Integrase Strand Transfer Inhibitors on the Horizon
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1 NORTHWEST AIDS EDUCATION AND TRAINING CENTER Integrase Strand Transfer Inhibitors on the Horizon David Spach, MD Clinical Director, Northwest AETC Professor of Medicine, University of Washington Presentation Prepared by: David Spach, MD Last Updated: January 25, 2012
2 Integrase Strand Transfer Inhibitors (ISTIs) on the Horizon 1. Elvitegravir and Quad Pill 2. Dolutegravir and 572-Trii
3 : INVESTIGATIONAL Elvitegravir
4 Elvitegravir, formerly GS-9137 Class: integrase strand transfer inhibitor Approval Status: Filed for NDA October 2011 Dose (Requires Boosting) - Standard Dosing: 150 mg once daily with food - With Atazanavir + Ritonavir or Lopinavir-Ritonavir: 85 mg once daily Fixed Dose Quad Pill : Elvitegravir-Cobicistat-Tenofovir-Emtricitabine Metabolism: via cytochrome P450 (CYP) 3A4 Pregnancy: category unknown Adverse Events: - Well tolerated - Cobicistat decreases estimated Creatinine clearance
5 : ADVERSE EFFECTS Urine Formation Glomerular Filtration Tubular Reabsorption Tubular Secretion Cobicistat Inhibits tubular secretion of creatinine Bowman s Capsule Proximal Tubule Distal Tubule Loop of Henle Collecting Tubule Creatinine Clearance - Estimated: Cockcroft-Gault - Actual: Iohexol clearance Excretion
6 Summary of Key Elvitegravir Studies Phase 3 Trials in Treatment Naïve - Study 102: Quad Pill versus EFV-TDF-FTC (Atripla) Phase 3 Trial: Treatment Naive - Study 103: Quad Pill versus RTV + ATZ +TDF-FTC Phase 3 Trials in Treatment Experienced - Study 145: Elvitegravir versus Raltegravir
7 Elvitegravir-Cobicistat-TDF-FTC versus Efavirenz-TDF-FTC Study 102: Design Study Design Protocol - N = Randomized, Double-blind - Phase 3 trial at 130 study sites - Conducted in U.S. and Puerto Rico - Age > 18 - Antiretroviral naive - No baseline NRTI, NNRTI mutations - HIV RNA > 5,000 copies/ml - No AIDS condition in previous 30 days *Elvitegravir-Cobicistat- Tenofovir-Emtricitabine (n = 348) ^Efavirenz- Tenofovir-Emtricitabine (n = 352) *Dosing: Elvitegravir (150 mg); Cobicistat (150 mg); Tenofovir (300 mg); Emtricitabine (200mg) ^Dosing: Efavirenz (600 mg); Tenofovir (300 mg); Emtricitabine (200mg) Source: Gilead Sciences Press Release, August 15, 2011.
8 Elvitegravir-Cobicistat-TDF-FTC versus Efavirenz-TDF-FTC Study 102: Week 48 Results Week 48: Virologic Response ( ITT-TLOVR*) Patients (%) with HIV RNA < 50 copies/ml Elvitegravir-Cobicistat-TDF-FTC Efavirenz-TDF-FTC 20 0 *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response Source: Gilead Sciences Press Release, August 15, 2011.
9 Elvitegravir-Cobicistat-TDF-FTC versus + RTV + ATZ + TDF-FTC Study 103: Design Study Design Protocol - N = Double-blind, randomized, phase 3 trial - Age > 18 - Antiretroviral naive - No baseline NRTI, NNRTI, or PI mutations - HIV RNA > 5,000 copies/ml - CD4 > 50 cells/mm 3 - No AIDS condition in previous 30 days *Elvitegravir-Cobicistat- Tenofovir-Emtricitabine (n = 353) ^Ritonavir + Atazanavir Tenofovir-Emtricitabine (n = 355) *Dosing (QD): Elvitegravir (150 mg); Cobicistat (150 mg); Tenofovir (300 mg); Emtricitabine (200mg) ^Dosing (QD): Ritonavir (100 mg); Atazanavir (300 mg); Tenofovir (300 mg); Emtricitabine (200mg) Source: Gilead Sciences Press Release, September 19, 2011.
