Background
Patients and methods
Inclusion criteria
Exclusion criteria
Patients
I-Clinical assessment
II. Biochemical assessment
III. Liver biopsy
IV. Serodiagnosis of HBV
V. HBV DNA examination
Treatment regimens and follow up
Patient Monitoring
Statistical analysis
Results
Number | 155 | |
---|---|---|
Age(years) | ||
X- ± SD | 41.8 ± 9.2 | |
Range | 19-59 | |
Sex
| ||
M | 125 | 80.6% |
F | 30 | 19.4% |
BMI
| ||
X- ± SD | 27.3 ± 3.6 | |
Range | 21- 40.5 | |
Duration of HCV infection (years) | ||
X- ± SD | 4.4 ± 3.6 | |
Range | 1-19 | |
Smoking status
| ||
Non | 81 | 52.2% |
Active | 57 | 36.8% |
Ex-smoker | 17 | 11.0% |
Basal ALT (× ULN) | ||
≤2 | 116 | 74.8% |
> 2 | 39 | 25.2% |
Basal AST (× ULN) | ||
≤ 2 | 124 | 80% |
> 2 | 31 | 20% |
Activity
| ||
1 | 52 | 33.6% |
2 | 71 | 45.8% |
3 | 32 | 20.6% |
Fibrosis
| ||
1 | 54 | 34.8% |
2 | 61 | 39.4% |
3 | 36 | 23.2% |
4 | 4 | 2.6% |
Basal HCV Viral Load (IU × 105) | ||
X- ± SD | 3.87 ± 5.7 | |
Range | 0.001-22.3 |
Occult HBV/HCV Dual Infection (n = 6) | HCV Monoinfection (n = 149) | Test | P | |||
---|---|---|---|---|---|---|
Age (years) |
t Test
| |||||
X- ± SD | 32.8 ± 6.3 | 42.2 ± 9.1 | 2.48 | 0.013* | ||
Range | 20 - 36 | 19 - 59 | ||||
Sex
| No. |
%
| No. |
%
|
X
2
| |
M | 6 | 100.0 | 119 | 79.9 | 0.49 | 0.48 |
F | 0 | 0.0 | 30 | 20.1 | ||
BMI
|
t Test
| |||||
X- ± SD | 25.7 ± 1.5 | 27.3 ± 3.6 | 1.1 | 0.27 | ||
Range | 24 - 27.5 | 21 - 40.5 | ||||
Basal ALT (× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤2 | 6 | 100.0 | 112 | 75.2 | 0.83 | 0.36 |
> 2 | 0 | 0.0 | 37 | 24.8 | ||
Basal AST (× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤2 | 4 | 66.7 | 122 | 81.9 | 0.16 | 0.68 |
> 2 | 2 | 33.3 | 27 | 18.1 | ||
Activity
| No. |
%
| No. |
%
|
X
2
| |
1 | 2 | 33.3 | 50 | 33.6 | 1.88 | 0.39 |
2 | 4 | 66.7 | 67 | 44.9 | ||
3 | 0 | 0.0 | 32 | 21.5 | ||
Fibrosis
| No. |
%
| No. |
%
|
X
2
| |
1 | 0 | 0.0 | 54 | 36.2 | ||
2 | 6 | 100.0 | 55 | 36.9 | 9.62 | 0.02* |
3 | 0 | 0.0 | 36 | 24.2 | ||
4 | 0 | 0.0 | 4 | 2.7 | ||
Basal HCV Viral Load (IU × 105) |
t Test
| |||||
X- ± SD | 10.05 ± 9.93 | 3.62 ± 5.4 | 2.74 | 0.006* | ||
Range | 0.4 - 22.3 | 0.001 - 22 | ||||
Anti-HBc
| No. |
%
| No. |
%
|
X
2
| |
Negative | 4 | 66.7 | 133 | 89.3 | 1.09 | 0.29 |
Positive | 2 | 33.3 | 16 | 10.7 | ||
Anti-HBs
| No. |
%
| No. |
%
|
X
2
| |
Negative | 6 | 100.0 | 131 | 87.9 | 0.07 | 0.79 |
Positive | 0 | 0.0 | 18 | 12.1 | ||
Response Rate
| No. |
%
| No. |
%
|
X
2
| |
Responder | 0.0 | 0.0 | 70 | 46.98 | 3.42 | 0.06 |
Non-responder | 6.0 | 100 | 79 | 53.02 |
Anti HBc | Test | P | ||||
---|---|---|---|---|---|---|
Positive (n = 18) | Negative (n = 137) | |||||
Age (years) |
t Test
| |||||
X- ± SD | 43.4 ± 9.1 | 41.6 ± 9.2 | 0.79 | 0.43 | ||
Range | 28-59 | 19-59 | ||||
Sex
| No. |
%
| No. |
%
|
X
2
| |
M | 16 | 88.9 | 109 | 79.6 | 0.39 | 0.53 |
F | 2 | 11.1 | 28 | 20.4 | ||
Activity
| No. |
%
| No. |
%
|
X
2
| |
1 | 2 | 22.15 | 50 | 36.5 | ||
2 | 12 | 66.7 | 59 | 43.1 | 5.02 | 0.08 |
3 | 4 | 22.15 | 28 | 20.4 | ||
Fibrosis
| No. |
%
| No. |
%
|
X
2
| |
1 | 4 | 22.2 | 49 | 35.7 | ||
2 | 6 | 33.3 | 56 | 41.0 | 5.55 | 0.13 |
3 | 8 | 44.4 | 28 | 20.4 | ||
