quit tx before 24 weeks

Any genotype 2 rapid responders out there decide to quit peg/ribavirin tx before 24 weeks? If so, did you still have a 6 mos SVR?  My Dr. says chances of SVR are better with the full 24 weeks, but I am really tired of it.  I'm at week 18 and thinking about quitting. thoughts?

[pigeonca]

If you're merely "tired of it," I'd go for the full 24 weeks.  OTOH, if you were UND at 4 weeks, and only then, and if you're suffering intolerable sides, you could consider quitting.  Your odds at SVR would be slightly reduced, however.  I quit after 13 weeks, but that's because the doctor insisted - I was having autoimmune reactions that were dangerous.  Am now awaiting results of my 4 months post PCR. with baited breath.

[FlGuy]

Haven't you been waiting a while for that pcr, or was the blood draw for it very recent?

[pigeonca]

I was supposed to get those results last Friday.  Went to the doctor's office where they told me that there was a "transportation error" and therefore I needed to have my blood drawn again, which I did post haste.  This was really infuriating, 'cause the so-called error happened more than a week earlier and - had I been notified - I could have retested in time for Friday's appointment. So now I have a new appt. for next Monday.  I had an UND 4 weeks after quitting, but that was 3 months ago, so I've been waiting with baited breath ever since then.  Thanks for asking. I hope you're in a better mood than I am.

[FlGuy]

On the brighter side, tx is over and you're recovering.  Just a few more days, barring any further transportation error.

[Lilla]

I am a geno 2b; took peg/rib for 24 weeks.  I inquired about 16 wk tx and my doctor said the FDA only recognizes the 24 week. I bit the bullet and did 24, finishing 2 weeks ago.  All during tx my blood counts showed a steady decline (lowest WBC was 1.8, RBC 3.43 and hemo 11.2).   My 6 month PCR will not be until January of 08.   I don't know if I'm a rapid responder or not due to confusion with doctors in beginning.  VL pre-tx was 1.8 MIL.   At end of week 3, it was 135 (I did have over a 4 log drop).   Next VL test was done at week 8 and it was UND <5.   End of treatment showed the same thing.    Current doctor felt that if I would have had test at end of week 4, I most likely would have been UND, but that's an opinion there.

Are your side effects unbearable?  

[meki]

Depends on your sides ---- and if you can hang in there.

It's important to follow the SOC.

But if you can't handle your sides (especially depression or suicidal thoughts) then talk to your doctor.

If it's just fatigue --- and the typical sides (aches, pains, nausea --- which are all AWFUL) then bite down hard and strap your boots on...

Cause you wouldn't want to quit -- and find out that one more week could have killed the virus... but you didn't.

I don't think rapid response means that you're und.. And NO ONE knows how long you need to be UND before you can achieve SVR.

(6 months minimum)

24 weeks seems like forever --- but it isn't.

I did it.

You can too.

Keep happy thoughts -- laugh -- fake it if you have to...

Hugs,

Meki

[GoofyDad]

There are data that suggest getting out early could be a wise call. But it's a trully personal decision. IMHO, first it should considered only if you are on a pretty substantial riba dose. Also - peg-intron *may* have an edge for early withdrawl (withdrawal) candidates. Consider your other factors: weight being a biggie. Higher baseline ALT may be a positive predictor. Full compliance is good - so is younger vs. older. Higher collesterol may be better,  

The biggest factors may be your liver condition, and your personal ability to tolerate a relapse. Low damage and a sense that a relapse wouldn't freak you out would be a strong vote for yes, in my book.

Put it all in a shaker with ice, stir, strain, garnish and sip. Then toss a coin and scatter some chicken bones.  

      

[trolisgirl]

I am right there with ya!   I have 6 shots left and there is light at the end of this tunnel!
I am also a genotype 2b and my starting VL was 2,380,000 and at week 12 my PCR showed UND and it gives me the strength to KEEP going to the full 24 weeks to make SURE this dragon is down for the count!
I asked the doc for meds for my sides like the rash and itching and nasal congestion.
Hang in there and throw a HUGE party once you are done & feeling up to it.
Here's to achieving SVR!
Sandra

[l-horn]

I was 'fed up' my last month of tx and I had done 44 weeks. I think it's party psychological that you just want it done so badly you start playing head games with yourself thinking, 'This is good enough, what difference will another x number of weeks make.'

Even though my last month probably wasn't any worse than the previous, it sure seemed that way. Try to hang in there. You can do it. You've come far. Pat yourself on the back and dig in for the last few weeks.

[CockSparrow]

The formatting got messed up. Heres the Viral Load Stats

800,000 IU/mL 58% 73%

CS

[CockSparrow]

The following stats are from the Accelerate study, link provided by drofi in a thread further down
http://www.medhelp.org/posts/show/211651

As you can see if you are not LVL, 16 weeks produces lower SVR rates than 24 weeks.
If you didn’t RVR you only have just over 50% chance of SRV, this is halved if Non RVRs do 16 weeks.

