Phase 1
Completed N=103
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Chronic Hepatitis C Virus
Source: ClinicalTrials.gov NCT01740791 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Percentage of Participants Experiencing Treatment Emergent Adverse Events — 17.6; 25.0; 26.7; 8.3 percentage of participants
Summary
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment Emergent Adverse Events |
17.6; 25.0; 26.7; 8.3; 37.5; 29.0 | — |
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
41.2; 25.0; 40.0; 58.3; 62.5; 33.3 | — |
| PRIMARY Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline |
-0.005; -3.104; -3.638; -3.338; -3.154; -3.648 | — |
| SECONDARY Absolute HCV RNA Level |
6.523; 6.639; 6.461; 6.459; 6.458; 6.335 | — |
| SECONDARY Number of Participants Achieving Reductions From Baseline in HCV RNA |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected |
0; 0; 0; 2; 0; 1 | — |
| SECONDARY Plasma HCV RNA Levels by Treatment and IL28B Genotype |
6.473; 3.410; 2.603; 1.762; 2.891; 2.539 | — |
| SECONDARY Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf |
113.8; 857.9; 2054.3; 2727.3; 4546.6 | — |
| SECONDARY PK Parameter of Velpatasvir: AUCtau |
86.4; 857.5; 1950.5; 2745.3; 5003.0 | — |
| SECONDARY PK Parameter of Velpatasvir: Cmax |
20.1; 110.8; 272.3; 372.8; 583.3; 16.2 | — |
| SECONDARY PK Parameter of Velpatasvir: CL/F |
61312.2; 37170.7; 27930.6; 49237.5; 38011.7; 59173.6 | — |
| SECONDARY PK Parameter of Velpatasvir: Ctau |
0.6; 10.8; 22.4; 30.8; 60.6 | — |
| SECONDARY Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints |
8; 4; 8; 8; 8; 7 | — |
Eligibility Criteria
Key Inclusion Criteria
- HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
- Agree to use protocol defined precautions against pregnancy
Key Exclusion Criteria
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
- Evidence of cirrhosis
- Evidence of current drug abuse
- Screening laboratory results outside the protocol specified requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01740791). 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.