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
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Drug: LDV/SOF
- Registration Number
- NCT02350569
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LDV/SOF LDV/SOF Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event Up to 4 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure Up to Posttreatment Week 12 Virologic failure was defined as:
* End of treatment virologic failure:
* Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment
* Virologic relapse:
* Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment HCV RNA measurement.Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 Days 1, 3, 5, 7, 14, 21, and 28