Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-450/r · 1 trial · 1 indication
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants |
| Group 2 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants |
| Group 3 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants |
| Group 4 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants |
| Group 5 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants |
| Group 6 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants |
| Group 7 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis |
| Group 8 | EXPERIMENTAL | ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis |
| Name | Type | Description |
|---|---|---|
| ABT-450/r | DRUG | Tablet; ABT-450; Capsule; ritonavir |
| ABT-267 | DRUG | Tablet |
| Ribavirin (RBV) | DRUG | Tablet |
Inclusion Criteria: * Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile * Subjects must meet one of the following: * Treatment-naive: Subject has never received antiviral treatment for hepatitis C infec...
ABT-450 is an investigational small molecule being developed by AbbVie Inc. for the treatment of Hepatitis C, including chronic Hepatitis C infection and Hepatitis C Virus Infection. It is being studied in combination with other antiviral agents such as ABT-333, ABT-072, ABT-267, and ribavirin to evaluate its safety and antiviral activity.
ABT-450 is a small molecule antiviral agent. While its specific molecular target is not disclosed in the available information, it is being studied for its antiviral activity against Hepatitis C Virus. Clinical trials evaluate its safety, tolerability, and effectiveness in patients with Hepatitis C Genotype 1 infection.
ABT-450 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the drug's safety and efficacy in treating Hepatitis C virus infections.
ABT-450 is in Phase 1 clinical development as an investigational drug for Hepatitis C. It has completed 12 clinical trials, including Phase 1 and Phase 2 studies, with a total enrollment of 3,343 participants. The drug is not yet approved and remains under clinical investigation.
ABT-450 has been studied in several clinical trials, including NCT01074008, a Phase 2 study evaluating its safety and antiviral activity with ABT-333 and ABT-072; NCT01221298, a pilot study with ritonavir, ABT-072, and ribavirin; NCT01685203, a study with ritonavir and ABT-267; and NCT02052362, a Phase 1 bioavailability study.
ABT-450/r refers to ABT-450 co-administered with ritonavir, a pharmacokinetic enhancer that boosts ABT-450's exposure. In clinical trials, ABT-450 is often dosed with ritonavir to improve its antiviral activity. The combination is studied as part of AbbVie's Hepatitis C treatment regimens.