Acquired INSTI Resistance. Daniel R. Kuritzkes, M.D. Division of Infectious Diseases Brigham and Women s Hospital Harvard Medical School
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1 Acquired INSTI Resistance Daniel R. Kuritzkes, M.D. Division of Infectious Diseases Brigham and Women s Hospital Harvard Medical School
2 Disclosures The speaker has received consulting honoraria, speaker fees or research grants from the following companies: Gilead GlaxoSmithKline Janssen Merck ViiV
3 Integrase strand-transfer inhibitors Smith et al Retrovirology 2018
4 Major primary INSTI resistance mutations Position Wild-type T E E G G Y Q N K Raltegravir AIK Q R KAT SAC RCH HRK H K Elvitegravir AIK Q R KAT SAC HRK H K Dolutegravir AIK Q R KAT SAC HRK H K Bictegravir AIK Q R KAT SAC HRK H K Mutations in RED associated with highest levels of reduced susceptibility or response. Mutations in BOLD reduce INSTI susceptibility or response. Adapted from the Stanford HIV Drug Resistance Database available at
5 Cross-resistance among INSTIs Smith et al Retrovirology 2018
6 VIKING study design and dolutegravir susceptibility Eron et al J Infect Dis 2013 DRK
7 BENCHMRK primary results Steigbigel RT et al N Engl J Med 2008
8 RAL resistance in BENCHMRK Cooper DA et al N Engl J Med 2008
9 Plasma HIV-1 RNA levels in patients developing INSTI resistance mutations Gallien S et al AIDS 2011
10 Raltegravir Resistance Evolution N155H N155H + Q148H Q148H + others N155H + Q148H Q148H Q148H + others Q148H + others Fransen S et al J Virol 2009 DRK Dartmouth
11 % population % population Fitness of INSTI-resistant mutants in presence of raltegravir Q148H N155H G140S/Q148H E92Q/N155H Days post-infection Days post-infection INSTI = integrase strand transfer inhibitor Hu et al J AIDS 2010 DRK Dartmouth
12 STARTMRK: Final 5-year data Rockstroh J et al JAIDS 2013
13 Resistance in STARTMRK Lennox et al Lancet 2009
14 Comparison of elvitegravir/cobicistat/tdf/ftc with EFV/TDF/FTC or ATV/r plus TDF/FTC Sax P et al, Lancet 2012; DeJesus E et al, Lancet 2012
15 : Resistance at time of virologic failure through week 48 Sax et al Lancet 2012
16 SPRING-2: Dolutegravir vs raltegravir Proportion of patients with plasma HIV-1 RNA <50 c/ml Raffi F et al Lancet Infect Dis 2013
17 Resistance in SPRING-2 Raffi F et al Lancet Infect Dis 2013
18 SINGLE: Resistance at virologic failure TDF/FTC/EFV Walmsley et al ICAAC 2012 DRK
19 B/F/TAF versus DTG + F/TAF Sax PE et al Lancet 2017
20 Resistance at time of virologic failure: B/F/TAF vs DTG + F/TAF B/F/TAF n=320 DTG + F/TAF n=325 Met criteria for resistance testing* 7 5 Assay failure 0 0 NRTI resistance detected 0 0 INSTI resistance detected 0 0 No resistance to any components of the treatment regimens occurred in either treatment group *Resistance testing performed for patients with confirmed virologic rebound to 200 copies/ml after Week 8. Sax PE et al IAS 2017 Paris 2
21 Resistance at time of virologic failure: B/F/TAF vs DTG/ABC/3TC B/F/TAF n=314 DTG/ABC/3TC n=315 Met criteria for resistance testing 1 4 Assay failure 0 1 NRTI resistance detected 0 0 INSTI resistance detected 0 0 No resistance to any components of the treatment regimens occurred in either treatment group Resistance testing performed for patients with a confirmed HIV-1 RNA 200 copies/ml or 200 copies/ml at last visit. NRTI, nucleoside reverse-transcriptase inhibitor. Gallant J et al IAS 2017 Paris 2
22 DTG resistance during initial ART in acute HIV infection Fulcher JA et al Clin Infect Dis 2018 (epub ahead of print)
23 SAILING: Week 48 results Cahn et al Lancet 2013
24 INSTI Resistance in SAILING Resistance mutations emerged in 4 of 354 (1%) in the DTG arm Q148S/G140S and R263K (2 patients) in DTG arm Resistance mutations emerged 17 of 361 (5%) in the RAL arm (p=0.003)
25 ACTG A5353: DTG/3TC dual therapy Taiwo B et al Clin Infect Dis 2018 (epub ahead of print)
26 Emergence of DTG resistance in monotherapy studies Study name N Efficacy VF (N) GRM/n GRM/VFs Mutations ITALY 20 95% DONOMO 86 88% 8 3/86 (3.5%) 3/8 (37.5%) DOLAM % 2 2/31 (65%) 2/2 (100%) REDOMO % 11 9/122 (7.4%) 9/11 (82%) DOLUFRENCH 28 89% 3 3/28 (11%) 3/3 (100%) 263K (1) 155H (1) 230R (1) 155H, 147G, 148R (1) 138K, 155H, 140S (1) (next slide) 138K, 140A, 148R (1), 74I, 92Q (1), 155H (1) Adapted from Blanco JL et al Curr Opin Infect Dis 2018
27 DTG resistance in REDOMO Adapted from Blanco JL et al Curr Opin Infect Dis 2018
28 Time to VF in DONOMO Wijting et al J Infect Dis 2018 (epub ahead of print)
29 Conclusions Resistance to RAL and ELV emerges at time of treatment failure Resistance to DTG and BIC not observed in trials of treatment-naïve participants DTG resistance can emerge in treatmentexperienced patients and in dual- or monotherapy Shared mutations result in cross-resistance DTG monotherapy should be avoided Although the barrier to resistance for DTG and BIC is high, the drugs are not foolproof. Intermittent adherence and inadequate drug exposure increase the risk of INSTI resistance
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