A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

AbbVie64 enrolled

Overview

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

The study population for Part 1, the PK study, included GT1-infected participants who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or GT4-infected participants who were TN or interferon (\[IFN\] or Pegylated-interferon alfa-2a or 2b \[pegIFN\] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Infection

Interventions

Ombitasvir/paritaprevir/ritonavirDRUG

Film-coated tablet for oral use

DasabuvirDRUG

Film-coated tablet for oral use

RibavirinDRUG

Film-coated tablet for oral use

Ombitasvir mini tablet

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening 2. HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2 3. Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country Exclusion Criteria: 1. Female participant who is pregnant, breastfeeding or is considering becoming pregnant 2. Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration. 3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test 4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration

Locations (21)

UCSF Benioff Childrens Hosp /ID# 136774

San Francisco, California, United States

Outcomes

Primary Outcomes

Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

Time frame: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing.

Time frame: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

Time frame: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

Time frame: At Week 2

Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing.

Time frame: At Week 2

Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.

Time frame: At Weeks 2 and 8

Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)

Data from ClinicalTrials.gov

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Secondary Outcomes

Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) \< lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.

Time frame: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) \< lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug.

Time frame: 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)

Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT \> ULN at baseline.

Time frame: 12 or 24 weeks after starting study drug, depending on treatment duration