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CP-034 Effectiveness of the combination ledipasvir/sofosbuvir for the treatment of hepatitis C virus infection
  1. JC Del Río Valencia,
  2. R Madera Pajin,
  3. R Asensi Díez,
  4. I Muñoz Castillo
  1. Hospital Regional Universitario Carlos Haya, Servicio Farmacia, MALAGA, Spain

Abstract

Background New direct acting antivirals (DAAs) for chronic hepatitis C have been developed. High rates of sustained virological response (SVR) have been reported. This represents an opportunity to eradicate hepatitis C virus (HCV) in these patients.

Purpose To assess the effectiveness of the combination of sofosbuvir (SOF) and ledipasvir (LDV) in HCV patients.

Material and methods This was a retrospective observational study between April 2015 and January 2016. Inclusion criteria: patients with HCV infection treated with SOF/LDV±ribavirin (RBV) during the study period. Exclusion criteria: patients with no data available. Outcomes collected: demographic data (age and sex); clinical data(baseline viral load (VL), SVR at week 12 (SVR12), 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 78 patients were included (71.79% men); mean age was 54.42±9.56 years. Based on the METAVIR score: F4 (cirrhosis) (37.18%), F3 (33.33%), F2 (23.08%), F1 (5.13%) and F0 (1.28%). HCV genotype was: 56.41% G1, 25.64% G3 and 17.95% G4. 25 patients (32.05%) were HIV coinfected. 16.66% had a liver transplant. 42.31% (33/78) had failed prior treatment, 81.81% were treated with peginterferon/RBV, 9.10% with peginterferon, 3.03% with RBV/peginterferon/protease inhibitor (IP), 3.03% with RBV/IP and 3.03% with simeprevir/SOF. According to baseline VL, 73% had VL >800 000 UI/mL. Patients with G1 (n=44) were treated with SOF/LDV for 12 weeks (5 patients were treated for 8 weeks). All patients achieved SVR12 including one patient treated with SOF/LDV+RBV for 12 weeks. Patients with G3 (n=20) were treated with SOF/LDV for 12 weeks (n=14) and achieved SVR12 in 50[p2]% (n=7); were treated with SOF/LDV+RBV for 12 weeks (n=6) and achieved SVR12 in 83.33% (n=5). Patients with G4 (n=14) were treated with SOF/LDV for 12 weeks and all achieved SVR12. The treatment was well tolerated.

Conclusion The combination of SOF/LDV±RBV was effective in non-responders and naive patients with HCV G1 and G4. The SVR12 rate achieved in our study confirms the results obtained in published clinical trials. For G3, our results are slightly lower than those achieved in the ELECTRON-2 trial; this could be due to the fact that only 10 naive patients were treated and 4 patients were pretreated with SOF/LDV without RBV.

No conflict of interest

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