Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study)
| Autor: | Anne Torbeyns, Misti Linaberry, Fiona McPhee, Eric Hughes, Eugene S. Swenson, Paul Y. Kwo, Steve Flamm, Mark S. Sulkowski, Zeid Kayali, Eric Lawitz, Philip D. Yin |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Daclatasvir Indoles Pyrrolidines Sofosbuvir Sustained Virologic Response Hepatitis C virus Hepacivirus medicine.disease_cause Gastroenterology Antiviral Agents Virus 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine Clinical endpoint Medicine Humans 030212 general & internal medicine NS5B Beclabuvir Sulfonamides Hepatology business.industry Imidazoles Valine Benzazepines Hepatitis C Chronic Middle Aged Viral Load Isoquinolines United States chemistry Asunaprevir 030211 gastroenterology & hepatology Drug Therapy Combination Female Carbamates business medicine.drug |
| Zdroj: | Liver international : official journal of the International Association for the Study of the Liver. 37(6) |
| ISSN: | 1478-3231 |
| Popis: | Background & Aims The phase 2, FOURward study (NCT02175966) investigated short-duration therapy (4/6 weeks) with four direct-acting antivirals (DAAs) with distinct mechanisms of action in patients infected with hepatitis C virus (HCV) genotype-1. Methods Non-cirrhotic patients were randomized 1:1 to DCV-TRIO (fixed-dose daclatasvir 30 mg, asunaprevir 200 mg and beclabuvir 75 mg) twice-daily + sofosbuvir 400 mg once-daily for 4 or 6 weeks. The primary endpoint was sustained virological response at post-treatment Week 12 (SVR12). Patients without SVR12 were offered retreatment based on the DAA resistance profile at failure; patients with resistance to ≤1 DCV-TRIO component received DCV-TRIO + RBV for 12 weeks. Results Twenty-eight patients with HCV genotype-1 were enrolled; 79% had genotype-1a infection and median baseline HCV-RNA levels were high (9 × 106 IU/mL). Most patients had undetectable HCV-RNA at end of treatment (96% [n=27/28]); however, relapse occurred in 77% (n=10/13) and 43% (n=6/14) treated for 4 and 6 weeks, leading to SVR12 rates of 29% (n=4/14) and 57% (n=8/14) respectively. SVR12 was higher in patients with lower baseline HCV-RNA ( |
| Databáze: | OpenAIRE |
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