Background The development of direct acting antiviral agents (DAAs) represents a significant improvement in hepatitis C virus (HCV) treatment. Interferon free combinations such as sofosbuvir (SOF) plus daclatasvir (DAC) have become available this year but at a high economic cost, and it is necessary to assess this with real life data.
Purpose To evaluate the short term efficacy and safety of SOF plus DAC for the treatment of HCV monoinfected patients.
Material and methods Observational study of patients who initiated therapy with SOF plus DAC between February and June 2015. Data were collected from electronic clinical history and the hospital’s electronic prescribing software. The following variables were collected: sex, HCV genotype, liver fibrosis stage, type of patient (pretreated/treatment naive), treatment duration, RNA viral levels before starting treatment, and 4 and 12 weeks afterwards. Monitoring of treatment efficacy was based on repeated measurements of HCV RNA levels.
Results 27 patients started treatment, 20 men and 7 women, 10 with ribavirin. Regarding type of patient, 4 were treatment naive, 15 pretreated and 8 unknown. Genotypes 1a, 1b and 3 corresponded to 12, 7 and 7 patients, respectively. Hepatic fibrosis stage F4/F3/F2 corresponded to 13, 8 and 6 patients, respectively. Duration of treatment was: 12 weeks for 23 patients and 24 weeks for 4 patients. 59.3% of patients achieved an undetectable viral load after 4 weeks, 37% had a viral load between 15 and 100 copies/mL and 3.7% had 194 copies/mL but continued treatment. After 12 weeks, 96.3% of patients achieved undetectable viral load and 100% after 24 weeks. Only 2 patients discontinued treatment, 1 for acute kidney injury and the other for liver transplantation. 44.45% of patients reported at least one side effects. Adverse events recorded were: asthenia (14.8%), insomnia (11.1%), headache (7.4%) and pruritus (3.7%).
Conclusion More than 50% of patients treated with the SOF-DAC combination had an undetectable level of HCV-RNA after 4 weeks and almost 100% after 12 weeks but these results are still preliminary; it is necessary to determine the sustained virological response to evaluate treatment efficacy. Regarding safety, the main adverse effect was asthenia but in general SOF-DAC was well tolerated.
No conflict of interest.
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