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Completed

NCT Number: NCT01740791

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection

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.

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Key information

Conditions

Chronic Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundacion De Investigacion De Diego, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

velpatasvir

Drug

Tablets administered orally

Other names: GS-5816

Placebo

Drug

Tablets administered orally

Primary outcomes

  1. Percentage of Participants Experiencing Treatment Emergent Adverse Events

    Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

    Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).

  2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

    A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.

  3. Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline

    Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17

    Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.

Secondary outcomes

  1. Absolute HCV RNA Level

    Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17

  2. Number of Participants Achieving Reductions From Baseline in HCV RNA

    Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17

    Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.

  3. Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected

    Time frame: Days 4, 5, 6, 7, and 8

    The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.

  4. Plasma HCV RNA Levels by Treatment and IL28B Genotype

    Time frame: Days 4, 5, 6, 7, 8, 10, and 17

  5. Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf

    Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1

    AUCinf is defined as the concentration of drug extrapolated to infinite time.

  6. PK Parameter of Velpatasvir: AUCtau

    Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  7. PK Parameter of Velpatasvir: Cmax

    Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.

    Cmax is defined as the maximum observed plasma concentration of drug.

  8. PK Parameter of Velpatasvir: CL/F

    Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose

    CL/F is defined as the apparent oral clearance following administration of the drug.

  9. PK Parameter of Velpatasvir: Ctau

    Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3

    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  10. Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints

    Time frame: First dose date up to Day 17

    The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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