10 Elvitegravir-Cobicistat-TDF-FTC versus + RTV + ATZ + TDF-FTC Study 103: Week 48 Results Week 48: Virologic Response ( ITT-TLOVR*) Patients (%) with HIV RNA < 50 copies/ml Elvitegravir-Cobicistat-TDF-FTC 90 RTV +Atazanavir + TDF + FTC 87 0 *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response Source: Gilead Sciences Press Release, September 19, 2011.
11 Elvitegravir versus Raltegravir in Treatment Experienced Study 145: Design Study Design Protocol - N = Double-blind, double-dummy, randomized - Phase 3 trial, 96 weeks - Treatment-experienced patients - Age > 18 - Resistance to at least 2 classes - Stable regimen for at least 30 days - HIV RNA > 1,000 copies/ml - No AIDS condition in previous 30 days Elvitegravir* (150 mg QD) + Ritonavir + Protease Inhibitor + 3 rd Antiretroviral Agent (n = 351) Raltegravir (400 mg BID) Ritonavir + Protease Inhibitor + 3 rd Antiretroviral Agent (n = 351) *Elvitegravir dose reduced to 85 mg QD with ritonavir-atazanavir and ritonavir-lopinavir Source: Molina JM, et al. Lancet. 2012;12:27-35.
12 Elvitegravir versus Raltegravir in Treatment Experienced Study 145: Week 48 Results Week 48: Virologic Response ( ITT-TLOVR*) 100 Elvitegravir Arm Raltegravir Arm Patients (%) with HIV RNA < 50 copies/ml ITT-TLOVR Baseline HIV RNA *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response Source: Molina JM, et al. Lancet. 2012;12:27-35.
13 Elvitegravir versus Raltegravir in Treatment Experienced Study 145: Week 96 Results Week 96: Virologic Response ( ITT-TLOVR*) 100 Elvitegravir Arm Raltegravir Arm Patients (%) with HIV RNA < 50 copies/ml ITT-TLOVR Baseline HIV RNA *ITT-TLOVR = Intention to Treat-Time to Loss of Virologic Response Source: Gilead Sciences Press Release, December 9, 2011.
14 Raltegravir and Elvitegravir Cross Resistance Raltegravir Resistance Pathways Primary Mutations N155H Q148H/K/R Y143R/H/C Source: Metifiot M, et al. Viruses. 2010;2:
15 Raltegravir and Elvitegravir Cross Resistance Raltegravir Resistance Pathways Primary Mutations N155H Q148H/K/R Y143R/H/C Elvitegravir Resistant to Elvitegravir Resistant to Elvitegravir Possible Elvitegravir Activity Source: Metifiot M, et al. Viruses. 2010;2:
16 Raltegravir and Elvitegravir: Cross Resistance Graphical Representation of Mean log10 Fold Change Values for Different Genotype Log 10 FC Raltegravir Elvitegravir NPM N155H Q148H Q148K Q148R Y143C Y143R NPM = no primary mutation Genotype Source: Van Wesenbeeck L, et al. Antimicrob Agents Chemother. 2011;55:321-5.
17 Elvitegravir Summary Points Pros - Efficacy similar to efavirenz and raltegravir - Attractive once daily dosing - Fixed-dosed Quad Pill regimen: one pill once a day - Well tolerated Cons - Requires boosting (with cobicistat or ritonavir) - High cross-resistance with raltegravir - Requires taking with food Clinical Use - Attractive first line agent as fixed drug combination pill - Not likely used in patients with raltegravir resistance
18 : INVESTIGATIONAL Dolutegravir
19 Dolutegravir, formerly S/GSK-572 Class: integrase strand transfer inhibitor Approval Staus: Not FDA Approved; in Phase 3 Trials Dose (with or without food): - Treatment Naive: 50 mg once daily - Treatment Experienced, ISTI-Naive: 50 mg once daily - ISTI Resistant: 50 mg twice daily Fixed Dose Combination: Abacavir-Lamivudine-Dolutegravir (572-Trii) Pregnancy: category unknown Adverse Events: - Small increases in serum creatinine (inhibition of creatinine secretion)
20 Dolutegravir: Summary of Key Studies Phase 2b Trial in Treatment Naïve - SPRING-1: Dose-ranging Dolutegravir versus Efavirenz Phase 2b Trials in Treatment Experienced - VIKING I: Dolutegravir 50 mg QD added to failing regimen - VIKING II: Dolutegravir 50 mg BID added to failing regimen
21 Dolutegravir ( 572 ) vs. Efavirenz in ARV-Naive SPRING-1: Study Design Study Design Protocol - N = Dose ranging, partially-blinded - Multicenter, phase 2b trial - Antiretroviral therapy-naïve - Age > 18 - HIV RNA > 1,000 copies/ml - CD4 > 200 cells/mm 3 - No baseline NNRTI mutations - Randomized to one of 4 arms - All given 2 NRTIs* Dolutegravir: 10 mg qd + 2NRTIs* (n = 53) Dolutegravir: 25 mg qd + 2NRTIs* (n = 51) Dolutegravir: 50 mg qd + 2NRTIs* (n = 51) Efavirenz: 600 mg qd + 2NRTIs* (n = 50) *2 NRTIs: Tenofovir-Emtricitabine + (67%); Abacavir-Lamivudine (33%) Source: van Lunzen J, et al. Lancet Infect Dis 2011;12:111-8.
