IDDF2019-ABS-0210 Preliminary efficacy and safety of 8-week glecaprevir/pibrentasvir in patients with HCV genotype 1–6 infection and compensated cirrhosis: the EXPEDITION-8 study
| Autor: | Federico J. Mensa, Chih-Wei Lin, Roger Trinh, Wan-Long Chuang, Stanley Wang, Christopher Hezode, Robert S. Brown, Eric Cohen, Gretja Schnell, Humberto Aguilar, Lino Rodrigues, Federico Rodriguez-Perez, Yiran B Hu, Barbara Rosado Carrion, Maria Buti, Gabor Horvath |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty education.field_of_study Cirrhosis Nausea business.industry Population Glecaprevir medicine.disease Pibrentasvir Discontinuation 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Internal medicine medicine 030211 gastroenterology & hepatology In patient medicine.symptom education business Adverse effect |
| Zdroj: | Clinical Hepatology. |
| DOI: | 10.1136/gutjnl-2019-iddfabstracts.284 |
| Popis: | Background The pangenotypic direct-acting antivirals glecaprevir (identified by AbbVie and Enanta) coformulated with pibrentasvir (G/P) are approved to treat chronic HCV genotype (GT) 1–6 infection. Eight-week G/P achieved high SVR12 rates in Phase 2 and 3 studies, but was not studied in patients with compensated cirrhosis. Based on the high SVR12 rates demonstrated in treatment-naive patients with HCV GT1–6 infection and compensated cirrhosis treated with 12-week G/P, this study evaluates the efficacy and safety of an 8-week G/P treatment duration in that population. Methods EXPEDITION-8 is an ongoing phase 3, non-randomized, single arm, open-label, multicenter study conducted in adults with chronic HCV GT1–6 infection with compensated cirrhosis who are HCV treatment-naive. A recently approved protocol amendment enabled the inclusion of HCV GT3-infected patients, who are not included in this analysis. G/P (300 mg/120 mg) is being dosed orally once-daily with food for 8 weeks. The primary efficacy endpoint is the SVR12 rate. Secondary endpoints are the on-treatment virologic failure and relapse rates. Adverse events and clinical laboratory abnormalities are being monitored in all patients. Results In total, 280 treatment-naive patients with compensated cirrhosis have enrolled and are included in the analysis. To date, 116 patients have completed the post-treatment week 12 visit; (figure 1) shows preliminary efficacy results for those with available post-treatment week 4 and/or 12 data. No virologic failures have occurred. Adverse events (AEs) have been mostly mild, with the most common (at least 5%) AEs being pruritus and fatigue (both 9%), headache (7%) and nausea (6%). No AEs have led to discontinuation of G/P; 5 serious AEs have occurred, none of which were deemed related to G/P. Conclusions In this ongoing study, G/P for 8 weeks in treatment-naive patients with HCV infection and compensated cirrhosis has been well-tolerated and achieved high rates of SVR, with no virologic failures to date. Updated efficacy and safety data will be presented at the meeting. |
| Databáze: | OpenAIRE |
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