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. 2017 Feb 17;12(2):e0172206. doi: 10.1371/journal.pone.0172206

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)