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Recently disclosed VX-950 side effect profile info...
by mremeet, Feb 05, 2007 12:00AM
During my last doctor visit I was given a revised VX-950 (telaprevir) consent form to review and sign. In the new form they had included some new information in regards to the observed side effects of teleprevir. I’ll excerpt the new/salient stuff here:
Blood Sampling: “If you already had a rash or if you develop a rash while on this study, one of the blood samples that have been collected will be used to look at certain genes in your immune cells. The samples will be used to see if there are changes in the genes that determine how these cells function. Certain enzymes that are involved in breaking down the drug will also be looked at to see if they have changed. Differences in these genes and enzymes may cause some people to have a higher risk of developing a skin rash.”
Potential risks based on clinical studies: “Skin rash appears to be the most common side effect associated with telaprevir. About 34% of study subjects receiving telaprevir in combination with pegylated interferon and ribavirin for up to 3 months experienced rash. This is compared to about 15% of those who received pegylated interferon and ribavirin alone. Most rashes have been mild to moderate in intensity. Up to 3% of subjects have experienced severe rash. Some of the subjects with severe rash have also had swelling, swollen lymph nodes or fever. Many of the rashes have been associated with itching. The rashes have resolved following discontinuation of the study medications and treatments applied to the skin or taken orally.”
(cont…)
Blood Sampling: “If you already had a rash or if you develop a rash while on this study, one of the blood samples that have been collected will be used to look at certain genes in your immune cells. The samples will be used to see if there are changes in the genes that determine how these cells function. Certain enzymes that are involved in breaking down the drug will also be looked at to see if they have changed. Differences in these genes and enzymes may cause some people to have a higher risk of developing a skin rash.”
Potential risks based on clinical studies: “Skin rash appears to be the most common side effect associated with telaprevir. About 34% of study subjects receiving telaprevir in combination with pegylated interferon and ribavirin for up to 3 months experienced rash. This is compared to about 15% of those who received pegylated interferon and ribavirin alone. Most rashes have been mild to moderate in intensity. Up to 3% of subjects have experienced severe rash. Some of the subjects with severe rash have also had swelling, swollen lymph nodes or fever. Many of the rashes have been associated with itching. The rashes have resolved following discontinuation of the study medications and treatments applied to the skin or taken orally.”
(cont…)
"Additional uncommon but serious side effects occurring in people taking telaprevir in combination with pegylated interferon and ribavirin included anxiety, mood disorder, itching skin, eye problems, heart attack and mass in a gland in the abdomen found on a CT scan."
"Additional side effects that were reported by more than 10% of subjects in the study included fatigue, flu-like illness, redness at the Peg-IFN injection site, fever, chills, general rain (ed note: “rain” probably means “pain”), dizziness, insomnia, joint pain and muscle aches."
Potential Risks Based on Non- Clinical Studies: "Studies to look at the safety of telaprevir have also been done in laboratory tests and in animals. Some of the lab tests on a type of mouse cells done using a mixture of telaprevir and related substances showed that damage to the genetic material of cells could occur. Pure telaprevir, the drug that is used for human studies has been re-tested in these same tests and has not shown genetic damages."
"In one study, rats in the higher dose groups, there were signs of damage to the testicles that included low sperm production and smaller and softer testicles. This was not seen in similar studies in dogs. Other tests showed that telaprevir may interfere with sex hormone receptors in rats but not in humans. Laboratory tests (inhibin B) to examine for changes in testicular function in humans have not shown adverse effects, but men in this study will continue to be studied."
frijole
I do wish they would have listed either the number or percentage of "Additional uncommon but serious side effects occurring in people taking telaprevir in combination with pegylated interferon and ribavirin included anxiety, mood disorder, itching skin, eye problems, heart attack and mass in a gland in the abdomen found on a CT scan."
Some of these are associated with standard combo as well.
Was it one heart attack? What gland in the abdomen and what kind of mass? Was this only one case?
I know you don't have the answers but I am just curious. It's difficult to distinguish what sides are introduced by just the telaprevir.
frijole - I believe you and I are in similar situations. Are you going to try and get in on the phase3 trials?
I am so sorry :)
Just thinking out loud - dont hve not much time - wanted to ask you (if you don't mind me asking) what did you think about it? You don't have to answer, of course.
I wonder if this rash (and their studying the genetics and immune system behind the rash, and their mention of "damage to the genetic material of cells" in the nonclinical studies) is going to mean that they are going to try to identify those who will have severe reactions. 34% on the rash is pretty high.
On the damage to genetic material of cells (in the nonclinical study) I was glad to see it was not seen with "pure" teleprevir in