Efficacy and safety of simeprevir in combination with peginterferon and ribavirin for patients with hepatitis C genotype 1 infection: A meta-analysis of randomized trials

Abstract

Background and aim: A simeprevir (SMV)-based regimen has shown promising results in treating chronic hepatitis C virus (HCV) infection. This meta-analysis aimed to assess the efficacy and safety of simeprevir for treating HCV genotype 1 infection.Methods: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, along with the reference lists of retrieved articles. The meta-analysis only included randomized controlled trials (RCTs) that compared the efficacy and safety of addition of SMV to peginterferon (PegIFN) and ribavirin (RBV) (triple regimen) with PegIFN/RBV alone (dual regimen) in treating chronic HCV genotype 1 infection.Results: A total of seven RCTs involving 2,301 patients were included. The triple regimen had a higher pooled sustained virologic response (SVR) rate [odds ratio (OR) = 4.57; 95% confidence interval (CI): 3.34-6.27; p < 0.001)] and lower pooled relapse rate [relative risk (RR) = 0.41; 95% CI: 0.33-0.50; p < 0.001] than the dual regimen had. The pooled incidence of adverse events (AEs) was comparable between the two regimens (RR = 1.01; 95% CI: 0.99-1.03; p = 0.339), whereas the incidence of serious AEs in the triple regimen was lower (RR = 0.7; 95% CI: 0.50-0.98; p < 0.05). Conclusions:The meta-analysis demonstrates that the addition of SMV to pegIFN and RBV is effective and well-tolerated in treating chronic HCV genotype 1 infection, with a low incidence of AEs.

Are There Still Difficult-to-Treat Patients with Chronic Hepatitis C in the Era of Direct-Acting Antivirals?

“…Triple therapy containing next-generation DAA, simeprevir (SMV), daclatasvir (DCV), or sofosbuvir (SOF), significantly improved the treatment response while reducing the therapy duration, but safety issues related to IFN remained [13][14][15]. The next step in the revolution of the therapy of chronic hepatitis C was the introduction of all-oral interferon-free regimens with the registration of pangenotypic options as the latest development.…”

Real‐world efficacy and safety of ombitasvir, paritaprevir/r+dasabuvir+ribavirin in genotype 1b patients with hepatitis C virus cirrhosis

“…Hepatitis C virus was discovered 27 years ago and this chronic infection is the main cause of end‐stage liver disease, hepatocellular carcinoma, and other liver‐related deaths . Approximately 180 million people from around the world are chronically infected with the HCV and the individual impact ranges from minimal histological changes to fibrosis and cirrhosis . Hepatitis C‐induced fibrosis in patients who attained sustained viral response (SVR) has a low, but real risk of hepatocellular carcinoma .…”

Viral hepatitis C treatment shortening – what is the limit?

“…The combination of PegIFNa, RBV and SMV, a protease inhibitor, was registered for treatment of GT1 and GT4 infected patients for 48 weeks with possible shortening to 24 weeks in treatment-naïve patients and relapsers after previous failure of PegIFNa + RBV therapy. Alongside the scope for using this regimen in GT4 infected patients, both the efficacy and safety profile were much more favorable in comparison to TVR and BOC-containing triple therapy [10]. However, the real revolution in the CHC treatment was the advent of SOF, a new DAA class representative, a HCV polymerase inhibitor (nonstructural protein 5B, NS5B), registered for patients infected with all HCV genotypes [11].…”