The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study
Copyright policy )The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study
According to the EASL and AASLD guidelines, the recommended treatment for patients who failed to achieve a sustained virologic response (SVR) on prior interferon-based triple therapy with protease inhibitors (PI), is a combination of sofosbuvir and NS5A inhibitors. Polish national recommendations also allow the use of paritaprevir/ritonavir/ombitasvir+dasasbuvir±ribavirin (PrODR) in this group of patients. The aim of the study was to evaluate the efficacy and safety of PrODR vs. ledipasvir/sofosbuvir±RBV (LSR) in PI-experienced patients in real-life setting.Our analysis included patients registered in the nationwide, investigators initiated, multicentre EpiTer-2 database. Among 4530 patients registered, 335 with genotype 1 (93% 1b) were previously treated with IFN-based regimens with PIs: 127 with boceprevir (BOC), 208 with telaprevir (TVR). Patients with advanced fibrosis (F3/F4) were significantly predominant (BOC 28.4%/61.4%, TVR 18.8%/64.4%, respectively). Subjects were assigned to IFN-free retreatment as follows: BOC - 64 (50.4%) PrODR and 63 (49.6%) LSR; TVR- 103 (49.5%) PrODR and 105 (50.5%) LSR.SVR rates were comparable for particular groups: BOC → PrODR- 100%; BOC → LSR - 98%; TVR → PrODR - 97%; TVR → LSR - 96% (intent-to treat analysis-ITT) and BOC → PrODR→100%; BOC → LSR - 99%; TVR → PrODR - 99%; TVR → LSR - 98% (modified intent-to treat analysis-mITT). Both treatment regimens had a favourable safety profile. Adverse events (AEs) were generally mild or moderate in severity. Three deaths were reported. The treatment was stopped due to AEs in five patients (three treated with PrODR and two with LSR).Efficacy and safety of treatment with PrODR and LSR is comparable in BOC or TVR-experienced patients.
Cyclopropanes, Male, chronic - drug therapy, Macrocyclic compounds - administration & dosage, Antiviral agents - adverse effects, Infectious and parasitic diseases, RC109-216, Hepacivirus, Chronic hepatitis C, Fluorenes - therapeutic use, Uracil - analogs & derivatives, Cohort Studies, 2-Naphthylamine, Sulfonamides - adverse effects, Anilides, Treatment outcome, Middle aged, viral - drug effects, Macrocyclic compounds - adverse effects, Uridine monophosphate - analogs & derivatives, Sustained virologic response, Protease inhibitors - adverse effects, Hepatitis C, multiple, Uridine monophosphate - therapeutic use, Retreatment, Cohort studies, Uracil - adverse effects, Drug Therapy, Combination, Female, Drug therapy, Protease inhibitors - administration & dosage, Research Article, Adult, Macrocyclic Compounds, Anilides - adverse effects, Lactams, Macrocyclic, Antiviral agents - administration & dosage, Interferons - administration & dosage, Interferons - adverse effects, Sulfonamides - administration & dosage, Antiviral Agents, Drug Resistance, Multiple, Viral, chronic - epidemiology, Humans, Ritonavir - adverse effects, Benzimidazoles - therapeutic use, Aged, combination, Ritonavir - administration & dosage, Uracil - administration & dosage, Fluorenes, Carbamates - administration & dosage, Anilides - administration & dosage, Poland - epidemiology, Protease inhibitors, Hepatitis C, Chronic, przewlekłe zapalenie wątroby typu C ; marskość wątroby ; inhibitory proteazy ; ponowne leczenie ; trwała odpowiedź wirusologiczna, Hepacivirus - genetics, Young adult, Drug resistance, Carbamates - adverse effects, Liver cirrhosis, Benzimidazoles, Hepacivirus - drug effects, Carbamates, Interferons, Chronic hepatitis C; Liver cirrhosis; Protease inhibitors; Retreatment; Sustained virologic response
Cyclopropanes, Male, chronic - drug therapy, Macrocyclic compounds - administration & dosage, Antiviral agents - adverse effects, Infectious and parasitic diseases, RC109-216, Hepacivirus, Chronic hepatitis C, Fluorenes - therapeutic use, Uracil - analogs & derivatives, Cohort Studies, 2-Naphthylamine, Sulfonamides - adverse effects, Anilides, Treatment outcome, Middle aged, viral - drug effects, Macrocyclic compounds - adverse effects, Uridine monophosphate - analogs & derivatives, Sustained virologic response, Protease inhibitors - adverse effects, Hepatitis C, multiple, Uridine monophosphate - therapeutic use, Retreatment, Cohort studies, Uracil - adverse effects, Drug Therapy, Combination, Female, Drug therapy, Protease inhibitors - administration & dosage, Research Article, Adult, Macrocyclic Compounds, Anilides - adverse effects, Lactams, Macrocyclic, Antiviral agents - administration & dosage, Interferons - administration & dosage, Interferons - adverse effects, Sulfonamides - administration & dosage, Antiviral Agents, Drug Resistance, Multiple, Viral, chronic - epidemiology, Humans, Ritonavir - adverse effects, Benzimidazoles - therapeutic use, Aged, combination, Ritonavir - administration & dosage, Uracil - administration & dosage, Fluorenes, Carbamates - administration & dosage, Anilides - administration & dosage, Poland - epidemiology, Protease inhibitors, Hepatitis C, Chronic, przewlekłe zapalenie wątroby typu C ; marskość wątroby ; inhibitory proteazy ; ponowne leczenie ; trwała odpowiedź wirusologiczna, Hepacivirus - genetics, Young adult, Drug resistance, Carbamates - adverse effects, Liver cirrhosis, Benzimidazoles, Hepacivirus - drug effects, Carbamates, Interferons, Chronic hepatitis C; Liver cirrhosis; Protease inhibitors; Retreatment; Sustained virologic response
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