Background
Methods
Study participants and study design
Laboratory analysis
Statistical analysis
Results
Study population and baseline characteristics
Treatment status | |||||
Characteristic | All patients (N = 235) | Experienced (N = 152) | Naïve (N = 83) |
P value T test |
P value Wilcoxon rank sum test |
Mean (SD) age (years) | 41.0 (10.0) | 42.6 (9.5) | 37.9 (10.2) | 0.0006 | <0.0001 |
Mean (SD) weight (kg) | 63.1 (13.4) | 64.9 (13.1) | 59.6 (13.2) | 0.0038 | 0.0082 |
Mean (SD) BMI (kg/m2) | 23.4 (4.7) | 24.2 (4.7) | 21.8 (4.5) | 0.0001 | 0.0002 |
Mean (SD) CD4 count (cells/uL) | 460.7 (322) | 513 (304) | 363 (334) | 0.0006 | <0.0001 |
n (%) | n (%) | n (%) |
P value Chi square |
P value Fisher | |
Sex | 0.597 | 0.677 | |||
Female | 139 (59.1) | 88 (57.9) | 51 (61.5) | ||
Male | 96 (40.9) | 64 (42.1) | 32 (38.6) | ||
Ethnicity | 0.744 | 0.762 | |||
Akan | 109 (46.8) | 72 (47.4) | 37 (45.7) | ||
Ewe | 44 (18.9) | 29 (19.1) | 15 (18.5) | ||
Ga | 28 (12.0) | 20 (13.1) | 8 (9.9) | ||
Other | 52 (22.3) | 31 (20.4) | 21 (25.9) | ||
WHO HIV stage | 0.630 | 0.619 | |||
1 | 55 (23.7) | 38 (25.3) | 17 (20.7) | ||
2 | 58 (25.0) | 36 (24.0) | 22 (26.8) | ||
3 | 92 (39.7) | 61 (40.7) | 31 (37.8) | ||
4 | 27 (11.6) | 15 (10.0) | 12 (14.6) | ||
HBeAg positive | 47 (20.0) | 28 (18.4) | 19 (22.9) | 0.413 | 0.495 |
HBeAb positive | 188 (80.0) | 122 (80.3) | 66 (79.5) | 0.891 | 1.000 |
HBeAg/eAb combination | 0.622 | 0.604 | |||
HBeAg positive/Ab negative | 41 (17.5) | 25 (16.5) | 16 (19.3) | ||
HBeAg negative/Ab positive | 182 (77.5) | 119 (78.3) | 63 (75.9) | ||
HBeAg negative/Ab negative | 6 (2.6) | 5 (3.3) | 1 (1.2) | ||
HBcIgM positive | 5 (2.1) | 4 (2.6) | 1 (1.2) | 0.469 | 0.659 |
Treatment status | |||||
Characteristic | All patients | Experienced | Naïve |
P value Chi square |
P value Fisher |
N = 235 (%) | (N = 152) | (N = 83) | |||
n (%) | n (%) | ||||
Alanine aminotransferase | 0.0012 | 0.0015 | |||
Normal (5-40 U/L) | 169 (71.9) | 120 (79.0) | 49 (59.0) | ||
Elevated > ULN | 66 (28.1) | 32 (21.1) | 34 (41.0) | ||
Aspartate aminotransferase | 0.0005 | 0.0008 | |||
Normal (5-50 U/L) | 178 (75.7) | 126 (82.9) | 52 (62.7) | ||
Elevated > ULN | 57 (24.3) | 26 (17.1) | 30 (36.1) | ||
Albumin | <0.0001 | <0.0001 | |||
Normal (36-50) | 153 (65.1) | 117 (77.0) | 36 (43.4) | ||
Low < LLN | 82 (34.9) | 35 (23.0) | 47 (56.6) | ||
HBV DNA (IU mL-1) | <0.0001 | <0.0001 | |||
< 20 | 97 (41.3) | 88 (57.9) | 9 (10.8) | ||
20 – 2000 | 58 (24.7) | 31 (20.4) | 27 (32.5) | ||
2001 - 20, 000 | 14 (6.0) | 4 (2.6) | 10 (12.1) | ||
> 20, 000 | 66 (28.1) | 29 (19.1) | 37 (44.6) | ||
Initial ART contain | |||||
3TC | 100 (42.6) | 100 (65.8) | -- | ||
3TC + TDF | 52 (22.1) | 52 (34.2) | -- | ||
