title: Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus.
abstract: The optimal retreatment strategy for hepatitis C virus (HCV) genotype 1-infected patients who fail direct-acting antiviral (DAA)-based regimens remains unknown. In this phase 2, open-label study conducted at a single center in the United States, patients with HCV genotype 1 infection who previously failed to achieve sustained virological response (SVR) on a DAA-based regimen were randomized to receive treatment with a fixed-dose combination tablet of sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin (RBV) for 12 weeks. Patients were stratified by their cirrhosis and past nonstructural protein (NS) 5A inhibitor exposure. The primary efficacy endpoint was the proportion of patients with SVR at 12 weeks after treatment (SVR12). SVR12 was achieved by 24 of 24 patients (100%; 95% confidence interval [CI], 86-100) receiving sofosbuvir-velpatasvir-voxilaprevir alone and 24 of 25 (96%; 95% CI, 80-100) receiving the same treatment with RBV. None of the patients discontinued sofosbuvir-velpatasvir-voxilaprevir therapy because of an adverse event (AE). The most commonly reported AEs with sofosbuvir-velpatasvir-voxilaprevir alone were diarrhea and bronchitis; and with sofosbuvir-velpatasvir-voxilaprevir plus RBV were fatigue, anemia, gastroenteritis, and nausea.
  
  
  
  A fixed-dose combination of sofosbuvir-velpatasvir-voxilaprevir was well tolerated and effective at achieving virological response in patients with HCV genotype 1 infection and past DAA treatment experience. (Hepatology 2017;65:1803-1809).
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Eric
authors.initials: E
authors.lastname: Lawitz
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Fred
authors.initials: F
authors.lastname: Poordad
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wells
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Hyland
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: Yin
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: Hadas
authors.initials: H
authors.lastname: Dvory-Sobol
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: Luisa M
authors.initials: LM
authors.lastname: Stamm
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Brainard
authors.affiliation: Gilead Sciences, Inc, Foster City, CA.
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Carmen
authors.initials: C
authors.lastname: Landaverde
authors.affiliation: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Julio
authors.initials: J
authors.lastname: Gutierrez
mesh_terms: D000328:Adult; D000368:Aged; D000621:Aminoisobutyric Acids; D000998:Antiviral Agents / Q000008:administration & dosage; D002219:Carbamates / Q000008:administration & dosage*; D016001:Confidence Intervals; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics* / Q000503:physiopathology; D006576:Heterocyclic Compounds, 4 or More Rings / Q000008:administration & dosage*; D006801:Humans; D047029:Lactams, Macrocyclic; D007930:Leucine / Q000031:analogs & derivatives; D047028:Macrocyclic Compounds / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D011446:Prospective Studies; D011810:Quinoxalines; D012254:Ribavirin / Q000008:administration & dosage*; D012720:Severity of Illness Index; D000069474:Sofosbuvir / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult; D001562:Benzimidazoles; D001578:Benzopyrans
chemical_list: D000621:Aminoisobutyric Acids; D000998:Antiviral Agents; D002219:Carbamates; D003521:Cyclopropanes; D006576:Heterocyclic Compounds, 4 or More Rings; D047029:Lactams, Macrocyclic; D007930:Leucine; D047028:Macrocyclic Compounds; D011392:Proline; D011810:Quinoxalines; D012254:Ribavirin; D000069474:Sofosbuvir; D013449:Sulfonamides; C000619503:voxilaprevir; C000604171:velpatasvir; D001562:Benzimidazoles; D001578:Benzopyrans