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ABT-493 coformulated with ABT-530

Phase 3

Hepatitis C Virus Infection | Small molecule | Infectious Disease |AbbVie Inc.|Last Updated: Jul 13, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

ABT-493 coformulated with ABT-530 · 1 trial · 4 indications

Phase 3 1
NCT02738138A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)Hepatitis C Virus Infection
COMPLETED153 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
Hepatitis C Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
12 weeks after 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.

Secondary Endpoints

Percentage of Participants With On-treatment Virologic Failure
Up to 12 weeks
Percentage of Participants With Post-treatment Relapse
From the end of treatment through 12 weeks after the last dose of study drug
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-493/ABT-530 for 8 weeksEXPERIMENTALHCV 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 weeksEXPERIMENTALHCV 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

Interventions

NameTypeDescription
ABT-493 coformulated with ABT-530DRUGTablet
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo

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...

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Frequently asked questions about ABT-493 coformulated with ABT-530

What is ABT-493 coformulated with ABT-530 used for?

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.

Who makes ABT-493 coformulated with ABT-530?

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.

What phase is ABT-493 coformulated with ABT-530 in?

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.

What clinical trials is ABT-493 coformulated with ABT-530 in?

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.

Is ABT-493 coformulated with ABT-530 the same as glecaprevir and pibrentasvir?

ABT-493 and ABT-530 are the investigational code names for the components of this drug combination. The trial data provided does not include alternative names, so it is not specified whether these correspond to glecaprevir and pibrentasvir or other approved names.