CROI 2013: New Drugs for Treatment and PrEP
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1 NORTHWEST AIDS EDUCATION AND TRAINING CENTER CROI 2013: New Drugs for Treatment and PrEP Brian R. Wood, MD Medical Director, NW AETC Project ECHO Assistant Professor of Medicine, University of Washington Presentation prepared by: Brian R. Wood, MD Last Updated: 3/14/12
2 Outline New drugs for Treatment - Dolutegravir (Integrase inhibitor) - Tenofovir alafenamide (TAF prodrug) - Cenicriviroc (CCR5-CCR2 inhibitor) - Maturation inhibitors - Attachment inhibitors New Drugs for PrEP - GSK-744 (Integrase inhibitor) - TDF intravaginal ring
3 Dolutegravir: SAILING Study
4 Summary of Key Dolutegravir (DTG) Studies Phase 2 Trial in Treatment Naïve - SPRING I: DTG vs. EFV (each with TDF-FTC or ABC-3TC) Phase 3 Trials in Treatment Naïve - SINGLE: DTG + ABC-3TC vs. EFV-TDF-FTC - SPRING 2: DTG vs. RAL (each with TDF-FTC or ABC-3TC) Phase 3 Trials in Treatment-Experienced - VIKING: DTG + OBR in setting of RAL resistance - SAILING: DTG vs. RAL in setting of regimen failure
5 Dolutegravir (DTG) vs. Raltegravir (RAL) for Salvage SAILING Study: Design Study Design Protocol - N = 715 HIV-infected adults - Double-blind, double-dummy - Ongoing phase 3 trial - ARV-experienced - Integrase inhibitor-naïve - Resistance to at least 2 drug classes (but not to integrase inhibitors) and HIV RNA >400 copies/ml - Randomized 1:1 DTG 50 mg QD + RAL placebo + 2 drugs (at least 1 fully active) (n = 354) RAL 400 mg BID + DTG placebo + 2 drugs (at least 1 fully active) (n = 361) *Primary endpoint: proportion with VL <50 at 48 weeks by FDA snapshot analysis *Results stratified by VL > or < 50,000, darunavir/ritonavir use, and # of fully active drugs Source: Pozniak A et al, CROI 2013, Abstract 179LB
6 Dolutegravir (DTG) vs. Raltegravir (RAL) for Salvage SAILING Study: Results Week 24 Interim Analysis: Virologic Response (FDA Snapshot) 100 Dolutegravir + BR Raltegravir + BR HIV RNA < 50 copies/ml All VL 50,000 VL >50,000 Source: Pozniak A, CROI 2013, Abstract 179LB
7 Tenofovir Alafenamide (TAF)
8 Tenofovir Alafenamide (TAF, formerly GS-7340) What is it? Novel pro-drug of tenofovir (TFV) Tenofovir alafenamide fumarate (TAF) Cathepsin A! Tenofovir disoproxil fumarate (TDF) Tenofovir (TFV) What is the advantage? - 10x ê plasma levels = less drug to bone, kidneys - 5x é intracellular levels = more in PBMC s, lymph tissue, key targets - Small dose = easily co-formulated (10 mg w/cobicistat, 25 mg w/out) Source: Zolopa AR et al, CROI 2013, Abstract 99LB
9 Tenofovir Alafenamide (TAF, formerly GS-7340) Study Design Protocol - Randomized, double-blind, controlled - Phase 2 - HIV-infected adults with HIV RNA >5,000, normal GFR, no resistance to TDF, FTC - Randomized 2:1 EVG-COBI-FTC-TAF (n = 112) EVG-COBI-FTC-TDF (n = 51) Key Results: - Proportion with VL <50 copies/ml at 24 weeks equivalent (87% vs. 90%) - Similar safety profile with mostly mild GI side effects - Both had increase in scr with decrease in egfr by week 2 but stable by week 24, though magnitude of changes less in TAF arm; less proteinuria, albuminuria and urine RBP w/taf - Decrease in BMD at hip and spine significantly less in TAF arm Source: Zolopa AR, CROI 2013, Abstract 99LB
10 Other New Drugs in the Pipeline
11 Cenicriviroc (CVC): CCR5-CCR2 Inhibitor CCR2 antagonism: ê metabolic syndrome, CV disease? Once daily, well-tolerated, few drug interactions Compared to EFV (both with TDF-FTC) at 24 weeks: - More virologic non-response with CVC (13% vs. 4%) - More virological failures at high viral loads with CVC - Increased CPK in CVC arm - More NRTI resistance in CVC arm and one switch to X4-tropism - All cholesterol types decreased with CVC, increased with EFV Supports phase 3 study? Sources: Gathe J et al, CROI 2013, Abstract 106 LB
12 Maturation Inhibitors Small molecules that block final step in HIV gag protein processing so that non-viable particles are produced No drug interactions, effective in multiclass resistance, led to 2-log viral load decline in phase 2 study Prototype, bevirimat, halted d/t rapid resistance development New, 2 nd generation drugs being studied MA p17 CA p24 p1 NC p7 p2 p6 N-terminus! C-terminus! Cleavage sites! Sources: Urano E et al, CROI 2013, Abstract 105
13 Attachment Inhibitors Block gp120 attachment to CD4 receptor BMS oral drug in study; no need for dose change with ATZ or RTV Sources: Langley D et al, CROI 2013, Abstract 542. Zhu L et al, CROI 2013, Abstract 534.
14 New Drugs for PrEP
15 New Drugs for PrEP GSK-744 (Integrase Inhibitor) - Long-acting, parenteral formulation, administered q1-3 months - 50 mg/kg IM x2, 4 weeks apart, protected macaques (N=8) from lowdose, weekly intrarectal challenges of SHIV (up to 8 challenges) - All untreated macaques (N=8) infected (at median of 2 weeks) TDF Intravaginal Ring - 1 application q1-3 months - Releases 2.4 mg/day - Protected female macaques (N=6) from 16 challenges of SHIV over 4 months (ring changed q4 weeks) - 11/12 infections in placebo group Sources: Andrews C et al, CROI 2013, Abstract 24LB. Smith J et al, CROI 2013, Abstract 25LB. Johnson T et al, Eur J of Pharm Sci, Dec
16 Questions?
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