CP-128 Experience of use in hospital with sofosbuvir: Efficacy and safety of treatment

Background The recent commercialisation of sofosbuvir in Spain has meant a big change for patients with hepatitis C. The preliminary results of the drug show a very high cure rate in patients not responding to conventional treatment. Purpose To analyse the efficacy and safety of sofosbuvir for the treatment of hepatitis C in patients treated at the outpatient unit of our hospital. Also, to compare these results with published clinical trials of this drug. Material and methods All patients treated with sofosbuvir were analysed: dates of start and end of each treatment, genotype, liver involvement, if they were previously treated or not, drug combination used and adverse effects were recorded. The primary endpoint was a sustained virologic response at 12 weeks (SVR12) after the end of therapy. Results Since its inclusion in the hospital (December 2014), 86 patients have started treatment with sofosbuvir, most of whom were infected with genotype 1 virus (51 patients) and had cirrhosis (45 patients). 29 patients had never received treatment for hepatitis C virus infection. The previously treated patients were distributed as follows: 42 with interferon and ribavirin and the rest with triple therapy (8 with telaprevir, 6 with boceprevir and 1 with simeprevir). The therapeutic combinations most used were sofosbuvir+simeprevir (38 patients). The most common adverse effects were asthenia (27 patients), muscular pain (16 patients) and insomnia and irritability (11 patients). 40 patients remained asymptomatic. In June 2015, a total of 43 patients had completed 12 weeks of treatment and 100% had achieved SVR12. Of this group, 32 were genotype I, 7 were genotype III and 4 were genotype IV. 28 patients had a diagnosis of cirrhosis. The drug combination most used in this group of patients was sofosbuvir+simeprevir (28 patients), followed by sofosbuvir+interferon+ribavirin (9 patients) and sofosbuvir+daclatasvir (6 patients). Conclusion In our hospital, the effectiveness of sofosbuvir was superior to response rates shown in the data published in clinical trials of this drug. The therapy has been well tolerated by patients, showing a safety profile similar to that described in the scientific literature. No conflict of interest.