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Viral load after the first 4 weeks
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Viral load after the first 4 weeks

Hallo, my husband has hepatitus (hepatitis) C 1b, fibrose 3, and is on he triple treatment (with Incivek) and got the results last week from week 4. It as 35. Now the doctor said he would have to do 1 year treatment in stead of 6 months. He is very upset and wants to stop after 6 months. Are there any people that know if 35 is too much? He had many millions before, so it sounds to me very good???
35 Comments Post a Comment
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Avatar_m_tn
Your doctor is correct, if one is not und at week 4 then 48 weeks is what they suggest for the best odds of gaining SVR... Good luck
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179856_tn?1333550962
Sorry he's not undetectible therefore 48 is the right number. Tell him not to feel bad back in the day a bunch of us had to 72 weeks. So, it's better than that!
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1815939_tn?1377995399
Welcome to the forum.

I am sorry that your husband did not reach an Undetectable status by the end of week 4.

Yes, as the others said, if a person does not reach an Undetectable status by week 4 then the person needs to do treatment for 48 weeks instead of 24 weeks.

35 sounds low, but that is 35 per milliliter of blood. When you multiply that by the entire blood volume, there are still many, many virons in the blood stream.

The treatment time frame is based on statistics. Those who did not become Undetectable at 4 weeks had higher cure rates if they did 48 weeks than if they did 24 weeks. In addition,the cure rates for those of us who did not attain UND status at 4 weeks is a bit lower just because we did not attain Undetectable status at 4 weeks. So, those of us who did not attain UND status by week 4 are all doing 48 weeks.

Because I was <43 but still detectable at 4 weeks, I am doing 48 weeks and am on the last 6.5 weeks.There are others on the forum doing 48 weeks.  It is doable. I found that I felt better as soon as I finished the Incivek. The other 2 drugs have side effects, but Incivek seems to have a lot more.

I would encourage him to do the 48 weeks if at all possible. If he does 24 weeks and then the virus shows up again he will have done 24 weeks for nothing and he will always wonder if he would have been cured had he done 48 weeks.

From Clinical Care Options:

"Telaprevir. The prescribing information for telaprevir in treatment-naive patients recommends that all patients begin with a 12-week period of triple therapy with telaprevir 750 mg 3 times daily (every 7-9 hours) plus pegIFN/RBV.[53] Telaprevir should be administered with food, specified as standard or high fat (standard-fat meal would be 21 g, such as 2 ounces of cheese or a half cup of nuts). After 12 weeks, telaprevir should be discontinued and pegIFN/RBV continued; for individuals with an eRVR (undetectable HCV RNA at Weeks 4 and 12), pegIFN/RBV should be continued to treatment Week 24. Conversely, for individuals without an eRVR, pegIFN/RBV should be continued through treatment Week 48 (Table 6). As with boceprevir, it is recommended that an HCV RNA assay with a lower limit of quantification of 25 IU/mL be used for evaluating virologic milestones for response-guided therapy. The prescribing information notes that treatment-naive patients with cirrhosis may benefit from receiving the longer duration of 36 weeks of pegIFN/RBV (ie, 48 weeks of total treatment), even if they achieve eRVR.

The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, confirming that this strategy results in a very high SVR rate (Figure 11). The robustness of response-guided therapy was confirmed by the ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir were randomized to receive either 12 weeks or 36 weeks of pegIFN/RBV, for a total therapy duration of 24 or 48 weeks, respectively (Capsule Summary).[30] Among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy. Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12). "

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx

Best of luck and please post again if you have other questions.
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Avatar_f_tn
Thank you and all for the answers...this is very helpfull
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1815939_tn?1377995399
I just re-read your post. You said your husband is at Stage 3 fibrosis. In that case, if I was you, I would surely do everything possible to convince him to stay on treatment for the 48 weeks.

