NCT02346721

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

Completed Phase 3 Results posted Last updated 16 November 2018

What this trial tests

Phase 3 trial testing SOF/VEL in Hepatitis C Virus Infection in 111 participants. Completed in 15 June 2016.

Timeline

23 February 2015

Primary endpoint
23 March 2016

15 June 2016

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	111
Start date	23 February 2015
Primary completion	23 March 2016
Estimated completion	15 June 2016
Sites	61 locations across France, Hong Kong, Italy, Belgium, United Kingdom, Germany, Canada, Puerto Rico

Drugs / interventions tested

• 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 drug.

Group	Value	95% CI
SOF/VEL 12 Weeks	97.3	92.3 – 99.4

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

Group	Value	95% CI
SOF/VEL 12 Weeks	0.9

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 drug, respectively.

SVR4

Group	Value	95% CI
SOF/VEL 12 Weeks	98.2	93.6 – 99.8

SVR24

Group	Value	95% CI
SOF/VEL 12 Weeks	97.3	92.3 – 99.4

Percentage of Participants With HCV RNA < LLOQ While on Treatment Secondary · Baseline to Week 12

Week 1

Group	Value	95% CI
SOF/VEL 12 Weeks	18.0	11.4 – 26.4

Week 2

Group	Value	95% CI
SOF/VEL 12 Weeks	55.0	45.2 – 64.4

Week 4

Group	Value	95% CI
SOF/VEL 12 Weeks	94.6	88.6 – 98.0

Week 6

Group	Value	95% CI
SOF/VEL 12 Weeks	99.1	95.1 – 100.0

Week 8

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.7 – 100.0

Week 10

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.7 – 100.0

Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	100.0	96.7 – 100.0

HCV RNA Change From Baseline Secondary · Baseline to Week 12

Change at Week 1

Group	Value	95% CI
SOF/VEL 12 Weeks	-4.23	± 0.592

Change at Week 2

Group	Value	95% CI
SOF/VEL 12 Weeks	-4.79	± 0.627

Change at Week 4

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.10	± 0.546

Change at Week 6

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.11	± 0.552

Change at Week 8

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.11	± 0.554

Change at Week 10

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.11	± 0.554

Change at Week 12

Group	Value	95% CI
SOF/VEL 12 Weeks	-5.11	± 0.556

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 12 Weeks	0.9

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 12 Weeks

Serious: 5/111 (5%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	SOF/VEL 12 Weeks
Cellulitis	Infections and infestations	—
Lymphangitis	Infections and infestations	—
Lower limb fracture	Injury, poisoning and procedural complications	—
Meniscus injury	Injury, poisoning and procedural complications	—
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (5 terms — click to expand)

Reaction	System	SOF/VEL 12 Weeks
Headache	Nervous system disorders	—
Fatigue	General disorders	—
Nausea	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Cellulitis, Lymphangitis, Lower limb fracture, Meniscus injury, Gallbladder adenocarcinoma, Hepatocellular carcinoma.

Data from ClinicalTrials.gov NCT02346721 adverse events section.

Sponsor's own description

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

Publications & conference data

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

1. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.
   Asselah T, Shafran SD, Bourgeois S, Lai CL, et al · · 2019 · cited 6× · PMID 31216086 · DOI 10.1111/jvh.13159
2. 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