NCT02536313 is a Phase 2 clinical trial of SOF/VEL/VOX in Hepatitis C Virus Infection, sponsored by Gilead Sciences.

Who is sponsoring NCT02536313?

NCT02536313 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02536313?

Interventions in NCT02536313: SOF/VEL/VOX, RBV.

What condition does NCT02536313 study?

NCT02536313 studies Hepatitis C Virus Infection.

Is NCT02536313 still recruiting?

NCT02536313 is currently completed. Last updated 25 February 2019.

Are results published for NCT02536313?

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

Last reviewed 2019-02-25 · How we verify

NCT02536313

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

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Completed Phase 2 Results posted Last updated 25 February 2019

What this trial tests

Phase 2 trial testing SOF/VEL/VOX in Hepatitis C Virus Infection in 49 participants. Completed in 28 June 2016.

Timeline

29 July 2015

Primary endpoint
28 March 2016

28 June 2016

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	29 July 2015
Primary completion	28 March 2016
Estimated completion	28 June 2016
Sites	1 location across United States

Drugs / interventions tested

SOF/VEL/VOX — full drug profile →
RBV — 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 (SVR) 12 Weeks After Cessation of Treatment (SVR12) Primary · Posttreatment Week 12

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Group	Value	95% CI
SOF/VEL/VOX	100.0	85.8 – 100.0
SOF/VEL/VOX + RBV	96.0	79.6 – 99.9

Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event Primary · Up to 12 weeks

Group	Value	95% CI
SOF/VEL/VOX	0
SOF/VEL/VOX + RBV	0

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Secondary · Posttreatment Weeks 4 and 24

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

SVR4

Group	Value	95% CI
SOF/VEL/VOX	100.0	85.8 – 100.0
SOF/VEL/VOX + RBV	96.0	79.6 – 99.9

SVR24

Group	Value	95% CI
SOF/VEL/VOX	100.0	85.8 – 100.0
SOF/VEL/VOX + RBV	96.0	79.6 – 99.9

Percentage of Participants With HCV RNA < LLOQ on Treatment Secondary · Weeks 1, 2, 4, 8 and 12

Week 1

Group	Value	95% CI
SOF/VEL/VOX	54.2	32.8 – 74.4
SOF/VEL/VOX + RBV	40	21.1 – 61.3

Week 2

Group	Value	95% CI
SOF/VEL/VOX	79.2	57.8 – 92.9
SOF/VEL/VOX + RBV	60.0	38.7 – 78.9

Week 4

Group	Value	95% CI
SOF/VEL/VOX	100	85.8 – 100.0
SOF/VEL/VOX + RBV	92.0	74.0 – 99.0

Week 8

Group	Value	95% CI
SOF/VEL/VOX	100.0	85.8 – 100.0
SOF/VEL/VOX + RBV	100.0	86.3 – 100.0

Week 12

Group	Value	95% CI
SOF/VEL/VOX	100.0	85.8 – 100.0
SOF/VEL/VOX + RBV	100.0	86.3 – 100.0

HCV RNA Change From Baseline/Day 1 Through Week 12 Secondary · Weeks 1, 2, 4, 8, and 12

Change at Week 1

Group	Value	95% CI
SOF/VEL/VOX	-4.63	± 0.737
SOF/VEL/VOX + RBV	-4.53	± 0.687

Change at Week 2

Group	Value	95% CI
SOF/VEL/VOX	-4.97	± 0.484
SOF/VEL/VOX + RBV	-4.95	± 0.566

Change at Week 4

Group	Value	95% CI
SOF/VEL/VOX	-5.10	± 0.419
SOF/VEL/VOX + RBV	-5.14	± 0.477

Change at Week 8

Group	Value	95% CI
SOF/VEL/VOX	-5.10	± 0.419
SOF/VEL/VOX + RBV	-5.18	± 0.461

Change at Week 12

Group	Value	95% CI
SOF/VEL/VOX	-5.10	± 0.419
SOF/VEL/VOX + RBV	-5.18	± 0.461

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

Virologic failure is 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/VOX	0
SOF/VEL/VOX + RBV	4.0

Adverse events — posted to ClinicalTrials.gov

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

SOF/VEL/VOX

Serious: 1/24 (4%)

Deaths: 0/24

SOF/VEL/VOX + RBV

Serious: 0/25 (0%)

Deaths: 0/25

Serious adverse events (1 terms)

Reaction	System	SOF/VEL/VOX	SOF/VEL/VOX + RBV
Pneumonia	Infections and infestations	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	SOF/VEL/VOX	SOF/VEL/VOX + RBV
Fatigue	General disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—

Most-reported serious reactions: Pneumonia.

Data from ClinicalTrials.gov NCT02536313 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of SOF/VEL/VOX

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
NCT03820258 — Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Do · Phase 2 · terminated
NCT03118843 — Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participate · Phase 3 · completed
NCT02639247 — Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV · Phase 3 · completed
NCT02639338 — Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection a · Phase 3 · 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 NCT02536313 (US National Library of Medicine, public domain)
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: 25 February 2019

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/NCT02536313.

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