Table 1.
Baseline characteristics
| Total N=150* |
Naïve-MONO N=65* |
Naïve-DUAL N=27* |
Exp-MONO N=52* |
Exp-DUAL N=6* |
|
|---|---|---|---|---|---|
|
| |||||
| Anti-HBV agents | |||||
| 3TC | 97 (64.7%) | 64 (98.5%) | 0 | 33 (63.5%) | 0 |
| ADV | 16 (10.7%) | 1 (1.5%) | 0 | 15 (28.8%) | 0 |
| TDF | 4 (2.7%) | 0 | 0 | 4 (7.7%) | 0 |
| 3TC+TDF | 18 (12.0%) | 0 | 15 (55.6%) | 0 | 3 (50.0%) |
| FTC+TDF** | 15 (10.0%) | 0 | 12 (44.4%) | 0 | 3 (50.0%) |
|
| |||||
| Age (years) | |||||
| Median (Q1, Q3) | 40 (35, 46) | 39 (35,42) | 44 (33,51) | 41 (37,46) | 48 (35,55) |
|
| |||||
| Sex | |||||
| Male | 144 (96.0%) | 62 (95.4%) | 26 (96.3%) | 50 (96.2%) | 6 (100%) |
| Female | 6 (4.0%) | 3 (4.6%) | 1 (3.7%) | 2 (3.8%) | 0 (0%) |
|
| |||||
| Race/Ethnicity | |||||
| White non-Hispanic | 85 (56.7%) | 29 (44.6%) | 14 (51.9%) | 39 (75.0%) | 3 (50.0%) |
| Black non-Hispanic | 39 (26.0%) | 19 (29.2%) | 11 (40.7%) | 8 (15.4%) | 1 (16.7%) |
| Hispanic (any race) | 19 (12.7%) | 13 (20.0%) | 0 (0%) | 4 (7.7%) | 2 (33.3%) |
| Asian, Pacific Islander | 6 (4.0%) | 3 (4.6%) | 2 (7.4%) | 1 (1.9%) | 0 (0%) |
| More than one race | 1 (0.7%) | 1 (1.5%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| IVD history | |||||
| Never | 134 (89.3%) | 61 (93.8%) | 27 (100%) | 42 (80.8%) | 4 (66.7%) |
| Previously | 16 (10.7%) | 4 (6.2%) | 0 (0%) | 10 (19.2%) | 2 (33.3%) |
|
| |||||
| Log10 HBV DNA (IU/mL) | [N=140] | [N=60] | [N=24] | [N=51] | [N=5] |
| Median (Q1, Q3) | 6.30 (1.65,8.52) | 8.26 (2.54, 8.92) | 7.18 (3.96, 8.59) | 4.09 (1.46***, 7.62) | 7.69 (1.46***, 8.12) |
|
| |||||
| HBeAg | [N=143] | [N=61] | [N=24] | ||
| Reactive | 84 (58.7%) | 38 (62.3%) | 14 (58.3%) | 28 (53.8%) | 4 (66.7%) |
| Non-reactive | 58 (40.6%) | 22 (36.1%) | 10 (41.7%) | 24 (46.2%) | 2 (33.3%) |
| Borderline | 1 (0.7%) | 1 (1.6%) | 0 (0%) | 0 (0%) | 0 (0%) |
| HBeAb | [N=143] | [N=61] | [N=24] | ||
| Reactive | 50 (35.0%) | 20 (32.8%) | 9 (37.5%) | 19 (36.5%) | 2 (33.3%) |
| Non-reactive | 93 (65.0%) | 41 (67.2%) | 15 (62.5%) | 33 (63.5%) | 4 (66.7%) |
|
| |||||
| HBV genotype **** | [N=103] | [N=46] | [N=23] | [N=31] | [N=3] |
| A | 71 (68.9%) | 31 (67.4%) | 16 (69.6%) | 22 (71.0%) | 2 (66.7%) |
| A/G | 2 (1.9%) | 1 (2.2%) | 1 (4.3%) | 0 (0%) | 0 (0%) |
| B | 1 (1.0%) | 1 (2.2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| C | 1 (1.0%) | 0 (0%) | 1 (4.3%) | 0 (0%) | 0 (0%) |
