The pipeline: Long-acting agents and new drugs. Charles Flexner, MD Johns Hopkins University
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1 The pipeline: Long-acting agents and new drugs Charles Flexner, MD Johns Hopkins University
2 Do we still need an ARV pipeline?
3 How close are we to having a universal antiretroviral regimen?
4 A universal low-cost ARV regimen? Dolutegravir 50 mg TAF 25 mg 3TC/FTC 300 or 200 mg mg vs mg QD for Atripla
5 What Motivates the ARV Pipeline? Less frequent dosing Once weekly orals Once monthly (or less) injectables/implantables Prevention/PreP Different drugs than used for treatment Off label use once approved Concerns about increased availability of generics TDF/3TC fixed-dose combination as an example
6 HIV Pipeline 2015 Flexner and Saag, Current Opin HIV AIDS 2013
7 HIV Pipeline 2015 Flexner and Saag, Current Opin HIV AIDS 2013
8 New NNRTI s: Why?
9 New NNRTI s: Doravirine
10 Doravirine Pharmacology Once-daily dosing Plasma t ½ hours Drug drug interaction potential: Metabolized via CYP3A4 Not a known CYP inducer or inhibitor No significant food effect Well-tolerated (no apparent CNS toxicity) No QTc prolongation seen Anderson MS et al., Antiviral Ther. 2015: in press
11 Anderson MS et al., Antiviral Ther. 2015
12 HIV Drug Therapy Glasgow Week Efficacy and Safety and Early CNS Tolerability of Doravirine, a Novel NNRTI, with TDF/FTC in ART-Naïve HIV-Infected Patients Josep M. Gatell 1, Javier O. Morales-Ramirez 2, Debbie P. Hagins 3, Melanie Thompson 4, Keikawus Arastéh 5, Christian Hoffmann 6, Sorin Rugina 7, Olayemi Osiyemi 8, Simona Erscoiu 9, Robin Dretler 10, Charlotte Harvey 11, Xia Xu 11, Hedy Teppler 11 for the P007 Study Team 1 Hospital Clinic/IDIBAPS. Univ of Barcelona, Spain; 2 Clinical Research Puerto Rico, San Juan, PR; 3 Chatham County Health Dept, Savannah, GA, USA; 4 AIDS Research Consortium of Atlanta, Atlanta, GA, USA; 5 EPIMED/Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; 6 ICH Study Center, Hamburg, Germany; 7 Spitalul Clinic de Boli Infectioase, Constanta, Romania; 8 Triple O Research Institute PA, West Palm Beach, FL, USA; 9 Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes," Bucharest, Romania; 10 Infectious Disease Specialists of Atlanta, Decatur, GA, USA; 11 Merck & Co., Inc., Whitehouse Station, NJ, USA Copyright 2014 Merck & Co. Inc. All Rights Reserved.
13 Patients: HIV-1+ ART-naïve HIV RNA 1,000 c/ml; CD4 count 100 cells/µl Protocol 007: Study Schema Part 1 Dose Ranging Phase (N=210) DOR 25 mg (n=41) DOR 50 mg (n=43) DOR 100 mg (n=42) DOR 200 mg (n=41) EFV 600 mg (n=43) 100 mg 100 mg 100 mg Part 1 Extension Phase DOR 100 mg Continue EFV Wk 24 Wk 36 Wk 48 Wk 96 P007 Week 24 Analysis for Dose Selection 6 Antiretroviral activity of DOR comparable to EFV Favorable safety profile at all doses Doravirine 100 mg selected for further development Part 1 DOR patients began switch to 100 mg at Week J Morales-Ramirez, et al. CROI 2014 [Abstr 92LB]. 13 Copyright 2014 Merck & Co. Inc. All Rights Reserved.
14 Virologic Response by Screening RNA Ad hoc analysis, Week 48 (Observed Failure) 100,000 c/ml >100,000 c/ml N: Gatell et al., Glasgow 2014 Copyright 2014 Merck & Co. Inc. All Rights Reserved.
