Phase 2
N=95
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
Hepatitis C Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT03036839 ↗Enrolled (actual)
95
Serious AEs
12.6%
Results posted
Dec 2019
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 93.3; 100.0; 84.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LDV/SOF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
93.3; 100.0; 84.2 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
97.8; 100.0; 84.2 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
93.3; 100.0; 84.2 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
84.4; 90.3; 84.2; 100.0; 100.0; 100.0 | — |
| SECONDARY HCV RNA |
1.17; 1.22; 1.18; 1.15; 1.15; 1.15 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.63; -4.71; -4.67; -4.61; -4.79; -4.71 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Developed Resistance to LDV and SOF |
— | — |
| SECONDARY Pharmacokinetics (PK) Parameter: AUCtau of LDV |
11923.9; 13632.7; 13542.5 | — |
| SECONDARY PK Parameter: AUCtau of SOF |
2435.4; 2296.6; 2838.2 | — |
| SECONDARY PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) |
234980.1; 269050.3; 280829.5 | — |
| SECONDARY PK Parameter: Cmax of LDV |
544.2; 618.4; 607.0 | — |
| SECONDARY PK Parameter: Cmax of SOF |
1059.8; 1005.8; 1052.5 | — |
| SECONDARY PK Parameter: Cmax of GS-331007 (Metabolite of SOF) |
9956.3; 11392.7; 11882.4 | — |
Summary
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
Eligibility Criteria
Key Inclusion Criteria
- Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03036839). 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.