There are only 4 stages of fibrosis. The next stage, Stage 4, is cirrhosis. As we age the fibrosis rate tends to pick up speed. No one knows how long it may take him to get to Stage 4. It could be 3 years or it could be 10 years. He may think treatment is bad (and it is), but advancing to Stage 4 and cirrhosis is worse. In addition, the cure rates for people with cirrhosis are considerably lower than for those with lower stages of fibrosis and people with cirrhosis face the possibility of many more complications while treating. He has the opportunity to treat now and hopefully attain a cure. It would be a shame to pass that opportunity up.  

Best of luck.
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Avatar_m_tn
Yes...48 is the proper protocol and to tag on to the good info. pooh has given (as always) if he happens to shorten his tx. and relapse as a result then he may have to wait 3 -5 years to tx. again  and with a good chance of slipping in to cirrhosis does not seem at all worth the risk

Good luck to you both....,,.

Will
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Avatar_f_tn
  Well, of course, I understand why your husband is very upset and dissapointed about the 48 weeks.
   But I think it would be a good idea for us to focus on some positives
for him:  after his 12 weeks of Incivek are over, he will only be doing the Interferon shot and the riba pills.  Many people (including myself, I did just those meds, for my first 4 weeks of Tx, as a "lead in" to my Victrelis regiment) find that after the bad side effects of the Incivek wear off, that the Interferon and the ribaviran are fairly easy to live with, in terms of side effects.
   I rarely get any ill side-effects, from my Interferon any more, now that I am at 22 weeks. Instead of your husband thinking of a whole year, it might be easier for him to take it one day, and one week, at a time.
    
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Avatar_f_tn
Hi! What a great advise you gave...just to take it one day at a time, a week at a time and so on....
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Avatar_f_tn
yes - indeed...one day at a time - and one mood at a time I guess. It must be changing all the time
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Avatar_f_tn
Unfortunately my husband who had ESLD had to stop the treatment after Week 5. Though it was extremely difficult, we were so disappointed that he was unable to continue. Our thoughts were that we needed to do everything we could to get rid of this insidious virus before it caused cancer which would possibly make him ineligible for a transplant.  The story does have a happier ending.   He remained "unquantifiable" for 8 months after stopping treatment. Though we recently learned the virus is now back, he did get his transplant and is doing great.  The fight against the virus will continue someday in the future  but at least he will have leveled the playing field now that he has a healthy liver.

So my advice to your husband is hang in there. Complete the treatment however long it takes. SVR will be so worth everything he has gone through.  It may prevent him from one day needing a liver transplant or getting liver cancer.  Keep your eyes on the prize!
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Avatar_f_tn
I agree with the posters above.  Many hepatologists are treating stage 3 like stage 4 with regard to length of treatment time with the PIs.  So many people with stage 3 are doing 48 weeks instead of 24 weeks anyway, due to the possibility of Cirrhosis.  So, he is in it for the long haul, but it is for the best with or without the UND at week 4.  Staying on treatment for 48 weeks will increase his chances of SVR.  If he were to stop treatment early and then have a relapse, it is likely that he would not be able to treat again with a PI, which would mean he would not be able to treat again until there are new treatment options in 2-5 years.  Given that he is already stage 3, he could develop Cirrhosis in that period of time, which is not good.
My advice:  do whatever you have to do to keep him on the 48 week course of treatment.  Remind him that he is lucky that he is able to treat, as there are many who have exhausted all treatment options and have no choice but to wait.  Remind him that he will indeed feel better when he finishes Incivek.  Make sure he's drinking plenty of water, and if possible, walking outside for a few minutes every day.  If he gets a rash or has signs of anemia, call his doc right away so that these side effects can be managed before they get worse.  These are things that will help him stay on treatment for the full 48 weeks.
Advocate1955
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Avatar_f_tn
PS:  He will very likely be UND with his week 8 results, and that will also help him feel more optimistic.
Advocate1955
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1986676_tn?1329866071
Your husband is just disappointed and that is understandable.
Advocate is correct when he gets his next UND it will motivate him
to keep going. Just don't focus on it too much now and he'll get past the let down of having to go longer.

Reva
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Avatar_m_tn
I'm in the same situation, I extended treatment past 24 weeks (now in my 27th week). I was detectable 44 at 4 weeks, and UND at 8 weeks (it's possible I became UND earlier at 5 weeks, but no test was done).

