NCT03118843

Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Completed Phase 3 Results posted Last updated 3 April 2019

What this trial tests

Phase 3 trial testing SOF/VEL/VOX in Hepatitis C Virus Infection in 31 participants. Completed in 19 March 2018.

Timeline

25 April 2017

Primary endpoint
19 March 2018

19 March 2018

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	31
Start date	25 April 2017
Primary completion	19 March 2018
Estimated completion	19 March 2018
Sites	27 locations across France, New Zealand, United Kingdom, Germany, Canada, Australia, United States

Drugs / interventions tested

• SOF/VEL/VOX — 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 Discontinuation of Therapy (SVR12) Primary · Posttreatment Week 12

SVR12 was 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	88.8 – 100.0

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

Group	Value	95% CI
SOF/VEL/VOX	0

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

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Group	Value	95% CI
SOF/VEL/VOX	100.0	88.8 – 100.0

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

Week 2

Group	Value	95% CI
SOF/VEL/VOX	51.6	33.1 – 69.8

Week 4

Group	Value	95% CI
SOF/VEL/VOX	96.8	83.3 – 99.9

Week 8

Group	Value	95% CI
SOF/VEL/VOX	100.0	88.8 – 100.0

Week 12

Group	Value	95% CI
SOF/VEL/VOX	100.0	88.8 – 100.0

Percentage of Participants With Virologic Failure Secondary · Up to Posttreatment Week 12

Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA \< LLOQ), 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

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

Change at Week 2

Group	Value	95% CI
SOF/VEL/VOX	-5.16	± 0.560

Change at Week 4

Group	Value	95% CI
SOF/VEL/VOX	-5.34	± 0.571

Change at Week 8

Group	Value	95% CI
SOF/VEL/VOX	-5.34	± 0.563

Change at Week 12

Group	Value	95% CI
SOF/VEL/VOX	-5.34	± 0.563

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SOF/VEL/VOX

Serious: 1/31 (3%)

Deaths: 0/31

Serious adverse events (2 terms)

Reaction	System	SOF/VEL/VOX
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Asthenia	General disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	SOF/VEL/VOX
Nausea	Gastrointestinal disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Upper respiratory tract infection	Infections and infestations	—
Abdominal distension	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Pain	General disorders	—
Pneumonia	Infections and infestations	—
Anxiety	Psychiatric disorders	—
Insomnia	Psychiatric disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Gastrointestinal haemorrhage, Asthenia.

Data from ClinicalTrials.gov NCT03118843 adverse events section.

Sponsor's own description

The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

Publications & conference data

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