Phase 3
Completed N=177
Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
Hepatitis C · HCV
Source: ClinicalTrials.gov NCT03092375 ↗
Enrolled (actual)
177
Serious AEs
4.0%
Results posted
Feb 2020
Primary outcomePrimary: SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants — 70; 46; 8; 3 Participants
◆ Published Evidence
Established
43citations · ~6 / year
Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy.
Summary
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.
Linked Publications (2)
-
Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy.
-
Linkage of resistance-associated substitutions in GT1 sofosbuvir + NS5A inhibitor failures treated with glecaprevir/pibrentasvir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants |
70; 46; 8; 3 | — |
| PRIMARY Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks |
18; 28; 3; 1 | — |
| PRIMARY Tolerability of G/P +/-RBV |
0; 0; 0; 0 | — |
| SECONDARY Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects) |
1; 1 | — |
| SECONDARY Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects |
5; 2 | — |
| SECONDARY Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects |
2; 0 | — |
| SECONDARY Difference in % of Relapse Between Cirrhotic Arms C & D |
1; 1 | — |
| SECONDARY Difference in SVR12 Rates for 12-wk vs 16 wk |
70; 46; 18; 28 | 0.161 |
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years of age at time of screening.
- A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection.
- Treatment must have been completed at least 1 month prior to Screening Visit.
- 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
- History of severe, life-threatening or other significant sensitivity to any drug.
- 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.
- 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) or anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history of HIV infection.
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- History or presence of liver decompensation.
Data sourced from ClinicalTrials.gov (NCT03092375) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.