Some months ago on a website someone posted here I saw that people who are 50 at 4 weeks, extending to 48 weeks is the best option.
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Avatar_m_tn
And a count of 25 per millilitre of blood is very low when you consider how incredibly tiny the hep C virus is.  When researchers used to call it "not A, not B" they searched for it for over ten years before they finally found it (in the 1980s).
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Avatar_f_tn
Thank you all for all your answers. Moods are better here now - the docter promised to look into it and have him also tested at 2 months again - and he does the accupunction, which really helps - I can recommend it to all. No real side effects untill now except tiredness. Usually we go for a week fasting and colon cleaning in a wellnesscentre, in august - but I think now this would be to much, does anybody know that? I also think that coloncleaning could reduce the effect of telepravir? The doctor said that fasting (with juices) would be fine, only ofcourse the medicine has to be taken with some fat. And I just realised about the coloncleaning - think its not wise?
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1815939_tn?1377995399
If it was me, I would skip the fasting and colon cleansing in August.

First, the Teleprevir has to be taken with at least 20 grams of fat, and preferably with some solid food or very thick food.  You do not want the Teleprevir going through the colon to fast. And it needs the fat for absorption.

Even without the Teleprevir, I would skip the fasting and colon cleansing until off treatment. In my opinion, the body does not need anything else going on or happening to it  (in addition to the harsh meds). Plus, luckily the side effects are mild so far. That does not mean they will stay that way. (Hopefully they will stay mild, but one cannot count on it.) If he starts getting nauseated he has to eat. The nausea is worsened by having no food in the stomach. Eating helps a lot of the side effects.

In addition, fasting is not easy on the body (I do not mean it is not beneficial, just that, at the time, it is not easy on the body). His body is already compromised with the Hep C and the harsh meds. Another change from "regular" could add more stress, which is not good while on Tx.

In reality, he would not be fasting anyway. He has to eat at least 3 meals a day with 20 grams of fat each. He also has to eat with the Ribavirin. So there is no way he could fast anyway.

I do not know what is involved in colon cleansing, but you do not want anything to interfere with medication absorption.

I would save the colon cleansing until after treatment is over.
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Avatar_f_tn
I agree.  Colon cleansing is difficult on the body.  It can be dehydrating, it can upset the balance in the gastrointestinal system, and can irritate the bowels even further.  I think it would just be too much while on this important treatment.  Glad to hear that the mood is better at your house!  :)
Advocate1955
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Avatar_f_tn
thanks, so he will just enjoy the massages and sauna....
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Avatar_f_tn
Hi, I have another question - my husband is not drinking any alcohol now for 2 months - but the doctor said that a beer avery now and then is not bad. What is your opinion about it? His ALAT and ASAT are fine now, but I think it might be harmfull for the treatment?In his depressed days he would like a beer sometimes!
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223152_tn?1346981971
whoa - a beer every now and then?  Not a good idea, especially while still on treatment.  If he just quit drinking 2 months ago he has had a lot of changes in his life in a short time.

My hepatologist said guardedly after treatment that an occasional drink for a birthday or holiday would be okay.  But that is after you are clear.  He also said he has had disasterous results telling people the can drink after tx.  It is an addiction and has a nasty little habit of taking charge.  Please find something else for his depression.
frijole
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Avatar_m_tn
but the doctor said that a beer avery now and then is not bad
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Your doctor is correct ,for anyone who has a beer now and then ,this is not harmful, however the fact you mentioned that he has not had a drink in 2 months leads to believe possibly he has a problem with alcohol and I concur fully with frijole ,,if that is the case too not indulge .


In his depressed days he would like a beer sometimes!
-----------------------------------------------------------------------

There is little that will fuel depression greater than alcohol for those that use this method to try and relieve such...

Good luck to you both going forward with tx....
.
Will
.