Duration on ART | -- | ||||
<1 year | 4 (1.7) | 4 (2.6) | |||
1 – 2 years | 38 (16.2) | 38 (25.0) | -- | ||
2 – 3 years | 21 (8.9) | 21 (13.8) | -- | ||
> 3 years | 89 (37.9) | 89 (58.6) | -- | ||
Ever forgotten meds? | 36 (23.7) | -- | |||
Do you take meds on time? | 16 (10.5) | -- | |||
Stop taking meds due to illness? | 12 (7.9) | -- | |||
Forgotten meds last weekend? | 14 (9.2) | -- | |||
Number of times not taken meds last week? | |||||
0 | 57 (37.5) | ||||
1 to 2 | 10 (6.6) | ||||
3 – 5 | 6 (3.9) | ||||
more than 5 | 3 (2.0) |
Factors associated with hepatitis B viremia
Characteristic | HBV DNA < 20 | HBV DNA ≥ 20 |
P-value T test |
P-value Wilcoxon rank sum test |
IU/mL (N = 64) | IU/mL (N = 88) | |||
Mean (SD) age (years) | 42.6 (9.6) | 42.7 (9.5) | 0.928 | 0.701 |
Mean (SD) weight (kg) | 65.9 (13.7) | 63.5 (12.2) | 0.262 | 0.326 |
Mean (SD) BMI (kg/m2) | 24.5 (4.6) | 23.9 (4.7) | 0.415 | 0.432 |
Mean (SD) CD4 count (cells/uL) | 539 (257) | 478 (358) | 0.244 | 0.157 |
n (%) | n (%) |
P value Chi square |
P value Fisher | |
Male sex | 30 (46.9 %) | 34 (53.1 %) | 0.019 | 0.021 |
Ethnicity | 0.656 | 0.679 | ||
Akan | 43 (59.7 %) | 29 (40.3 %) | ||
Ewe | 14 (48.3 %) | 15 (51.7 %) | ||
Ga | 13 (65.0 %) | 7 (35.0 %) | ||
Other | 18 (58.1 %) | 13 (41.9 %) | ||
WHO HIV stage | 0.086 | 0.095 | ||
1 | 24 (63.2 %) | 14 (36.8 %) | ||
2 | 21 (58.3 %) | 15 (41.7 %) | ||
3 | 37 (60.7 %) | 24 (39.3 %) | ||
4 | 4 (26.7 %) | 11 (73.3 %) | ||
HBeAg positive | 0 | 28 (100.0 %) | <0.0001 | <0.0001 |
HBeAb positive | 85 (69.7 %) | 37 (30.3 %) | <0.0001 | <0.0001 |
HB eAg/E Ab combination | <0.0001 | <0.0001 | ||
HBeAg positive/Ab negative | 0 | 25 (100.0 %) | ||
HBeAg negative/Ab positive | 85 (71.4 %) | 34 (28.6 %) | ||
HBeAg negative/Ab negative | 3 (60.0 %) | 2 (40.0 %) | ||
HBeAg positive/Ab positive | 0 | 3 (100.0 %) | ||
HBcIgM positive | 0 | 4 (100.0 %) | 0.0175 | 0.030 |
Alanine aminotransferase | 0.0001 | 0.0002 | ||
Normal (5-40 U/L) | 79 (65.8 %) | 41 (34.2 %) | ||
Elevated > ULN | 9 (28.1 %) | 23 (71.9 %) | ||
Aspartate aminotransferase | 0.0004 | 0.0008 | ||
Normal (5-50 U/L) | 81 (64.3 %) | 45 (35.7 %) | ||
Elevated > ULN | 7 (26.9 %) | 19 (73.1 %) | ||
Characteristic | HBV DNA < 20 IU mL-1 | HBV DNA ≥ 20 IU mL-1 |
P value Chi square |
P value Fisher |
n (%) | n (%) | |||
Albumin | 0.096 | 0.119 | ||
Normal (36-50 g/L) | 72 (61.5 %) | 45 (38.5 %) | ||
Low < LLN | 16 (45.7 %) | 19 (54.3 %) | ||
Initial ART contain | 0.971 | 1.000 | ||
3TC (n = 100) | 42 (42.0 %) | 58 (58.0 %) | ||
3TC + TDF (n = 52) | 22 (42.3 %) | 30 (57.7 %) | ||
Duration on ART | 0.969 | 0.972 | ||
<1 year | 3 (75.0 %) | 1 (25.0 %) | ||
1 – 2 years | 22 (57.9 %) | 16 (42.1 %) | ||
2 – 3 years | 12 (57.1 %) | 9 (42.9 %) | ||