4 | 0 | 0.0 | 4 | 2.9 | ||
Basal HCV Viral Load (IU × 105) |
t Test
| |||||
X- ± SD | 9.43 ± 9.9 | 3.1 ± 4.5 | 4.66 | < 0.001* | ||
Range × 105 | 0.62-22.3 | 0.001-21 | ||||
Basal ALT(× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤ 2 | 14 | 77.8 | 102 | 74.5 | 0.001 | 0.98 |
> 2 | 4 | 22.2 | 35 | 25.5 | ||
Basal AST (× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤ 2 | 16 | 88.9 | 108 | 78.8 | 0.48 | 0.49 |
> 2 | 2 | 11.1 | 29 | 21.2 | ||
HBV DNA
| No. |
%
| No. |
%
|
X
2
| |
Positive | 2 | 11.1 | 4 | 2.9 | 1.09 | 0.29 |
Negative | 16 | 88.9 | 133 | 97.1 | ||
Response Rate
| No. |
%
| No. |
%
|
X
2
| |
Responder | 4 | 22.2 | 66 | 48.2 | 5.58 | 0.018* |
Non-responder | 14 | 77.8 | 71 | 51.8 | ||
Anti-HBs
| No. |
%
| No. |
%
|
X
2
| |
Positive | 4 | 22.2 | 14 | 10.2 | 1.22 | 0.26 |
Negative | 14 | 77.8 | 123 | 89.8 |
Anti HBs | Test | P | ||||
---|---|---|---|---|---|---|
Positive (n = 18) | Negative (n = 137) | |||||
Age (years) |
t Test
| |||||
X- ± SD | 43.4 ± 6.5 | 41.6 ± 9.5 | 0.79 | 0.43 | ||
Range | 29-53 | 19-59 | ||||
Sex
| No. |
%
| No. |
%
|
X
2
| |
M | 16 | 88.9 | 109 | 79.6 | 0.39 | 0.53 |
F | 2 | 11.1 | 28 | 20.4 | ||
Activity
| No. |
%
| No. |
%
|
X
2
| |
1 | 7 | 38.9 | 45 | 32.8 | ||
2 | 11 | 61.1 | 60 | 43.8 | 5.42 | 0.06 |
3 | 0 | 0.0 | 32 | 23.4 | ||
Fibrosis
| No. |
%
| No. |
%
|
X
2
| |
1 | 4 | 22.2 | 50 | 36.5 | ||
2 | 12 | 66.7 | 49 | 35.8 | 6.6 | 0.08 |
3 | 2 | 11.1 | 34 | 24.8 | ||
4 | 0 | 0.0 | 4 | 2.9 | ||
Basal HCV Viral Load (IU × 105) |
t Test
| |||||
X- ± SD | 2.3 ± 3.9 | 4.1 ± 5.9 | 1.24 | 0.21 | ||
Range | 0.006-12.9 | 0.001-22.3 | ||||
Basal ALT (× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤ 2 | 16 | 88.9 | 102 | 74.5 | 1.12 | 0.29 |
> 2 | 2 | 11.1 | 35 | 25.5 | ||
Basal AST (× ULN) | No. |
%
| No. |
%
|
X
2
| |
≤ 2 | 18 | 100 | 108 | 78.8 | 4.69 | 0.03 |
> 2 | 0.0 | 0.0 | 29 | 21.2 | ||
HBV DNA
| No. |
%
| No. |
%
|
X
2
| |
Positive | 0 | 0.0 | 6 | 4.4 | 0.82 | 0.36 |
Negative | 18 | 100 | 131 | 95.6 | ||
Response Rate
| No. |
%
| No. |
%
|
X
2
| |
Responder | 10 | 55.6 | 60 | 43.8 | 0.89 | 0.34 |
Non-responder | 8 | 44.4 | 77 | 56.2 | ||
Anti-HBc
| No. |
%
| No. |
%
|
X
2
| |
Positive | 4 | 22.2 | 14 | 10.2 | 1.22 | 0.26 |
Negative | 14 | 77.8 | 123 | 89.8 |
Patient | 1 | 2 | 3 | 4 | 5 | 6 |
---|---|---|---|---|---|---|
Age (years) | 20 | 36 | 21 | 37 | 35 | 34 |
Sex
| M | M | M | M | M | M |
Baseline ALT (× ULN) | 1.5 | 1 | 1.5 | 1 | 1 | 1 |
Duration of HCV Infection (years) | 1 | 13 | 2 | 12 | 2 | 2 |
PostTreatment ALT (× ULN) | 1 | 1 | 1 | 1 | 0.5 | 0.5 |
COBAS HBV DNA Level (IU/ml) | 2980 | 2210 | 2880 | 2010 | 128 | 149 |
Serological Status
| ||||||
Anti-HBc
| -ve | +ve | -ve | +ve | -ve | -ve |
Anti-HBs
| -ve | -ve | -ve | -ve | -ve | -ve |
METAVIR Score
| ||||||
Activity (A)
| A2 | A2 | A2 | A2 | A1 | A1 |
Fibrosis (F)
| F2 | F2 | F2 | F2 | F2 | F2 |
Basal HCV Load (IU/ml) | 0.4 × 105 | 22.3 × 105 | 0.39 × 105 | 22.1 × 105 | 7.2 × 105 | 7.23 × 105 |
Post-Treatment HCV Load (IU/ml) | 1.4 × 105 | 6 × 105 | 1.38 × 105 | 5.59 × 105 | 0.0028 × 105 | 0.027 × 105 |
Response to IFN
| NR | NR | NR | NR | RR | RR |