Table 1. Cross-study frequency of pre- and on-treatment integrase genotypes with or without T97A mutation.
Study Drug(s)a | Study No. | PT POPb | Pre-Treatment | On-Treatmentc | |||
---|---|---|---|---|---|---|---|
INSTI Treatment Arm | Integrase Genotype | T97A; Pre-Existing (Enrolled on INSTI) | Primary INSTI RAMs | T97A Aloned (Emergent) | |||
TDF | 01-934/ 99–903 | TN | 0 | 200 | 1 (0) | - | - |
99–907 | TE | 0 | 110 | 0 | - | - | |
EVG (125 mg)/r+OBR | 183–0105 | TE | 73 | 277 | 0 | 37 | 0 |
EVG (85/150 mg)/r+BR | 183-0130/0145/ 0152 | TE | 375 | 164 | 3 (3) | 30 | 6 (5) |
RAL (400 mg)+BR | 183–0145 | TE | 351 | 152 | 0 | 26 | 2 (2) |
EVG (150 mg)/ COBI/FTC/TDF | 236-0102/0103/ 0104/0118/ 0128 | TN | 1071 | 475 | 17 (14) | 15 | 1 (1) |
EVG (150 mg)/ COBI/FTC/TAF or EVG (150 mg)/ COBI/FTC/TDF | 292-0102/0104/ 0106/ 0111 | TN | 2011 | 1989 | 26 (1) | 14 | 0 |
Total: | 3881 | 3367 | 47 (18) | 122 | 9 (8) |
BR, background regimen; OBR, optimized background regimen; PT POP, patient population; TE, treatment-experienced; TN, treatment-naive; INSTI, integrase strand transfer inhibitor; TDF, tenofovir disoproxil fumarate; EVG, elvitegravir; RAL, raltegravir
a OBR included ≥2 NRTIs ± ENF with documented ≥1 PI mutation(s). BR included active PI + active/inactive 2nd agent (NRTI, ETR, MVC, ENF) with EVG 85 mg once a day (ATV/r or LPV/r), EVG 125 mg once a day (DRV/r, FPV/r, or TPV/r), or RAL 400 mg twice a day.
b Patients were either highly antiretroviral treatment-experienced (INSTI-naive) with 1–2 class resistance or antiretroviral treatment-naive (INSTI-naive).
c Only patients that received clinically approved EVG 150 mg once a day, bioequivalent EVG 85/125 mg once a day, or RAL 400 mg twice a day were included in on-treatment analysis of integrase genotypes.
d Alone, defined as in the absence of primary INSTI RAM(s)