Table 1.
Demographic and Baseline characteristics for the enrolled participants (n=41).
| All participants (n=41) | Historical resistance to lamivudine | No historical lamivudine resistance | p value | |
|---|---|---|---|---|
| (n=21) | (n=20) | |||
| Male sex, n (%) | 32 (78·1) | 16 (76·2) | 16 (80) | 0·768 |
| Age (years), median (IQR) | 52·4 (45·4-56·9) | 53·4 (47·1-57·6) | 50·8 (42·9-55·3) | 0·636 |
| Time since HIV diagnosis (years), median (IQR) | 20·6 (15-25·1) | 21·5 (17·5-23·5) | 16·9 (12-27·4) | 0·342 |
| HIV mechanism of transmission, n (%) | 0·383 | |||
| Men who have sex with men | 14 (34·1) | 5 (23·8) | 9 (45) | |
| Heterosexual | 9 (22) | 6 (28·6) | 3 (15) | |
| Intravenous drug users | 13 (31·7) | 8 (38·1) | 5 (25) | |
| Other | 5 (12·2) | 2 (9·5) | 3 (15) | |
| CD4 count (cells/mm3), median (IQR) | ||||
| Nadir | 196 (93-290) | 160 (99-216) | 259 (70-314) | 0·161 |
| Baseline | 673 (531-842) | 705 (531-871) | 647 (530-800) | 0·527 |
| ART duration (years), median (IQR) | 18 (13·1-21·4) | 18·8 (17·2-21) | 13·1 (7·9-21·6) | 0·085 |
| Duration of suppressed plasma HIV RNA (years), median (IQR) | 6 (3·3-11) | 7·7 (4-12) | 5·3 (3-8.9) | 0·272 |
| Number of previous ART regimens, median (IQR) | 6 (4-10) | 7 (5-10) | 4 (2-7) | 0·427 |
| Type of ART regimen at baseline, n (%) | 0·002 | |||
| 2 NRTI + bPI | 8 (19.5%) | 7 (33·3) | 1 (5) | |
| 2 NRTI + NNRTI | 9 (22) | 2 (9·5) | 7 (35) | |
| 1 NNRTI + bPI | 5 (12·2) | 5 (23·8) | 0 (0) | |
| 1 NRTI + bPI | 14 (34·1) | 3 (14·3) | 11 (55) | |
| bPI monotheraphy | 5 (12·2) | 4 (19) | 1 (5) | |
| Baseline ART including lamivudine or emtricitabine | 28 (68·3) | 9 (42·9) | 19 (95) | <0·001 |
| Time from historical RNA genotype to baseline proviral DNA sequencing | 12·9 (11·1-14·4) | 13·4 (11·1-14·6) | 10·4 (4·3-13·6) | 0·152 |
| M184V (Proviral DNA Sanger genotype)* | 2 (4·9) | 2 (9·5) | 0 (0) | 0·488 |
| M184V/I detected by NGS in proviral DNA, n (%) | ||||
| >20% | 8 (19·5) | 7 (33) | 1 (5) | 0·046 |
| >10% | 13 (31·7) | 11 (52·4) | 2 (10) | 0·007 |
| >5% | 17 (45·5) | 14 (66·7) | 3 (15) | 0·002 |
| >1% | 27 (65·9) | 20 (95·2) | 7 (35) | <0·01 |
| K65R/E/N detected by NGS in proviral DNA, n (%)† | ||||
| >20% | 1 (2·4) | 1 (4·8) | 0 (0) | 1 |
| >10% | 2 (4·9) | 2 (9·5) | 0 (0) | 0·488 |
| >5% | 2 (4·9) | 2 (9·5) | 0 (0) | 0·488 |
| >1% | 3 (7·3) | 3 (14·3) | 0 (0) | 0·233 |
Abbreviations: 3TC: lamivudine. ART: antiretroviral treatment. bPI: boosted protease inhibitor. FTC: emtricitabine. NRTI: Nucleoside reverse transcriptase inhibitors. NNRTI: Non- Nucleoside reverse transcriptase inhibitors (NRTIs). NGS: Next-Generation Sequencing.
⁎
Protocol violation.
†
Of those who initiated cART prior to labour.