Gastroenterol Res

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

**Table 1.** Demographic and Clinical Characteristics of Patients at Baseline with Treatment Regimen
Characteristics	All patients (n = 52)	Treatment regimens	P value
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
Male	39 (75.0)	25 (78.1)	8 (66.7)	6 (75.0)	0.737
Female	13 (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)
< 800,000	23 (44.2)	16 (50.0)	5 (41.7)	2 (25.0)	0.435
≥ 800,000	29 (55.8)	16 (50.0)	7 (58.3)	6 (75.0)
Prior treatment
Naive	43 (82.7)	26 (81.3)	11 (91.7)	6 (75.0)	0.591
Experienced	9 (17.3)	6 (18.8)	1 (8.3)	2 (25.0)
Comorbidities
Diabetes	15 (28.8)	8 (53.3)	5 (33.3)	2 (13.3)	0.535
Hypertension	28 (53.8)	16 (57.1)	7 (25.0)	5 (17.9)	0.768
Coronary artery disease	2 (3.8)	1 (50.0)	1 (50.0)	0	0.601
Kidney disease	3 (5.8)	0	2 (66.7)	1 (33.3)	0.073
Chronic anemia	2 (3.8)	0	1 (50.0)	1 (50.0)	0.169
Cirrhosis
Absent	42 (80.8)	28 (87.5)	11 (91.7)	3 (37.5)	0.003*
Present	10 (19.2)	4 (12.5)	1 (8.3)	5 (62.5)
MELD score
< 10	44 (84.6)	29 (90.6)	10 (83.3)	5 (62.5)	0.142
≥ 10	8 (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 1. Demographic and Clinical Characteristics of Patients at Baseline with Treatment Regimen

Characteristics

All patients (n = 52)

Treatment regimens

P 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

Male

39 (75.0)

25 (78.1)

8 (66.7)

6 (75.0)

0.737

Female

13 (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)

< 800,000

23 (44.2)

16 (50.0)

5 (41.7)

2 (25.0)

0.435

≥ 800,000

29 (55.8)

16 (50.0)

7 (58.3)

6 (75.0)

Prior treatment

Naive

43 (82.7)

26 (81.3)

11 (91.7)

6 (75.0)

0.591

Experienced

9 (17.3)

6 (18.8)

1 (8.3)

2 (25.0)

Comorbidities

Diabetes

15 (28.8)

8 (53.3)

5 (33.3)

2 (13.3)

0.535

Hypertension

28 (53.8)

16 (57.1)

7 (25.0)

5 (17.9)

0.768

Coronary artery disease

2 (3.8)

1 (50.0)

0.601

Kidney disease

3 (5.8)

2 (66.7)

1 (33.3)

0.073

Chronic anemia

2 (3.8)

1 (50.0)

0.169

Cirrhosis

Absent

42 (80.8)

28 (87.5)

11 (91.7)

3 (37.5)

0.003*

Present

10 (19.2)

4 (12.5)

1 (8.3)

5 (62.5)

MELD score

< 10

44 (84.6)

29 (90.6)

10 (83.3)

5 (62.5)

0.142

≥ 10

8 (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)

