Phase 4
Completed N=60
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
PT-NANBH
Source: ClinicalTrials.gov NCT02480166 ↗
Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Sep 2017
Primary outcomePrimary: Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment — 19; 34; 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objectives of this study are to describe the efficacy of:
1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment |
19; 34; 4 | — |
| SECONDARY Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age ≥18 years
- HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
- Selected to start on treatment by their treating providers
- Willing and able to provide informed consent
- Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Lactating females must agree to discontinue nursing before the study drug is administered
Exclusion Criteria
- Previous recipient of a liver transplant
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
Data sourced from ClinicalTrials.gov (NCT02480166). 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.