I wouldnt pay that much attention to the actual numbers it’s the trend that’s important.
16 weeks = higher relapse rates unless you have low viral load before you started.
If you were LVL 16 weeks is all you need. LVL = <400,000IU/mL
If you are on weight based Riba then maybe LVL could be 600,000IU.

G2 SVR (ITT) 16 Weeks 24 Weeks
G2   Overall 62% 75%

Geno 2   RVR 78% 85%
G2   Non RVR 26% 53%

800,000 IU/mL 58% 73%

Liver Steatosis 65% 79%
F3/F4 Fibrosis 50% 64%

Hope this helps with your decision
CS

[CockSparrow]

Doesnt seem to like LVL stats so in long hand
VL below 400K SVR 16 weeks 83% 24 weeks 82%
VL 400K-800K SVR 16 weeks 68% 24 weeks 79%
VL Above 800K SVR 16 weeks 58% 24 weeks 73%

See if this works
CS

[meki]

"I think it's party psychological "

Party eh???

LMAO!

Oh yeah baby -- - just me and my bubbly water!

GRIN

Meki
Ps. CS has the right of it.

[nygirl7]

You know, one early resulting study shouldn't really determine something that could cure you for the rest of your life just because you are tired of it.  It's not THAT much longer but the SVR would be forever!  Give yourself every single chance you can.  Why chance having to do it all over AGAIN and next time for 48 weeks?

It's not worth it.  Hang in there.  i'm a big fat crybaby and if I could handle 72 weeks...you CAN do this so do it.

[jmjm530]

There is more optimistic study data than posted using weight-based ribavirin (Acclerate uses fixed-dose) but if you were still detectible (>50) at week 4, then you really should do 24 weeks, especially since you are already so close. As to your tooth infection, def have it looked at right away by your dentist. Antibiotics shouldn't be a problem,  but neglecting dental work on treatment can turn into a big one.

All the best,

-- Jim

[fellix]

I was looking at some of the recent shorten-the-duration studies for gentype 2/3 and yes all I want is to get this over with.  My baseline was not <400,000 however and I got a 3 log drop at week 4 (but still detected) - So I think I'll tough it out for the full 24 weeks.   Thanks to all for the kind comments.  

Here's another but unrelated question:  should I be concerned with a possible tooth infection if my neutrophils are somewhat low? and/or is there any problems with taking antibiotics for the infection?          

[pigeonca]

It sounds like RVR takes precedence over starting viral load. Nowhere are there any stats that combine RVR with a VL above 800K.  Anybody have an answer on that?

[GoofyDad]

I didn't mention VL or RVR in my post  - woe is me - I'm getting rusty. I thikn you're right - RVR trumps baseline predictors. But I'd personallyt probably still rather be sitting with RVR and LVL than RVR and HVL. I think .....

Fellix - some docs would say non RVR could call for extending beyond 24. Look at CS's stats above... looks like 53% for 24 weeks. You could probably improve on that with longer tx. Note that my position completely tipped based on no RVR....

Good luck and good health...

[CockSparrow]

With G2s & G3s HVL wins, when deciding to shorten Tx, so you are spot on. with
"RVR and LVL than RVR and HVL. I think ..... "

In fact with 3s definately and possibly 2s HVL should = 48 weeks.

Fellix
Here is some more info and this one you may not like.
Because G2s & 3s had such lousy SVR rates if they didnt RVR in the accelerate study. (They are no better with PegIntron BTW)
Studies 4&5 in the Pegasys insert were re evaluated to see if 48 weeks made a difference for those who didnt RVR. It did.
SVR rates went up to 76%. This is a combined G2/3 figure so the G2 rate could well be higher.
Just what you wanted to hear ay. Ask about shortening Tx and now need to thing about lengthening.
Sorry about that.

pigeonca
In Accelerate VL trumped RVR, so RVR+HVL should mean doing at least SOC and probably 48 weeks especially for G3s.
For G1s Roche recommend 24 weeks for RVR+LVL and 48 weeks for RVR+HVL
Interestingly this different for G4s. Roche recommend 24 weeks for for all G4s who RVR.
CS

[jmjm530]

Don't have time today to dig out too many studies, but the first one I found tthat used WEIGHT-BASED ribavirin showed a 77% SVR rates for those geno 2's and 3's who did not RVR, not the lower rates mentioned above.

A few thoughts:

1. The Accelerate study did not use weight-base ribavirin and although the authors say this doesn't matter, the overall SVR rates for it's subjects seems much lower than any other study which are usually 80%.

