Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (MAGELLAN-3)
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Chronic Hepatitis C (HCV), HCV Genotype 1 (HCV GT1), HCV Genotype 2 (HCV GT2), HCV Genotype 3 (HCV GT3), HCV Genotype 4 (HCV GT4), HCV Genotype 5 (HCV GT5), HCV Genotype 6 (HCV GT6), Compensated Cirrhosis, Non-cirrhotics, Virologic failure
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
- Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
- Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
- Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
- Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.
Exclusion Criteria:
- History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
- Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg).
- Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.
- Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
- Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.
Sites / Locations
- Digestive Health Specialists of the Southeast /ID# 155719
- Ruane Clinical Research Group /ID# 155714
- Digestive Disease Associates - Baltimore /ID# 155713
- Henry Ford Health System /ID# 155720
- University of Buffalo /ID# 155721
- Carolinas Center For Liver Dis /ID# 155731
- Gastro One /ID# 155729
- TX Liver Inst, Americ Res Corp /ID# 157881
- Royal Brisbane and Women's Hospital /ID# 200944
- The Royal Melbourne Hospital /ID# 155727
- University of Calgary /ID# 155726
- Beijing Di Tan Hospital, Capital Medical University /ID# 218496
- West China Hospital, Sichuan University /ID# 217613
- The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
- Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
- Zentru fur HIV und Heaptogastroenterologie /ID# 155592
- Asklepios Klinik St. Georg /ID# 155733
- Samsung Medical Center /ID# 214844
- Auckland City Hospital /ID# 200945
- Waikato Hospital /ID# 155728
- Dunedin Hospital /ID# 155591
- Medical Company Hepatolog /ID# 214314
- Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
- Duplicate_Karolinska Univ Sjukhuset /ID# 155735
- Inselspital, Universitätsspital Bern /ID# 155716
- Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.