NCT02607800 (POLARIS-2) is a Phase 3 clinical trial of SOF/VEL/VOX in Hepatitis C, sponsored by Gilead Sciences.

Who is sponsoring NCT02607800?

NCT02607800 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02607800?

Interventions in NCT02607800: SOF/VEL/VOX, SOF/VEL.

What condition does NCT02607800 study?

NCT02607800 studies Hepatitis C.

Is NCT02607800 still recruiting?

NCT02607800 is currently completed. Last updated 5 March 2019.

Are results published for NCT02607800?

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

Last reviewed 2019-03-05 · How we verify

NCT02607800: POLARIS-2

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 and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy

Completed Phase 3 Results posted Last updated 5 March 2019

What this trial tests

Phase 3 trial testing SOF/VEL/VOX in Hepatitis C in 943 participants. Completed in 11 January 2017.

Timeline

16 November 2015

Primary endpoint
10 October 2016

11 January 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	943
Start date	16 November 2015
Primary completion	10 October 2016
Estimated completion	11 January 2017
Sites	93 locations across France, New Zealand, United Kingdom, Germany, Canada, Puerto Rico, Australia, United States

Drugs / interventions tested

SOF/VEL/VOX — full drug profile →
SOF/VEL — full drug profile →

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Hepatitis C. 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 Discontinuation of Therapy (SVR12) Primary · Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	95.2	93.0 – 96.9
SOF/VEL 12 Weeks	98.2	96.4 – 99.2

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

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	0
SOF/VEL 12 Weeks	0.5

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

SVR4

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	96.4	94.4 – 97.9
SOF/VEL 12 Weeks	98.9	97.4 – 99.6

SVR 24

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	95.0	92.7 – 96.7
SOF/VEL 12 Weeks	98.0	96.2 – 99.1

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 8 Weeks	24.8	21.0 – 28.8
SOF/VEL 12 Weeks	22.7	18.9 – 26.9

Week 2

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	65.9	61.5 – 70.0
SOF/VEL 12 Weeks	61.3	56.5 – 65.9

Week 4

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	92.4	89.7 – 94.6
SOF/VEL 12 Weeks	92.0	89.1 – 94.4

Week 8

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	99.2	98.0 – 99.8
SOF/VEL 12 Weeks	99.8	98.7 – 100.0

Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	99.8	98.7 – 100.0

Change From Baseline in HCV RNA Secondary · Baseline; Weeks 1, 2, 4, 8, and 12

Week 1

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	-4.23	± 0.689
SOF/VEL 12 Weeks	-4.24	± 0.679

Week 2

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	-4.75	± 0.747
SOF/VEL 12 Weeks	-4.77	± 0.646

Week 4

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	-4.95	± 0.750
SOF/VEL 12 Weeks	-4.99	± 0.656

Week 8

Group	Value	95% CI
SOF/VEL/VOX 8 Weeks	-4.99	± 0.754
SOF/VEL 12 Weeks	-5.03	± 0.655

Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.03	± 0.656

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/VOX 8 Weeks	4.2
SOF/VEL 12 Weeks	0.7

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/VOX 8 Weeks

Serious: 15/501 (3%)

Deaths: 0/501

SOF/VEL 12 Weeks

Serious: 7/440 (2%)

Deaths: 0/440

Serious adverse events (25 terms)

Reaction	System	SOF/VEL/VOX 8 Weeks	SOF/VEL 12 Weeks
Acute myocardial infarction	Cardiac disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Biliary colic	Hepatobiliary disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Clostridium difficile colitis	Infections and infestations	—	—
Perineal abscess	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Multiple fractures	Injury, poisoning and procedural complications	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Myositis	Musculoskeletal and connective tissue disorders	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebral haemorrhage	Nervous system disorders	—	—
Alcohol withdrawal syndrome	Psychiatric disorders	—	—
Depression	Psychiatric disorders	—	—
Suicide attempt	Psychiatric disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Peripheral artery occlusion	Vascular disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	SOF/VEL/VOX 8 Weeks	SOF/VEL 12 Weeks
Headache	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Insomnia	Psychiatric disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Acute myocardial infarction, Angina pectoris, Atrial fibrillation, Small intestinal obstruction, Chest pain, Biliary colic, Cholelithiasis, Clostridium difficile colitis.

Data from ClinicalTrials.gov NCT02607800 adverse events section.

Sponsor's own description

The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.

Publications & conference data

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

Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Jacobson IM, Lawitz E, Gane EJ, Willems BE, et al · · 2017 · cited 163× · PMID 28390869 · DOI 10.1053/j.gastro.2017.03.047
Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies.
Grebely J, Feld JJ, Wyles D, Sulkowski M, et al · · 2018 · cited 32× · PMID 29450210 · DOI 10.1093/ofid/ofy001
Hepatitis C Care in the Department of Veterans Affairs: Building a Foundation for Success.
Belperio PS, Chartier M, Gonzalez RI, Park AM, et al · · 2018 · cited 24× · PMID 29778256 · DOI 10.1016/j.idc.2018.02.011
Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.
Zignego AL, Monti M, Gragnani L. · · 2018 · cited 10× · PMID 30333452 · DOI 10.23750/abm.v89i3.7718
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 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

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not 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 NCT02607800 (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: 5 March 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/NCT02607800.

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