0.5 (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
Characteristics	All patients (n = 52)	Treatment response	Univariate P value	Multivariate P value
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)	0.055	NA
Age group
< 65	39 (75.0)	38 (77.6)	1 (33.3)	0.151	NA
≥ 65	13 (25.0)	11 (22.4)	2 (66.7)
Sex
Male	39 (75.0)	36 (73.5)	3 (100)	0.414	NA
Female	13 (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)	0.630	NA
BMI (kg/m²)
< 30	35 (67.3)	32 (65.3)	3 (100)	0.296	NA
≥ 30	17 (32.7)	17 (34.7)	0
HCV RNA (IU/mL)
< 800,000	23 (44.2)	21 (42.9)	2 (66.7)	0.412	NA
≥ 800,000	29 (55.8)	28 (57.1)	1 (33.3)
Prior treatment
Naive	43 (82.7)	41 (83.7)	2 (66.7)	0.442	NA
Experienced	9 (17.3)	8 (16.3)	1 (33.3)
Comorbidities
Diabetes	15 (28.8)	13 (86.7)	2 (13.3)	0.196	NA
Hypertension	28 (53.8)	26 (92.9)	2 (7.1)	0.559	NA
Coronary artery disease	2 (3.8)	2 (100)	0	0.887	NA
Kidney disease	3 (5.8)	2 (66.7)	1 (33.3)	0.166	NA
Chronic anemia	2 (3.8)	2 (100)	0	0.887	NA
Cirrhosis
Absent	42 (80.8)	41 (83.7)	1 (33.3)	0.091	NA
Present	10 (19.2)	8 (16.3)	2 (66.7)
MELD score
< 10	44 (84.6)	43 (87.8)	1 (33.3)	0.058	NA
≥ 10	8 (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)	0.872	NA
Platelets (×1000/mL)	203.4 (35 - 341)	206.3 (35 - 341)	156.7 (63 - 299)	0.228	NA
Albumin (g/dL)	4.2 (3.0 - 4.7)	4.2 (3.0 - 4.7)	3.6 (3.2 - 3.9)	0.039	0.99*
AST (IU/L)	41.1 (13 - 123)	40.0 (13 - 123)	58.0 (34 - 98)	0.252	NA
ALT (IU/L)	55.5 (9 - 220)	56.2 (9 - 220)	45.0(16 - 92)	0.650	NA
Bilirubin (mg/dL)	0.6 (0.2 - 1.9)	0.5 (0.2 - 1.2)	1.0 (0.3 - 1.9)	0.048	0.99*

Table 2. Demographic and Clinical Characteristics of Patients at Baseline by Treatment Response

Characteristics

All patients (n = 52)

Treatment response

Univariate P value

Multivariate 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)

0.055

Age group

< 65

39 (75.0)

38 (77.6)

1 (33.3)

0.151

≥ 65

13 (25.0)

11 (22.4)

2 (66.7)

Sex

Male

39 (75.0)

36 (73.5)

3 (100)

0.414

Female

13 (25.0)

13 (26.5)

BMI (kg/m²)

28.0 (17.0 - 43.7)

28.1 (17.0 - 43.7)

26.5 (25.0 - 27.4)

0.630

BMI (kg/m²)

< 30

35 (67.3)

32 (65.3)

3 (100)

0.296

≥ 30

17 (32.7)

17 (34.7)

HCV RNA (IU/mL)

< 800,000

23 (44.2)

21 (42.9)

2 (66.7)

0.412

≥ 800,000

29 (55.8)

28 (57.1)

1 (33.3)

Prior treatment

Naive

43 (82.7)

41 (83.7)

2 (66.7)

0.442

Experienced

9 (17.3)

8 (16.3)

1 (33.3)

Comorbidities

Diabetes

15 (28.8)

13 (86.7)

2 (13.3)

0.196

Hypertension

28 (53.8)

26 (92.9)

2 (7.1)

0.559

Coronary artery disease

2 (3.8)

2 (100)

0.887

Kidney disease

3 (5.8)

2 (66.7)

1 (33.3)

0.166

Chronic anemia

2 (3.8)

2 (100)

0.887

Cirrhosis

Absent

42 (80.8)

41 (83.7)

1 (33.3)

0.091

Present

10 (19.2)

8 (16.3)

2 (66.7)

MELD score

< 10

44 (84.6)

43 (87.8)

1 (33.3)

0.058

≥ 10

8 (15.4)

6 (12.2)

2 (66.7)

Laboratory tests

Hemoglobin (g/dL)

13.7 (9.0 - 17.0)

13.5 (12.5 - 14)

0.872

Platelets (×1000/mL)

203.4 (35 - 341)

206.3 (35 - 341)

156.7 (63 - 299)

0.228

Albumin (g/dL)

4.2 (3.0 - 4.7)

3.6 (3.2 - 3.9)

0.039

0.99*

AST (IU/L)

41.1 (13 - 123)

40.0 (13 - 123)

58.0 (34 - 98)

0.252

ALT (IU/L)

55.5 (9 - 220)

56.2 (9 - 220)

45.0(16 - 92)

0.650

Bilirubin (mg/dL)

0.6 (0.2 - 1.9)

0.5 (0.2 - 1.2)

1.0 (0.3 - 1.9)

