DI-044 Effectiveness of the combination sofosbuvir and daclatasvir for the treatment of hepatitis C virus infection

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Abstract

Background

New direct acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection achieve high rates of sustained virological response (SVR) which has changed the therapeutic strategy.

Purpose

To assess the effectiveness of the combination sofosbuvir (SOF) and daclatasvir (DCV) in HCV patients.

Material and methods

A retrospective observational study was conducted between September 2014 and September 2015. Inclusion criteria were: patients with HCV infection treated with SOF/DCV during the study period. Drug interactions with the usual patient medication were analysed through the Web (hep-druginteractions.org/interactions.aspx). Variables collected: demographics: age and sex. Clinical data: basal viral load (VL), SVR at week 12/24 (SVR12/24), defined as HCV RNA titres <15 IU/mL. METAVIR score: F0-F4. Liver transplant, HCV genotype (G), HIV coinfection, previous treatments for HCV and side effects. Data were collected from the medical records of patients.

Results

32 patients were included (43.75% women); mean age 57.9±7.8 years. According to METAVIR score: F4 (cirrhosis) (62.51%), F3 (15.62%), F2 (12.5%), F1 (3.12%) and F0 (6.25%). The HCV genotype was: 53.12% G1 and 46.88% G3. 3 patients (9.37%) were HIV coinfected; 28.12% had a liver transplant and 3.13% a kidney transplant; 43.75% (14/32) had failed prior treatment. 78.58% were treated with peginterferon/ribavirin (RBV) and 21.42% with RBV/peginterferon/protease inhibitor (IP). According to the basal VL, 46.87% had a VL >800 000 UI/mL. Patients with G1 (n=17): 6 patients were treated with SOF/DCV for 12 weeks and 11 patients with SOF/DCV for 24 weeks. 100% achieved SVR12 as in the AI444-040 study. Patients with G3 (n=15): 14 patients were treated for 12 weeks with SOF/DCV and 92.86% (n=13) achieved SVR12; 1 patient treated with SOF/DCV for 24 weeks achieved SVR24=100%. Our patients had rates of SVR12: naïve 100% (10/10) vs 90% (91/101) in the ALLY-3study; non-responders: SVR12: 80% (4/5) vs 86% (44/51) in the ALLY-3 study. The treatment was well tolerated. No drug interactions were found with the patients’ usual medication.

Conclusion

SVR12/24 rates achieved in our study confirmed the results obtained in the AI444-040 study in patients with G1: naïve and non-responders achieved SVR12 rates of 100%. However, we observed differences in response in patients with the G3 genotype compared with the ALLY-3 study. In our study, there was only 1 patient treated for 24 weeks, so it is not possible to draw reliable conclusions about SVR24 in patients with G3.

Conclusion

No conflict of interest

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