What are the side effects of the trial drugs?

I know there were people on here doing the clinical. How are they doing, how long and what are the new side?
My doctor said one of the side effects was fat which would move from one location to the other. I laughed but he acted as if this was not good. I thought, WOW, I could deal with that.

[Tippyclubb]

Hi Cindy I was in the Vertex Telaprevir trial and did tx for 6 months.  I had just about every side effect, except the mouth sores.  

I am EOT now for 7 weeks and feeling great.  So far still UND!  Having skins issues, blisters, small rashes, and hair still falling out.  Still having thyroid issues too , but doctor is working on getting that straightened out.

[diane1975]

Hi Cindy, I have been in the Pegasys/Copegus clinical trial for 36 weeks and I have 12 more weeks. I have had severe nausea,vomitting,diarrhea,skin rashes,itching,severe blisters in mouth,tongue and throat. My hair is falling out. I have severe HA's ,bone aches, dangerously low WBC and RBC which I get 2 shots for a week at the Infusion center.  I have had 3 blood transfusions,have lost 50 lbs.which I am happy about! My mental state was really scarey at times but not so bad anymore. I have mental confusion and short term memory loss but it has gotten better also. I still have managed to work everyday. I am happy I stuck with it. I am thankful I had the opportinity to be part of this study. Good luck!!      Diane      Also I have an awesome nurse and Hepatologist!!

[newleaf09]

I finished Schering Plough's boceprevir trial June 1 (SPRINT 2).  It was a Phase 3 trial.  My arm of the trial started with the standard peg/riba for one month then added 6 mos of boceprevir, so 7 mos. total, 6 on the PI.

I had pretty much all of the possible peg & riba side effects except for thyroid problems & my blood stayed crashed (and peg reduced) for 2/3 of the 7 mos.  The informed consent for boceprevir said that it could cause reduction of both hemoglobin and neutrophils and I think it contributed to keeping my hgb around 10.2 (not dangerous but miserably tired) and dangerously low neutrophils (had to use Neulasta to keep them up enough to stay in TX).  Only other side effect was a funny taste in mouth from the boceprevir. Think that's specific to boceprevir, not other trial drugs.

I'm not a good case to look at for response to the trial drug because I cleared immediately on the peg/riba before the drug started.  I do feel the boceprevir added another whole layer of guarantee for a cure, though, and that it caused the treatment to be harder on me than peg/riba alone would have been.  The good thing was that, with the trial drug added, I was allowed to stop at 7 months instead of going the standard 11, avoiding 4 whole months of potential peginterferon damage.  

I am 11 weeks post-TX now and, except for still rebuilding all of my former stamina and strength, I am physically 100% now and totally confident of achieving SVR.  The trial was a good experience for me.

[nygirl7]

My doctor said one of the side effects was fat which would move from one location to the other. "

Sorry I'm not in a trial but have been on this forum about five years now and I've never heard of fat moving from one location to another.  People losing weight? Yes. People gaining weight? Yes. But moving......no.

Mostly the regular side effects to combo treatment are listed above however by adding some of the "add-ons" (the trial drugs) in addition to the interferon and ribavisin cause them to be more severe.

However, most people find treatment isn't pleasant but it is doable and can lead to a cure.

[WriteItDown]

Changes in fat distribution is a known side-effect of some protease inhibitors.  I believe one sees it discussed mostly in regard to HIV patients using PI's, but I'm not sure if that's because they've been used longer in HIV treatment; or if the PI's used for Hep-C patients don't have those same side effects.

You can easily read all about it by Googling "protease inhibitors fat distribution" or something like that.

I wonder if anyone here who did a trial with the protease inhibitors had any such experience.  I don't think I've seen it mentioned....

[newleaf09]

I saw posts about fat buildup around the waist on this forum but don't think they were from people on PI's.  Did not happen to me on Boceprevir, thank heavens.  

[Andiamo1]

The PIs for HCV do not cause fat to build up.  They do have plenty of sides: severe rash, nausea, anemia and GI distress.  

On the plus side, they work great.  I am SVR after trying 7 times with interferon and then interferon and riba and then pegylated interferon and riba.  All failed until I did the triple therapy.

[cindyh113]

Thanks for the responses. Tells me my dr. doesn't know everything. Although I do have a hard time remembering what he says. Now, I do remember the word protease. Hopefully I'll get to try again using a 3rd drug.
Thanks,
Cindy

[WriteItDown]

My husband just started a clinical trial of a new protease inhibitor (provided he's one of the lucky ones and does not get the placebo), combined with SOC.

I will try to give info as he goes forward.  So far he's only done one week, but his sides have been minimal.  This new PI is supposed to have very good anti-viral potency, and since less of it has to be taken than with Telaprevir or Boceprevir, there is some hope that its sx may not be as bad.