Background The new direct acting antiviral (DAAs) agents allow treatment of hepatitis C virus (HCV) infections with high rates of success. As innovative treatments, they will require close monitoring to evaluate effectiveness.

Purpose To evaluate the effectiveness of the combination simeprevir plus sofosbuvir in HCV patients.

Material and methods Retrospective and observational study between October 2014 and March 2015. Inclusion criteria: patients with HCV infection treated with SOF+SMV during the study. Exclusion criteria: patients with no data were available. Variables: demographics, age and sex. Clinical: basal viral load (VL), rapid virological response (HCV RNA undetectable 4 weeks after the start of treatment), VL week 12 and sustained virological response at week 12 (SVR12), defined as HCV RNA titres <15 IU/mL. METAVIR scores: F0-F4. Liver transplant, HCV genotype, HIV co-infection, previous treatments for HCV. Data were collected from the medical records of patients.

Results 68 patients were included (42 male), mean age of 55.7 ± 9.9 years. 33.82% (23/68) were naive and 66.17% (45/68) had failed prior treatment with ribavirina+Peg-interferon alpha. 19.12% (13/68) were co-infected with HIV-1. 17.65% (12/68) had a liver transplant. According to METAVIR scores: 69.12% (47/68) were F4, 16.18% (11/68) were F3, 11.76% (8/68) were F1-F2 and 2.94% (2/68) were F0. The HCV genotype was: 91.18% (62/68) genotype 1, with 19.12% (13/68) genotype 1a and 50% (34/68) genotype 1b. 22.06% (15/68) of patients were genotype 1 with no definition of sub-genotype. 8.82% (6/68) were genotype 4. According to basal VL, 70.6% (48/68) had VL >800 000 UI/mL. Rapid virological response was achieved in 85.29% of patients. At week 12, 98.53% of patients had HCV RNA undetectable. Only one patient had a VL of 266 IU/mL. SVR12 was achieved in 88.24% of patients. The rapid virological response and SVR12 rates in our study are consistent with those obtained in the COSMOS study (rapid virological response 81% and SVR12 93% in the ITT population in both treatments cohorts).

Conclusion The combination of simeprevir and sofosbuvir was effective in non-responders and treatment naive patients with chronic infection with HCV genotypes 1 and 4.

References and/or Acknowledgements COSMOS study.

No conflict of interest.