But people; notice that the participants were 1b's;
Hmmmmmm no 1a's?
Also notice a slew of new long hard to pronounce side effects (almost as hard to pronounce as some of the new drug names...... which don't exactly roll off the tongue.
"Serious (spacing for emphasis-willy) adverse events occurred in five patients. Three patients experienced Grade 2/3 fever (pyrexia), one patient developed Grade 2 hypochondriasis, and one patient developed Grade 4 elevated bilirubin levels (hyperbilirubinemia) that led to study discontinuation at week 2. There were three additional discontinuations due to adverse events: two transaminase elevations at weeks 12 and 16 and one lymphopenia at week 52 (off-study) in a patient with alfa/RBV added at week six. The most commonly reported on-treatment adverse events occurring in at least three patients were headache (14/43), nasopharyngitis (14/43), liver enzyme increases (12/43 ALT increase and 10/43 AST increase), diarrhea (Grade 1, 11/43), and fever (pyrexia, 8/43). There were no deaths in this study and no clinically relevant changes in electrocardiogram parameters. "
Keep in mind that the side effects for the new PI's have been characterized as "mild", if that helps you understand what "serious" might mean.
First off, I didn't understand the question. I wondered if you meant that if the trial had IFN, then how would we differentiate the sides?, but off course, in this case it is ALL oral, meaning no interferon.
So the question is if the sides can still be compared to regular SOC or triple therapy.
I don't have an answer, but to me it seemed to be a different set of sides than I normally see, and possibly the severity *could* be worse. The sides I keep seeing for the general write up for the pi's seem to be "mild" and outside of the rash, somewhat consistent with regular SOC, just moreso.
They couldn't be *that bad* or they would have had more discontinuations.
I mention it not to be alarmist, but for years i read about the "mild" symptoms of Teleprevir/incivek, but when many people started treating I started reading about sh1tting razor blades and lava or firerrhea. : ) There is sometimes a little gap between what we read and understand and the actual experience. : )
But no..... generally ALT's drop in most cases during standard SOC.
The grade 4 hyperbilirubinemia seems to have been serious, since that person was probably yellow and most certainly was discontinued from the study (....and at week 2!!)
The Grade 2 hypochondriasis...... I had to look that one up. : ) Hypochondria; they thought they were sick. Maybe that one wasn't so serious. : )
It is hard to compare. If you look at study after study you would think that the SOC control arms would churn out a relatively consistent output of response rates and yet they reaaaaalllllly don't. It's a huge range from 40-60%.
So...... I don't really know the answer, but my impression is that there is some difference.
I wondered about the hypochondriasis as well. But as I read about it, it does say it is considered to be a pretty serious mental illness and can be quite debilitating. I might be a little leary of a drug that could cause me to develop that degree of anxiety.
This is very interesting. Can't wait to see what happens during phase III. Could be very promising especially for "null responders" facing or life with cirrhosis. Right now as a null responder I and my hepatologist plan on doing triple therapy with either Victrelis or Incivek right before my transplant. I figure it is worth a shot so to speak. My odds are 30% at best, while for many others with cirrhosis the odds are only 15%. So something like this could be a game changer even for us on both sides of transplant. We can only hope. We have got to clear the hep C or it may destroy or donor livers too is only a few years instead of decades.
As far as adverse effects. Again just speaking for cirrhotics we have the potential with current drugs to have very serious AEs and possibly liver failure so the stakes are high already. Obviously we are all different and the exact circumstances for each of us is different. So as always it is a risk vs benefit that only the patient can make a decision about.
That's posting this!
Phase III will telling us a lot more.
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