Sustained virologic response after therapy with the HCV protease inhibitor narlaprevir in combination with peginterferon and ribavirin is durable through long-term follow-up

• Published in: Journal of viral hepatitis 2013-04, Vol.20 (4), p.e78-e81
• Main Authors: Hotho, D. M., de Bruijne, J., Spaan, M., Treitel, M. A., Boonstra, A., de Knegt, R. J., Janssen, H. L. A., Reesink, H. W.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antiviral Agents - administration & dosage; Dipeptides - administration & dosage; direct acting antivirals; Double-Blind Method; Drug Therapy, Combination - methods; durable; Female; Follow-Up Studies; Hepacivirus - isolation & purification; hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Interferon-alpha - administration & dosage; Male; Middle Aged; Placebos - administration & dosage; Polyethylene Glycols - administration & dosage; Recombinant Proteins - administration & dosage; Ribavirin - administration & dosage; RNA, Viral - blood; Sulfones - administration & dosage; sustained virologic response; Treatment Outcome; Viral Load
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/jvh.12012

Summary 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.