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Why 48 weeks and not 24 weeks?
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Why 48 weeks and not 24 weeks?

I have not questioned this treatment or its success, but if I am undetected at week 4, then why am I on the tx for 48 weeks and not 24 weeks?  I am genotype 1A, my VL was 88,000 when I started tx, and I am on week 13 of the Pegasys/ribavirin combo tx. If I am still undetected at 24 weeks, why would I need to take it longer?
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Avatar_m_tn

Methods: Patients chronically infected with HCV-1 (n=235) and a screening viremia ≦600,000IU/mL (real-time PCR) were treated with peginterferon alfa-2b 1.5mg/kg subcutaneously once weekly plus ribavirin 800-1400mg/day based on body weight for 24 weeks.

Results: End-of-treatment and sustained virologic response rates were 80 and 50%, respectively. The 48-week historical control (Manns et al., Lancet 2001;358:958-65) had similar end-of-treatment (74%) but higher sustained virologic response rates (71%). This difference was due to a high virologic relapse rate after 24 weeks of therapy (37%) compared with the historical control (4%). A subset of patients who had undetectable serum HCV-RNA at treatment week 4, however, achieved similar sustained virologic response rate (89%) as in the control group (85%).

Conclusions: HCV-1 infected patients with a low baseline HCV-RNA concentration who become HCV-RNA negative at week 4 may be treated for 24 weeks without compromising sustained virologic response rates.


http://www.natap.org/2005/HCV/122805_05.htm
18 Comments Post a Comment
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Avatar_m_tn
The reason is because your doing just SOC, now if your not cirrhotic and since you did have a RVR there is a study out there that does show that 24 weeks can work when somebody starts out with such a low viral load...

If I can find the study or maybe someone else here has it I will post it, all that said ask your doctor about it as he should be up on all of this... Would I risk having a RVR by doing only 24 weeks? No... Unless there was some serious problem during treatment.......... Best to you
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Avatar_m_tn

Methods: Patients chronically infected with HCV-1 (n=235) and a screening viremia ≦600,000IU/mL (real-time PCR) were treated with peginterferon alfa-2b 1.5mg/kg subcutaneously once weekly plus ribavirin 800-1400mg/day based on body weight for 24 weeks.

Results: End-of-treatment and sustained virologic response rates were 80 and 50%, respectively. The 48-week historical control (Manns et al., Lancet 2001;358:958-65) had similar end-of-treatment (74%) but higher sustained virologic response rates (71%). This difference was due to a high virologic relapse rate after 24 weeks of therapy (37%) compared with the historical control (4%). A subset of patients who had undetectable serum HCV-RNA at treatment week 4, however, achieved similar sustained virologic response rate (89%) as in the control group (85%).

Conclusions: HCV-1 infected patients with a low baseline HCV-RNA concentration who become HCV-RNA negative at week 4 may be treated for 24 weeks without compromising sustained virologic response rates.


http://www.natap.org/2005/HCV/122805_05.htm
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Avatar_m_tn
"Would I risk having a RVR by doing only 24 weeks?"

Maybe I should clear up what I mean, you were und at week 4 on just SOC so you had whats called a RVR. Which means your odds are really good at becoming SVR. I am not sure I Would  risk that by only doing 24 weeks
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1815939_tn?1377995399
I agree with Can-do. I would not risk doing less than 48 weeks.
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1986676_tn?1329866071
Ditto on Can-do and Pooh.

Although tx is difficult, you want to do what ever it takes to do the job.

You only get one shot a these meds!

Based on previous tx chances are you'll clear the virus for good this time.

Don't try any short cuts unless they're for medical reasons.

Regards, Reva
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5249831_tn?1407717326
I am on peginterferon alfa-2a 180ug/0.5ml subcutaneously once weekly plus ribavirin 800mg/day. I understand most of data you provided, can-do-man.  I am not familiar with "HCV-1 (n=235)" the 235 part.

I have no intention of stopping, and I trust the doctor, and I know there is only one shot at this, plus I'm not paying a cent. I am only starting to ask questions now, and it's hard to sort through some of the information that is posted.  Thank you both for responding, it means a lot to me.
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1669790_tn?1333666195
I was also a genotype 1a, had a low viral load starting trt, was doing just Inf/Riba and was Und at 4 weeks.  I know exactly what you're going through.  I was also aware of the study Can-do referred to, showing the results for 24 week trt, but if I recall correctly, that was with geno 1b patients.  Even so, I had major reservations for cutting trt in half.  My approach was - once I got to 24 weeks and if trt was still tolerable, I'd continue on.  Once I got there, the next step was making it to 36 weeks.  Once there, I knew I could make it to the end.

The one thing I wanted to avoid at all costs was to have to redo this trt.  I wanted to do my best to continue on to eliminate any remaining virons and put this all behind me.  It is now over a year past eot and it all worked out for me, and it all seems like a distant memory.  

I'd suggest to just do your best to hang in as long as you can.  If for some reason you do have to stop which leads you to the need of retreating, you do have the opportunity to do triple trt with one of the protease inhibitors - which should be only 24 weeks, but likely more challenging.  

