A Phase 2 interventional study of SOF/VEL and RBV in Hepatitis C Virus Infection, sponsored by Gilead Sciences. Completed at 30 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 69 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
Drug: SOF/VEL · Drug: RBV
400/100 mg FDC tablet administered orally once daily
Also known as: GS-7977/GS-5816, Epclusa®
Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ On-treatment
Time frame: Baseline to Week 24
HCV RNA Change From Baseline
Time frame: Baseline to Week 24
Percentage of Participants With Virologic Failure
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
Time frame: Up to Posttreatment Week 24
Participants were enrolled at 31 study sites in North America and Asia Pacific. The first participant was screened on 01 December 2014. The last study visit occurred on 15 September 2016.
| Milestone | SOF/VEL+RBV |
|---|---|
| Started | 69 |
| Completed | 63 |
| Not completed | 6 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrew consent | 2 |
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
| percentage of participants | SOF/VEL+RBV |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 91.3 (82.0 to 96.7) |
| percentage of participants | SOF/VEL+RBV |
|---|---|
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 5.8 |
SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
| percentage of participants | SOF/VEL+RBV |
|---|---|
| SVR4 | 92.8 (83.9 to 97.6) |
| SVR24 | 89.9 (80.2 to 95.8) |
| percentage of participants | SOF/VEL+RBV |
|---|---|
| Week 1 | 15.9 (8.2 to 26.7) |
| Week 2 | 60.9 (48.4 to 72.4) |
| Week 4 | 91.3 (82.0 to 96.7) |
| Week 6 | 98.5 (92.1 to 100.0) |
| Week 8 | 97.1 (89.8 to 99.6) |
| Week 12 | 98.5 (92.0 to 100.0) |
| Week 16 | 100.0 (94.6 to 100.0) |
| Week 20 | 100.0 (94.6 to 100.0) |
| Week 24 | 100.0 (94.6 to 100.0) |
| log10 IU/mL | SOF/VEL+RBV |
|---|---|
| Week 1 | -4.45 ± 0.615 |
| Week 2 | -5.04 ± 0.685 |
| Week 4 | -5.18 ± 0.719 |
| Week 6 | -5.23 ± 0.669 |
| Week 8 | -5.23 ± 0.675 |
| Week 12 | -5.23 ± 0.679 |
| Week 16 | -5.23 ± 0.679 |
| Week 20 | -5.23 ± 0.679 |
| Week 24 | -5.23 ± 0.679 |
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
| percentage of participants | SOF/VEL+RBV |
|---|---|
| Percentage of Participants With Virologic Failure | 7.2 |
Collected over Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOF/VEL+RBV | 0/69 (0%) | 1/69 (1.4%) | 55/69 (79.7%) |
| Event | SOF/VEL+RBV |
|---|---|
| NephrolithiasisRenal and urinary disorders | 1/69 |
| Event | SOF/VEL+RBV |
|---|---|
| FatigueGeneral disorders | 22/69 |
| NauseaGastrointestinal disorders | 15/69 |
| HeadacheNervous system disorders | 12/69 |
| InsomniaPsychiatric disorders | 11/69 |
| PruritusSkin and subcutaneous tissue disorders | 10/69 |
| Upper respiratory tract infectionInfections and infestations | 9/69 |
| IrritabilityPsychiatric disorders | 9/69 |
| RashSkin and subcutaneous tissue disorders | 9/69 |
| Viral upper respiratory tract infectionInfections and infestations | 6/69 |
| Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders | 6/69 |
Safety Analysis Set: participants who received at least 1 dose of study drug
| Age, Continuous(years) | SOF/VEL+RBV |
|---|---|
| Mean | 57 ± 7.7 |
| Sex: Female, Male(Participants) | SOF/VEL+RBV |
|---|---|
| Female | 16 |
| Male | 53 |
| Race/Ethnicity, Customized(Participants) | SOF/VEL+RBV |
|---|---|
| Black or African American | 3 |
| White | 61 |
| Asian | 2 |
| Native Hawaiian or Pacific Islander | 3 |
| Race/Ethnicity, Customized(Participants) | SOF/VEL+RBV |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 64 |
| Region of Enrollment(Participants) | SOF/VEL+RBV |
|---|---|
| United States | 35 |
| New Zealand | 29 |
| Australia | 5 |
| IL28b Status(Participants) | SOF/VEL+RBV |
|---|---|
| CC | 23 |
| CT | 32 |
| TT | 14 |
| HCV RNA(log10 IU/mL) | SOF/VEL+RBV |
|---|---|
| Mean | 6.4 ± 0.67 |
| HCV RNA Category(Participants) | SOF/VEL+RBV |
|---|---|
| < 800,000 IU/mL | 15 |
| ≥ 800,000 IU/mL | 54 |
Plan to share: Yes — Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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