A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)

AbbVie100 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Hepatitis C HCV Hepatitis C Virus

Interventions

glecaprevir/pibrentasvirDRUG

Tablet; glecaprevir coformulated with pibrentasvir

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, at least 18 years of age at time of screening. * Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection. * Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening. * Subjects must be documented as non-cirrhotic. * Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine. Exclusion Criteria: * Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. * Clinical history of fibrosing cholestatic hepatitis post-transplant. * Re-transplantation of the liver or kidney. * Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening. * History of post-transplant complications related to hepatic or renal vasculature.

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir \[SOF\]/ledipasvir \[LDV\] + ribavirin \[RBV\] OR SOF + daclatasvir \[DCV\] + RBV). Participants with missing data after backward imputation were counted as non-responders.

Time frame: 12 weeks after the last dose of study drug (up to 24 weeks)

Secondary Outcomes

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

Time frame: Up to 12 weeks

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Time frame: From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)

Data from ClinicalTrials.gov

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