Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access
Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc
Journal website http://www.gastrores.org

Original Article

Volume 11, Number 2, April 2018, pages 130-137


Direct-Acting Antivirals in Chronic Hepatitis C Genotype 4 Infection in Community Care Setting

Figures

Figure 1.
Figure 1. Treatment groups with different regimens.
Figure 2.
Figure 2. Treatment response in all groups measured by overall SVR 12.

Tables

Table 1. Demographic and Clinical Characteristics of Patients at Baseline with Treatment Regimen
 
CharacteristicsAll patients (n = 52)Treatment regimensP value
Harvoni® (n = 32)Viekira Pak® (n = 12)Epclusa® (n = 8)
Data are presented as mean (range) or number (percentage). *P value < 0.05: statistically significant. BMI: body mass index; HCV: hepatitis C virus; RNA: ribonucleic acid; APRI: AST-to-platelet ratio index; MELD: model for end-stage liver disease; AST: aspartate transaminase; ALT: alanine transaminase.
Age (years)52.2 (19 - 79)53.5 (22 - 79)49.3 (19 - 70)51.1 (36 - 72)0.698
Sex
  Male39 (75.0)25 (78.1)8 (66.7)6 (75.0)0.737
  Female13 (25.0)7 (21.9)4 (33.3)2 (25.0)
BMI (kg/m2)28.0 (17.0 - 43.7)27.8 (18.0 - 43.7)27.6 (17.0 - 37.0)29.6 (20.0 - 39.0)0.683
HCV RNA (IU/mL)
  < 800,00023 (44.2)16 (50.0)5 (41.7)2 (25.0)0.435
  ≥ 800,00029 (55.8)16 (50.0)7 (58.3)6 (75.0)
Prior treatment
  Naive43 (82.7)26 (81.3)11 (91.7)6 (75.0)0.591
  Experienced9 (17.3)6 (18.8)1 (8.3)2 (25.0)
Comorbidities
  Diabetes15 (28.8)8 (53.3)5 (33.3)2 (13.3)0.535
  Hypertension28 (53.8)16 (57.1)7 (25.0)5 (17.9)0.768
  Coronary artery disease2 (3.8)1 (50.0)1 (50.0)00.601
  Kidney disease3 (5.8)02 (66.7)1 (33.3)0.073
  Chronic anemia2 (3.8)01 (50.0)1 (50.0)0.169
Cirrhosis
  Absent42 (80.8)28 (87.5)11 (91.7)3 (37.5)0.003*
  Present10 (19.2)4 (12.5)1 (8.3)5 (62.5)
MELD score
  < 1044 (84.6)29 (90.6)10 (83.3)5 (62.5)0.142
  ≥ 108 (15.4)3 (9.3)2 (16.7)3 (37.5)
Laboratory tests
  Hemoglobin (g/dL)13.7 (9.0 - 17.0)13.8 (10.0 - 17.0)13.1 (9.0 - 16.0)13.9 (10.0 - 16.0)0.476
  Platelets (×1000/mL)203.4 (35 - 341)201.8 (63 - 341)245.5 (152 - 330)146.6 (35 - 199)0.004*
  Albumin (g/dL)4.2 (3.0 - 4.7)4.2 (3.2 - 4.7)4.1 (3.0 - 4.6)3.9 (3.0 - 4.7)0.224
  AST (IU/L)41.1 (13 - 123)39.2 (14 - 92)35.3 (13 - 107)57.1 (21 - 123)0.154
  ALT (IU/L)55.5 (9 - 220)51.1 (9 - 165)50.3 (10 - 220)81.2 (48 - 141)0.154
  Bilirubin (mg/dL)0.6 (0.2 - 1.9)0.6 (0.2 - 1.9)0.5 (0.2 - 0.9)0.6 (0.2 - 1.1)0.762

 

Table 2. Demographic and Clinical Characteristics of Patients at Baseline by Treatment Response
 
