What are my chances?

[lrup1952]

Hi,

I trust my dr. and my nurse however I know there are years of experience on this site and I would like to just ask your opinion.  I know my body will be the one to determine the final outcome but I trust you all and respect your knowledge.

I went for 4 week labs and my VL was detectable at 54.

Red/white cells had a drop but nothing to worry about at this point.  Will do labs again in 1-1/2 weeks because of drop in platelets (78,000) to ensure they don't go to 50 or drop below.  If they do my dr. will reduce riba + int but leave me on incivek at full dose until platelets rebound.  If this happens (hopefully it won't) and I have to do a drug reduction what are my chances of being under 54 at week 8?

If I am not under 54 my dr. says he will stop all meds and I will be kept in mind for next trials1?!

Kidneys/thyroids all functioning properly.

Thank you!

[pooh55811]

I agree with Ceanothus. The Incivek was by far the worst of the 3 drugs in terms of side effects while taking it. After I finished the Incivek, I noticed an improvement almost immediately. It is all relative. After I finished Incivek, I still did not feel great and I sure was not going to be able to run any marathons, but the Incivek was so debilitating and had such severe side effects, that there was a vast difference in how I felt while on Incivek and how I felt after I finished Incivek. I remember thinking, I feel like a new woman (and that was the day after I finished Incivek). Like I said, it is all relative. I still had side effects from the Inf. and Riba, but I was not as sick on those drugs as I had been on Incivek.

Unfortunately for me, my rash appeared about week 10 and that rash and itching got increasingly worse as the weeks wore on because my treating team was clueless and hesitant to treat it. Plus they had no idea how to treat it. If they had been on top of the rash and treated it immediately, I would have had a much easier and smoother treatment for the remaining 36 weeks of Tx. But I never got completely adequate Tx until 4 months after the rash and itching started. During those 4 months I was miserable and virtually hibernated in my house wearing only a light weight cotton nightgown, slathered in creams and ointments, with the temperature about 66-68 degrees. When I finally got appropriate and adequate Tx for the rash and itching it was like a miracle. Then, even though there were still side effects, I finally felt like a human being again and I was able to do more. Like I said, if my side effects had been properly managed (rash, nausea, vomiting, anal problems), I would have had a much easier treatment. After the sides were finally appropriately treated, the rest of treatment went relatively smoothly. There were still side effects, but nothing like the nausea, vomiting, and rash issues I had been dealing with (because they were finally being treated). Again, I want to stress, there were still side effects, weakness, severe fatigue, periods of feeling faint, brain fog, no motivation and no energy, neurological symptoms, etc. So it was not a cake walk. But it was doable. I only wish my side effects had been appropriately addressed earlier. (That is why I always urge people to get their docs on board with the side effect Tx because treatment is so much more bearable if the side effects are controlled.)

To put things in perspective, though, when I say I felt better, that does not mean I felt great. I recall in May 2012, after having been on Tx since late Sept. 2011, I was trying to clean the master bathroom where I had the litter boxes (I moved the litter boxes to a new area). Well, that was a job. It took me almost 2 weeks to do it. In fact, it took me several days just to mop the floor and thoroughly clean it. I could work only for a bout a half hour at a time and then I had to rest for a half hour or more. Then work a little more, then rest again. So improvement is relative. At least I was no longer hanging onto walls for support when I walked.

While I felt much better towards the end of Tx, and, in some ways, I felt better than I had felt before Tx, I did have some weird side effects pop up late in treatment. Those were from the interferon. Those were the neurological side effects, the psoriasis, and the gum recession. But, other than the neurological side effects, which are now gone, those late side effects were not nearly as troublesome or aggravating as the earlier side effects I had with incivek and then the rash.

I found that the last half of treatment went fast and it was considerably easier than the first part. I don't think that is true for everyone, but it was for me. I had a little psychological system of goals and goal points and that is really what made it easier for me, I think. When I was finished with Incivek, not only was I finished with Inc, but I was also 1/4 of the way finished with Tx. Then it was 1/3 of the way. Then 1/2 and so on. By the summer I was counting weeks and/or shots, LOL. And by late July I was counting days. Eventually I was counting pills left.

Just figure out some system that works for you and stay the course. It is well worth it. Also, it is "only" 48 weeks and 48 weeks is not much compared to the life that one gains with SVR.

[ceanothus]

In my opinion the Incivek is definitely the worst of the three. I suspect it would've been too harsh to even be approved if it had required using it much longer than 12 weeks. When I finished the Incivek it took about 5 days to notice any improvement at all, but then I improved a lot. I had about two weeks of feeling not just better, but actually great! I've heard this from others too, so be prepared so you can take full advantage of that period if you get it. If I'd known it was coming I would have planned a vacation for that time. After a couple of weeks the sx of the two remaining drugs began very slowly building up so that by the time I was at week 42 I was really dragging badly - but I never felt so poisoned as I did by the Incivek. Halfway to the end of the Incivek is great, and the next 6 weeks will go more quickly than the first 6 weeks did. The first ones are hardest because its new and a shock, as it becomes more your new normal it will go faster. Hang in there!

