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filibuvir · 3 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 | - |
| 1. filibuvir + Oral Contraceptives | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Filibuvir | DRUG | 300 mg BID |
| Placebo | DRUG | BID |
| filibuvir + Oral Contraceptives | DRUG | This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28). |
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...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
Filibuvir was studied as a treatment for chronic hepatitis C, including hepatitis C virus genotype 1 infection. It was developed by Pfizer as an oral small molecule and evaluated in clinical trials in treatment naive patients with HCV genotype 1, as well as in drug interaction studies involving methadone and oral contraceptives.
Filibuvir is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials of filibuvir, including a Phase 2 study in treatment naive hepatitis C virus genotype 1 subjects and Phase 1 drug interaction studies.
Filibuvir is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. The clinical program includes Phase 1 drug interaction studies and a completed Phase 2 trial in treatment naive hepatitis C virus genotype 1 subjects.
Filibuvir has been evaluated in three completed clinical trials: NCT01210404, a Phase 1 drug interaction study with methadone in subjects on chronic methadone maintenance; NCT00987337, a Phase 2 trial in treatment naive hepatitis C virus genotype 1 subjects; and NCT00918476, a Phase 1 study of filibuvir's effect on oral contraceptive pharmacokinetics.