Yes how long the patient were infected before treatment is a confounding variable. Yes BIT225 is an HIV antiviral. This has been known for more than 15 years (more like 20 years). What is not known is if it is an effective antiviral in patients dosed at 200mg/day. Even more concerning is it is not known if it is doing anything clinically useful in patients at this dose.
At the moment all we have is BIT225 appears to be reducing the level of sCD163. While high levels of this marker have been correlated with a number of bad clinical outcomes, we don't know that reducing it directly will have any effect on the course of the disease. Worryingly, others have tried to reduce sCD163 levels in HIV patients using other drugs (I provided the link to this research in one of my earlier posts) and found no clinical benefit. It maybe that the decline in sCD163 is so dramatic that this is a very promising result, but any progress to phase 3 will require that clinical benefit is shown first (phase 2b).
On the rather petty topic of if this trial was a placebo-controlled study or not, it wasn't. It appears that while the patients in the control arm were given a placebo version of the BIT225 pill, the study was controlled by standard treatment. The control patients were not just given a placebo, they were given the standard Atripa treatment. This sort of study has a name (positive-control study), not placebo-controlled study. This really is a very trivial argument about what different trial types are called and we really should not waste anymore time on it.
BIT Price at posting:
17.0¢ Sentiment: None Disclosure: Not Held
