ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

Treatments: Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02517515

M13-767

Details and patient eligibility

About

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Enrollment: 650 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
• Chronic hepatitis C virus (HCV) infection prior to study enrollment.
• Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
• Per local standard practice, documented absence of cirrhosis.
• Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
• Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.

Exclusion criteria

• HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
• Any current or past clinical evidence of cirrhosis.
• Any primary cause of liver disease other than chronic HCV infection.
• Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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650 participants in 2 patient groups

Double-blind 3-DAA

Experimental group

Description:

Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Treatment:

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Double-blind Placebo Followed by Open-label 3-DAA

Experimental group

Description:

Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Treatment:

Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir