Table 2.
Trials of dolutegravir in treatment-experienced HIV-1-positive patients
| Trial | Population | Antiretrovirals | Outcomesa | Emergent DTG resistance mutations |
|---|---|---|---|---|
| SAILING53 | Resistance to ≥1 drug in ≥2 classes | DTG (n=354) RAL (n=361) | At 48 weeks DTG 71% RAL 64% |
R263R (FC 1.12) R263R (FC 1.93) R263R (FC 1.1) R263R (FC 1.9) E138T/A + T97A (FC > max) V151I (FC 0.92) |
| VIKING55,c | RAL resistance and ≥1 drug in ≥3 classes | DTG daily (n=27) DTG twice daily (n=24) |
At 24 weeks DTG daily 41% DTG twice daily 75% |
L74I/M, E138A (FC 38) L74M/I, T97A, G140S, Q148H (FC 68) N155H (FC 6.6) N155H (FC 8.4) T97A, E138K, N155H (FC 93) E92Q, T97A (FC 42) E138K, N155H (FC 63) |
| VIKING-356 | RAL/ELV resistance and ≥1 drug in ≥3 classes | DTG twice daily (n=183) | At 24 weeks DTG 69% | Not available |
| VIKING-457 | RAL/ELV resistance and ≥1 drug in ≥2 classes | DTG twice daily (n=30) | At 24 weeks DTG 47% | L74L/Mb T97A T97A T97A E138K S147G N155H |
Notes:
a
Percentage of cohort achieving HIV RNA <50 copies/mL at specified dates.
b
FC not provided.
c
Adapted from Eron JJ, Clotet B, Durant J, et al; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with ralte gravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013;207(5):740–748.55
Abbreviations: RAL, raltegravir; DTG, dolutegravir; ELV, elvitegravir; FC, fold change in phenotype resistance; max, maximum.