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Expanded Access Program for ibalizumab in Resistant HIV-1
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This Expanded Access Program provides ibalizumab, an investigational new drug, for eligible patients with resistant HIV-1.
https://ibalizumab-eap.com/
see map where providers are, in NYC:
Jacobi Medical Center
Bronx, New York, United States, 10461
Contact: Angelo Seda, RN 718-918-3662 Jason.Leider@nbhn.net
Principal Investigator: Jason Leider, MD
Chelsea Village Medical
New York, New York, United States, 10011
Contact: Lynne Bartell 212-929-2629 Lynne@CVMNYC.COM
Principal Investigator: Alexander McMeeking, MD
Palm Springs, California, United States, 92262
Contact: Erik Hernandez 760-778-7799 Ehernandez@palmtreeclinical.com
Contact:
Shayna Phillips 760-778-7799 sphillips@palmtreeclinical.com
Principal Investigator: Richard Loftus, MD
CROI: LONG-ACTING IBALIZUMAB IN PATIENTS WITH MULTI-DRUG RESISTANT HIV-1: A 24-WEEK STUDY - (02/16/17)
CROI: Theratechnologies Announces New Data from the Pivotal Phase III Trial of HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab - (02/16/17)
CROI: CROI Summary 2017: Antiretroviral treatment - where we are now / New HIV Drugs & Treatments - Joseph J. Eron MD Professor of Medicine University of North Carolina at Chapel Hill - (03/06/17)
CROI: New HIV Drugs at CROI / CROI Antiretroviral Treatment Summary / Long Acting HIV Therapies - (03/31/17)
from Jules: There are 20 reports here on new HIV drugs including 15 reports on long acting new HIV drugs. Nonetheless, safety and tolerability remain issues. Long term safety and toxicity are associated with ARTs, HIV drugs. The discussion always comes up: do we need new HIV drugs, there are so many - the answer is a resounding YES. Despite the large number of presentations at CROi of new HIV drugs and despite that many comment the pipeline is full - NO, we continue to have essentially only protease inhibitors, NNRTIs and integrase inhibitors for most treatment scenarios - WE NEED new classes of HIV drugs IF they are safer and less toxic, that is what is missing. So I would not call the pipeline "flush" - at CROI we have new NNRTI, new PI, new integrase inhibitor, but the only new class and its in very early development is a capsid inhibitor and granted it looks interesting because its also potentially a long acting therapy. GRANTED, ViiV now has the BMS attachment inhibitor and acquired the BMS maturation inhibitor, but we are waiting for the attachment but the maturation inhibitor was discontinued due to "gastrointestinal intolerability and treatment-emergent drug resistance". In the Viiv acquisition of new BMS drugs they also acquired a unique long acting with multiple modes of action drug called Combinectin, previously BMS986197 and now GSK3732394, "a biologic with 3 independent and synergistic modes of HIV entry inhibition that could potentially be self-administered as a long-acting subcutaneous injection, a projected half-life of GSK3732394 of ∼40 hours", here is the latest report from Glasgow 2016 http://www.natap.org/2016/GLASGOW/GLASGOW_27.htm
So what is the long term safety and adverse effects profile for the GSK attachment inhibitor? here is early short term safety data http://www.natap.org/2014/IDSA/IDSA_65.htm
- The potential adverse effects and toxicities associated with the currently used classes of HIV drugs - NNRTIs, protease, integrase - include increased risks associated with aging related affects like cognitive, brain or neurologic adverse effects, increasing risk factors for cardiovascular disease & adverse metabolic effects including diabetes, potential bone and kidney adverse effects, and of course lipodystrophy: lipoatrophy and/or increased VAT belly fat which increase risk for heart disease, brain & cognitive disorders - even with new ARTs including integrase inhibitors a significant percent of patients from a study comparing raltegravir to a protease inhibitors darunavir/r and atazanavir/r 16%-18% of study participants experienced >10% limb fat loss and 6-8% 20% limb fat loss, and 29%-33%% experienced VAT belly fat gain, of note baseline viral load over 100,000 was associated with much higher fat changes in VAT & SAT, presented at CROI 2015 by Grace McComsey (ACTG5260s) http://www.natap.org/2015/CROI/croi_149.htm
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