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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sofosbuvir 100 mg+PEG+RBV

Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir tablet(s) administered orally once daily

PEG

Intervention Type DRUG

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

RBV

Intervention Type 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).

Sofosbuvir 200 mg+PEG+RBV

Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir tablet(s) administered orally once daily

PEG

Intervention Type DRUG

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

RBV

Intervention Type 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).

Sofosbuvir 400 mg+PEG+RBV

Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

Sofosbuvir tablet(s) administered orally once daily

PEG

Intervention Type DRUG

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

RBV

Intervention Type 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).

Placebo+PEG+RBV

Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match sofosbuvir administered orally once daily

PEG

Intervention Type DRUG

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

RBV

Intervention Type 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).

Interventions

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Sofosbuvir

Sofosbuvir tablet(s) administered orally once daily

Intervention Type DRUG

Placebo

Placebo to match sofosbuvir administered orally once daily

Intervention Type DRUG

PEG

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

Intervention Type DRUG

RBV

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).

Intervention Type DRUG

Other Intervention Names

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Sovaldi® GS-7977 PSI-7977 Pegasys® Copegus®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No