Background Direct acting antivirals (DAAs) have become elective treatment for chronic hepatitis C virus (HCV) infection but final data regarding routine medical practice are still limited.
Purpose The objective of this study was to assess treatment effectiveness and safety of DAAs in real practice.
Material and methods Descriptive, retrospective, non-interventional study. Inclusion criteria: all HCV monoinfected patients who started treatment with DAAs from January 2014 to March 2015. Exclusion criteria: patients with liver transplant.
The following variables were collected from the digital medical record: demographics, degree of fibrosis, clinical data (decompensated cirrhosis, hepatocellular carcinoma), response to previous HCV treatment and viral genotype, viral load and analytical data (at baseline and at the end of treatment) and adverse events.
Primary effectiveness endpoint was SVR12 (sustained virologic response 12 weeks after the end of treatment). Secondary endpoint was virologic response (undetectable virus load) and normalisation of serum transaminases at the end of treatment.
Safety was evaluated by laboratory abnormalities and adverse events (AEs).
Results 48 patients were included: 29 (60.4%) were male; average age 60 years (SD=8.1).
Distribution of virus genotypes were: genotype 1a=8 (16.7%) patients; 1b=33 (68.7%); 2=1 (2.1%); 3=4 (8.3%); and 4=2 (4.2%).
42 (87.5%) patients were cirrhotic, 17 (40.5%) of these were decompensated and 5 (10.4%) had a hepatocellular carcinoma.
24 patients (50%) were treatment naïve, 20 (41.7%) had a failed prior therapy with peginterferon/ribavirin and 4 (8.3%) with a protease inhibitor.
The prescribed DAAs were: SOF+SMV=27 (56.2%), SOF+DCV=10 (20.9%), OTP/PTV/r+DSV=5 (10.4%), SMV+P-INF=3 (6.2%), SOF/LDV=1 (2.1%), DCV+SMV=1 (2.1%) and SOF=1 (2.1%). Ribavirin was present in 33 (68.7%) treatments.
Treatment duration was 12 weeks in 34 (70.8%) patients and 24 weeks in 14 (29.1%).
SVR12 was achieved in 31 (88.6%) patients with available laboratory data (72.9%). At the end of the treatment, virologic response was achieved in 100% of patients with data available (89.6%), and 85% of patients with available laboratory data (83.3%) had normalised serum transaminases.
Most frequent AEs were: asthenia 25 (52%), ribavirin associated anaemia 15 (45.5%), pruritus 16 (33.3%), dry skin 10 (20.8%) and insomnia 10 (20.8%).
Conclusion Data show a high percentage of SVR12 and a totally virologic response at the end of treatment. Moreover, AEs did not differ from those described in clinical trials. DDAs seemed to be efficacious and well tolerated in real clinical practice.
References and/or Acknowledgements
Rev Esp Quimioter 2015;28(Suppl 1):48-51
References and/or AcknowledgementsNo conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.