Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2 DAA · 1 trial · 3 indications
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. |
| Arm B | ACTIVE_COMPARATOR | ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| Arm C | ACTIVE_COMPARATOR | ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. |
| Name | Type | Description |
|---|---|---|
| 2 DAA | DRUG | ABT-450/r/ABT-267 tablets |
| RBV | DRUG | Ribavirin tablets |
Inclusion Criteria: * Chronic hepatitis C, genotype 4-infection (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] level greater than 1,000 IU/mL at Screening) * Subjects must meet one of the following: * Treatment-naive: Subject has never received antiviral treatment for HCV infection OR * T...
2 DAA is an investigational small molecule being studied for the treatment of hepatitis C virus (HCV) infection, specifically genotype 4 HCV. It is a direct-acting antiviral regimen being evaluated in combination with ribavirin in adults.
2 DAA is being developed by AbbVie Inc. (NYSE: ABBV). The company is a biopharmaceutical firm focused on research and development of therapeutic products across multiple disease areas.
2 DAA is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its safety and efficacy.
2 DAA has been studied in one completed Phase 3 clinical trial, NCT02247401. This trial evaluated the coadministration of ABT-450/ritonavir/ABT-267 with ribavirin in adults with genotype 4 hepatitis C virus in Egypt, enrolling 160 participants.
Yes, 2 DAA refers to the combination regimen ABT-450/ritonavir/ABT-267, which was studied in the clinical trial NCT02247401. This regimen was evaluated with ribavirin for the treatment of genotype 4 hepatitis C virus infection.