Table 2.
Current and Nadir CD4 Cell Count, Plasma Viral Load, Genital Tract HIV-1 RNA, Highly Active Antiretoviral Therapy Regimen, and Antiretroviral Resistance Profile at Baseline
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GT HIV-1 RNA by compartment (copies/mL) |
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Drug resistance profile at baseline |
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| Patient No. | Hyst. | Baseline CD4 (cells/μL) | Nadir CD4 (cells/μL) | PVL (copies/mL) | Endocervix | Ectocervix | Vagina | HAART regimen at baseline | New HAART regimen after changea | Major NRTI/NNRTI mutations | Major (and minor) PI mutations | Number of active drugs in new HAART regimen |
| Women with 3 or more active ARVs in HAART regimen after change | ||||||||||||
| 1 | No | 225 | 175 | 2800 | 4720 | ≤3300 | ≤3300 | 3TC, d4T, EFV | DDI3, TDF2, ATZ3 | M184V, T215Y/Y188L, | D30N, (L63P, A71V), N88D | 3 |
| 2b | No | 98 | 10 | 11,000 | 3760 | ≤3300 | 11,200 | AZT, 3TC, EFV | DDI1, TDF1, ATZ1 | M184V/K103N, P225H | (L63P) | 3 |
| 3b | No | 110 | 48 | 11,000 | 4240 | 46,400 | 18,400 | AZT, 3TC, NVP | ABC1, TDF1, LPV1 | M184V/K103N | – | 3 |
| 4 | No | 185 | 120 | 18,000 | 10,400 | ≤3300 | ≤3300 | AZT, 3TC, EFV | AZT1, TDF1, FTC5, LPV1 | M184V/L100I, K103N, | (L33I/V, M36I, L63P) | 3 |
| 5 | No | 591 | 389 | 27,000 | ≤3300 | ≤3300 | ≤3300 | 3TC, DDI, EFV | TDF1, FTC1, ATZ1 | K103N | (L63P, A71T) | 3 |
| 6c | No | 230 | 73 | 780,000 | 4880 | ≤3300 | 5200 | TDF, FTC, EFV | TDF1, FTC1, LPV1 | – | (L63P) | 3 |
| 7 | No | 237 | 46 | 150,000 | 104,0000 | 880,000 | NA | TDF, FTC, FPV | DDI1, ABC2, TPV1 | M184V | (L63P) | 3 |
| 8 | Yes | 214 | 138 | 10,000 | – | – | ≤3300 | DDI, TDF, FPV | AZT1, 3TC1, ABC1, DRV1 | – | (L10I, L63P, A71T, G73S), L90M | 4 |
| Women with 2 or fewer active ARVs in HAART regimen after change | ||||||||||||
| 9 | No | 108 | 31 | 16,000 | ≤3300 | ≤3300 | ≤3300 | 3TC, DDI, EFV | 3TC5, TDF1, ATZ1 | L74V, Y115F, M184V/L100I, K103N, P225H | (M36I, L63P) | 2 |
| 10b,c | No | 223 | 17 | 32,000 | 26,400 | NA | NA | d4T, TDF, EFV | d4T4, TDF2, ATZ1 | D67N, K70R, K219E | (L63P) | 2 |
| 11 | No | 416 | 79 | 2600 | ≤3300 | ≤3300 | 5360 | AZT, 3TC, ABC | EFV1, ATZ1 | M41L, D67N, M184V, L210W, T215Y | (M36I, L63P) | 2 |
| 12b,c | Yes | 230 | 88 | 21,000 | – | – | 13,000 | AZT, 3TC, NVF | DDI4, TDF3, EFV1 | M184V, L210W, T215Y | D30N, (L63P, A71T), N88D | 2 |
| 13b,c | No | 63 | 11 | 390,000 | 136,000 | 408,000 | 304,000 | 3TC, DDI, TDF, LPV | AZT4, 3TC5, TDF3, LPV5 | M41L, L74V, M184V, L210W, T215F/L100I, K103N, | (L10I), I154V, (L63P, A71V), V82A, I84V, L90M, (V11VI) | 1 |
| 14b,c | No | 353 | 265 | 4500 | ≤3300 | ≤3300 | ≤3300 | DDI, TDF, NVP | TDF4, FTC3, NVP5 | M41L, L74V, L210W, T215Y/V108I, Y181C, | – | 1 |
| 15 | No | 307 | 141 | 1800 | ≤3300 | ≤3300 | 112,0000 | 3TC, d4T, LPV | TDF1, FTC5, LPV4 | M184V/K103N | (L10F), M46I, I54V, I84V | 1 |
| 16c | Yes | 189 | 120 | 11,000 | – | – | ≤3300 | DDI, TDF, ATZ | TDF4, FTC1, ATZ5 | M41L, L74V, T215Y/ K103N, | (L10R, K20M, M36I), M46L, (L63P, G73S), V82T, L90M | 1 |
Regimens coded from 1 to 5 based on level of drug resistance using the baseline genotype: (1) susceptible, (2) potential low level resistance, (3) low-level resistance, (4) intermediate resistance, and (5) high-level resistance. Antiretrovirals with either intermediate or high baseline resistance were considered to not be active agents in the changed HAART regimen.
Refers to women who also had genital tract genotype profiles.
Refers to women who had follow-up genotype profiles.
NRTIs, nucleoside reverse transcriptase inhibitors; AZT, zidovudine; 3TC, lamivudine; DDI, didanosine; TDF, tenofovir; d4T, stavudine; FTC, emtricitabine; ABC, abacavir; NVF, nelfinavir; LPV, lopinavir; ATZ, atazanvir; FPV, fosamprenavir; DRV, darunavir; TPV, tipranivir; NNRTIs, non-nucleoside reverse transcriptase inhibitors; EFV, efavirenz; GT, genital tract; Hyst., hysterectomy status; PI, protease inhibitor.