Hepatitis C virus therapy with peg-interferon and ribavirin in Myanmar: A resource-constrained country

doi:10.3748/wjg.v22.i43.9613

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastroenterol. Nov 21, 2016; 22(43): 9613-9622
Published online Nov 21, 2016. doi: 10.3748/wjg.v22.i43.9613

Table 1 Sustained virologic response according to patient characteristics at baseline (n = 288) n (%)

	Achieved SVR		P value
	Yes (n = 237)	No (n = 51)	P value
Demographics
Sex
Male	101 (87.1)	15 (12.9)	0.081
Female	136 (79.1)	36 (20.9)
Age
Mean ± SD	45.9 ± 10.4	50.1 ± 8.5	0.007
Median (range)	48.00 (11.0-68.0)	49.00 (34.0-66.0)	0.016
≤ 20	5 (100)	0 (0)	0.017
21-40	57 (87.7)	8 (12.3)
41-60	164 (82.4)	35 (17.6)
> 60	11 (57.9)	8 (42.1)
Pretreatment conditions/comorbidities
HCV/HIV coinfection	4 (100)	0 (0)	0.350
Diabetes mellitus	21 (91.3)	2 (8.7)	0.238
Previous alcohol consumption	45 (81.8)	10 (18.2)	0.919
High pretreatment ALT (> 40)	166 (81.8)	37 (18.2)	0.722
High pretreatment Hgb (≥ 12 g/dL)	182 (81.3)	42 (18.8)	0.386
High pretreatment WBC (≥ 4000 mm³)	225 (82.7)	47 (17.3)	0.432
High pretreatment platelet (≥ 150000/mm³)	189 (84.8)	34 (15.2)	0.043
High pretreatment albumin (≥ 3.5 g/dL)	212 (84.5)	39 (15.5)	0.012
High pretreatment HCV RNA (≥ 800000 IU/mL)	144 (79.1)	38 (20.9)	0.065
Liver stiffness
F ≤ 2	133 (92.4)	11 (7.6)	< 0.001
F3-4	104 (72.2)	40 (27.8)
IL-28B polymorphism
rs8099917TT	204 (82.3)	44 (17.7)	0.634
rs8099917Non-TT	18 (78.3)	5 (21.7)
Unknown	15 (88.2)	2 (11.8)
rs12979860CC	196 (82.4)	42 (17.6)	0.618

ALT: Alanine aminotransferase; HCV: Hepatitis C virus; Hgb: Hemoglobin; HIV: Human immunodeficiency virus; SVR: Sustained virologic response; WBC: White blood cell.

Table 2 Sustained virologic response by treatment modifications and hepatitis C virus genotype (n = 288) n (%)

	Achieved SVR		P value
	Yes(n = 237)	No(n = 51)	P value
Dose reduction
Any dose reduction	43 (79.6)	11 (20.4)	0.570
Peg-IFN only	9 (100)	0 (0)	0.157
Ribavirin only	12 (70.6)	5 (29.4)	0.193
Both peg-IFN and ribavirin	22 (78.6)	6 (21.4)	0.587
Genotype
1	42 (75.0)	14 (25.0)	0.314
2	4 (100)	0 (0)
3	123 (84.8)	22 (15.2)
6	68 (81.9)	15 (18.1)

Peg-IFN: Pegylated-interferon; SVR: Sustained virologic response.

Table 3 Sustained virologic response according to fibrosis score and genotype (n = 288) n (%)

	Total patients	F ≤2 (n = 144)		F 3-4 (n = 144)		P value
	Total patients	SVR+	SVR-	SVR+	SVR-	P value
All genotypes	288	133 (46)	11 (4)	104 (36)	40 (14)	0.034
Genotype 1	56	26 (46)	3 (5)	16 (29)	11 (20)	0.009
Genotype 2	4	0 (0)	0 (0)	4 (100)	0 (0)
Genotype 3	145	60 (41)	4 (3)	63 (43)	18 (12)	0.008
Genotype 6	83	47 (57)	4 (5)	21 (25)	11 (13)	0.002

SVR: Sustained virologic response.

Table 4 Relapse according to patient characteristics at baseline (n = 283) n (%)

	Relapse (n = 49)	No relapse (n = 234)	P value
Relapse	49 (17.3)	234 (82.7)
Demographics
Sex
Male	14 (12.4)	99 (87.6)	0.074
Female	35 (20.6)	135 (79.4)
Age
mean ± SD	50.4 ± 8.5	46.0 ± 10.2	0.006
Median (range)	50.00 (34.0-66.0)	48.00 (11.0-68.0)	0.011
≤ 20	0 (0)	4 (100)	0.013
21-40	7 (10.9)	57 (89.1)
41-60	34 (17.3)	162 (82.7)
> 60	8 (42.1)	11 (57.9)
Pre-treatment/comorbidities
HCV/HIV coinfection	0 (0)	3 (100)	0.426
Diabetes mellitus	2 (8.7)	21 (91.3)	0.254
Previous alcohol consumption	9 (17.0)	44 (83.0)	0.943
High pretreatment ALT (> 40)	36 (17.9)	165 (82.1)	0.678
High pretreatment Hgb (≥ 12g/dL)	40 (18.3)	179 (81.7)	0.434
High pretreatment WBC (≥ 4000 mm³)	45 (16.9)	222 (83.1)	0.403
High pretreatment platelet (≥ 150000/mm³)	32 (14.7)	186 (85.3)	0.032
High pretreatment albumin (≥ 3.5 g/dL)	37 (15.0)	209 (85.0)	0.009
High pretreatment HCV RNA (≥ 800000 IU/mL)	36 (20.3)	141 (79.7)	0.082
Liver stiffness
F ≤ 2	9 (6.5)	130 (93.5)	< 0.001
F3-4	40 (27.8)	104 (72.2)
IL28B polymorphism
rs8099917TT	42 (17.3)	201 (82.7)	0.592
rs8099917Non-TT	5 (21.7)	18 (78.3)
Unknown	2 (11.8)	15 (88.2)	0.918
rs12979860CC	40 (17.2)	193 (82.8)	0.569

