HCV Genotype 1 and HCV Genotype 1/HIV-1 co-infected subjects MedDRA version: 18.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female at least 18 years of age at time of screening. 2. Screening laboratory result indicating HCV GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve (i.e., patient has never received a single dose of any approved or nvestigational regimen) or treatmentexperienced (has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy). 5. Subjects must be non-cirrhotic. Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients: 6. HIV-1 ART naïve with CD4 = 500 cells/mm3 [or CD4+ % =29%] at Screening and plasma HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 40 ;Inclusion criteria: 1. Male or female at least 18 years of age at time of screening. 2. Screening laboratory result indicating HCV GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve (i.e., patient has never received a single dose of any approved or nvestigational regimen) or treatmentexperienced (has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy). 5. Subjects must be non-cirrhotic. Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients: 6. HIV-1 ART naïve with CD4 = 500 cells/mm3 [or CD4+ % =29%] at Screening and plasma HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 40 ;Inclusion criteria: 1. Male or female at least 18 years of age at time of screening. 2. Screening laboratory result indicating HCV GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve (i.e., patient has never received a single dose of any approved or nvestigational regimen) or treatmentexperienced (has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy). 5. Subjects must be non-cirrhotic. Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients: 6. HIV-1 ART naïve with CD4 = 500 cells/mm3 [or CD4+ % =29%] at Screening and plasma HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. History of severe, life-threatening or other significant sensitivity to any component of the study drug. 2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection. ;Exclusion criteria: 1. History of severe, life-threatening or other significant sensitivity to any component of the study drug. 2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection. ;Exclusion criteria: 1. History of severe, life-threatening or other significant sensitivity to any component of the study drug. 2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. 6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the non-inferiority of the SVR12 rates among mono-infected HCV GT1 DAA-naïve subjects (the percentage of subjects achieving a 12- week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks following therapy]) of 12 weeks of treatment with the combination regimen ABT 493/ABT-530 to the historical SVR rate established by current approved standard of care regimens for mono-infected HCV GT1 DAA-naïve subjects (ombitasvir/paritaprevir/ritonavir + dasabuvir ± RBV or SOF/LDV for 12 weeks); ? To show the non-inferiority in SVR12 rates among mono-infected HCV GT1 DAA-naïve subjects of the ABT-493/ABT-530 regimen for 8 weeks versus 12 weeks of treatment; and ? To assess the safety of 8 and 12 weeks of treatment with the combination regimen ABT-493/ABT-530;Secondary Objective: The percentage of subjects with SVR12 among mono-infected HCV GT1 subjects; ? The percentage of subjects with SVR12 among all HCV GT1 subjects; ? The percentage of subjects with SVR12 among subjects with HCV GT1/HIV-1 co-infection; ? The percentage of subjects with SVR12 among prior SOF treatment experienced HCV GT1 subjects; ? The percentages of subjects with on-treatment virologic failure; ? The percentages of subjects with post-treatment relapse.;Primary end point(s): 1. Efficacy of the 12-week treatment duration (Arm A): lower bound of the two-sided 95% confidence interval for the percentage of subjects in Arm A achieving SVR12 is greater than 91% among mono-infected HCV GT1 DAA-naive subjects. 2. Non-inferiority of the 8-week treatment duration (Arm B) to Arm A in SVR12 using a non-inferiority margin of 5% in the per protocol (PP) population among mono-infected HCV GT1 DAA-naïve subjects, as described below. 3. Non-inferiority of Arm B to Arm A in SVR12 using a non-inferiority margin of 5% among mono-infected HCV GT1 DAA-naïve subjects. ;Timepoint(s) of evaluation of this end point: 12 weeks following the last dose of study drug;Main Objective: To show the non-inferi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? the percentage of subjects with SVR12 in the ITT-MS population (ITT mono-infected HCV GT1 subjects); ? the percentage of subjects with SVR12 in the ITT population; ? the percentage of subjects with SVR12 among subjects with HCV GT1/HIV-1 co-infection; ? the percentage of subjects with SVR12 among prior SOF-treatment experienced HCV GT1 subjects; ? the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA = 100 IU/mL after HCV RNA 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA = 100 IU/mL after HCV RNA 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA = 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA = LLOQ at the end of treatment with at least 6 weeks of treatment), and ? the percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; excluding subjects who have been shown to be reinfectedwith further breakdown by relapse versus reinfection based on HCV population sequencing). ;Timepoint(s) of evaluation of this end point: 12 weeks following the last dose of study drug | — |
Countries
Australia, Austria, Belgium, Canada, Chile, Germany, Hungary, Israel, Korea, Republic of, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk;EU Clinical Trials Helpdesk;EU Clinical Trials Helpdesk ;;
Abbvie Ltd.;Abbvie Ltd.;Abbvie Ltd.
Outcome results
None listed