Ibalizumab Phase 3 Results and Susceptibility to Drug-Resistant HIV
March 28, 2018
CROI 2018 included a poster on the most recent HIV drug, ibalizumab, which was given FDA approval in the US during the conference week.
Ibalizumab is a monoclonal antibody that post-attachment, blocks HIV entry into cells while preserving normal CD4 functions. After an initial loading dose, it is given by infusion every two weeks.
Baseline susceptibility data was presented for 38/40 highly treatment-experienced participants in the 24-week, single arm, phase 3 TBM-301 study. At baseline, 50% of participants had resistance to at least three classes, with major mutations to NRTIs, NNRTIs, PIs and INIs on 93%, 85%, 83% and 61%, respectively.
Results from the main study were previously reported in HTB last year, but in summary, include 83% of participants meeting the primary endpoint of >0.5 log reduction in viral load seven days after adding a single dose as virtual monotherapy to the background failing combination and mean viral load reduction of 1.1 log copies/mL. Background ART was then optimised with 24-week follow-up. 
At week 24, viral load was <50 copies/mL in 43% (50% < 200 c/mL) with median viral load reductions of 1.6 log at week 24.
The poster at CROI presented results of in vitro analysis showing that ibalizumab retained sensitivity irrespective of baseline resistance to NRTIs, NNRTIs, PIs and INSTIs.
Although ibalizumab is not currently approved in the EU, the company are actively pursuing the regulatory pathway in Europe.
[Note from TheBodyPRO: This article was originally published by HIV i-Base on March 28, 2018. We have cross-posted it with their permission.]
This article was provided by HIV i-Base. It is a part of the publication The 25th Conference on Retroviruses and Opportunistic Infections. Visit HIV i-Base's website to find out more about their activities, publications and services.
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