Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-450/ritonavir · 3 trials · 4 indications
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation \[LLOQ\] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.
The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G).
| Arm | Type | Description |
|---|---|---|
| ABT-450/r and ABT-530 plus RBV | EXPERIMENTAL | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
| 2-DAA + PegIFN/RBV | EXPERIMENTAL | 2-direct-acting antiviral (2-DAA: ABT-450 \[paritaprevir\] 200 mg once daily \[QD\], ritonavir 100 mg QD, ABT-267 \[ombitasvir\] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks (Substudy 1) and followed by pegIFN and RBV alone for an additional 24 weeks (Substudy 2). |
| Group A | EXPERIMENTAL | Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks. |
| Group B | EXPERIMENTAL | Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks. |
| Group C | EXPERIMENTAL | Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks. |
| Group D | EXPERIMENTAL | Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks. |
| Group E | EXPERIMENTAL | Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks. |
| Group F | EXPERIMENTAL | Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks. |
| Group G | EXPERIMENTAL | Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks. |
| Group H | EXPERIMENTAL | Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks. |
| Group I | EXPERIMENTAL | Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks. |
| Group J | EXPERIMENTAL | Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks. |
| Group K | EXPERIMENTAL | Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks. |
| Group L | EXPERIMENTAL | Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks. |
| Group M | EXPERIMENTAL | Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks. |
| Group N | EXPERIMENTAL | Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| ABT-450/ritonavir (r) | DRUG | Tablet |
| ABT-530 | DRUG | Tablet |
| Ribavirin (RBV) | DRUG | Tablet |
| ABT-450/r | DRUG | ABT-450 (tablets) dosed with ritonavir (capsules or tablets) |
| ABT-267 | DRUG | ABT-267 (tablets) |
| pegylated interferon alpha-2a (pegIFN) | DRUG | pegIFN alpha-2a (syringe) |
| ABT-450 | DRUG | ABT-450 tablets |
| ABT-333 | DRUG | ABT-333 tablets |
| Ribavirin | DRUG | Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided). |
| Ritonavir | DRUG | Ritonavir capsules |
Inclusion Criteria: * Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to \<38 kg/m2. * Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV. * Subject has plasma HCV RNA level \> 10,000 ...
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.