Clinical Trials Study
Copyright ©The Author(s) 2019.
World J Gastroenterol. May 14, 2019; 25(18): 2229-2239
Published online May 14, 2019. doi: 10.3748/wjg.v25.i18.2229
Table 1 Demographic and clinical characteristics of patients n (%)
CharacteristicPatients
Age
n104
Mean (yr ± SD)49.9 ± 10.5
Min, max (yr)29.0, 78.0
Median (yr) (IQR)51.5 (41.0, 58.2)
Gender
n104
Female46 (44.2)
Male58 (55.8)
Ethnicity
n104
Hispanic or Latino48 (46.2)
Not Hispanic or Latino56 (53.8)
Race
n104
White91 (87.5)
Black11 (10.6)
Unknown2 (2)
Current comorbidities
n104
Hypertension46 (44.2)
Obesity35 (33.7)
Cirrhosis, Child-Pugh A21 (20.2)
Hepatic steatosis18 (17.3)
Diabetes mellitus, type II17(16.3)
Hyperlipidemia17 (16.3)
Chronic kidney disease3 (3)
Coronary artery disease3 (3)
Atherosclerosis1 (1)
Congestive heart failure1 (1)
HIV1 (1)
Genotype
n100
GT1a86 (86)
GT1b14 (14)
Prior HCV treatment
n100
IFN2 (2)
IFN+RBV3 (3)
PegIFN1 (1)
PegIFN+RBV10 (10)
Table 2 Adverse events reported during the HEARTLAND study
Most common adverse eventsPatients reporting AE (n = 100)
Fatigue12 (12%)
Headache10 (10%)
Insomnia9 (9%)
Diarrhea8 (8%)
Anemia6 (6%)
Nausea6 (6%)
Pruritus5 (5%)
Rash4 (4%)
Upper respiratory infection3 (3%)
Urinary tract infection3 (3%)
Table 3 Mean short form 36 version 2 scores using the normative based scores
End of treatment
Baseline
P value
(n = 67)(n = 67)(Paired)
Physical functioning45.6 ± 11.344.4 ± 11.00.3389
Physical45.3 ± 10.842.2 ± 10.40.0152
Bodily pain46.3 ± 12.043.9 ± 11.20.1103
General health49.0 ± 10.844.6 ± 10.50.0004
Vitality50.4 ± 11.946.0 ± 10.60.0066
Social functioning45.4 ± 11.942.7 ± 12.10.0530
Emotional45.2 ± 12.141.8 ± 11.40.0272
Mental Health46.6 ± 12.644.1 ± 10.40.0287
Physical component summary46.8 ± 10.744.4 ± 9.10.0404
Mental component summary47.1 ± 13.743.6 ± 11.60.0112