Phase 2 Completed N=74 Randomized Double-blind Treatment

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Hepatitis C · HCV · Chronic Hepatitis C Infection · Hepatitis C Genotype 1

Source: ClinicalTrials.gov NCT01074008 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Jan 2015

Primary outcomePrimary: Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment — -4.07; -3.91; -4.11; -1.14 log10 IU/mL — p=<0.001

Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment	-4.07; -3.91; -4.11; -1.14; -1.07; -1.57	<0.001 sig
PRIMARY Maximum Plasma Concentration (Cmax) of ABT-450	34.4; 165; 2923	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of ABT-450	2.5; 4.8; 3.0	—
PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450	250; 1122; 17351	—
PRIMARY Maximum Plasma Concentration (Cmax) of Ritonavir	563; 851; 1098	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of Ritonavir	4.8; 5.3; 4.5	—
PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir	4518; 7638; 8663	—
PRIMARY Maximum Plasma Concentration (Cmax) of ABT-072	390; 1218; 1748	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of ABT-072	4.5; 2.8; 3.1	—
PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072	3678; 9413; 14126	—
PRIMARY Maximum Plasma Concentration (Cmax) of ABT-333	800; 1201	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of ABT-333	4.5; 7.0	—
PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333	4315; 6431	—
SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	87.5; 75.0; 100.0; 37.5; 12.5; 42.9	0.001 sig
SECONDARY Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12	100.0; 87.5; 100.0; 100.0; 62.5; 100.0	0.013 sig
SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12	87.5; 87.5; 100.0; 75.0; 50.0; 85.7	0.005 sig

Eligibility Criteria

Inclusion Criteria

Chronic hepatitis C virus (HCV), genotype 1 infection (HCV ribonucleic acid level greater than or equal to 100,000 IU/mL) at screening
Liver biopsy within 3 years with histology consistent with HCV-induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV
Treatment naïve male or female between the ages of 18 and 65
Females must be post-menopausal for more than 2 years or surgically sterile
Negative screen for drugs and alcohol
Negative hepatitis B surface antigen (HBsAg) and anti-human immunodeficiency virus antibodies (anti-HIV Ab)
No use of cytochrome P450 3A (CYP3A) and cytochrome P450 2C8 (CYP2C8) enzyme inducers or inhibitors within 1 month of dosing
Be in a condition of general good health, as perceived by the investigator, other than HCV infection

Exclusion Criteria

Significant sensitivity to any drug
Use of herbal supplements within 2 weeks prior to study drug dosing
History of major depression within 2 years
Prior treatment with any investigational or commercially available anti-HCV agents
Abnormal laboratory tests

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01074008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.