Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487199

M15-461

2015-002012-33 (EudraCT Number)

Details and patient eligibility

About

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
• Chronic kidney disease stage 4 or stage 5.

Exclusion criteria

• Females who are pregnant or breastfeeding
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
• HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
• Abnormal laboratory tests
• Current enrollment in another investigational study
• Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
• Current treatment with a direct acting antiviral agent (DAA) containing regimen
• Any evidence of liver cirrhosis or liver cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

HCV GT1a (3-DAA)

Experimental group

Description:

Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (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

HCV GT4 (2-DAA)

Experimental group

Description:

Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) for 12 weeks.

Treatment:

Drug: ombitasvir/paritaprevir/ritonavir