CharacteristicsAll patients (n = 52)Treatment responseUnivariate P valueMultivariate P value
SVR (n = 49)No SVR (n = 3)
Data are presented as mean (range) or number (percentage). *Only variables with the P value < 0.05 in univariate analysis were assessed. BMI: body mass index; HCV: hepatitis C virus; RNA: ribonucleic acid; APRI: AST-to-platelet ratio index; MELD: model for end-stage liver disease; AST: aspartate transaminase; ALT: alanine transaminase.
Age (years)52.2 (19 - 79)51.2 (19 - 79)68.0 (64 - 74)0.055NA
Age group
  < 6539 (75.0)38 (77.6)1 (33.3)0.151NA
  ≥ 6513 (25.0)11 (22.4)2 (66.7)
Sex
  Male39 (75.0)36 (73.5)3 (100)0.414NA
  Female13 (25.0)13 (26.5)0
BMI (kg/m2)28.0 (17.0 - 43.7)28.1 (17.0 - 43.7)26.5 (25.0 - 27.4)0.630NA
BMI (kg/m2)
  < 3035 (67.3)32 (65.3)3 (100)0.296NA
  ≥ 3017 (32.7)17 (34.7)0
HCV RNA (IU/mL)
  < 800,00023 (44.2)21 (42.9)2 (66.7)0.412NA
  ≥ 800,00029 (55.8)28 (57.1)1 (33.3)
Prior treatment
  Naive43 (82.7)41 (83.7)2 (66.7)0.442NA
  Experienced9 (17.3)8 (16.3)1 (33.3)
Comorbidities
  Diabetes15 (28.8)13 (86.7)2 (13.3)0.196NA
  Hypertension28 (53.8)26 (92.9)2 (7.1)0.559NA
  Coronary artery disease2 (3.8)2 (100)00.887NA
  Kidney disease3 (5.8)2 (66.7)1 (33.3)0.166NA
  Chronic anemia2 (3.8)2 (100)00.887NA
Cirrhosis
  Absent42 (80.8)41 (83.7)1 (33.3)0.091NA
  Present10 (19.2)8 (16.3)2 (66.7)
MELD score
  < 1044 (84.6)43 (87.8)1 (33.3)0.058NA
  ≥ 108 (15.4)6 (12.2)2 (66.7)
Laboratory tests
  Hemoglobin (g/dL)13.7 (9.0 - 17.0)13.7 (9.0 - 17.0)13.5 (12.5 - 14)0.872NA
  Platelets (×1000/mL)203.4 (35 - 341)206.3 (35 - 341)156.7 (63 - 299)0.228NA
  Albumin (g/dL)4.2 (3.0 - 4.7)4.2 (3.0 - 4.7)3.6 (3.2 - 3.9)0.0390.99*
  AST (IU/L)41.1 (13 - 123)40.0 (13 - 123)58.0 (34 - 98)0.252NA
  ALT (IU/L)55.5 (9 - 220)56.2 (9 - 220)45.0(16 - 92)0.650NA
  Bilirubin (mg/dL)0.6 (0.2 - 1.9)0.5 (0.2 - 1.2)1.0 (0.3 - 1.9)0.0480.99*

 

Table 3. SVR 12 Rates in Patients Receiving Harvoni® by Population Subgroup
 
ResponseSVR 12 rateUnivariate P valueMultivariate P value
Data presented as number/total number (percent). *Only variables with the P value < 0.05 in univariate analysis were assessed. BMI: body mass index; HCV: hepatitis C virus; RNA: ribonucleic acid; APRI: AST-to-platelet ratio index; MELD: model for end-stage liver disease; ALT: alanine transaminase.
Overall30/32 (93.8)
Age group
  < 6522/23 (95.7)0.490NA
  ≥ 658/9 (88.9)
Sex
  Male23/25 (92.0)1.000NA
  Female7/7 (100)
BMI (kg/m2)
  < 3021/23 (91.3)1.000NA
  ≥ 309/9 (100)
HCV RNA (IU/mL)
  < 800,00014/16 (87.5)0.242NA
  ≥ 800,00016/16 (100)
Prior treatment
  Naive25/26 (96.2)0.345NA
  Experienced5/6 (83.3)
Comorbidities
  Diabetes7/8 (87.5)0.444NA
  Hypertension15/16 (93.8)1.000NA
  CAD1/1 (100)1.000NA
  Kidney disease0N/ANA
  Chronic anemia0N/ANA
Cirrhosis
  Absent28/28 (100)0.0120.996*
  Present2/4 (50)
ALT (IU/L)
  < 4015/17 (88.2)0.486NA
  ≥ 4015/15 (100)