0.048

0.99*

**Table 3.** SVR 12 Rates in Patients Receiving Harvoni® by Population Subgroup
Response	SVR 12 rate	Univariate P value	Multivariate 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.
Overall	30/32 (93.8)
Age group
< 65	22/23 (95.7)	0.490	NA
≥ 65	8/9 (88.9)
Sex
Male	23/25 (92.0)	1.000	NA
Female	7/7 (100)
BMI (kg/m²)
< 30	21/23 (91.3)	1.000	NA
≥ 30	9/9 (100)
HCV RNA (IU/mL)
< 800,000	14/16 (87.5)	0.242	NA
≥ 800,000	16/16 (100)
Prior treatment
Naive	25/26 (96.2)	0.345	NA
Experienced	5/6 (83.3)
Comorbidities
Diabetes	7/8 (87.5)	0.444	NA
Hypertension	15/16 (93.8)	1.000	NA
CAD	1/1 (100)	1.000	NA
Kidney disease	0	N/A	NA
Chronic anemia	0	N/A	NA
Cirrhosis
Absent	28/28 (100)	0.012	0.996*
Present	2/4 (50)
ALT (IU/L)
< 40	15/17 (88.2)	0.486	NA
≥ 40	15/15 (100)

Table 3. SVR 12 Rates in Patients Receiving Harvoni® by Population Subgroup

Response

SVR 12 rate

Univariate P value

Multivariate 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.

Overall

30/32 (93.8)

Age group

< 65

22/23 (95.7)

0.490

≥ 65

8/9 (88.9)

Sex

Male

23/25 (92.0)

1.000

Female

7/7 (100)

BMI (kg/m²)

< 30

21/23 (91.3)

1.000

≥ 30

9/9 (100)

HCV RNA (IU/mL)

< 800,000

14/16 (87.5)

0.242

≥ 800,000

16/16 (100)

Prior treatment

Naive

25/26 (96.2)

0.345

Experienced

5/6 (83.3)

Comorbidities

Diabetes

7/8 (87.5)

0.444

Hypertension

15/16 (93.8)

1.000

CAD

1/1 (100)

1.000

Kidney disease

N/A

Chronic anemia

N/A

Cirrhosis

Absent

28/28 (100)

0.012

0.996*

Present

2/4 (50)

ALT (IU/L)

< 40

15/17 (88.2)

0.486

≥ 40

15/15 (100)

**Table 4.** SVR 12 Rates in Patients Receiving Viekira Pak® by Population Subgroup
Response	SVR 12 rate	P 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.
Overall	11/12 (91.7)
Age group
< 65	9/9 (100)	0.250
≥ 65	2/3 (66.7)
Sex
Male	7/8 (87.5)	1.000
Female	4/4 (100)
BMI (kg/m²)
< 30	7/8 (87.5)	1.000
≥ 30	4/4 (100)
HCV RNA (IU/mL)
< 800,000	5/5 (100)	0.583
≥ 800,000	6/7 (85.7)
Prior treatment
Naive	10/11 (90.9)	1.000
Experienced	1/1 (100)
Comorbidities
Diabetes	4/5 (80.0)	0.417
Hypertension	6/7 (85.7)	1.000
CAD	1/1 (100)	1.000
Kidney disease	1/2 (50)	0.167
Chronic anemia	1/1 (100)	1.000
Cirrhosis
Absent	10/11 (90.9)	1.000
Present	1/1 (100)
MELD score
< 10	9/10 (90.0)	1.000
≥ 10	2/2 (100)
ALT (IU/L)
< 40	8/8 (100)	0.333
≥ 40	3/4 (75)

Table 4. SVR 12 Rates in Patients Receiving Viekira Pak® by Population Subgroup

Response

SVR 12 rate

P 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.

Overall

11/12 (91.7)

Age group

< 65

9/9 (100)

0.250

≥ 65

2/3 (66.7)

Sex

Male

7/8 (87.5)

1.000

Female

4/4 (100)

BMI (kg/m²)

< 30

7/8 (87.5)

1.000

≥ 30

4/4 (100)

HCV RNA (IU/mL)

< 800,000

5/5 (100)

0.583

≥ 800,000

6/7 (85.7)

Prior treatment

Naive

10/11 (90.9)

1.000

Experienced

1/1 (100)

Comorbidities

Diabetes

4/5 (80.0)

0.417

Hypertension

6/7 (85.7)

1.000

CAD

1/1 (100)

1.000

Kidney disease

1/2 (50)

0.167

Chronic anemia

1/1 (100)

1.000

Cirrhosis

Absent

10/11 (90.9)

1.000

Present

1/1 (100)

