Background The possibility of prescribing the new direct acting antiviral (DAA) agents for the treatment of hepatitis C virus (HCV) in interferon free regimens, with high cure and low discontinuation rates described in clinical trials, represents an opportunity to eradicate HCV in our patients.
Purpose In this study, we analysed preliminary efficacy data of these regimens against HCV in the everyday practice of an infectious disease outpatient clinic.
Material and methods Observational retrospective study. Baseline characteristics and HCV-RNA quantification at weeks 4, weeks12/24 (end of treatment) and weeks 4 and12 post-treatment were collected and analysed for every mono- and HIV/HCV co-infected patient who started HCV therapy between 15 March and 5 October 2015. The regimens prescribed (SOF+SMP±RBV, SOF/LDV±RBV, 3D/2D±RBV, PR+SOF, SOF+DCV+RBV) were in line with current guidelines and approved drugs at every time. Data were analysed using SPSS statistical package.
Results 54 patients (83.3% male) were included, 47 (87%) were HIV/HCV co-infected, median basal CD4 value of 582 (371–797) and HIV-RNA undetectable in 36 (66.7%) cases. 45 patients (83.33%) were ex-injecting drug users.
According to genotype, 34 (62.96%) patients were G1 (of which, 19 were 1a, 12 1b and 3 unknown subtype), 1 (1.85%) was G2, 10 (18.52%) were G3 and 9 (16.6%) were G4. 34 (62.96%) patients were cirrhotic, 7 (13%) with previous decompensation episodes (5 oedemato-ascitic and 2 hepatocellular carcinoma). 28 (51.85%) were treatment naïve, and the expected duration was 12 weeks in 46 (85.12%) patients.
HCV-RNA was undetectable at week 4 (RVR) in 44 (86.27%) patients of the 51 available at the end of the study. 100% of 40 patients who completed treatment achieved end of treatment response (ETR) and 36 (97.3%) of the 37 with quantification at week 4 post-treatment had SVRx4 (1 relapser at week 4 post-therapy). 17 (94.44%) have already gained SVRx12, but there is one relapser who previously achieved SVRx4.
Both relapsers were naïve and cirrhotic, one G1a, treated with SOF/LED+RBV, and the other G3, treated with SOF/DCL+RBV.
Conclusion In our series, there was a high proportion of patients achieving SVRx4 and SVRx12, similar to those reported previously. Despite this, with these data, ETR, and even SVRx4, cannot be considered predictors of success at 100% in HCV treatment.
No conflict of interest.
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