ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus (HCV)

Treatments: Drug: ABT-333; Drug: ribavirin; Drug: ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT02517528

M14-491

Details and patient eligibility

About

This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.

Enrollment: 104 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.

2. Chronic HCV-infection prior to study enrollment.

3. Screening laboratory result indicating HCV genotype 1b-infection.

4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.

5. Per local standard practice, documentation of cirrhosis by one of the following methods:

   • Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,
   • FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.

Exclusion criteria

1. HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.

2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).

3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

5. Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.

6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)

7. Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:

   • Hemochromatosis
   • Alpha-1 antitrypsin deficiency
   • Wilson's disease
   • Autoimmune hepatitis
   • Alcoholic liver disease
   • Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.

8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Experimental group

Description:

ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks

Treatment:

Drug: ABT-450/r/ABT-267

Drug: ribavirin

Drug: ABT-333