Table 1.
Demographic and Baseline Characteristics for the Intent-to-Treat Exposed Population
| Parameter | Cohort I, DTG 50 mg Once Daily (n = 27) | Cohort II, DTG 50 mg Twice Daily (n = 24) |
|---|---|---|
| Age, y | 48 (19–61) | 47 (33–68) |
| Male sex | 25 (93) | 18 (75) |
| Race | ||
| White, Caucasian/European heritage | 23 (85) | 18 (75) |
| White, Arabic/North African heritage | 1 (4) | 1 (4) |
| African American/African heritage | 3 (11) | 5 (21) |
| CD4+ T-cell count, cells/mm3 | 114 (19–729) | 202 (19–528) |
| Plasma HIV-1 RNA level, log10 copies/mL | 4.5 (2.6–6.1) | 4.3 (3.3–5.8) |
| CDC class C disease | 16 (59) | 8 (33) |
| Hepatitis virus coinfection | ||
| HBsAg positive | 0 | 2 (9) |
| HCV antibody positive | 2 (7) | 6 (26) |
| HBV or HCV status missing | 4 (15) | 2 (9) |
| HBsAg and HCV antibody positive | 0 | 0 |
| Duration of prior ART, y | 14 (4–21) | 15 (3–22) |
| No. of prior ART drugs | 17 (6–24) | 15 (6–19) |
| Prior ART treatment | ||
| Etravirine | 19 (70) | 11 (46) |
| Enfuvirtide | 22 (81) | 13 (54) |
| Darunavir/ritonavir | 23 (85) | 14 (58) |
| Maraviroc | 10 (37) | 9 (38) |
| Current RAL failure | 21 (78) | 20 (83) |
| Baseline INI resistance/integrase mutational pathway | ||
| Q148H/K/R + 2 mutationsa | 3 (11) | 2 (8) |
| Q148H/K/R + 1 mutationsa | 4 (15) | 8 (33) |
| Mixed Q148H/K/R with Y143C/H/R or N155H | 2 (7) | 1 (4) |
| N155H | 4 (15) | 6 (25) |
| Y143C/H/R | 12 (44) | 6 (25) |
| Otherb | 2 (7) | 1 (4) |
| Baseline DTG FC | 1.46 (0.55–35) | 2.72 (0.87–9.48) |
| Baseline RAL FC | >161 (0.6–166) | >128 (0.8–183) |
| PSS of failing regimen = 0c | 18 (67) | 15 (63) |
| PSS of OBR = 0 (on day 11) | 12 (44) | 1 (4) |
Data are no. (%) of subjects or median (range).
Abbreviations: ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; DTG, dolutegravir; FC, fold change in 50% inhibitory concentration; HBsAg, hepatitis B virus surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; INI, integrase inhibitor; OBR, optimized background regimen; PSS, phenotypic susceptibility score; RAL, raltegravir.
a Mutations at L74, E138, or G140.
b Subjects with no Q148, Y143, or N155 mutations at day 1.
c PSS on fully active agents.