2. Most of these studies use 50 IU/ml as UND, not the more sensitive tests.

3. Given that Felix had a three-log drop by week 4, I just don't see more than 24 weeks unless there was compelling evidence in a WEIGHT-BASED ribavirin study to -- or at least the strong recommendation by one or two well-respected hepatologists.

[jmjm530]

http://www.hivandhepatitis.com/hep_c/news/2006/092906_a.html

[mremeet]

I'd go the distance, you're already in for a dime might as well go for that dollar. Just think of us geno 1's and how long we have to treat (especially nygirl!). Also, have you noticed how many geno 2 relapsers there are around here?? There's a surprising number of them. Remember even if you really are in the ~80% SVR bracket with 24 weeks of treatment, that still leaves about 20% that end up relapsing. The odds really aren't THAT unlikely you could fail treatment - if you're in a line of ten people and two people are randomly pulled from that line, are you that confident you aren't going to be one of those people??

[CockSparrow]

Jim Accelerate uses ITT stats. Wouldnt mind betting that the mentioned study is using Per Protocol Stats.
No G2 should even consider the shorter course if they dont RVR. In fact 48 weeks needs to be seriously considered for Non RVRs withou a starting LVL. With G3s you could put foward a strong argument that you do 16 weeks or 48 weeks as the difference between 16 and 24 weeks didnt reach Accelerates statistical significance margin for most G3 subgroups.

In my view Accelerate should be the starting point for shortening Tx decisions as it is;
a. Is the largest study done on shorten Tx
b. Was based on the way we actually treat. The 16 & 24 week arms we randomized at the beginning not after you RVRed.

Only then should the smaller studies be brought in to the picture if you fit one of the accelerate subgroups that had only a small difference between 16 and 24 weeks.
The risk of relapse especially for G2s was too high to do otherwise.

WinR stated that WBR had little effect on SVR in either 24 or 48 week arms except for G3 HVL and that was a maybe.

I was quite suprised that G3s dont seem to benifit much from the extra 8 weeks. I would have expected the opposite.
CS

[jmjm530]

CS: No G2 should even consider the shorter course if they dont RVR.
-------------------
I never said they should, in fact the opposite. My point was that going beyond 24 weeks  (like 48 weeks) based on the Acclerate study (fixed-dose riba) may not be the wisest move. It's always important in all these decisions to factor in the negative aspects of prolonged exposure to the tx drugs. As to per protocol stats or not, that should always be investigated, never assumed, and then matched to how a particular person does. If someone is compliant with the meds, then the per protocol stats should work fine, in fact much better then looking at the overall data.

-- Jim

-- Jim

[CockSparrow]

I agree. I wish studies gave both.
For G2s around 70% SVR for NON RVRs seems a common Per Protocol stat.
Its not Accelerate as such that leads towards 48 weeks but the original studies that Roche used to get pegasys approved. After they were re evaulated after accelerate.
CS

[GoofyDad]

"In fact with 3s definately and possibly 2s HVL should = 48 weeks."

Glad you weren't making the call on my tx. A top tier hepatology group advised me (GT3, early stage 4, 1.1 mill VL) to stop at 26 weeks based on RVR, full compliance, WBR. Worked for me. Cheers!

At the time, I researched Mangia, von Wagner, and others and all seemed to support this conclusion.

[CockSparrow]

Should have also mentioned 24 weeks didnt work for me
CS

[CockSparrow]

Not my call its what NV15942 says after it was reevaluated after accelerate.
G3 HVL have high relpase rates so well done on SVR
CS

[fellix]

Thanks CS, Goofy and Jim.  

Do you have the pubs you been referring to listed in biblio?  I would like to research a bit more about benefits of extended duration.  If a bit longer will substantially? increase odds of SVR (and not have to go through this again),  I would like to know more about it.  I was only stage I going into this by the way, not sure that matters much however.   fellix        

[jmjm530]

If you're going to go the "pubs", I strongly suggest you get the full-text articles and not the free abstracts on the net. Goofy listed a few, above, and I'll try and hunt some up, but again, def pay for the full articles online. And h*ll, yes, it would matter to me being a stage 1. Why risk 48 weeks of exposure to the treatment drugs when you have so little liver damage and that 24 weeks probably is enough. The idea isn't to kill the virus at all costs but to kill it at what is the most *reasonable* cost.

-- Jim

[CockSparrow]

Goofy oops NV15492 didn’t suggest 48 weeks only for Non RVRs
There is mounting evidence that G3s with HVL may need 48 weeks regardless of RVR though.
RVR does reduce relapse rates but they are still a little high.
A study called GET-C is currently being run to evaluate G3 HVL and with WBR & 48 weeks.

