Table 3. Genotypic Resistance with Dolutegravir-based ART and Standard Care.*.
| End Point | ODYSSEY A | ODYSSEY B | ||
|---|---|---|---|---|
| Dolutegravir | Standard Care | Dolutegravir | Standard Care | |
| Virologic failure by 96 wk — no./total no. (%)† |
11/154 (7) | 30/157 (19) | 31/196 (16) | 40/200 (20) |
| Resistance after virologic failure — no./total no. (%)‡ | ||||
| Any drug class | 0/11 | 28/29 (97) | 23/29 (79) | 36/40 (90) |
| NRTI | 0/11 | 18/29 (62) | 21/29 (72) | 31/40 (78) |
| NNRTI | 0/11 | 27/29 (93) | 22/29 (76) | 36/40 (90) |
| Protease inhibitor | 0/11 | 0/29 | 2/29 (7) | 3/40 (8) |
| INSTI | 0/11 | — | 4/22 (18) | — |
| Emerging resistance after virologic failure — no. (%)§ | ||||
| Any drug class | 0 | 21 (97) | 6 (22) | 6 (19) |
| NRTI | 0 | 13 (62) | 2 (8) | 3 (10) |
| NNRTI | — | 19 (88) | — | 2 (100) |
| Protease inhibitor | — | — | — | 2 (5) |
| INSTI¶ | 0 | — | 4 (18) | — |
INSTI denotes integrase strand-transfer inhibitor, NNRTI nonnucleoside reverse-transcriptase inhibitor, and NRTI nucleoside (or nucleotide) reverse-transcriptase inhibitor.
A total of 112 participants had a virologic end-point event by week 96 (defined as a confirmed viral load of ≥400 copies per milliliter after week 36 or a lack of virologic response by week 24 followed by a switch in ART); 5 participants had a virologic end-point event after meeting a clinical component of the composite primary end point.
Major International AIDS Society (IAS) drug-resistance mutations were defined according to the 2019 update of the IAS drug-resistance mutations. Shown are the percentages of participants with resistance after virologic failure, among those with virologic failure by week 96 who had a post-treatment failure resistance test available for the drug class. (The integrase gene was not sequenced for the standard-care group.)
Among participants with virologic failure and exposure to the drug class, emerging resistance was estimated under an assumption of the same proportion of new resistance in participants with an available baseline resistance test and those without.
Four participants had resistance to dolutegravir (Q148R in one participant, Q148K in one, G118RS in one, and G118RS and R263K in one).