NCT02378961 is a Phase 2 clinical trial of VOX in Hepatitis C Virus Infection, sponsored by Gilead Sciences.

Who is sponsoring NCT02378961?

NCT02378961 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02378961?

Interventions in NCT02378961: VOX, SOF/VEL.

What condition does NCT02378961 study?

NCT02378961 studies Hepatitis C Virus Infection.

Is NCT02378961 still recruiting?

NCT02378961 is currently completed. Last updated 3 March 2020.

Are results published for NCT02378961?

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

Last reviewed 2020-03-03 · How we verify

NCT02378961

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

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

Completed Phase 2 Results posted Last updated 3 March 2020

What this trial tests

Phase 2 trial testing VOX in Hepatitis C Virus Infection in 128 participants. Completed in 26 January 2016.

Timeline

16 February 2015

Primary endpoint
21 September 2015

26 January 2016

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	16 February 2015
Primary completion	21 September 2015
Estimated completion	26 January 2016
Sites	34 locations across New Zealand, Puerto Rico, United States

Drugs / interventions tested

VOX — full drug profile →
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 treatment.

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	87.9	71.8 – 96.6
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	93.3	77.9 – 99.2
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	96.6	82.2 – 99.9

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

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	6.7
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	3.4

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 treatment, respectively.

SVR4

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	90.9	75.7 – 98.1
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	96.7	82.8 – 99.9
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	100.0	88.1 – 100.0

SVR24

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	87.9	71.8 – 96.6
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	93.3	77.9 – 99.2
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	96.6	82.2 – 99.9

Percentage of Participants With HCV RNA < LLOQ on Treatment Secondary · Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Week 1

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	33.3	18.0 – 51.8
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	20.0	7.7 – 38.6
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	33.3	18.6 – 51.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	10.	2.2 – 27.4

Week 2

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	81.8	64.5 – 93.0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	73.3	54.1 – 87.7
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	72.2	54.8 – 85.8
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	58.6	38.9 – 76.5

Week 4

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	100.0	89.4 – 100.0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	100.0	88.4 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	88.9	73.9 – 96.9
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	89.7	72.6 – 97.8

Week 6

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	100.0	89.4 – 100.0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	100.0	88.4 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	97.2	85.5 – 99.9
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	96.6	82.2 – 99.9

Week 8

Group	Value	95% CI
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	100.0	88.1 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	100.0	88.1 – 100.0

Week 10

Group	Value	95% CI
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	100.0	88.1 – 100.0

Week 12

Group	Value	95% CI
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	100.0	90.3 – 100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	100.0	87.7 – 100.0

HCV RNA Change From Baseline Secondary · Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Change at Week 1

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	-4.51	± 0.568
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	-4.28	± 0.546
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-4.51	± 0.594
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-4.24	± 0.510

Change at Week 2

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	-4.91	± 0.786
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	-4.84	± 0.648
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-4.95	± 0.619
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-4.96	± 0.592

Change at Week 4

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	-5.01	± 0.857
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	-4.99	± 0.661
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-5.14	± 0.709
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-5.25	± 0.567

Change at Week 6

Group	Value	95% CI
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	-5.01	± 0.857
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	-4.99	± 0.661
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-5.19	± 0.716
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-5.29	± 0.572

Change at Week 8

Group	Value	95% CI
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	-4.98	± 0.672
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-5.19	± 0.718
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-5.30	± 0.571

Change at Week 10

Group	Value	95% CI
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-5.19	± 0.718
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-5.30	± 0.571

Change at Week 12

Group	Value	95% CI
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	-5.19	± 0.718
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	-5.32	± 0.566

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

* 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
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	12.1
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	6.7
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic	0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic	3.4

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.

VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic

Serious: 0/33 (0%)

Deaths: —

VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic

Serious: 0/30 (0%)

Deaths: —

VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic

Serious: 0/36 (0%)

Deaths: —

VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic

Serious: 1/29 (3%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	VOX+SOF/VEL 6 Weeks, Treat…	VOX+SOF/VEL 8 Weeks, Treat…	VOX+SOF/VEL 12 Weeks, Trea…	VOX+SOF/VEL 12 Weeks, Trea…
Gastroenteritis	Infections and infestations	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	VOX+SOF/VEL 6 Weeks, Treat…	VOX+SOF/VEL 8 Weeks, Treat…	VOX+SOF/VEL 12 Weeks, Trea…	VOX+SOF/VEL 12 Weeks, Trea…
Headache	Nervous system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Increased appetite	Metabolism and nutrition disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Chromaturia	Renal and urinary disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Most-reported serious reactions: Gastroenteritis.

Data from ClinicalTrials.gov NCT02378961 adverse events section.

Sponsor's own description

The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

Publications & conference data

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

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial.
Gane EJ, Kowdley KV, Pound D, Stedman CA, et al · · 2016 · cited 50× · PMID 27486033 · DOI 10.1053/j.gastro.2016.07.038
Genotype 3-hepatitis C virus' last line of defense.
Zarębska-Michaluk D. · · 2021 · cited 17× · PMID 33776369 · DOI 10.3748/wjg.v27.i11.1006
Efficacy and safety of direct-acting antiviral regimen for patients with hepatitis C virus genotype 2: a systematic review and meta-analysis.
Lei PK, Liu Z, Ung COL, Hu H. · · 2024 · PMID 39350091 · DOI 10.1186/s12876-024-03414-5

Verify or expand the search:

Other trials of VOX

Trials testing the same drug.

NCT05400408 — Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study · NA · unknown
NCT05399615 — Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study · NA · withdrawn
NCT05224622 — Detection of COVID-19 Using Breath Analysis - Validation Study. · NA · completed
NCT02533427 — Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Represent · Phase 1 · completed
NCT02378935 — Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 · 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 NCT02378961 (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: 3 March 2020

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/NCT02378961.

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

NCT02378961

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 (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of VOX

Other recruiting trials for Hepatitis C Virus Infection

Other Gilead Sciences trials

Verify against primary sources