Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-493/ABT-530 · 6 trials · 6 indications
SVR12 was defined as plasma 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. The primary efficacy endpoint was non-inferiority of the ABT-493/ABT-530 8-week regimen (Arm A) to the sofosbuvir and ribavirin 12 week regimen (Arm B) in SVR12 using a non-inferiority margin of 10% in the intent-to-treat (ITT) population.
SVR12 was defined as plasma 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.
SVR12 was defined as plasma 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.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis. |
| Arm B | ACTIVE_COMPARATOR | sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis. |
| Arm C | EXPERIMENTAL | ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis. |
| Arm D | EXPERIMENTAL | ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis. |
| ABT-493/ABT-530 | EXPERIMENTAL | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| Arm A DB Active Drug | EXPERIMENTAL | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period) |
| Arm B DB Placebo | EXPERIMENTAL | Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) |
| Arm B OL Active Drug | EXPERIMENTAL | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period) |
| Name | Type | Description |
|---|---|---|
| ABT-493/ABT-530 | DRUG | Co-formulated tablet |
| sofosbuvir (SOF) | DRUG | Tablet |
| ribavirin (RBV) | DRUG | Capsule |
| OBV/PTV/r | DRUG | Co-formulated tablet |
| Placebo for ABT-493/ABT-530 | DRUG | tablet |
Inclusion Criteria: * Females were postmenopausal for at least 2 years prior to screening; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Scr...
ABT-493 is an investigational small molecule being developed for the treatment of chronic hepatitis C virus (HCV) infection, including genotype 2 infection, and has been studied in patients with hepatic impairment. It is in Phase 3 clinical development and is not yet approved by the FDA.
ABT-493 is a direct-acting antiviral that targets the hepatitis C virus. It is being studied in combination with ABT-530 for the treatment of chronic HCV infection. The specific molecular target of ABT-493 has not been disclosed in the available clinical trial information.
ABT-493 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the safety and efficacy of ABT-493, often in combination with ABT-530, for the treatment of chronic hepatitis C virus infection.
ABT-493 is in Phase 3 clinical development for chronic hepatitis C virus infection. It is an investigational drug and has not received FDA approval. Completed Phase 3 trials have evaluated its efficacy and safety in Japanese adults with chronic HCV infection, including those with genotype 2.
ABT-493 has been studied in several clinical trials, including NCT02707952 and NCT02723084, which are Phase 3 studies in Japanese adults with chronic hepatitis C virus infection. Additional Phase 1 trials, such as NCT02296905 and NCT02442258, evaluated its pharmacokinetics in subjects with hepatic or renal impairment.
ABT-493 is also known as glecaprevir. It is being developed by AbbVie in combination with ABT-530, which is known as pibrentasvir. This combination has been studied in clinical trials for the treatment of chronic hepatitis C virus infection.