Table 5 Relapse by treatment modifications and hepatitis C virus genotype (n = 283) n (%)

	Relapse Yes	Relapse No	P value
	(n = 49)	(n = 234)	P value
Dose reduction
Any dose reduction	10 (19.2)	42 (80.8)	0.686
Peg-IFN only	0 (0)	9 (100)	0.163
Ribavirin only	4 (26.7)	11 (73.3)	0.325
Both peg-IFN and ribavirin	6 (21.4)	22 (78.6)	0.544
Genotype
1	14 (25.0)	42 (75.0)	0.279
2	0 (0)	4 (100)
3	21 (14.7)	122 (85.3)
6	14 (17.5)	66 (82.5)

Table 6 Preliminary analysis of sustained virologic response outcome by treatment duration and prognostic baseline factors in patients with genotype 3 hepatitis C virus infection

Comparison or stratum	OR (95%CI)	P value
Age	1.02 (0.97-1.08)	0.432
Liver fibrosis (F3-4 vs F ≤ 2)	0.18 (0.05-0.67)	0.010
Sex (female vs male)	0.41 (0.14-1.16)	0.093
Treatment duration (48 wk vs 24 wk)	2.05 (0.42-9.92)	0.371

Table 7 Sustained virologic response outcome by prognostic baseline factors in patients with genotypes 1, 3, and 6 hepatitis C virus infection

Comparison or stratum	OR (95%CI)	P value
Age	1.00 (0.96-1.04)	0.904
Genotype (1 vs 6)	0.74 (0.30-1.84)	0.433
Genotype (3 vs 6)	1.33 (0.58-3.05)	0.433
High pretreatment HCV RNA (≥ 800000 IU/mL)	0.42 (0.19-0.92)	0.029
High pretreatment albumin (≥ 3.5 g/dL)	2.63 (1.11-6.22)	0.028
High pretreatment platelet (≥ 150000/mm³)	1.00 (0.45-2.25)	0.992
Liver fibrosis (F3-4 vs F ≤ 2)	0.19 (0.08-0.48)	< 0.001
Sex (female vs male)	0.57 (0.28-1.16)	0.120
Treatment duration (48 wk vs 24 wk)¹	2.05 (0.42-9.92)	0.371

¹Only in patients with genotype 3 HCV infection. HCV: Hepatitis C virus.

Table 8 Adverse events and treatment modifications (n = 288) n (%)

	48 wk treatment (n = 162)	24 wk treatment (n = 126)
Dose reduction
Any dose reduction	34 (21.0)	20 (15.9)
Peg-IFN only	3 (1.9)	6 (4.8)
Ribavirin only	13 (8.0)	4 (3.2)
Both peg-IFN and ribavirin	18 (11.1)	10 (7.9)
Hematological adverse events
Hemoglobin reduction = 1.5 g/dL from pretreatment value	121 (74.7)	85 (67.5)
Erythropoietin use	99 (61.1)	62 (49.2)
Severe anemia (Hgb < 7 g/dL)	4 (2.5)	3 (2.4)
WBC < 4000 cells/mm³	110 (67.9)	86 (68.3)
Platelet reduction < 150000 cells/mm³	75 (46.3)	72 (57.1)
General adverse events
Fatigue	115 (71)	89 (70.6)
Poor appetite	92 (56.8)	82 (65.1)
Itchiness	16 (9.9)	11 (8.7)
Skin rash	5 (3.1)	0 (0)
Joint pain	20 (12.3)	13 (10.3)
Myalgia/muscle aches	9 (5.6)	8 (6.3)
Hair loss	34 (21)	17 (13.5)
Dizziness	36 (22.2)	31 (24.6)
Insomnia	63 (38.9)	49 (38.9)
Irritability	5 (3.1)	2 (1.6)
Depression	13 (8.0)	5 (4.0)
Thyroid dysfunction	7 (4.3)	1 (0.8)

Citation: Hlaing NKT, Banerjee D, Mitrani R, Arker SH, Win KS, Tun NL, Thant Z, Win KM, Reddy KR. Hepatitis C virus therapy with peg-interferon and ribavirin in Myanmar: A resource-constrained country. World J Gastroenterol 2016; 22(43): 9613-9622
URL: https://www.wjgnet.com/1007-9327/full/v22/i43/9613.htm
DOI: https://dx.doi.org/10.3748/wjg.v22.i43.9613