MELD score

< 10

9/10 (90.0)

1.000

≥ 10

2/2 (100)

ALT (IU/L)

< 40

8/8 (100)

0.333

≥ 40

3/4 (75)

**Table 5.** SVR 12 Rates in Patients Receiving Epclusa® by Population Subgroup
Response	SVR 12 rate	P 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.
Overall	8/8 (100)
Age group
< 65	7/7 (100)	N/A
≥ 65	1/1 (100)
Sex
Male	6/6 (100)	N/A
Female	2/2 (100)
BMI (kg/m²)
< 30	4/4 (100)	N/A
≥ 30	4/4 (100)
HCV RNA (IU/mL)
< 800,000	2/2 (100)	N/A
≥ 800,000	6/6 (100)
Prior treatment
Naive	6/6 (100)	N/A
Experienced	2/2 (100)
Comorbidities
Diabetes	2/2 (100)	N/A
Hypertension	5/5 (100)	N/A
CAD	0	N/A
Kidney disease	1/1 (100)	N/A
Chronic anemia	1/1 (100)	N/A
Cirrhosis
Absent	3/3 (100)	N/A
Present	5/5 (100)
MELD score
< 10	5/5 (100)	N/A
≥ 10	3/3 (100)
ALT (IU/L)
< 40	0	N/A
≥ 40	8/8 (100)

Table 5. SVR 12 Rates in Patients Receiving Epclusa® by Population Subgroup

Response

SVR 12 rate

P value

Overall

8/8 (100)

Age group

< 65

7/7 (100)

N/A

≥ 65

1/1 (100)

Sex

Male

6/6 (100)

N/A

Female

2/2 (100)

BMI (kg/m²)

< 30

4/4 (100)

N/A

≥ 30

4/4 (100)

HCV RNA (IU/mL)

< 800,000

2/2 (100)

N/A

≥ 800,000

6/6 (100)

Prior treatment

Naive

6/6 (100)

N/A

Experienced

2/2 (100)

Comorbidities

Diabetes

2/2 (100)

N/A

Hypertension

5/5 (100)

N/A

CAD

N/A

Kidney disease

1/1 (100)

N/A

Chronic anemia

1/1 (100)

N/A

Cirrhosis

Absent

3/3 (100)

N/A

Present

5/5 (100)

MELD score

< 10

5/5 (100)

N/A

≥ 10

3/3 (100)

ALT (IU/L)

< 40

N/A

≥ 40

8/8 (100)

**Table 6.** Treatment Adverse Events
Adverse event	Treatment Regimen	P value
Data presented as number (percent).
Fatigue	12 (37.5)	1 (8.3)	1 (12.5)	0.092
Headache	1 (3.1)	0	0	0.727
Dizziness	4 (12.5)	1 (8.3)	0	0.554
Nausea	3 (9.4)	0	2 (25.0)	0.178
Vomiting	1 (3.1)	0	0	0.727
Photosensitivity	2 (6.3)	0	1 (12.5)	0.493
Skin rash	2 (6.3)	0	0	0.522
Itching	4 (12.5)	0	0	0.258
Arthralgia	5 (15.6)	1 (8.3)	0	0.430
Anemia	3 (9.4)	5 (41.7)	1 (12.5)	0.039
Thrombocytopenia	1 (3.1)	0	1 (12.5)	0.342
Leukopenia	3 (9.4)	2 (16.7)	1 (12.5)	0.793

Table 6. Treatment Adverse Events

Adverse event

Treatment Regimen

P value

Harvoni®

Viekira Pak®

Epclusa®

Data presented as number (percent).

Fatigue

12 (37.5)

1 (8.3)

1 (12.5)

0.092

Headache

1 (3.1)

0.727

Dizziness

4 (12.5)

1 (8.3)

0.554

Nausea

3 (9.4)

2 (25.0)

0.178

Vomiting

1 (3.1)

0.727

Photosensitivity

2 (6.3)

1 (12.5)

0.493

Skin rash

2 (6.3)

0.522

Itching

4 (12.5)

0.258

Arthralgia

5 (15.6)

1 (8.3)

0.430

Anemia

3 (9.4)

5 (41.7)

1 (12.5)

0.039

Thrombocytopenia

1 (3.1)

1 (12.5)

0.342

Leukopenia

3 (9.4)

2 (16.7)

1 (12.5)

0.793