Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/18/2018 |
| Start Date: | August 2014 |
| End Date: | April 2016 |
A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Randomized Study to Investigate the Effect of Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the effect of sustained virologic
response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)
and on neurocognition as measured by neurocognitive tests. This study will also evaluate the
antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.
During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF
FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,
participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12
weeks.
response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)
and on neurocognition as measured by neurocognitive tests. This study will also evaluate the
antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.
During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF
FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,
participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12
weeks.
Inclusion Criteria:
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Chronic genotype 1 HCV infection
- Screening laboratory values within defined thresholds
- Use of protocol-specified method(s) of contraception if female of childbearing
potential or sexually active male
Exclusion Criteria:
- Clinically-significant illness (other than HCV) or any other major medical disorder
that may interfere with treatment, assessment, or compliance with the protocol.
Current or prior history of any of the following:
- Hepatic decompensation
- Solid organ transplantation
- Significant pulmonary or cardiac disease
- Chronic liver disease of a non-HCV etiology
- Hepatocellular carcinoma (HCC)
- Infection with hepatitis B virus (HBV)
- Infection with human immunodeficiency virus (HIV)
- History of recent epilepsy (within 2 years of screening) or cerebral vascular
accident (CVA)
- Structural brain damage
- Presence of cirrhosis
- Contraindication to MRI
- Pregnant or nursing female
- Prior treatment NS5A directly-acting antiviral agent. Any interferon (IFN)-containing
regimen within 8 weeks of Screening
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