15 Primary Safety Comparison: CNS Events, All Causality Parts 1 & 2 Combined, Week 8 Significantly fewer patients on DOR had 1 CNS event by week 8 (p<0.001) Suicidal ideation 0 0,9 % of Patients with 1 CNS Event Attention disturbance Somnolence 0 0 0,9 2,8 DOR 100 mg (N=108) EFV (N=108) Δ (95% CI) 22.2% 43.5% (-33.2, -8.8) Depression Hallucination Nightmares 1,9 0,9 2,8 0,9 5,6 8,3 Efavirenz Doravirine 100 mg Abnormal dreams 5,6 16,7 Insomnia 2,8 6,5 Dizziness 9,3 27,8 Gatell et al., Glasgow % of patients with 1 event Copyright 2014 Merck & Co. Inc. All Rights Reserved.
16 Future Directions for Doravirine 100 mg daily dose selected for future study Phase 3 trials well underway New FDC s in development Positioning: First-line? Second-line? Something else?
17 New InSTI s: Cabotegravir Both oral and long-acting?
18 LATTE-1 Study Results Margolis et al., Lancet Infect Dis 2015; 15: 1145
19 LATTE-2 Study Design Margolis and Boffito, Current Opinion HIV AIDS 2015; 4: 246
20 LATTE-2 Study Design Margolis and Boffito, Current Opinion HIV AIDS 2015; 4: 246
21 LA/ER Drugs: What s next?
22 LA/ER Drugs: Broadly-neutralizing monoclonal antibodies
23 Caskey et al., New Engl J Med 2016; 375: 2019
24 Effect of VRC01 on Viral Rebound Bar et al., New Engl J Med 2016; 375: 2037
25 Effect of VRC01 on Viral Rebound Bar et al., New Engl J Med 2016; 375: 2037
26 Effect of VRC01 on Viral Rebound Bar et al., New Engl J Med 2016; 375: 2037
27 Effect of VRC01 on Viral Rebound Bar et al., New Engl J Med 2016; 375: 2037
28 Bar et al., New Engl J Med 2016; 375: 2037
29 Broadly-neutralizing monoclonal antibodies Potential advantages Humanized, well-tolerated Extendification possible LA version of VRC01 in clinical development May induce beneficial host cell-mediated immunity ADCC responses Use in prevention applications, PrEP Potential disadvantages Expensive Intravenous route of administration Pre-existing resistance commonplace Select for resistance viruses
30 LA ARV s: New technologies
31 LA ARV Implants Tenofovir Alafenamide M Gunawardana et al., Antimicrob Agents Chemother 2015; 59: 3913
32 LA ARV Implants Tenofovir Alafenamide M Gunawardana et al., Antimicrob Agents Chemother 2015; 59: 3913
33 M K P la s m a C o n c e n tra tio n (n g /m L ) MK-8591 (EFdA) Implant Formulations Release Effective Drug Levels for >180 days F o r m u la tio n # 1 (n = 4 ) F o r m u la tio n # 2 (n = 4 ) T im e (d a y s ) >180-day extended release from solid state formulations after a single injection in rats. Data suggest the potential to provide coverage for durations up to 1 year. - Grobler JA et al. CROI, 2/22-2/25, 2016, Boston, MA 33
34 Long Acting ARV Implants Potential advantages over injectables Removable More consistent and predictable drug release PK not dependent on injection site May remain in place for years (inert, non-degradable subcutaneous versions) Potential disadvantages over injectables Specialized device required for insertion Minor surgical procedure to remove Regulated as both a drug and a device Difficulty moving to a generic marketplace
35 LA ARV s: Gaps and Opportunities
36 Long Acting ARV s: Knowledge Gaps Oral lead-in required? Minimum injection frequency? Number of injections/volume allowed per dose? How many drugs in the regimen? How to manage toxicity? What to do about missed doses? How to quit? How to manage the long PK tail?
37 Long Acting ARV s: Opportunities Developing investigational agents targeted specifically for LA regimens Cabotegravir as a paradigm New technologies Implants Use of physiologically-based pharmacokinetic (PBPK) modeling to predict human pharmacokinetics, required potency, and release rates of new formulations
38
39 Acknowledgements Johns Hopkins University Jane McKenzie-White Jennifer Robinson Caren Freel Meyers Chelsea Westminster, London Marta Boffito Division of AIDS, NIAID Daniella Livnat Peter Kim Univ. of Liverpool Andrew Owen Marco Siccardi Steve Rannard UNMC Sue Swindells Howard Gendelman FUNDING SOURCES NIAID Bill and Melinda Gates Foundation Clinton Health Access Initiative
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