 

Table 4. SVR 12 Rates in Patients Receiving Viekira Pak® by Population Subgroup
 
ResponseSVR 12 rateP value
Data presented as number/total number (percent). BMI: body mass index; HCV: hepatitis C virus; RNA: ribonucleic acid; APRI: AST-to-platelet ratio index; MELD: model for end-stage liver disease; ALT: alanine transaminase.
Overall11/12 (91.7)
Age group
  < 659/9 (100)0.250
  ≥ 652/3 (66.7)
Sex
  Male7/8 (87.5)1.000
  Female4/4 (100)
BMI (kg/m2)
  < 307/8 (87.5)1.000
  ≥ 304/4 (100)
HCV RNA (IU/mL)
  < 800,0005/5 (100)0.583
  ≥ 800,0006/7 (85.7)
Prior treatment
  Naive10/11 (90.9)1.000
  Experienced1/1 (100)
Comorbidities
  Diabetes4/5 (80.0)0.417
  Hypertension6/7 (85.7)1.000
  CAD1/1 (100)1.000
  Kidney disease1/2 (50)0.167
  Chronic anemia1/1 (100)1.000
Cirrhosis
  Absent10/11 (90.9)1.000
  Present1/1 (100)
MELD score
  < 109/10 (90.0)1.000
  ≥ 102/2 (100)
ALT (IU/L)
  < 408/8 (100)0.333
  ≥ 403/4 (75)

 

Table 5. SVR 12 Rates in Patients Receiving Epclusa® by Population Subgroup
 
ResponseSVR 12 rateP value
Data presented as number/total number (percent). BMI: body mass index; HCV: hepatitis C virus; RNA: ribonucleic acid; APRI: AST-to-platelet ratio index; MELD: model for end-stage liver disease; ALT: alanine transaminase.
Overall8/8 (100)
Age group
  < 657/7 (100)N/A
  ≥ 651/1 (100)
Sex
  Male6/6 (100)N/A
  Female2/2 (100)
BMI (kg/m2)
  < 304/4 (100)N/A
  ≥ 304/4 (100)
HCV RNA (IU/mL)
  < 800,0002/2 (100)N/A
  ≥ 800,0006/6 (100)
Prior treatment
  Naive6/6 (100)N/A
  Experienced2/2 (100)
Comorbidities
  Diabetes2/2 (100)N/A
  Hypertension5/5 (100)N/A
  CAD0N/A
  Kidney disease1/1 (100)N/A
  Chronic anemia1/1 (100)N/A
Cirrhosis
  Absent3/3 (100)N/A
  Present5/5 (100)
MELD score
  < 105/5 (100)N/A
  ≥ 103/3 (100)
ALT (IU/L)
  < 400N/A
  ≥ 408/8 (100)

 

Table 6. Treatment Adverse Events
 
Adverse eventTreatment RegimenP value
Harvoni®Viekira Pak®Epclusa®
Data presented as number (percent).
Fatigue12 (37.5)1 (8.3)1 (12.5)0.092
Headache1 (3.1)000.727
Dizziness4 (12.5)1 (8.3)00.554
Nausea3 (9.4)02 (25.0)0.178
Vomiting1 (3.1)000.727
Photosensitivity2 (6.3)01 (12.5)0.493
Skin rash2 (6.3)000.522
Itching4 (12.5)000.258
Arthralgia5 (15.6)1 (8.3)00.430
Anemia3 (9.4)5 (41.7)1 (12.5)0.039
Thrombocytopenia1 (3.1)01 (12.5)0.342
Leukopenia3 (9.4)2 (16.7)1 (12.5)0.793