Hope all goes well for you and all the sides are manageable.  Best wishes for you.
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Avatar_f_tn
n=235 is the number of people in the study for genotype 1's.

Hang in there you can do this!

Jules
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4705307_tn?1408435812
I would only like to say, for me I have to fight my sense of reason daily. And looking for an easy out. Hoping beyond hope that I might hear my Dr. say, We can stop tx at 24 weeks, bet on the come.
Not an option! Being a 3a and no RVR at week 4.
Like you, I have gotten myself to a point, @ week 21 where I look at my meds in the fridge, and realize that is the end of the upward fight, meaning once this set is gone I have started on the downward slope. And every day from that point is the added insurance that I may achieve my goal, SLAY THE DRAGON!!!
I have realized too, at some level I am jealous, ugly place to be. In that comes anger, and discontent. Trying to comprehend all the whys and how comes,and of course the poor me's. LOL.
My reality I just dont like being sick, and have come to appreciate that all of  us are engage in this battle, and none have have an easy road.
I too look forward to the time when all of this is but a memory, and thank God that it will only be a mental memory, and the sufferage will be as if it never were.
Last and most important, to me. Echoing a response from pooh in an earlier therad of mine. To paraphase. If I were to stop tx at @ anytime short of the recomended 48 weeks and relapsed, how would I feel?
That thought has seemed to keep my resolve, and accept the course and embrace each day, at its close as a success :).



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5249831_tn?1407717326
You're right, I don't want to relapse, so I will be doing the entire 48 weeks. As for triple tx, I tried and my body rejected the drug, see my post called "Brain seizures from Victrelis (Boceprevir)".  Compared to the Vic the side effects are manageable.

Your stats sound similar to mine, so it's nice to know you made it through.
I am very positive the virus will stay away.  I was told that after achieving SVR, there is still an imprint of the virus that lives in me. Correct me if I'm wrong.
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5249831_tn?1407717326
Yes, the reality is that I'm sick and anemic. I have good moments and bad moments/hours/days, but I'm taking it day by day. I have never been sick in my life so I didn't think I would get any side effects LOL!  I got nearly every one. Incredible muscle and joint pain, fatigue, and irritability, dry mouth, weird tongue and mouth sores, plus loud ringing in my ears is the worst of it. As I said above, compared to the side effects of Vic, this is much easier if that makes sense!  The other half, the mental side effects like manic-depression, anger, irritability and obsessiveness were a surprise and I do not see a smile on my face at times. I make the most of my good moments, and try to laugh and be at peace with myself.  It's nice to know I'm surrounded by people who have done it, are doing it, failed and retried, and conquered it.
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1669790_tn?1333666195
"I was told that after achieving SVR, there is still an imprint of the virus that lives in me. Correct me if I'm wrong."

Yes, that's one way to put it.  Once you've tested positive for HCV, even after you acquire SVR, you will always test positive for antibodies.

Quick story - My primary ran a liver panel along with the PCR for my one year follow-up.  When he came into the room, he had a concerned look on his face and stated that I needed to see a hepatologist to consider further trt.  For a few minutes I was freaking out and in total disbelief.  After reviewing the test results, I quickly saw that I was still Und, and he was referring to the fact that I was antibody positive.  It was a huge relief.  
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5249831_tn?1407717326
235 people in the study doesn't seem like much, does it?
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5249831_tn?1407717326
Can tx be repeated if the virus returns either after tx is completed, or after SVR is achieved?
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5249831_tn?1407717326
I found out I'm still undetected at week 12!  The doctor also said that if I'm still undetected at 24 weeks, they MAY stop tx. This does seem to fall in line with the study.
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1840891_tn?1383280315
Congratulations on the UND!
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Avatar_m_tn
That study was only 235 people, you are a genotype 1a and they do have somewhat lower (not much) SVR rates then a type 1b..... And if flcyclist is correct and they were type 1b in that study that would give me great pause being your a 1a.

Myself I understand its tempting to stop but you could be risking what seems to be a sure SVR.......... Even if the % is only 4% better doing the 48 weeks, I want every bit of those odds on my side...

Wishing you the best..........
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1669790_tn?1333666195
Can tx be repeated if the virus returns either after tx is completed, or after SVR is achieved?

If there is a breakthrough (increase in VL prior to eot) or a relapse (after eot), yes, trt can be repeated if only Interferon/Ribaviron was the chosen therapy.  There are several forum members that have treated multiple times and succeeded after the 3rd or 4th attempt, especially those using one of the protease inhibitors.  My understanding is that once a protease inhibitor has been used in triple therapy and a breakthrough or relapse occur, the only possible options may be the newer oral therapies.  Unfortunately, I'm not familiar with these orals, so possibly someone with more knowledge can jump in to help with that.  

Hopefully this will not be of any concern for you and you nail it the first time with SOC just as I did.  It is looking great for you now considering you were RVR at 4 weeks.  Stay focused, keep a positive attitude and time will click away for you.  Best of luck.
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