Gut Liver.  2017 Jul;11(4):551-558. 10.5009/gnl16525.

Simeprevir-Based Triple Therapy with Reduced Doses of Pegylated Interferon α-2a Plus Ribavirin for Interferon Ineligible Patients with Genotype 1b Hepatitis C Virus

• Tamai H
• Ida Y
• Kawashima
• Shingaki N
• Shimizu R
• Moribata K
• Nasu T
• Maekita T
• Iguchi M
• Kato J
• Nakao T
• Kitano M

• KMID: 2412236
• DOI: http://doi.org/10.5009/gnl16525

Abstract

BACKGROUND/AIMS
The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR).
METHODS
One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose).
RESULTS
The patients' median age was 70 years, and 70 patients were cirrhotic. Three patients (3%) discontinued treatment due to adverse events. The SVR rate was 64%. Factors that significantly contributed to the SVR included the γ-glutamyl transferase and α-fetoprotein levels, interleukin-28B (IL28B) polymorphism status, and the level and reduction of HCV RNA at weeks 2 and 4. The multivariate analysis showed that the IL28B polymorphism status was the only independent factor that predicted the SVR, with a positive predictive value of 77%.
CONCLUSIONS
Simeprevir-based triple therapy with reduced doses of PEG-IFN and ribavirin was safe and effective for IFN ineligible patients infected with genotype 1b HCV. IL28B polymorphism status was a useful predictor of the SVR.

Keyword

Hepacivirus; Pegylated interferon; Ribavirin; Simeprevir; Interleukin-28B

MeSH Terms

Aged
Antiviral Agents/*administration & dosage
Drug Therapy, Combination
Female
Genotype
Hepacivirus/*drug effects/genetics
Hepatitis C/*drug therapy/genetics/virology
Humans
Interferon-alpha/*administration & dosage
Male
Polyethylene Glycols/*administration & dosage
Prospective Studies
Recombinant Proteins/administration & dosage
Ribavirin/*administration & dosage
Simeprevir/*administration & dosage
Sustained Virologic Response
Antiviral Agents
Interferon-alpha
Recombinant Proteins
Polyethylene Glycols
Ribavirin
Simeprevir