Efficacy of ledipasvir/sofosbuvir with or without ribavirin for 12 weeks in genotype 1b HCV patients previously treated with a nonstructural protein 5A inhibitor‐containing regimen. Issue 10 (4th May 2018)

• Record Type: Journal Article
• Authors: Ikeda, Hiroki; Watanabe, Tsunamasa; Shimizu, Hirohito; Hiraishi, Tetsuya; Kaneko, Rena; Baba, Toshiyuki; Takahashi, Hideaki; Matsunaga, Kotaro; Matsumoto, Nobuyuki; Yasuda, Hiroshi; Okuse, Chiaki; Iwabuchi, Shogo; Suzuki, Michihiro; Itoh, Fumio
• Is Part Of: Hepatology research. Volume 48:Issue 10(2018)
• Page Start: 802
• Page End: 809
• Publication Date: 2018-05-04
• Subjects: hepatitis C virus -- ledipasvir -- nonstructural protein 5A inhibitor -- P32 deletion -- retreatment -- ribavirin -- sofosbuvir; Liver -- Diseases -- Periodicals; Liver Diseases -- Periodicals; Foie -- Maladies -- Périodiques; 616.362
• DOI: 10.1111/hepr.13074
• Languages: English
• ISSNs: 1386-6346

Abstract

Abstract : Aim: The therapeutic benefit of adding ribavirin (RBV) to 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) for patients who experienced failure of a previous nonstructural protein (NS) 5A inhibitor‐containing regimen is unclear. Methods: A total of 29 genotype 1b HCV patients who had failed prior daclatasvir (DCV) plus asunaprevir (ASV) treatment were retreated for 12 weeks of LDV/SOF, with or without RBV. Antiviral efficacy and predictive factors associating with a sustained virological response at 24 weeks (SVR24) were evaluated retrospectively. Results: SVR24 was achieved in 67% (10/15) of patients who received LDV/SOF with, and 64% (9/14) without, RBV. The SVR24 rates were 80% in patients with, and 58% without, mild fibrosis (FIB‐4 < 3.25). The SVR24 rate was lower with unfavorable IL28B rs8099917 SNP genotypes; specifically, the TT, TG and GG had SVR24 rates of 78%, 50% and 40%. The SVR24 rate was lower with a poor response to prior DCV plus ASV, where relapse, viral breakthrough and no response had SVR24 rates 71%, 58% and 0%. The SVR24 rate was lower with the number of NS5A resistance‐associated substitutions (RAS), where 2, 3, 4 and 5 RAS had SVR24 rates of 78%, 67%, 50% and 0%. A patient with an NS5A‐P32 deletion, which shows resistance to next‐generation NS5A inhibitors, was retreated with LDV/SOF with RBV and achieved SVR24. Conclusions: The addition of RBV to 12 weeks of LDV/SOF has little therapeutic benefit when retreating patients in whom a prior NS5A inhibitor‐containing regimen had failed.