any experience with the new PI's?

[youngladywfear]

can anyone here please tell me about their experiences as far as side effects with the new PI's? if you've done the clinical trial with them and recieved the PI and not the placebo, please tell me about the side effects you experienced with them? i'm curious to know if they are worse than the side effects associated with the soc. thanks!

[mremeet]

I took Telaprevir+SOC in the PROVE 1 trial. The Telaprevir certainly added a new dimension to treatment, and for me that turned out to be a terrible hardship. I was able to tolerate it for the first month and a half, but after that it caused a horrible rash that forced a cessation of Telaprevir and almost terminated my treatment. It really got out of hand.

But that was early in the drug's development, before they knew what its side effect profile was. My doctor wasn't sure what was going on at first, and by the time it became apparent the TVR was the culprit, my treatment had degraded into a real dermatological fiasco. Nowadays though, doctors have a good idea of who's starting to get the nasty rash and to discontinue the TVR before it gets out of hand. And most people don't get the bad rash anyway, only about 30% (from memory) get a substantial rash. And even those that do break out with the bad rash usually only do so after at least a month of treatment. Fortunately, Telaprevir offers most of it's utility as an antiviral in the first several weeks of treatment. It helps to get the virus cleared out really quickly while the IFN and riba build up in your bloodstream to finalize the kill over a longer period of time. So in the case of TVR, even with its sometimes nasty side effect profile, it can be an extremely useful drug for most people. It can easily halve treatment while very substantially increasing odds of being cured. It's truly a quantum leap forward in HCV treatment, a much needed one at that.

[WriteItDown]

My husband just finished a clinical trial of TMC435, a new protease inhibitor, + SOC. He was very lucky: he got the protease inhibitor and RVR and stopped at 24 weeks.

He was treatment-naive, so he had no regular SOC to compare his tx to, but his symptoms were overall fairly mild, and there were really not any symptoms that one wouldn't have expected with regular SOC.  He did have a little bit of gastric upset and some bowel problems for a few weeks, but it did not persist and it was unpleasant, not debilitating. That may have been the PI but we don't know.

I know some people say treating with a PI is a lot harder than plain SOC; but, like everything else to do with tx, it seems very individual, and for my husband it did not seem as if it was worse.

[pkhend]

My husband is participating in the RocheI trial for a protease inhibitor RO5190591. He has had every possible side effect including a 40 pound weight loss, shortness of breath, and extreme fatigue.  He's now at week 14 and determined to continue to wk. 24.  His Hgb dropped recently to 9.2 and the riba dosage was reduced by one tablet daily.  His Hgb today was 10.2.  He was RVR at wk 4 and has remained negative.  He received SOC plus trial drugs for wks. 1-12 then continued with only SOC.  No noticable differrence in sides after dropping the trial drugs.  Please know that most people in the Roche trial  in our area experienced few side effects.  His trial nurse says he was just one of the unlucky ones in that respect, but fortunate in that he was a fast responder.  He feels very blessed to be the huffing and puffing stick man:)
Pat

[annieCinMD]

I treated with SCH900518 with Ritonavir and was already so sick from SOC (I got the rollover arm, added the study drug at week 16) that I can't really say for sure. I think it gave me stomach issues as that's when I really quit eating and lost weight, but I attribute the worst of my issues to interferon.

[APKhaos]

I treated with Telaprevir + Pegasys + Riba, 12 weeks with the PI & 12 weeks without.
Hard to say if the sides were worse than SOC, but there were times that they were a bit rugged. HGB dropped from 16 to 10 and bounced around 10 for the duration. No rescue required, but I was not running any marathons. Rash was a problem, but others in the trial had such severe rash that they had to quit dosing. No matter what the sides were, its worth all that to see an SVR.

[can-do-man]

Also treated with boceprevir in the latest trial, had to have procrit most of tx, including my first tx. Never had any problems with it. BTW, diarrhea was also a problem but my doctor kept it under control.

I found the PI trial much easier then my first tx with SOC.

[maxygirl]

The trial did not allow for blood boosters unless it was a panic situation. I had a few times where my hemoglobin fell to 87 and I still was not given boosters or dose reduction.  It came up into the 90's.  I really didn't want them to reduce anyway.

[Rockerforlife]

Just finished 36 weeks of BOC/RIBA/PEG combo...my second round and no side effects during or after,but loads of worry and stress

[newleaf09]

I think that if you surveyed the forum members who used Procrit to increase red cell production and fligrastim (Neupogen or Neulasta) to increase neutrophil production, you would find that only a few had bone pain.  I used both and had no side effects whatsoever from either one, except that my blood counts increased and I was able to stay on treatment.  If either drops too dangerously low, your physician can stop your treatment.  Using the growth stimulating factors is, in my opinion, usually preferable to dose reduction or stopping treament.  You only want to do this once.

[youngladywfear]

ok, so since you both happened to develop anemia, did you therefore have to take the growth shots? my doctor has informed me that if my red or white counts drop too low that i'll have to take a growth shot, which pulls out the red or whites from my bone marrow. she has also informed me this can be severely painful, so i'm guessing that it more than likely is. in which case i'd honestly rather do 48 weeks of treatment minus the growth shots rather than 24 weeks of treatment with these growth shots, yes? i mean, did you guys have to do the groeth shots as a result of the anemia?

[newleaf09]

On boceprevir, I had GI problems and maybe the anemia was worse.  I'm not positive about the anemia since they treated the trial participants with Procrit whenever we started to edge down towards an HGB of 10.  The GI effect involved diarrhea such that the entire colon empties out.  It worried me about nutrient absorption and if I had it to do over again, I would insist on treatment for the diarrhea instead of just noting it in my chart.  Thankfully, I won't have to repeat TX ever again.

[maxygirl]

I also did a Roche phase 2 trial for a protease inhibitor RO5190591.  I became anemic within the first couple of weeks and stayed that way throughout the 24 week treatment.  

I took the trial drug for 12 weeks and just assumed I would feel better when I was on only 2 SOC drugs.  Not true!  I felt slightly worse and I was not the only patient to notice.  Interesting....I finished Feb. 18 and now just waiting to feel normal again.  It was not a horrible experience compared to some of the stories I have read on this blog.  It was not fun but very doable.

[epiphiny]

I have done a trial for RG7128 Roche's Polymerase Inhibitor currently in Phase 2b trials.

I was treatment experienced so I was aware of the side effects to expect from SOC and therefore able to discern if I had any difference in effects with the addition of the PI.

I am happy to report I had NO adverse events relating to the PI.  I did develop anemia very quickly within 4 weeks which was a difference between that and my previous experience however I was also on a much larger dose of Ribavirin (1200 rather than 800) so that may have contributed.