Study on Glecaprevir/Pibrentasvir in Patients with Renal Impairment
This study examines the efficacy and safety of glecaprevir/pibrentasvir in HCV patients with renal impairment. Results show high SVR12 rates across all major HCV genotypes, well-tolerated treatment, and no virologic failures, making it a promising option for this challenging population.
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EXPEDITION-4 Study: glecaprevir/pibrentasvir in patients with renal impairment Design Single arm Open label W12 18 years, HCV genotype 1 to 6 HCV RNA 1000 IU/mL eGFR (MDRD) < 30 mL/min Treatment-na ve or treatment- experienced with IFN/PEG-IFN RBV or SOF + RBV PEG-IFN (exclusion of genotype 3 with previous HCV treatment) Compensated cirrhosis allowed No HBV or HIV co-infection Acute renal failure excluded N = 104 GLE/PIB SVR12 GLE/PIB : 100/40 mg 3 tablets QD Objective SVR12(HCV RNA < 15 IU/mL), with 2-sided 95% CI, by ITT EXPEDITION-4 Gane E. NEJM 2017; 377:1448-55
EXPEDITION-4 Study: glecaprevir/pibrentasvir in patients with renal impairment Baseline characteristics and SVR12 GLE/PIB , N = 104 Mean age, years Female, % Race : White / Black / Asian, % Median BMI, kg/m2 Genotype 1a / 1b / 1 other / 2 / 3 / 4 / 5 / 6, % Median HCV RNA, log10IU/mL Compensated cirrhosis, % Treatment-experienced, % (IFN-based / SOF-based) Chronic kidney disease stage, % eGFR 15-29 ml/min/1.73 m2 eGFR < 15 ml/min/1.73 m2(hemodialysis) Baseline polymorphism, % NS3 only NS5A only NS3 + NS5A 57 24 62 / 24 / 9 26 22 / 28 / 2 / 16 / 11 / 19 / 1 / 1 5.9 19 42 (95 / 5) 13 87 (82) 1 25 0 102/104 (98% [95% CI : 95-100]) [1 discontinuation, 1 LTFU] SVR12, by ITT, n/N (%) EXPEDITION-4 Gane E. NEJM 2017; 377:1448-55
EXPEDITION-4 Study: glecaprevir/pibrentasvir in patients with renal impairment Adverse events and laboratory abnormalities, % GLE/PIB , N = 104 Any adverse event Serious adverse event related to study drug Adverse event leading to discontinuation Death Adverse events in > 10% of patients, % Pruritus Fatigue Nausea Laboratory abnormalities, % Hemoglobin grade 3 (6.5-8 g/dL) AST grade 2 (> 3 x ULN) ALT grade 2 (> 3 x ULN) Total bilirubin grade 3 ( > 3 x ULN) 71 24 0 4 * 1 ** 20 14 12 5 0 0 1 * Diarrhea ; pruritus ; pulmonary edema, hypertensive cardiomyopathy with congestive failure ; hypertensive crisis ** Serious adverse event of cerebral hemorrhage, not related to study drug, at post-treatment W2 EXPEDITION-4 Gane E. NEJM 2017; 377:1448-55
EXPEDITION-4 Study: glecaprevir/pibrentasvir in patients with renal impairment Summary GLE/PIB (300 mg/120 mg QD) achieved high efficacy in patients with stage 4 or 5 chronic kidney disease and HCV infection 98% ITT SVR12rate across all major HCV genotypes No virologic failures GLE/PIB was well tolerated with a favorable safety profile in this difficult-to-treat population: No drug-related serious adverse event No grade 2 laboratory abnormalities in ALT or AST EXPEDITION-4 Gane E. NEJM 2017; 377:1448-55