| D | 7 (6.8%) | 3 (6.5%) | 0 (0%) | 4 (12.9%) | 0 (0%) |
| F | 1 (1.0%) | 1 (2.2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| G | 18 (17.5%) | 8 (17.4%) | 4 (17.4%) | 5 (16.1%) | 1 (33.3%) |
| H | 2 (1.9%) | 1 (2.2%) | 1 (4.3%) | 0 (0%) | 0 (0%) |
|
| |||||
| ART history | |||||
| Naïve | 70 (46.7%) | 51 (78.5%) | 18 (66.7%) | 0 (0%) | 1 (16.7%) |
| Experienced | 80 (53.3%) | 14 (21.5%) | 9 (33.3%) | 52 (100%) | 5 (83.3%) |
|
| |||||
| ART regimen ***** | |||||
| 2 NRTI + 1 Boosted PI | 17 (11.3%) | 7 (10.8%) | 7 (25.9%) | 2 (3.8%) | 1 (16.7%) |
| 2 NRTI + 1 PI | 29 (19.3%) | 7 (10.8%) | 2 (7.4%) | 20 (38.5%) | 0 (0%) |
| 2 NRTI + 2 PI | 5 (3.3%) | 2 (3.1%) | 0 (0%) | 3 (5.8%) | 0 (0%) |
| 2 NRTI + 1 NNRTI | 45 (30.0%) | 26 (40.0%) | 15 (55.6%) | 4 (7.7%) | 0 (0%) |
| 2 NRTI + 1 NNRTI + 1 PI | 14 (9.3%) | 8 (12.3%) | 0 (0%) | 6 (11.5%) | 0 (0%) |
| 2 NRTI + 1 NNRTI + 2 PI | 3 (2.0%) | 0 (0%) | 0 (0%) | 3 (5.8%) | 0 (0%) |
| 3 NRTI | 10 (6.7%) | 8 (12.3%) | 1 (3.7%) | 1 (1.9%) | 0 (0%) |
| 3 NRTI + 1 Boosted PI | 3 (2.0%) | 0 (0%) | 2 (7.4%) | 1 (1.9%) | 0 (0%) |
| 3 NRTI + 1 PI | 4 (2.7%) | 0 (0%) | 0 (0%) | 4 (7.7%) | 0 (0%) |
| 3 NRTI + 1 NNRTI | 9 (6.0%) | 5 (7.7%) | 0 (0%) | 1 (1.9%) | 3 (50.0%) |
| Other | 11 (7.3%) | 2 (3.1%) | 1 (3.7%) | 7 (13.5%) | 2 (33.3%) |
|
| |||||
| Nadir CD4 (cells/mm3) | |||||
| Median (Q1, Q3) | 142 (49, 257) | 106 (49, 254) | 188.5 (43, 326) | 140 (53, 232) | 124.5 (32, 204) |
|
| |||||
| CD4 count (cells/mm3) | [N=147] | [N=65] | [N=27] | [N=49] | [N=6] |
| Median (Q1, Q3) | 223.5 (115.5, 378.5) | 185 (81.5, 322) | 229 (91, 376) | 268.5 (182.5, 479) | 192 (139, 318) |
|
| |||||
| Log10 HIV RNA (copies/mL) | [N=147] | [N=65] | [N=27] | [N=49] | [N=6] |
| Median (Q1, Q3) | 4.48 (2.84, 4.84) | 4.69 (4.33, 5.26) | 4.55 (4.11, 4.80) | 2.90 (2.53, 4.48) | 4.61 (1.70, 4.84) |
*
Smaller N’s [noted in brackets] for some measures based on available data. Percentages may not total 100% due to rounding.
**
One patient received ADV prior to study participation, and it was discontinued after the start of FTC+TDF as the antiretroviral regimen.
***
HBV DNA limit of detection 29 IU/mL in log10 is 1.46
****
HBV genotypes were done only on samples with HBV DNA > 600 IU/mL.
*****
NRTI = nucleoside reverse transcriptase inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor; PI = protease inhibitor