Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Filibuvir · 2 trials · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) \- or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) |
| Arm B | EXPERIMENTAL | Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4) \- or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4) |
| Arm C | PLACEBO_COMPARATOR | Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks |
| 1.0 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Filibuvir | DRUG | 300 mg BID |
| Placebo | DRUG | BID |
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 regimen...
Filibuvir is an investigational small molecule being developed for the treatment of chronic Hepatitis C, Hepatitis C, and Hepatitis. It is intended for use in patients with these viral liver infections, including those who are treatment naive with genotype 1 HCV.
Filibuvir is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available information, so its exact mechanism of action is not detailed here.
Filibuvir is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
Filibuvir is in Phase 2 clinical development. It has completed one Phase 2 trial and two Phase 1 trials, but it is not approved and remains investigational.
Filibuvir has been studied in three completed trials: NCT00918476, a Phase 1 drug interaction study; NCT00987337, a Phase 2 trial in treatment naive HCV genotype 1 subjects; and NCT01210404, a Phase 1 drug interaction study with methadone.
Filibuvir is also known by the code name PF-00868554. This alternative name is used in some clinical and research contexts to refer to the same investigational drug.