Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Drug: LDV/SOF
- Registration Number
- NCT02251717
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Genotype 1 or 4 chronic HCV infection
- Have received a kidney transplant more than 6 months before the Baseline visit
- Cirrhosis determination
- Screening laboratory parameters within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key
- Pregnant or nursing female or male with pregnant female partner
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain -resolved skin cancers)
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Planned or anticipated second kidney transplant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LDV/SOF 24 wk LDV/SOF Participants will receive LDV/SOF FDC for 24 weeks. LDV/SOF 12 wk LDV/SOF Participants will receive LDV/SOF FDC for 12 weeks.
- 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 Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 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 With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.