pharmafileAugust 17, 2018
Tag: Ibalisumab , HIV
In a study of 40 patients with multidrug resistant HIV-1 infections in whom multiple antiretroviral therapies had failed, 83% experienced a decrease in viral load of at least 0.5 log10 copies per millilitre from baseline. The drug was shown to have had significant antiviral activity over a 25 week period.
The most common adverse event was diarrhoea, which was experienced by 20% of patients. However four patients died from causes related to the underlying illness. One patient did suffer from a serious adverse event, the immune reconstitution inflammatory syndrome that was deemed to be related to ibalizumab therapy. However the small sample size may have meant that the ability to detect less common adverse events was limited.
The non-immunosuppressive, monoclonal antibody acts by inhibiting the viral entry process. The FDA approved the drug for multidrug resistant HIV-1 in March of this year. Although the sample size was small and "patients served as their own controls with a 7-day period of continued use of the failing background regimen preceding the addition of ibalizumab", the results are promising for those with multidrug resistant HIV infections.
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