Phase 2
Completed N=16
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
Source: ClinicalTrials.gov NCT02350569 ↗Enrolled (actual)
16
Serious AEs
25.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 87.5 percentage of participants
Summary
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
87.5 | — |
| PRIMARY Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) |
87.5 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
6.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 |
0; 12.5; 18.8; 33.3; 93.3; 100.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
- HCV RNA infection with quantifiable virus at screening
- Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
- Currently on the liver transplantation wait list
- Screening electrocardiogram (ECG) without clinically significant abnormalities.
- A negative serum pregnancy test result is required for females
Key Exclusion Criteria
- Any previous solid organ transplant
- Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
- HIV infection or a positive hepatitis B virus surface antigen result
- History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
- Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
- Prior exposure to an HCV non-structural protein (NS)5A inhibitor
- Patients on hemodialysis prior to or at the time of transplantation will be excluded
- Creatinine clearance (CLcr) < 40 mL/min at screening or < 40 mL/min on day of transplant
- Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
- Receipt or planned receipt of an organ from an HCV positive donor
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02350569). 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.