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Completed

NCT Number: NCT01054729

Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion de Diego, Santurce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treatment-naive males and females, 18-65 years of age
  • Genotype 1 HCV infection
  • Negative pregnancy test for females of childbearing age
  • Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion criteria

  • Hepatitis B or HIV infection
  • Pregnant or breast feeding females or male partners of pregnant females
  • Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
  • History or evidence of medical condition associated with chronic liver disease other than HCV

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir tablet(s) administered orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

Placebo

Drug

Placebo to match sofosbuvir administered orally once daily

PEG

Drug

Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.

Other names: Pegasys®

RBV

Drug

Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Other names: Copegus®

Primary outcomes

  1. Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period

    Time frame: Baseline to Week 4

    Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.

Secondary outcomes

  1. Change in Circulating HCV RNA at Week 4

    Time frame: Baseline to Week 4

  2. Percentage of Participants With Rapid Virologic Response at Week 4

    Time frame: Week 4

    Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.

  3. Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment

    Time frame: Post-treatment Weeks 12 and 24

    SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).

  4. Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.

    Cmax is defined as the maximum concentration of drug.

  5. Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.

  6. Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).

    AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time.

  7. Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).

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

  8. Plasma Pharmacokinetics of GS-331007: Cmax at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.

  9. Plasma Pharmacokinetics of GS-331007: Cmax at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.

  10. Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).

  11. Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).

  12. Plasma Pharmacokinetics of GS-566500: Cmax at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.

  13. Plasma Pharmacokinetics of GS-566500: Cmax at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.

  14. Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

    The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).

  15. Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27

    Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

    The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).

  16. Percentage of Participants Who Developed Resistance to Sofosbuvir

    Time frame: Baseline to Week 4

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jan 22, 2010
Registry last updated
Apr 17, 2014

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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