[lrup1952]

Thank you, thank you, thank you.  

What is amazing to me is that you both have so much to offer to everyone and when I keep up with your stories I am absolutely floored about how you encourage everyone with not just hope but such great information.

I am sick to do 48 weeks but will adjust my strategy to get through this.  I was determined to finish this journey, of course that is when I didn't expect to do 48 weeks LoL

You really can't imagine how much I appreciate you both!  Pooh, I wish you the best on SVR.

Can you answer one more question - which of these three drugs do you think is the worst?  If I can move forward I am hopeful; that when I finish the incivik (1/2 way there almost) that the other two drugs won't do me in.

Thanks!

[pooh55811]

One thing to keep in mind is that you will have to do 48 weeks of treatment because you were DET at week 4. But, if you are UND at 12 weeks, and you do 48 weeks of Tx, you have about a 64% chance for SVR (cure). That is the high number. Some studies put the SVR rate slightly lower, but I took the 64% figure. I researched this thoroughly because I was DET at 4 weeks on Incivek and so I did 48 weeks of treatment. I knew my chances dropped as soon as I was DET at 4 weeks, but I think 64% is still good odds. (That info is in one of the links I provided, the one with the tables.)

Just FYI, hrsepwrguy was DET at 4 and 8 weeks (if I recall correctly) and he is now SVR after 48 weeks of treatment. He had a 24 week post end of treatment VL and it was UND. I had a 12 week post end of treatment VL and it was UND so I have a 99.7% chance of SVR. I will have resuts for my 24 week post EOT VL soon. I should SVR. So just hang in there. We can SVR even if we are still DET at 4 weeks.  : )

[ceanothus]

I agree completely with Pooh (I always do), but want to add that most doctors do not make any changes in tx unless the platelets drop BELOW 50. At that point many hepatologists will choose to boost the platelet count by prescribing Promacta before resorting to reducing the interferon and ribavirin doses, especially if you are not responding rapidly. Your doctor is perfectly correct about not reducing the dosage of Incivek however, as that should never be reduced – its all or nothing with that one. I hope you can stick with the full doses for the full period, but at least until you achieve UND status. Once you are UND it seems that modest reductions in doses have only very tiny effects on SVR.

[lrup1952]

Thank you!  I also looked up the guidelines and as you said I can continue.  I am leaving a message for my dr. to make sure I understood correctly what he said.  I will also question what will be done if my platelets drop again.

Again, thank you.  I worry that there is so much discussed I am not understanding it all.  I try to read all I can but I have to tell you I am not smart enough to understand it all.

[pooh55811]

"Will do labs again in 1-1/2 weeks because of drop in platelets (78,000) to ensure they don't go to 50 or drop below.  If they do my dr. will reduce riba + int but leave me on incivek at full dose until platelets rebound."
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I don't know why your doc would reduce Riba for low platelets. It would be recommended to reduce Interferon but not Riba for low platelets.

"Thrombocytopenia"
"Platelet counts often drop in the setting of interferon and ribavirin therapy, due at least in part to interferon suppression of platelet production in the bone marrow. Patients with cirrhosis, who may begin treatment with low platelet counts due to portal hypertension, can be particularly affected.

Management
Manufacturer guidelines recommend reducing interferon dosage (to 135 µg peginterferon alfa-2a or to 50% of peginterferon alfa-2b) when the platelet count falls below 80,000/µL, and suspending interferon for platelet counts below 50,000/µL.(8,9) "

http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp


If this happens (hopefully it won't) and I have to do a drug reduction what are my chances of being under 54 at week 8?
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I am not sure there are statistics on that particular scenario.


BTW, here is the link for the data in the previous post:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

[pooh55811]

I keep losing my response to your so will do it in stages:

"I went for 4 week labs and my VL was detectable at 54. .....If I am not under 54 (at week 8) my dr. says he will stop all meds and I will be kept in mind for next trials1?! "
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Your doctor is not following protocol if he/she terminates treatment due to VL of 54 at 8 weeks. If your VL is below 1000 at week 4 or 12 (including week 8), you should be able to continue treatment, so if it is 54 at week 8, you should be able to continue treatment (according to the futility rules).

"Discontinuation of Dosing"
"Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions. Discontinuation of therapy is recommended in all patients with
(1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or
(2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2)."

Table 2: Treatment Futility Rules: All Patients

HCV-RNA
Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin

HCV-RNA    
Week 24: Detectable     Discontinue peginterferon alfa and ribavirin

If I were you I would discuss this with my doc ASAP. If your doc is not going to follow the recommended protocols and futility rules, then I would look for another doctor who does follow the recommended protocols.

Many people still have a VL at week 8 and they do continue treatment and they do attain SRV (cure).

Since you were detectable at week 4, you will have to treat for 48 weeks.