Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

Pfizer288 enrolled

Overview

The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

288

Conditions

Hepatitis Hepatitis C

Interventions

FilibuvirDRUG

300 mg BID

FilibuvirDRUG

600 mg BID

PlaceboDRUG

BID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects at least 18 years of age. * HCV seropositive. * HCV RNA \>10,000 IU/mL at screening. * HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible. * Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents). * Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization. * Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP \>50 and \<100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization. Exclusion Criteria: * Co-infection with either HIV or HBV. * Evidence of severe or decompensated liver disease. * Subjects with liver disease unrelated to HCV infection. * Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling. * Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling. * Abnormal ECG suggestive of clinically significant cardiac disease or QTc\>450msec. * History of organ transplant. * Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers. * Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up. * Pregnant or nursing females. * Males whose female partner is pregnant.

Locations (77)

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Viral Response (SVR) at Week 72

For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 24 (End of Treatment \[EOT\]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.

Time frame: Week 72

Secondary Outcomes

Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48

Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response \[RVR\]), Week 12 (early viral response \[EVR\]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels \<15 IU/mL.

Time frame: Week 4, 12, 24, 48

Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)

A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were \<15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.

Time frame: 12 weeks after completion of therapy (Week 36 or 60)

Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)

SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were \<15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Anaheim, California, United States

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...and 67 more locations