Safety and efficacy of sofosbuvir/ledipasvir and sofosbuvir/daclatasvir in the treatment of hepatitis C in patients with decompensated cirrhosis

Abstract

Background Hepatitis C virus (HCV)-related decompensated cirrhosis is a severe life-threatening illness. The safety of direct-acting antivirals (DAAs) has opened a gate of hope for that subgroup of patients who were previously contraindicated for interferon therapy. Objective We aimed at the investigation of the safety and efficacy of different DAAs regimens in the treatment of HCV-related decompensated cirrhosis patients, to determine sustained virological response (SVR)12 rates and to analyze the factors associated with response. Methods A retrospective, single-center study including HCV-related decompensated cirrhosis patients who received DAAs. Demographic, laboratory and clinical data were analyzed. The SVR12 rate was the primary outcome measure. Secondary outcomes included the predictors of response, changes in the baseline model for end-stage liver disease and child-turcotte-pugh (CTP) scores, and fibroindices (APRI and fibrosis-4 index) at 12 weeks after treatment. Results In total, 145 eligible patients (141 with CTP class B and 4 with class C) were enrolled in this study. SVR12 was achieved by 88.06% (118/134) of efficacy population on different DAAs regimens, Treatment was discontinued in 11 patients because of severe side effects without any deaths. Younger age showed a significant positive association with SVR12. Conclusions DAAs can be used for the treatment of HCV-related decompensated liver disease, with acceptable SVR12 rates and safety profiles.

End Treatment Response and Sustained Viral Response in Patients With Hepatitis C Virus Receiving Sofosbuvir and Daclatasvir

“…In this study increasing age does not depict any significant association between the achievement of SVR and ETR similar to the study done in the past but there was a significant association observed between decreasing age and attainment of SVR in a study done by Ahmed et al [24] and Mushtaq et al [18]. Another study done by El Kassas et al showed age >50 years have a significant association with SVR [22].…”

“…In this study, ALT remained the same for patients who attained ETR and SVR but an increase in ALT levels was observed who did not achieve ETR and SVR from 45.33±2.89 to 61.00±0 but the association was insignificant, but a study done by El Raziky et al and El Kassas showed a decrease in ALT levels with significant association [22,23].…”

Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial

“…There was no improvement in efficacy outcomes for any experimental arm versus SOC. Adverse events reported for the investigational regimens were broadly consistent with their known safety profiles, 11 , 12 , 28 , 29 , 30 , 31 , 32 and all treatments were well tolerated.…”

Pharmacogenes that demonstrate high association evidence according to CPIC, DPWG, and PharmGKB

“…Genetic testing of patients using the indicated antiviral agents may be useful to ensure optimal therapeutic efficacy. Alternatively, the new hepatitis C therapies such as sofosbuvir, ledipasvir, and daclatasvir, which are not known to be affected by the mutations in IFNL3 and IFNL4 genes, can be used ( 64 ). However, it has been reported that selected polymorphisms in the ABCB1 and HNF-α genes influence the concentration of sofosbuvir plasma metabolite ( 65 ).…”