In my view all G3s who don’t RVR or have HVL, F3/F4 or steatosis should at least consider WBR and/or 48 weeks.
While it is true that G3s are more likely than not to SVR with 24 weeks the above subgroups have quite high relapse rates. The following from the link below kinda explains it
http://www.medscape.com/viewarticle/554497_print

In the study of 24-week treatment by Zeuzem et al., it was suggested that patients with genotype 3 and HCV RNA concentration higher than 800 000 IU/mL cannot be treated for only 24 weeks
The above study didn’t use WBR.

The second issue is whether steatosis or fibrosis are factors that negatively affect the results of short term treatment. After 24 weeks of treatment in genotypes 2 and 3 patients, Zeuzem et al.[17] showed that the presence of fatty liver infiltration reduced the rate of response and increased the rate of relapse.[16] Surprisingly, in this study the steatosis percentage significantly associated with a lower rate of response was very low (5%).

There is at least one study that suggest steatosis isn’t associated with lower SVR rates with G3s but it treated for 48 weeks.

The following from the above link is a good example of the issues with 48 weeks. The benefits of 48 weeks would need to be quite high to make up for the withdrawal rate with longer Tx.
In the 24-week treatment study for genotype 1, the rate of adverse events was 11%; discontinuation of treatment was required in 3% and dose reduction in 26%.[23] Among the historical controls (48 weeks) of this study,[16] the rate of adverse events leading to therapy withdrawals was 14%. Thus, the safety profile of the short-treatment course has improved compared with the standard treatment length.
One last thing with your risk factors for relapse I personally would have talked your Doc into 48 weeks even if I RVRed.
I do realise that this means many would be overtreating. It comes down to whether you are prepared to retreat again for longer and harder.

I alternate between doing the minimum Tx and then hitting it as hard as you can take the second time, if you relapse. With doing everything to SVR first time around.
Not convinced (yet) that retreating is the best option for those that fail shorter Tx.
The fact that 24 weeks worked for you is excellent but it would not be universal with your risk factors.

We both seem to be advocating individualising treatment rather than standard SOC.
Everone should do whatever they think is the best option for them.
Understanding what the risks are for relapse goes a long way in helping make this decision.
CS

[jmjm530]

You will find references and exerpts for many of the studies here, but again, a summary is never a substitute for the full-text version.
http://www.hivandhepatitis.com/hep_c/hepc_news_genotype.html#two

A couple of other things to keep in mind:

(1) Since none of us here are in the 'field', it's always a good idea to bounce these studies off of, and get direction from a good liver specialist. Possibly excessive, but I consulted five during treatment when making important decisions like tx length. Yes, I brought up the studies, but in the end I leaned heavily  on these specialists take of the studies.

(2) While you were not literally an RVR, you did have more than a three-log drop at week 4. Does this make you an "almost" RVR? Do any of the studies break down the data that finely? Or as a non-RVR are you comparing yourself to others who may have had less than a one-log drop at week 4. Again, these studies have limitations, especially in cases like yours where you may have a borderline response. On a personal note, I became non-detectible at week 6, but the liver specialists I consulted with still considered me an RVR to a certain extent.

(3) Lastly, the liver damage thing again. You don't have much liver damage and therefore risking 48 weeks of treatment drug exposure should not be gotten into lightly. Be very sure -- studies, xtra consultations, etc, -- or you can possibly end up doing more harm than good.

All the best,

-- Jim

[CockSparrow]

I agree with Jim, you will need the full studies. The abstract only tells half the story.
The SVR rate from 15942 was 76% heres a link http://www.natap.org/2007/DDW/DDW_01.htm
This is a reevaluation of study 5 in the pegasys insert which said 48 weeks was unessary for G2s&3s and uses ITT stats and doseage like Accelerate did.
The Per Protocol stats will be higher.

However it is the combined figure for G2s&3s and therfore doesnt indicate which geno gained most benifit. Could well be manily G3s as they had really lousy SVR rates with 24 weeks.

At an educated guess you would only gain about 15-20% may less with extending Tx, so i am inclined to agree with Jim. WB riba might be a better option but talk to your Doc.
Take the Accelerate study with you.
CS

[CockSparrow]

jmjm530 Our posts crossed. And Yeh I had wondered whether just misssing RVR was better than just hitting EVR, I havent found much and I have looked.

RVR is a little different for 2s & 3s than for G1s. It does appear to be the case that a miss is a miss though. I would like to know who makes up the 53% and who makes up the 47% as it includes drop outs.

I'll see if i can find the study but you would have about a 70% chance of SVR which is still pretty good. I'll try and work out Accelerates Per Protocol stats for you.
CS

[CockSparrow]

Accelerate Per protocol stats (I think)
31% of G2s didnt RVR which equates to 109 people in the 24 week group.
87% completed Tx in the 24 week arm but no break down by Geno.
As it was roughly 50/50 split i'll assume 87% G2s.

I hopeless at maths but somewhere around 66% Non RVR G2s achieved SVR that completed Tx.
Which is a bit better than 53%

Hope this helps
CS