Phase 2
Completed N=10
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
Source: ClinicalTrials.gov NCT02301936 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 88.9; 100.0 percentage of participants
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
88.9; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) |
88.9; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
33.3; 0; 66.7; 0; 88.9; 100.0 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.20; -3.86; -3.86; -4.63; -3.98; -5.05 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
11.1; 0 | — |
| SECONDARY Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score |
1.2; 8.5; 2.7; 5.8; 2.3; 3.5 | — |
| SECONDARY Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score |
2.2; -4.7; 3.2; -3.3; -3.9; 2.2 | — |
| SECONDARY Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
4.6; -0.2; 9.8; 14.5; 11.7; 13.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic genotype 1 or 4 infected patients with sickle cell disease
- HCV RNA ≥ 1, 000 IU/mL at screening
- Cirrhosis determination by transient elastography
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Pregnant or nursing female
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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 treatment, assessment or compliance with the protocol
Note: Other protocol defined inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02301936). 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.