Table 1.
Characteristics and outcomes of patients on DBLR
| Characteristics | Dolutegravir combined with another ARV (n = 31) | Dolutegravir monotherapy (n = 21) |
|---|---|---|
| Before DBLR | ||
| age, years | 53 (48–61) | 47 (41–65) |
| male | 17 (55%) | 13 (62%) |
| duration with HIV infection, years | 17 (11–24) | 11 (5–16) |
| CDC stage | ||
| A | 18 (58%) | 17 (81%) |
| B | 4 (13%) | 3 (14%) |
| C | 9 (29%) | 1 (5%) |
| coinfection | ||
| HBV | 2 (6%) | 1 (5%) |
| HCV | 2 (6%) | 2 (10%) |
| CD4 count nadir, cells/mm3 | 199 (134–281) | 310 (280–468) |
| highest PVL, log copies/mL | 5.3 (4.7–5.6) | 4.5 (4.3–5.5) |
| prior lines of ART, n | 7 (4–11) | 5 (3–7) |
| prior virological failure(s) | ||
| with any regimen | 20 (65%) | 5 (24%) |
| with a regimen including INI | 8 (26%) | 1 (5%) |
| last regimen | ||
| dual therapy | 14 (45.2%) | 6 (28.6%) |
| triple therapy | 15 (48.4%) | 15 (71.4%) |
| quadruple therapy | 2 (6.5%) | — |
| last PVL <50 copies/mL | 25 (81%)a | 21 (100%) |
| duration PVL <50 copies/mL, years | 3.7 (1.4–8.3)b | 5.9 (3.5–9.9) |
| last CD4 count, cells/mm3 | 702 (495–867) | 768 (563–936) |
| last CD4/CD8 ratio | 0.8 (0.5–1.1) | 1.4 (0.9–1.5) |
| last HIV DNA, log copies/106 PBMCs | 2.9 (2.7–3.0) | 2.7 (2.1–3.1) |
| reason for changing to DBLR | ||
| simplification | 18 (58.1%) | 15 (71.4%) |
| adverse reaction/toxicity | 6 (19.4%) | 6 (28.6%) |
| virological failure | 6 (19.4%) | — |
| drug–drug interactions | 1 (3.2%) | — |
| After DBLR | ||
| total follow-up, weeks | 50 (30–74) | 32 (29–45) |
| CD4 count increase at last visit, cells/mm3 | 8 (−72 to 88)c | 1 (−122 to 91)c |
| all PVL values | 107 (100%) | 72 (100%) |
| <20 copies/mL | 102 (95%) | 71 (99%) |
| 20–49 copies/mL | 3 (3%) | 1 (1%) |
| 50–199 copies/mL | 1 (1%) | — |
| ≥200 copies/mL | 1 (1%) | — |
| last PVL <50 copies/mL | 30 (97%)d | 21 (100%)e |
| ΔeGFR, mL/min/1.73 m2 | −4.5 (−11 to 4)c | 0 (−6 to 6)c |
eGFR, estimated glomerular filtration rate calculated using the MDRD formula; HBV/HCV, hepatitis B/C virus.
Values are given as median (IQR) or n (%).
aSix patients had detectable PVL at baseline: 66, 76, 711, 850, 2410 and 6750 copies/mL, respectively.
bFor the 25 patients with undetectable PVL at baseline.
cNo statistical difference between baseline and last follow-up visit.
dTwenty-nine out of 31 patients (94%) also showed <20 copies/mL.
eAll showed <20 copies/mL.