Phase 2
Completed N=59
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
Source: ClinicalTrials.gov NCT03036852 ↗Enrolled (actual)
59
Serious AEs
18.6%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 94.9; 92.0; 100.0; 93.8 percentage of participants
Summary
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
94.9; 92.0; 100.0; 93.8; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) |
96.6; 96.0; 100.0; 93.8; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) |
94.9; 92.0; 100.0; 93.8; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.54; -4.69; -3.78; -5.07; -4.23; -5.29 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
67.8; 76.0; 85.7; 43.8; 50.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
3.4; 4.0; 0; 6.3; 0; 0 | — |
| SECONDARY Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment |
— | — |
| SECONDARY Pharmacokinetic (PK) Parameter: AUCtau of SOF |
2381.9 | — |
| SECONDARY PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) |
230989.2 | — |
| SECONDARY PK Parameter: AUCtau of VEL |
4279.4 | — |
| SECONDARY PK Parameter: Cmax of SOF |
1041.0 | — |
| SECONDARY PK Parameter: Cmax of GS-331007 (Metabolite of SOF) |
9776.2 | — |
| SECONDARY PK Parameter: Cmax of VEL |
226.9 | — |
| SECONDARY PK Parameter: Ctau of VEL |
137.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03036852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.