title: Sustained virologic response after therapy with the HCV protease inhibitor narlaprevir in combination with peginterferon and ribavirin is durable through long-term follow-up.
abstract: Achievement of a sustained virologic response (SVR) after peginterferon (PEG-IFN) and ribavirin (RBV) treatment is considered to be a marker for the cure of chronic hepatitis C virus (HCV) infection. Long-term follow-up of patients with SVR after treatment with a direct acting antiviral has not yet been described. We used a randomized placebo-controlled, double-blind, two-period phase 1b trial that was conducted in 40 HCV genotype 1 (treatment-naïve and treatment-experienced)-infected patients. Nineteen patients achieved SVR after treatment with the HCV protease inhibitor narlaprevir followed by PEG-IFN/RBV. In these patients, HCV-RNA tests were scheduled at 3, 6, 12 and 24 months after end of treatment. Patients were followed for a median of 27 months (range 15-32) after end of treatment with a median number of follow-up visits of 4 (range 3-8). All patients remained HCV-RNA negative over time. SVR achieved following narlaprevir and PEG-IFN/RBV-therapy was durable up to 32 months after the end of treatment.
authors.affiliation: Departments of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
authors.forename: D M
authors.initials: DM
authors.lastname: Hotho
authors.forename: J
authors.initials: J
authors.lastname: de Bruijne
authors.forename: M
authors.initials: M
authors.lastname: Spaan
authors.forename: M A
authors.initials: MA
authors.lastname: Treitel
authors.forename: A
authors.initials: A
authors.lastname: Boonstra
authors.forename: R J
authors.initials: RJ
authors.lastname: de Knegt
authors.forename: H L A
authors.initials: HL
authors.lastname: Janssen
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003521:Cyclopropanes; D004151:Dipeptides / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D007930:Leucine / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011392:Proline / Q000031:analogs & derivatives; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*; D013450:Sulfones / Q000008:administration & dosage*; D016896:Treatment Outcome; D014508:Urea; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D003521:Cyclopropanes; D004151:Dipeptides; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D010919:Placebos; D012367:RNA, Viral; D011994:Recombinant Proteins; D013450:Sulfones; C552043:narlaprevir; D011092:Polyethylene Glycols; D012254:Ribavirin; D014508:Urea; D011392:Proline; C417083:peginterferon alfa-2b; D007930:Leucine