Background New direct-acting antivirals (DAAs) for chronic hepatitis C have been marketed and have changed the therapeutic landscape of this pathology.
Purpose To assess the effectiveness and security of new direct-acting antiviral agents for HCV.
Material and methods Retrospective study carried out from January 2015 to December 2016. Collected data: genotype, schedule, duration and previous treatment, hepatic fibrosis stage (HFS), basal viral load (VL), rapid viral response (RVR, VL ≤15 IU/mL at week 4), VL at the end of the treatment and sustained virological response (SVR) at week 12 and 24. Treatments were validated by the pharmacist according to European and Spanish Associations for the Study of the Liver.
Results One hundred and twenty-six patients. Males: 75.4%. Average age: 52. 15 patients HIV coinfectated. 70.6% genotype 1, 2. 4% genotype 2, 13. 5% genotype 3% and 13. 5% genotype 4. 48.4% HFS 4, 16.7% HFL 3, 23.8% HFL 2, 9.4% HFL 0%–1. 38.9% were not naive for the treatment, of which 40.8% were non-responders to previous treatments, 6.1% partial responders, 14.3% relapsers and 34.7% discontinued treatment because of adverse effects.
The duration of the treatment was 12 weeks for 75.4% of the patients, 24 weeks for 23% and 8 weeks for 1.6%. RVR was achieved in 67 of 75 (89.9%): 98.1% raised negative VL and 1.9% were non-responders at the end of the treatment. 96.2% and 94.4% achieved SVR at week 12 and 24 respectively. Three relapsers were identified in both evaluations at week 12 and 24: three were genotype 1 and three were genotype 3. Four were diagnosed with hepatic fibrosis stage 4 and two with stage 3.
Adverse effects were identified in 40.5% of the patients. The most common were asthenia (21.4%), insomnia (4.7%) and pruritus (14.3%). Rash was identified in one patient and renal impairment in one patient as well. One patient died because of advanced cirrhosis and another one of cardiac insufficiency congestive.
Conclusion New direct antiviral agents show a high rate of effectiveness similar to the published clinical trials. The evaluation of SVR is necessary at week 12, 24 and at the end of the treatment. Adverse effects were mild-moderate for the majority of the patients and were mainly related to ribavirine.
No conflict of interest
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