Table 1.
Baselinea Characteristics of the 148 PWH and 4-Class Drug-Resistant Virus
| Baseline Characteristics | Median (IQR) or Frequency (%) |
|---|---|
| Age, y | 49 (44–53) |
| Male gender | 115 (78) |
| HCVAb positive | 31 (21) |
| HBsAg positive | 13 (9) |
| Years from HIV diagnosis | 20.4 (16.2–24.5) |
| Years of ART | 16.8 (14.0–19.7) |
| Pre-ART plasma HIV-RNA, log10 copies/mL | 5.18 (4.95–5.67) |
| Nadir CD4+ cell count, cells/µL | 92 (18–203) |
| Previous AIDS events | 58 (39) |
| Previous non-AIDS events | 31 (21) |
| Diabetes | 9 (6) |
| Decompensated cirrhosis | 1 (1) |
| Malignancies | 24 (16) |
| MACE | 4 (3) |
| CKD, eGFR <60 mL/min/1.73 m2 | 3 (2) |
| Number of available genotypic resistance tests per individual | 3 (2–6) |
| Residual genotypic susceptibility score, RGSS scoreb | 5.5 (3.75–9.5) |
| NRTI RGSS | 0.5 (0–2) |
| NNRTI RGSS | 1 (0.5–2.5) |
| PI RGSS | 1 (0–4) |
| INSTI RGSS | 1 (0.5–2) |
| Previous exposure to maraviroc | 50 (34) |
| Previous exposure to enfurvitide | 56 (38) |
| Most frequent ART regimens | |
| DRV/b+DTG | 21 (14.2) |
| DRV/b+DTG+MVC | 9 (6.1) |
| DRV/b+DTG+ETV | 8 (5.4) |
| FTC/TAF+DRV/b+DTG | 8 (5.4) |
| 3TC+DRV/b+DTG | 6 (4.1) |
| DRV/b+DTG+RPV | 5 (3.4) |
| INSTI-including regimen | 128 (86.5) |
| Plasma HIV-1 RNA ≥50 copies/mL | 137 (93) |
| Plasma HIV-RNA, log10 copies/mL | 3.49 (2.37–4.48) |
| CD4+ cell count, cells/µL | 346 (169–600) |
| CD8+ cell count, cells/µL | 946 (629–1284) |
| CD4+/CD8+ ratio | 0.35 (0.20–0.61) |
Abbreviations: 4DR, 4-class drug-resistant; ART, antiretroviral therapy; chronic CKD, kidney disease; eGFR, estimated glomerular filtration rate; INSTI, integrase strand transfer inhibitor; MACE, major adverse cardiovascular event; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RGSS, Residual Genotypic Susceptibility Score.
aBaseline is defined as the date with the first evidence of a 4DR virus.
bThe RGSS was estimated according to the cumulative data of the available plasma genotyping resistance tests recorded for each patient until baseline. Based on the patient’s cumulative resistance mutations, the level of resistance of each of 24 antiretroviral drugs (excluding maraviroc, enfuvirtide) was calculated using the Genotypic Resistance Interpretation Algorithm of the Stanford HIV Drug Resistance Database Program (version 8.8, last updated on 2019-02-13; http://hivdb.stanford.edu). For each of the 24 Food and Drug Administration–approved antiretroviral drugs, a drug penalty score was assigned according to the degree of resistance. Antiretroviral drug resistance was scored as 1 point if classified as “susceptible” or “potential low-level or low-level resistance,” as 0.5 points if classified as “intermediate resistance,” and as 0 points if classified as “high-level resistance.” In people with a documented virological failure to an INSTI regimen (n = 21; 11 individuals failed raltegravir, 8 dolutegravir, and 2 elvitegravir), antiretroviral drug resistance (of the failed drug) was scored as 0.5 points; similarly, people previously failing maraviroc-containing (n = 50) or enfuvirtide-containing (n = 56) regimens were labeled resistant to these agents and scored as 0.5 points.