Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

University of Florida

Status and phase: Completed; Phase 3

Conditions: Hepatitis C; HCV

Treatments: Drug: Ribavirin 200Mg Tablet; Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03092375

OCR16260 (Other Identifier)

B16-439

Details and patient eligibility

About

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

Full description

The primary purpose of this study is to compare the efficacy and safety of glecaprevir and pibrentasvir (G/P) for 12 weeks to G/P for 16 weeks in non-cirrhotic NS5A (non-structural protein 5a)-inhibitor plus sofosbuvir ± RBV (Ribavirin) treatment-experienced adults with HCV genotype 1 (GT1) infection, and to compare the efficacy and safety of G/P with RBV for 12 weeks to G/P without RBV for 16 weeks in NS5A-inhibitor plus sofosbuvir (SOF) ± RBV treatment-experienced adults with compensated cirrhosis and GT1 infection.

Enrollment: 177 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female at least 18 years of age at time of screening.
2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection.
3. Treatment must have been completed at least 1 month prior to Screening Visit.
4. Screening laboratory result indicating chronic HCV GT1 infection. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements and must voluntarily sign and date an informed consent.

Exclusion criteria

1. History of severe, life-threatening or other significant sensitivity to any drug.
2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
3. 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.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history of HIV infection.
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
6. History or presence of liver decompensation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 4 patient groups

Arm A: G/P 300 mg/120 mg QD for 12 Wks

Experimental group

Description:

Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.

Treatment:

Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

Arm B: G/P 300 mg/120 mg QD for 16 Wks

Experimental group

Description:

Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)

Treatment:

Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks

Experimental group

Description:

Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)

Treatment:

Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

Drug: Ribavirin 200Mg Tablet

Arm D: G/P 300 mg/120 mg QD for 16 Wks

Experimental group

Description:

Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)

Treatment:

Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg