Trial · NCT02607800

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

NCT02607800, Phase 3, Completed, Gilead Sciences; results first posted 2017-11-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02607800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607800

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02607800
Status: Completed
Phases: Phase 3
Enrollment: 943 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Hepatitis C
Interventions: SOF/VEL/VOX, SOF/VEL
First posted: 2015-11-18
Last updated: 2019-03-05
Other registries' IDs: eudract:2015-003460-36
Results first posted: 2017-11-08

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Primary	Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event	Up to 12 weeks
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	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.
Secondary	Percentage of Participants With HCV RNA < LLOQ On Treatment	Weeks 1, 2, 4, 8, and 12
Secondary	Change From Baseline in HCV RNA	Baseline; Weeks 1, 2, 4, 8, and 12
Secondary	Percentage of Participants With Virologic Failure	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

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug	percentage of participants	NUMBER
PRIMARY	Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event	Up to 12 weeks	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	Full Analysis Set	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HCV RNA < LLOQ On Treatment	Weeks 1, 2, 4, 8, and 12	Percentage of participants in Full Analysis Set with on-treatment data were analyzed.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in HCV RNA	Baseline; Weeks 1, 2, 4, 8, and 12	Participants in the Full Analysis Set with available data were analyzed.	log10 IU/mL	MEAN
SECONDARY	Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	Full Analysis Set	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SOF/VEL/VOX 8 Weeks		95.2	95% Confidence Interval 93.0 to 96.9	percentage of participants
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SOF/VEL 12 Weeks		98.2	95% Confidence Interval 96.4 to 99.2	percentage of participants
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event	SOF/VEL/VOX 8 Weeks		0		percentage of participants
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event	SOF/VEL 12 Weeks		0.5		percentage of participants
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SOF/VEL/VOX 8 Weeks	SVR4	96.4	95% Confidence Interval 94.4 to 97.9	percentage of participants
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SOF/VEL 12 Weeks	SVR4	98.9	95% Confidence Interval 97.4 to 99.6	percentage of participants
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SOF/VEL/VOX 8 Weeks	SVR 24	95.0	95% Confidence Interval 92.7 to 96.7	percentage of participants
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SOF/VEL 12 Weeks	SVR 24	98.0	95% Confidence Interval 96.2 to 99.1	percentage of participants
Percentage of Participants With HCV RNA < LLOQ On Treatment	SOF/VEL/VOX 8 Weeks	Week 1	24.8	95% Confidence Interval 21.0 to 28.8	percentage of participants
Percentage of Participants With HCV RNA < LLOQ On Treatment	SOF/VEL 12 Weeks	Week 1	22.7	95% Confidence Interval 18.9 to 26.9	percentage of participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SOF/VEL/VOX 8 Weeks	502
Overall Study	STARTED	SOF/VEL 12 Weeks	441
Overall Study	COMPLETED	SOF/VEL/VOX 8 Weeks	492
Overall Study	COMPLETED	SOF/VEL 12 Weeks	430
Overall Study	NOT COMPLETED	SOF/VEL/VOX 8 Weeks	10
Overall Study	NOT COMPLETED	SOF/VEL 12 Weeks	11

Source ClinicalTrials.gov

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	SOF/VEL/VOX 8 Weeks	88	501
other	Diarrhoea	Gastrointestinal disorders	SOF/VEL 12 Weeks	32	440
other	Nausea	Gastrointestinal disorders	SOF/VEL/VOX 8 Weeks	80	501
other	Nausea	Gastrointestinal disorders	SOF/VEL 12 Weeks	40	440
other	Asthenia	General disorders	SOF/VEL/VOX 8 Weeks	32	501
other	Asthenia	General disorders	SOF/VEL 12 Weeks	27	440
other	Fatigue	General disorders	SOF/VEL/VOX 8 Weeks	106	501
other	Fatigue	General disorders	SOF/VEL 12 Weeks	91	440
other	Arthralgia	Musculoskeletal and connective tissue disorders	SOF/VEL/VOX 8 Weeks	19	501
other	Arthralgia	Musculoskeletal and connective tissue disorders	SOF/VEL 12 Weeks	24	440

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SOF/VEL/VOX 8 Weeks	0	501
Total, all-cause mortality	SOF/VEL 12 Weeks	0	440
Total, other adverse events	SOF/VEL/VOX 8 Weeks	280	501
Total, other adverse events	SOF/VEL 12 Weeks	213	440
Total, serious adverse events	SOF/VEL/VOX 8 Weeks	15	501
Total, serious adverse events	SOF/VEL 12 Weeks	7	440

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28390869	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SOF/VEL/VOX 8 Weeks vs SOF/VEL 12 Weeks: deaths from any cause	Trial comparisons
SOF/VEL/VOX 8 Weeks vs SOF/VEL 12 Weeks: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02607800/results?page=2

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