CI
SOF/VEL 12 Weeks	95.3	89.3 – 98.5

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Primary · Up to 12 weeks

Group	Value	95% CI
SOF/VEL 12 Weeks	1.9

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Secondary · Posttreatment Weeks 4 and 24

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

SVR4

Group	Value	95% CI
SOF/VEL 12 Weeks	95.3	89.3 – 98.5

SVR24

Group	Value	95% CI
SOF/VEL 12 Weeks	95.3	89.3 – 98.5

Percentage of Participants With HCV RNA < LLOQ on Treatment Secondary · Up to 12 Weeks

Week 1

Group	Value	95% CI
SOF/VEL 12 Weeks	25.7	17.7 – 35.2

Week 2

Group	Value	95% CI
SOF/VEL 12 Weeks	68.0	58.0 – 76.8

Week 4

Group	Value	95% CI
SOF/VEL 12 Weeks	92.2	85.3 – 96.6

Week 6

Group	Value	95% CI
SOF/VEL 12 Weeks	99.0	94.7 – 100.0

Week 8

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.4 – 100.0

Week 10

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.4 – 100.0

Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.4 – 100.0

HCV RNA Change From Baseline/Day 1 Secondary · Baseline to Week 12

Change at Week 1

Group	Value	95% CI
SOF/VEL 12 Weeks	-4.47	± 0.606

Change at Week 2

Group	Value	95% CI
SOF/VEL 12 Weeks	-4.97	± 0.577

Change at Week 4

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.15	± 0.560

Change at Week 6

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.18	± 0.572

Change at Week 8

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.17	± 0.575

Change at Week 10

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.17	± 0.575

Change at Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.17	± 0.575

Percentage of Participants With Virologic Failure Secondary · Up to Posttreatment Week 24

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

Group	Value	95% CI
SOF/VEL 12 Weeks	1.9

Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment Secondary · Up to 12 Weeks

Week 4

Group	Value	95% CI
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	94.4
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	97.1
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	100

Week 8

Group	Value	95% CI
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	96.3
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	97.1
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	100

Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	96.2
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	100
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	92.9

Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 Secondary · Week 12; Posttreatment Week 12

Change at Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	0.09	± 0.196
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	0.04	± 0.107
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	0.00	± 0.083

Change at Posttreatment Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	0.04	± 0.153
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	0.02	± 0.142
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	-0.06	± 0.204

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 Weeks Plus 30 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)

Serious: 2/56 (4%)

Deaths: —

SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)

Serious: 0/35 (0%)

Deaths: —

SOF/VEL 12 Weeks (Non TDF Containing Regimens)

Serious: 0/15 (0%)

Deaths: —

Serious adverse events (4 terms)

Reaction	System	SOF/VEL 12 Weeks (Boosted …	SOF/VEL 12 Weeks (Non-Boos…	SOF/VEL 12 Weeks (Non TDF …
Localised infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Urinary tract infection bacterial	Infections and infestations	—	—	—
Radial nerve palsy	Nervous system disorders	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	SOF/VEL 12 Weeks (Boosted …	SOF/VEL 12 Weeks (Non-Boos…	SOF/VEL 12 Weeks (Non TDF …
Fatigue	General disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Abnormal dreams	Psychiatric disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Seasonal allergy	Immune system disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Toothache	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Chest discomfort	General disorders	—	—	—
Fungal infection	Infections and infestations	—	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Nervousness	Psychiatric disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Localised infection, Sepsis, Urinary tract infection bacterial, Radial nerve palsy.

Data from ClinicalTrials.gov NCT02480712 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

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.
Wyles D, Bräu N, Kottilil S, Daar ES, et al · · 2017 · cited 109× · PMID 28369210 · DOI 10.1093/cid/cix260
Pharmacologic Considerations in the Treatment of Hepatitis C Virus in Persons With HIV.
MacBrayne CE, Kiser JJ. · · 2016 · cited 14× · PMID 27363437 · DOI 10.1093/cid/ciw220
Profile of Sofosbuvir and Velpatasvir Combination in the Treatment of Chronic Hepatitis C in Children and Adolescents: Current Evidence.
Brigham D, Narkewicz MR. · · 2024 · cited 5× · PMID 38230373 · DOI 10.2147/tcrm.s326099

Verify or expand the search:

Other trials of SOF/VEL

Trials testing the same drug.

NCT04211909 — Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosb · Phase 3 · completed
NCT04112303 — Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults Wit · Phase 3 · completed
NCT03501550 — Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL) · Phase 2 · completed
NCT03074331 — Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection · Phase 3 · completed
NCT03036852 — Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Diseas · Phase 2 · 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 NCT02480712 (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: 16 November 2018

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/NCT02480712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02480712: ASTRAL-5

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of SOF/VEL

Other recruiting trials for Hepatitis C Virus Infection

Other Gilead Sciences trials

Verify against primary sources