Background The development of direct acting antiviral agents (DAAs) represents a significant improvement in hepatitis C virus (HCV) treatment, particularly to allow interferon free therapy. It is important to decide which treatment is best suited to each patient.
Purpose To analyse the efficacy and safety of an interferon free regimen—a fixed dose combination of the nucleotide polymerase inhibitor sofosbuvir (400 mg) and the HCV NS5A inhibitor ledipasvir (90 mg).
Material and methods Observational study of patients who initiated therapy with sofosbuvir/ledipasvir between April 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), HIV co-infection, 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 Of the 33 patients studied, 25 were men and 9 were co-infected with HIV. Regarding type of patient, 8 were treatment naive, 19 pretreated and 6 unknown. Genotypes 1a, 1b and 4 corresponded to 18, 12 and 3 patients, respectively. Hepatic fibrosis stage F4/F3/F2 corresponded to 14, 9 and 9, patients, respectively, and one woman had stage F0 who wished to get pregnant. Duration of treatment was: 8 weeks for 2 patients, 12 weeks for 26 patients and 24 weeks for 5 patients. 54.5% of patients achieved an undetectable viral load after 4 weeks, maintained after 12 weeks in all cases. 45.5% did not achieve undetectable viral load after 4 weeks but these patients achieved it by week 12. No one discontinued treatment for lack of response. No major adverse events were recorded: asthenia (30.3%), headache (27.3%), pruritus (3%) and irritability (3%).
Conclusion More than 50% of patients treated with sofosbuvir/ledipasvir had an undetectable level of HCV RNA after 4 weeks and 100% after 12 weeks but these results are still preliminary; it is necessary to determine the sustained virological response to evaluate treatment efficacy. The main adverse effects were asthenia and headache, and corresponded to the safety profile described in clinical trials.
No conflict of interest.
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