Safety of oral direct acting antiviral regimens for chronic hepatitis C in real life conditions.
OBJECTIVE
Direct acting antivirals (DAA) are extremely effective to treat chronic hepatitis C. The aim of this study was to evaluate, by using objective variables, the safety of DAA combinations under clinical practice conditions.


METHODS
A retrospective study was carried out in mono-infected patients with chronic hepatitis C treated with DAA between January and December 2015 in our centre. Discontinuations, treatment modifications, deaths and laboratory parameters were studied (liver function tests, hemoglobin, creatinine and lipid profile at baseline, weeks 4, 8 and post 12). Temporal variation of laboratory parameters was analyzed by t-test for paired data, and comparison between groups was made by t-test for independent samples and ANOVA.


RESULTS
227 patients were included (40.5% cirrhotic). Sustained virological response (SVR) was achieved in 97.3% of patients. In only one case was the antiviral medication suspended due to toxicity, and there were no voluntary treatment discontinuations. The use of ribavirin (RBV) was associated with mild transient hyperbilirubinemia (41.2%) and anemia (32.6%, with RBV dose reduction in 7.9% of cases). There was an elevation in total cholesterol and LDL-cholesterol (LDL-C) during and after treatment: mean increase of 23 mg/dL (0.59 mmol/L) and 22 mg/dL (0.57 mmol/L), respectively in post 12 (p < .0001). An increment of 20% of patients with cholesterol levels over optimal figures was observed after DAA completion.


CONCLUSIONS
DAA have an optimum safety profile in real life conditions, with infrequent discontinuation and minor laboratory alterations.
a Department of Pharmacy , Complejo Hospitalario de Navarra , Pamplona , Spain.|b CIBER Epidemiología y Salud Pública (CIBERESP) , Madrid , Spain.|c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.
Regina
R
Juanbeltz
d Liver Unit, Department of Gastroenterology , Complejo Hospitalario de Navarra , Pamplona , Spain.
Silvia
S
Goñi Esarte
c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.|d Liver Unit, Department of Gastroenterology , Complejo Hospitalario de Navarra , Pamplona , Spain.
Juan Isidro
JI
Úriz-Otano
d Liver Unit, Department of Gastroenterology , Complejo Hospitalario de Navarra , Pamplona , Spain.
Ana
A
Martínez Echeverría
c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.|d Liver Unit, Department of Gastroenterology , Complejo Hospitalario de Navarra , Pamplona , Spain.
Inmaculada
I
Elizalde
c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.|d Liver Unit, Department of Gastroenterology , Complejo Hospitalario de Navarra , Pamplona , Spain.
José Manuel
JM
Zozaya
b CIBER Epidemiología y Salud Pública (CIBERESP) , Madrid , Spain.|c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.|e Instituto de Salud Pública de Navarra , Pamplona , Spain.
Jesús
J
Castilla
a Department of Pharmacy , Complejo Hospitalario de Navarra , Pamplona , Spain.|c Instituto de Investigación Sanitaria de Navarra (IdiSNA) , Pamplona , Spain.
Ramón
R
San Miguel
D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004338:Drug Combinations; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013030:Spain; D016896:Treatment Outcome
D000998:Antiviral Agents; D004338:Drug Combinations
Antiviral agents; cholesterol; chronic hepatitis C; direct acting antiviral; drug monitoring; drug safety; ribavirin