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Label indication MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). FDA label
Also known as ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
ABT-493 coformulated with ABT-530 · 1 trial · 4 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 active study drug.
| Arm | Type | Description |
|---|---|---|
| ABT-493/ABT-530 for 8 weeks | EXPERIMENTAL | HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks |
| ABT-493/ABT-530 for 12 weeks | EXPERIMENTAL | HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-493 coformulated with ABT-530 | DRUG | Tablet |
Inclusion Criteria: 1. Male or female, at least 18 years of age at time of Screening. 2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection. 3. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load gr...
ABT-493 coformulated with ABT-530 is an investigational small molecule combination being developed for the treatment of Hepatitis C Virus (HCV) infection. It is studied in adults with chronic HCV genotype 1-6 infection, including those coinfected with HIV-1 and those with compensated cirrhosis or without cirrhosis.
ABT-493 coformulated with ABT-530 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the efficacy and safety of this experimental drug combination in patients with chronic Hepatitis C Virus infection.
ABT-493 coformulated with ABT-530 is in Phase 3 clinical development. It is an investigational drug combination, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
ABT-493 coformulated with ABT-530 was studied in a Phase 3 clinical trial with the identifier NCT02738138, known as EXPEDITION-2. This completed trial evaluated the efficacy and safety of the drug combination in 153 adults with chronic Hepatitis C Virus genotype 1-6 infection and HIV-1 coinfection.