Objective:
Hepatitis C virus (HCV) infection is a significant health problem for patients with bleeding disorders due to the absence of highly effective HCV screening of blood products prior to the early 1990s. The aim of this analysis was to evaluate the safety and efficacy of the ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) among patients with a history of bleeding disorders.
Methods:
Data from 11 Phase 2 and 3 registrational studies conducted across 18 countries worldwide were included. HCV genotype (GT) 1–6-infected patients with compensated liver disease received G/P for 8, 12 or 16 weeks. The sustained virologic response 12 weeks after end of treatment (SVR12) rate and safety are reported.
Results:
Sixty-two patients with history of bleeding disorders were identified, the most common disorder being hemophilia (37%, [23/62]). The remaining 63% (39/62) of patients had other disorders, including Von Willebrand disease. The cohort was 76% (47/62) male and 89% (54/62) white race with a mean age of 50.5 years (standard deviation ± 12.1). Additionally, 23% (14/62) had compensated cirrhosis. The HCV genotype breakdown among the patients was: GT1, 39%; GT2, 18%; GT3, 21%; GT4, 13%, GT5, 8%; GT6, 2%. In addition to bleeding disorders, a medical history of anemia was reported in 16% (10/62) of patients. SVR12 was achieved in 100% (62/62) of patients. Adverse events (AEs) were reported in 68% (42/62) of patients, and 37% (23/62) of patients experienced an AE assessed as possibly related to study drugs. Serious AEs (SAE) were reported in 3 (5%) patients, none being assessed as related to the study drugs; 2 of these SAEs (1 per patient) were associated with the underlying bleeding disorder. There was 1 (2%) AE leading to discontinuation of study drug (dyspepsia); the patient went on to achieve SVR12. There was 1 (2%) non-treatment emergent death reported, occurring 60 days after the last dose of study drug. Post-baseline grade ≥3 laboratory abnormalities occurred in 3 patients: one each in hemoglobin, aspartate aminotransferase and bilirubin (all n = 1; 2%), without concurrent elevations in alanine aminotransferase.
Conclusions:
G/P achieved a 100% SVR12 rate in patients with a history of bleeding disorders and demonstrated a favorable safety profile, thus providing support for treatment of chronic HCV infection with the G/P regimen in this patient population.