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FDA Ibalizumab Expected Approval Date / 2 New HIV Drugs for Heavily Treated with Multi-Drug resistance
  Theratechnologies Announces Decision by the FDA to Extend the Ibalizumab Review Period to April 3, 2018 - (11/16/17)
In a notice received today by TaiMed from the FDA, the Prescription Drug User Fee Act ("PDUFA") target action date has been extended to April 3, 2018. The three-month extension period is the FDA's standard extension period.
2 New HIV Drugs For Heavily Treated with Multi-Drug Resistance
For heavily treated and multi drug resistant HIV+ these 2 new drugs now in last stages waiting for FDA approval...these slides were presented by Trip Gulick MD at EACS.


the 1st presentation of the phase 3 study results, this & Ibalizumab are being reviewed now for FDA approval
Phase 3 Study of Fostemsavir in Heavily Treatment-Experienced HIV-1-Infected Participants: Day 8 and Week 24 Primary Efficacy and Safety Results (BRIGHTE Study, Formerly 205888/AI438-047) - (10/30/17)


At IAS we learned due to GI upset the maturation inhibitor was stopped but several newer in this class are under development.
GSK Discontinues BMS' Maturation Inhibitor.....http://www.natap.org/2017/HIV/041717_01.htm
Early Safety, Tolerability and Pharmacokinetic Profile of GSK2838232, a Novel 2nd Generation HIV Maturation Inhibitor, as Assessed in Healthy Subjects - (06/20/17)
IAS/2017:Resistance Profile of HIV-1 Maturation Inhibitor GSK3532795 / GSK28338232 - (09/07/17)
An Analysis of Neurologic and Psychiatric Adverse Events of Subjects Receiving the Investigational HIV-1 Maturation Inhibitor (MI) GSK3532795/BMS-955176 - (09/07/17)


The new capsid inhibitor works at 2 points - assembly of capsid & disassembly of capsid
CROI: Discovery of Novel Potent HIV Capsid Inhibitors with Long-Acting Potential- - (02/16/17)


Here is an extensive list of links to all the new drug studies & new regimens presented at many conferences this year starting at CROI and through IAS & other conferencesHIV Drug Pipeline- - (09/14/17)
CROI: A Phase 2 Open-Label Trial of Antibody UB-421 Monotherapy as a Substitute for HAART-- - (03/06/17)
MK-8591 is a noteworthy & of particular interest new type of HIV drug that is being looked at as a long acting therapy & for PrEP prevention...
CROI/2017: Antiviral Activity of EFdA [MK-8591] Against NRTI-Sensitive and -Resistant Strains of HIV-2- - (02/24/17)
"potential pre-exposure prophylaxis agent to prevent HIV transmission in women and their infants......MK-8591 (or EFdA) is a NRTI with very potent in vitro activity against HIV....Viral suppression was maintained for at least 7 days after the last dose. This study provides proof of concept for a once weekly oral dosing strategy of MK-8591....."Our data demonstrated that EFdA efficiently prevents both vaginal and oral HIV transmission. Together with EFdA's relatively low toxicity and high potency against drug-resistant HIV strains, these data support further clinical development of EFdA as a potential pre-exposure prophylaxis (PrEP) agent to prevent HIV transmission in women and their infants."
CROI: MK-8591 Concentrations at Sites of HIV Transmission and Replication- - (02/23/17)
IAS: Single Doses as Low as 0.5 mg of the Novel NRTTI MK-8591 Suppress HIV for At Least Seven Days-- - (07/26/17)
IAS: Weekly Oral MK-8591 Protects Male Rhesus Macaques against Repeated Low Dose Intrarectal Challenge with SHIV109CP3-- - (07/23/17)
IAS: MK-8591 Protects 8 of 8 Macaques From Rectal SHIV 6 Days After Dosing- - (07/23/17)
GLASGOW: HIV Combinectin GSK3732394: A Long-Acting Inhibitor With Multiple Modes of Action/a>- - (10/30/16)
PRO 140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update- (03/01/17)

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