Background Simeprevir, sofosbuvir and daclatasvir are new drugs for the treatment of hepatitis C virus (HCV) and are apparently safer than preceding treatments. Due to the limited patient profiles in clinical trials as well as limited length, adverse events (AEs) in patient groups with special characteristics and low incidence or long term AEs have not been defined.

Purpose To learn about the safety aspects of simeprevir, sofosbuvir and daclatasvir, and to detect AEs not previously described.

Material and methods Retrospective study from August 2014 to April 2015 of AEs registered in a cohort of patients diagnosed with chronic hepatitis C treated with simeprevir, sofosbuvir and/or daclatasvir. Recorded data were: age, sex, baseline laboratory values and FibroScan, viral genotype, pharmacotherapeutic information and referred AEs. The information was obtained from Farmatools software and medical records.

Results 39 patients were included (average age 52.2 years, 22/39 male) and 66.6% had a FibroScan value exceeding 12 kPa. HCV genotypes were: 1b (53.8%), 1a (15.4%) and other (30.8%). Pretreated patients comprised 49.7%. Treatments included ribavirin and/or peginterferon (61.5%); 38.5% were not treated.

53 different AEs were detected in 152 patient, all of which were mild in severity. 92.3% of patients reported an AE. No patient had to be hospitalised or discontinue therapy because of AEs. Detected disorders were: 19.6% gastrointestinal, 12.4% skin and subcutaneous tissue, 12.4% nervous system, 11.1% blood and lymphatic system, 11.1% musculoskeletal and connective tissue, 10.5% psychiatric and 22.9% other disorders. The most prevalent AEs were anaemia (41.1%), pruritus (38.5%) and fatigue (28.2%). 97.4% of anaemia cases were grade 1 and associated with ribavirin included treatments; 2.6% were grade 2. Anaemia was also registered in a patient treated with sofosbuvir and daclatasvir. Patients reported AEs not previously described for these drugs: bone pain (2/39), urinary retention (2/39) and osteochondritis (1/39). A higher incidence of anticholinergic AEs were observed with co-administration of simeprevir and sofosbuvir.

Conclusion Simeprevir, sofosbuvir and daclatasvir seem to be safer than previous direct acting antivirals used to treat HCV. The most frequent and severe AEs were mainly due to ribavirin. Due to the low sample size, infrequent or rare AEs could not be detected. It would be useful to extend the study to detect new AEs.

No conflict of interest.