> 3 years | 51 (57.3 %) | 38 (42.7 %) | ||
Ever forgotten meds? | 26 (72.2 %) | 10 (27.8 %) | 0.046 | |
Do you take meds on time? | 8 (50.0 %) | 8 (50.0 %) | 0.499 | |
Stop taking meds due to illness? | 9 (75.0 %) | 3 (25.0 %) | 0.211 | |
Forgotten meds last weekend? | 10 (71.4 %) | 4 (28.6 %) | 0.282 | |
Number of times not taken meds last week? | -- | |||
0 | 35 (61.4 %) | 22 (38.6 %) | ||
1 - 2 | 7 (70.0 %) | 3 (30.0 %) | ||
3 – 5 | 4 (66.7 %) | 2 (33.3 %) | ||
more than 5 | 1 (33.3 %) | 2 (66.7 %) |
Characteristic | HBV DNA < 20 IU/mL | HBV DNA ≥ 20 IU/mL |
P-value T test |
P-value Wilcoxon rank sum test |
(N = 64) | (N = 88) | |||
Mean (SD) age (years) | 39.6 (8.0) | 37.7 (10.4) | 0.616 | 0.288 |
Mean (SD) weight (kg) | 66.2 (9.5) | 58.8 (13.4) | 0.116 | 0.092 |
Mean (SD) BMI (kg/m2) | 23.7 (4.9) | 21.6 (4.4) | 0.184 | 0.209 |
Mean (SD) CD4 count (cells/uL) | 561.7 (504.5) | 338.8 (302.7) | 0.228 | 0.144 |
n (%) | n (%) |
P-value Chi square |
P-value Fisher | |
Male sex | 4 (12.5 %) | 28 (87.5 %) | 0.701 | 0.728 |
Ethnicity | 0.404 | 0.381 | ||
Akan | 6 (16.2 %) | 31 (83.8 %) | ||
Ewe | 0 (0.0 %) | 15 (100.0 %) | ||
Ga | 1 (12.5 %) | 7 (87.5 %) | ||
Other | 2 (9.5 %) | 19 (90.5 %) | ||
WHO HIV stage | 0.265 | 0.174 | ||
1 & 2 | 2 (5.1 %) | 37 (94.9 %) | ||
3 & 4 | 7 (16.3 %) | 36 (83.7 %) | ||
HBeAg positive | 0 (0.0 %) | 19 (100.0 %) | 0.083 | 0.110 |
HBeAb positive | 9 (13.6 %) | 57 (86.4 %) | 0.107 | 0.193 |
HBeAg/E Ab combination | 0.361 | 0.339 | ||
HBeAg positive/Ab negative | 0 (0.0 %) | 16 (100.0 %) | ||
HBeAg negative/Ab positive | 9 (14.3 %) | 54 (85.7 %) | ||
HBeAg negative/Ab negative | 0 (0.0 %) | 1 (100.0 %) | ||
HBeAg positive/Ab positive | 0 (0.0 %) | 3 (100.0 %) | ||
HBcIgM positive | 0 (0.0 %) | 1 (100.0 %) | 0.726 | 1.000 |
Alanine aminotransferase | 0.622 | 0.731 | ||
Normal (5–40 U/L) | 6 (12.2 %) | 43 (87.8 %) | ||
Elevated > ULN | 3 (8.8 %) | 31 (91.2 %) | ||
Aspartate aminotransferase | 0.320 | 0.473 | ||
Normal (5–50 U/L) | 7 (13.5 %) | 45 (86.5 %) | ||
Elevated > ULN | 2 (6.5 %) | 29 (93.6 %) | ||
Albumin | 0.945 | 1.000 | ||
Normal (36–50 g/L) | 4 (11.1 %) | 42 (89.4 %) | ||
Low < LLN | 5 (10.6 %) | 19 (54.3 %) |
Factors associated with viremia in multivariate analysis
Factor | All patients | ART-experienced | ||||
---|---|---|---|---|---|---|
Odds ratio | 95 % Confidence Interval |
P value | Odds ratio | 95 % Confidence Interval |
P value | |
Sex (Male vs Female) | -- | -- | -- | 2.1 | 1.0 – 4.2 | 0.0320 |
ART (Naïve vs. Experienced) | 10.1 | 4.6 – 21.9 | <0.0001 | -- | -- | -- |
ALT (Elevated vs. Normal) | 3.7 | 1.8 – 7.9 | 0.0006 | 4.8 | 2.1 – 12.1 | 0.0001 |
ALB (low vs. normal) | -- | -- | -- | 1.9 | 0.8 – 4.2 | 0.1326 |