22 100 Dolutegravir ( 572 ) vs. Efavirenz in ARV-Naive SPRING-1: Study Results 48 Week Data: Virologic Response (TLOVR) HIV RNA < 50 copies/ml Dolutegravir: 10 mg Dolutegravir: 25 mg Dolutegravir: 50 mg Efavirenz: 600 mg All regimens included 2 NRTIs: Tenofovir-Emtricitabine or Abacavir-Lamivudine Source: van Lunzen J, et al. Lancet Infect Dis 2011;12:111-8.
23 Dolutegravir in Patients with Raltegravir Resistance VIKING Study (Cohorts I & II): Design Day 1 Day 11 Week 24 Functional Monotherapy Phase Randomize Continuation Phase Planned Analysis Cohort I: Dolutegravir: 50 mg QD Cohort II: Dolutegravir: 50 mg BID Cohort I: Dolutegravir: 50 mg QD + OBR Cohort II: Dolutegravir: 50 mg BID + OBR Study Design Cohort I (N = 27); Cohort II (N = 24) Single arm, Phase II Trial Documented raltegravir resistance Documented resistance to > 3 ARV classes HIV RNA > 1,000 copies/ml (Median HIV RNA= 4.3 log 10 copies/ml Day 0 to 10: Raltegravir replaced with Dolutegravir Day 11 to Week 24: Dolutegravir + OBR Source: Soriano V, et al. 13 th EACS 2011: Abstract PS1/2LB.
24 Dolutegravir in Patients with Raltegravir Resistance VIKING Study (Cohorts I & II): Week 24 Results 100 Cohort I (N = 27) Cohort II (N = 24) Proportion of Patients (%) HIV RNA < 400 copies/ml HIV RNA < 50 copies/ml Source: Soriano V, et al. 13 th EACS 2011: Abstract PS1/2LB.
25 ANTIRETROVIRAL THERPAY Dolutegravir Activity Against Raltegravir-Resistant HIV Minimal or no Impact on Dolutegravir Activity - N155H +/- secondary mutations - Y143R/H/C +/- secondary mutations - Q148H/K/R single mutations Significant Decrease in Dolutegravir Activity - Q148H/K/R + secondary mutations (G140S/A; E138K/A) - G118R (not reported in vivo) - Dolutegravir 50 mg BID appears active
26 Dolutegravir: Program in Development Phase 3 Program In Development: Treatment Naive - SPRING 2: Dolutegravir versus Raltegravir - SINGLE: Dolutegravir-ABC-3TC versus Efavirenz-TDF-FTC Phase 3 Program In Development: Treatment Experienced - SAILING: Dolutegravir versus Raltegravir (integrase naïve)
27 Dolutegravir Summary Points Pros - Efficacy similar to efavirenz - Convenient (one pill per day without meal restrictions) - Plans for fixed drug Tri Effective in patients with raltegravir failure Cons - Lacking phase 3 data - Tri-572 with HIV RNA > 100,000 copies/ml due to abacavir Clinical Use - Very attractive as 2 nd line regimen and salvage - Possible first line agent with fixed-drug preparation
28 End
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