Background Treatment with a daily fixed dose combination of ledipasvir/sofosbuvir (LDV/SOF) in tablet form, with and without ribavirin (RBV), has exhibited promising results for the treatment of patients with hepatitis C virus (HCV).
Purpose To compare the efficacy and safety of LDV/SOF and LDV/SOF/RBV regimens for the treatment of HCV.
Material and methods A prospective observational study from April 2015 to January 2016 was carried out in all patients who had completed treatment for HCV with LDV/SOF or LDV/SOF/RBV. Data analysed were: sex, HCV genotype (GT), liver fibrosis, duration of treatment, adverse events, naïve patient, HIV/HCV coinfected patient and HCV-RNA in peripheral blood at 12 weeks after completion of treatment. Data were obtained from laboratory application, outpatient dispensing programme and medical record review. Assessment of effectiveness was based on achievement of a sustained virologic response (SVR), defined as the absence of HCV-RNA by polymerase chain reaction 12 weeks after stopping treatment (SVR12).
Results 38 patients, 27 (71.05%) men, completed treatment of HCV, 24 (63.15%) with LDV/SOF and 14 (36.85%) with LDV/SOF/RBV. 19 (50%) patients were naïve and 10 (26.31%) were coinfected HIV/HCV. Duration of treatment was 12 weeks for 26 (96.30%) patients who received LDV/SOF and 24 weeks for 1 patient. In the LDV/SOF/RBV group, duration of the treatment was 12 weeks for 14 (100%) patients. 22 (91.66%) patients with HCV-GT 1, and 2 patients with HCV-GT 4, received LDV/SOF. 11 (78.56%) patients with HCV-GT 1, 2 patients with GT 3 and 1 patient with GT 5 received LDV/SOF/RBV. Liver fibrosis for the group who received LDV/SOF was of F1 in 1 patient, F2 in 5 (20.83%), F3 in 8 (33.33%) and F4 in 10 (41.66%) patients. In the LDV/SOF/RBV group, 1 patient was F3 and 13 (92.85%) patients were F4.
SRV12 was undetectable in 22 (91.66%) patients in the group who received LDV/SOF and was undetectable for 14 (100%) patients in the LDV/SOF/RBV group. In the LDV/SOF group, 6 (18.2%) patients had adverse events, and 1 patient required immediate suspension of treatment for anaemia and bleeding. Further adverse reactions were tiredness in 3 patients, headache in 2 patients and insomnia in 1 patient. In the LDV/SOF/RBV group, 6 (37.6%) patients had adverse events: anaemia in 4 (25%) patients, ocular thrombosis in 1 patient and renal failure in 1 patient.
Conclusion Sofosbuvir/ledipasvir, administered with and without ribavirin for the treatment of HCV, was shown to be effective in 94.73% of the study population and was generally safe and well tolerated.
No conflict of interest
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