Safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in hepatitis C genotype 1 patients including those with decompensated cirrhosis who failed prior treatment with simeprevir/sofosbuvir

Abstract

Single tablet fixed-dose combination LDV/SOF ± RBV is efficacious and well tolerated in patients who previously failed treatment with SIM/SOF, including those with decompensated cirrhosis and recurrent hepatitis C following liver transplantation.

Management of patients with chronic hepatitis C failing repeated courses of interferon‐free direct acting antiviral combination therapy

“…Most published data have focused on retreatment of patients who failed one IFN‐free DAA therapy. The 21% failure rate in the present study is in the range of that reported in other studies . Before controlled trials with SOF/VEL/VOX and G/P have become available the evidence for retreatment of patients who had failed IFN‐free DAA therapy was based on GT1 patients retreated with SOF/LDV plus RBV for 12 to 24 weeks after relapse to SOF containing IFN‐free regimens in clinical trials .…”

Editorial: retreatment of DAA‐failures—no problem at all?

“…They included a relatively large population of genotype 1 patients who did not respond to sofosbuvir + simeprevir. Of note, they confirm that switching from a protease inhibitor (simeprevir) to a NS5A‐inhibitor (ledipasvir) might be sufficient in the majority of these patients reaching a similar efficacy as reported for boceprevir‐ and telaprevir‐experienced patients . Their results are even more impressive when considering that 87% of the study cohort had liver cirrhosis .…”

“…Of note, they confirm that switching from a protease inhibitor (simeprevir) to a NS5A‐inhibitor (ledipasvir) might be sufficient in the majority of these patients reaching a similar efficacy as reported for boceprevir‐ and telaprevir‐experienced patients . Their results are even more impressive when considering that 87% of the study cohort had liver cirrhosis . Most recently, the fixed dose combination of sofosbuvir, velpatasvir and voxilaprevir has been approved for retreatment of DAA failures in the USA and Europe.…”

“…However, due to the need for a protease inhibitor this regimen is not suitable for patients with decompensated liver cirrhosis . Therefore, the most important finding of Modi et al might be the high efficacy that was observed in the vulnerable group of patients with decompensated liver disease . Current EASL guidelines recommend a 24 weeks course of treatment with RBV in all DAA‐experienced patients with F3 fibrosis or liver cirrhosis to ensure high SVR rates .…”

“…It is quite interesting that the good results by Modi et al were achieved despite the fact that most patients were either treated for only 12 weeks or without RBV. The main limitation of their study is certainly the lack of data on the presence of RAS . Therefore, it remains unclear, whether a favourable RAS profile has contributed to the excellent treatment results.…”