18 years HCV genotype 16 HCV RNA gt 1 000 IUmL Treatmentnaïve TN or treatmentexperienced TE without DAA except SOF With or without cirrhosis Chronic kidney disease stage 3b 4 or 5 ID: 772788
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≥ 18 years, HCV genotype 1-6 HCV RNA > 1 000 IU/mLTreatment-naïve (TN) or treatment-experienced (TE) without DAA except SOFWith or without cirrhosisChronic kidney disease stage 3b, 4 or 5 * No HBV or HIV co-infection EXPEDITION-V Study: GLE/PIB in patients with renal impairment Design EXPEDITION-V Gane E. N Engl J Med. 2017; 377:1448-55 GLE/PIB: 100/40 mg 3 tablets QD, administered regardless of timing of dialysis ( hemo- or peritoneal) N = 84 No randomisationOpen label N = 4 N = 13 GLE/PIB W8 GLE/PIB GLE/PIB W12 W16 * stage 3b: eGFR ≥ 30 to < 45 mL/min/1.73m² ; stage 4: eGFR ≥ 15 to < 30 mL ; stage 5: eGFR<15 mL or dialysis-dependent Primary endpoint SVR 12 (HCV < LLOQ) 8W: no cirrhosis, TN (GT 1 to 6) or TE (GT 1,2, 4,-6 12W: cirrhosis, TN (GT 1 to 6) or TE (GT 1,2, 4,-6) 16W: TE, GT3
GLE/PIB 8W N = 84 GLE/PIB 12W N = 13 GLE/PIB 16W N = 4 Median age, years (range) 59 (32-84) 58 (49-87) 62 (54-70) Male, N (%) 51 (61%) 7 (54%) 2 (50%) Race: White, N (%) 62 (74%) 8 (62%) 4(100%) Median BMI, kg/m 2 (range) 24.9 (16.8-53.5) 28.7 (17.1-41.1) 24.3 (17.7-26.8) Genotype: 1 / 2 / 3 / 4 / 5 / 6, % 54 / 31 / 11 / 4 / 0 / 0 69 / 8 / 15 / 8 / 0 / 0 0 / 0 / 100 / 0 / 0 / 0 Median HCV RNA, log10 IU/mL5,9 (3.2-7.2)5.6 (4.8-7.2)6.6 (5.4-6.9)Fibrosis F0-F1 / F2 / F3 / F4, %73 / 6 / 19 / 10 / 0 / 0 / 100100 / 0 / 0 / 0Naïve/experienced, %82 / 1892 / 80 / 100CKD stage 3b / 4 / 5, %5 / 17 / 7923 / 15 / 620 / 25 / 75On dialysis, N (%)66 (79%)8 (62%)3 (75%) Baseline characteristics EXPEDITION-V Gane E. N Engl J Med. 2017; 377:1448-55 EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Primary Endpoint (SVR 12)* 1 patient had missing data and 2 patients discontinued treatment** 1 patient with NS5A Y93H RAS achieved SVR12 EXPEDITION-V Gane E. N Engl J Med. 2017; 377:1448-55 13 84 4 101 98 96 * 100 100 97 100 ** N = % EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Overall N = 101 Any adverse event 55 Grade ≥ 3 adverse event / serious adverse event 13 / 12 * Adverse event leading to discontinuation 2 Adverse events in > 5% of patients Pruritus Hypertension Generalized pruritus Bronchitis Diarrhea 22 22 12 12 10 Laboratory abnormalities AST grade ≥ 3 (5 x ULN) ALT grade ≥ 3 (5 x ULN) Total bilirubin grade 3 (> 3 x ULN) 0 0 0 Adverse events and laboratory abnormalities, % * No AE related to treatment No death observedEXPEDITION-VGane E. N Engl J Med. 2017; 377:1448-55EXPEDITION-V Study: GLE/PIB in patients with renal impairment
EXPEDITION-V Gane E. N Engl J Med. 2017; 377:1448-55 Renal function Of the 24 patients with CKD stage 3b or 4 and with available results, eGFR remained unchanged from screening to end of treatment and post-treatment week 4: 27.1 ± 9.2 vs 26.4 ± 9.8 vs 27.4 ± 11.6 mL/min/1.73m² CKD stage remained unchanged in 22/24 patients with end of treatment results and declined in 2/24 from screening to end of treatment EXPEDITION-V Study: GLE/PIB in patients with renal impairment
EXPEDITION-V Gane E. N Engl J Med. 2017; 377:1448-55 Summary GLE/PIB is highly efficacious in patients with chronic kidney disease stage 3b to 5 with the label recommended treatment durations based on genotype, cirrhosis status and prior treatment experience Treatment was well-tolerated Overall, renal function remained unchanged after treatment in pre-dialysis patients assessed EXPEDITION-V Study: GLE/PIB in patients with renal impairment