Background The use of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) patients has been a controversial issue over the past years in medicine. It has changed the HCV treatment paradigm, becoming a disease that can be cured. An extensive literature has documented the efficacy of these agents in the general population with cure rates>90%.
Purpose Evaluate DAAs real-life effectiveness and safety in mono-infected HCV patients.
Material and methods Observational, retrospective and analytical study, involving mono-infected HCV patients treated with DAAs since April 2016 in a teaching general hospital. Demographic variables: genotype(GT), liver fibrosis, treatment naïve or not, DDAs combination, treatment duration and sustained viral response at week 12 post-treatment (SVR-12) were obtained from the electronic health record. Data were collected in Excel®2010 and statistical intention to treat analysis (ITT) was performed with SPSS®v21.
Results A total of 391 patients have been treated with DDAs, 330 of whom have been followed up until week 12 post-treatment. Of these 330 patients: 43.64% (144) were females, mean age 58.62 years (min 22 – max 85); 48.79% (161) GT1a, 42.12% (139) GT1b, 0.30% (1) GT1c, 0.61% (2) GT2, 4.85% (16) GT3, 3.03% (10 )GT4, 0.30% (1) GT5; 2.73% (9) F0, 6.06% (20) F1, 29.69% (98) F2, 19.70 (65) F3, 37.58% (124) F4% and 4.24% (14) undetermined fibrosis; 24.85% (82) interferon pretreated (50 no responders – NR, 32 relapses – RR); 5.76% (19) SOF+SMV, 22.73% (75) with SOF+DCV, 40% (132) SOF/LDP, 29.39% PTV/r/OBV+DSV, 2.12% (7) ELB/GZP; 9.09% (30) were treated within 8 weeks, 5.21% (169) within 12 weeks and 39.69% (131) within 24 weeks.
IIT analysis determined that 96.97% (320) patients had RVS12: two exitus; four patients dropped out the medication: three with SOF+LDP and one with SOF+DCV. Two patients discontinued treatment because of adverse events – AE (headache and nausea); two virologic failures with PTV/r/OBV+DSV and other two relapsers: one with PTV/r/OBV+DSV and one with SOF+SMV. Therefore, 100% (seven) of patients with EBV/GZP achieved SVR-12, 96.90% (94) with PAR/OMB+DAS, 96.96% (128) with SOF+LDP, 97.33% (73) with SOF+DAC and 94.74% (one) with SOF+SMP.
Conclusion High SVR-12 rates have been achieved in real-world settings with similar data to those clinical trials. Virological failures and relapsers were due to wrong genotyped assignment. Therapeutic drop-outs were caused by specific individual factors, such as social problems and acute processes that caused DDAs discontinuation, but also two cases of AE. Even so, a new generation of DDAs leads to better tolerance. These results suggest that eradication of HCV is feasible, carrying out a good screening strategy and high treatment access.
No conflict of interest
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