Simeprevir-Based Triple Therapy with Reduced Doses of Pegylated Interferon α-2a Plus Ribavirin for Interferon Ineligible Patients with Genotype 1b Hepatitis C Virus
Hideyuki Tamai,
Yoshiyuki Ida,
Akira Kawashima,
Naoki Shingaki,
Ryo Shimizu,
Kosaku Moribata,
Tetsushi Nasu,
Takao Maekita,
Mikitaka Iguchi,
Jun Kato,
Taisei Nakao,
Masayuki Kitano
Affiliations
Hideyuki Tamai
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Yoshiyuki Ida
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Akira Kawashima
Department of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan
Naoki Shingaki
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Ryo Shimizu
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Kosaku Moribata
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Tetsushi Nasu
Department of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan
Takao Maekita
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Mikitaka Iguchi
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Jun Kato
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Taisei Nakao
Department of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan
Masayuki Kitano
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Background/AimsThe 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%.Conclusion : sSimeprevir-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.