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190885_tn?1333029491
if your husband feels like drinking a beer while on tx i would say the drugs aren't working as well as they should...is he eating the right amount of fat? lots of folks on tx have a tough time just drinking enough water....my doctor wouldn't even see anyone that drank alcohol...i think it was at least 6 months before tx.. having hep c and still drinking is really not a good idea.....good luck...billy
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Avatar_f_tn
He is not having a problem with alcohol, he is just asking himself why it would be bad. I agree with the fact that its not a good idea, but why would it affect more then anti depressive pills or sleepingpills? For the drinking of water: he drinks loads of water and tea and lemonade and 0% beer - no problems with drinking liquids only food gets more difficult. The fat he takes enough.
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Avatar_m_tn
A beer or two every once in awhile will not effect is treatment, studies have shown it has no effect on the outcome of treatment. Alcohol does not cause Hep-C or prevent someone from being cured... The problem begins when one or two leads to several on a regular bases and further damages is liver....... Is it a good ideal way to treat depression?..Nope
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Avatar_f_tn
YES!! he is no UND, we are so happy. But now another question - does this mean that one stays UND usually during the whole treatment - and then after you have stopped it might come back? Or does it fluctuate also during the treatment - so we have to be so nervous every month???
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Avatar_f_tn
Congratulations to you and your husband on reaching UND.  This increases his chances of clearing Hep C significantly.  I am assuming this is his week 8 test, so at least now you know that if he remains UND, he will be able to continue treatment.
Not everyone remains UND.  Some people have a viral breakthrough, which means that the virus bounces back to a detected level during treatment and they have to discontinue treatment.  Some people have a relapse, which means that the virus comes back to a detected level after completing treatment.
Hopefully neither of these things will happen to your husband and he will remain UND.  Hopefully he won't be too nervous every month, now that he has reached UND, but yes, unfortunately, it is not a 100% sure thing.  His chances are good, so he should persevere and be happy about his UND results.
Advocate1955
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Avatar_f_tn
Thanks - yes I understand that after completing the treatment it can come back - but a relapse means taht it comes back during treatment?
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1815939_tn?1377995399
Congratulations to both of you on your husband's Undetectable status at week 8.

As you know, now he will continue treatment for a full 48 weeks. (12 weeks of triple med treatment with Incivek and then another 36 weeks with just Interferon and Riba).

His chances of staying UND are fairly good. His VL was at 35 at week 4 and he is now UND at week 8. Hopefully he will stay UND throughout treatment.

There is a chance that he could have what is called a "viral breakthrough." A viral breakthrough is when he has reached UND status (in his case at 8 weeks) and then the virus reappears later during treatment and starts to increase. This does happen in some cases. It is not common, but it does happen.

If he stays UND throughout the rest of treatment, then his chances are good for cure. There is a chance of relapse after finishing treatment. Relapse is when he is UND at the end of treatment and then the virus reappears after the end of treatment.

He is in the same boat with hrsepwrguy and me and a few others. We were Detectable at week 4 but UND at week 8. Both hrsepwrguy and me have stayed UND throughout the rest of treatment. (Others have also.) I have a week and a half to go. Then all I have to worry about is possible relapse (the rate of which is fairly low).

I have to be honest and tell you that his chance of cure is potentially lower because he was not UND at 4 weeks. Those people, the ones who are UND at 4 weeks, have a very high rate of cure. Those of us who do not become UND until 12 weeks, have a lower chance of cure (but it is still good, about 64%). The studies were based on the 4 week and 12 week viral loads. There are no statistics for those of us who were DET at 4 weeks and UND at 8 weeks.

If he stays UND throughout the rest of treatment, then the relapse rate is about 4%.

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

Outcome for Subjects without SVR
On-treatment virologic failure a 7% (26/363) 29% (105/361)
Relapse b 4% (11/298) 24% (53/220)
Other c 11% (41/363) 10% (37/361)

a On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
b Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA at the end of treatment.
c Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.


Here is the paragraph from Clinical Care Options that discusses the trial results. (See the last sentence of the paragraph.) (eRVR is UND at weeks 4 and 12):

"The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, confirming that this strategy results in a very high SVR rate (Figure 11). The robustness of response-guided therapy was confirmed by the ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir were randomized to receive either 12 weeks or 36 weeks of pegIFN/RBV, for a total therapy duration of 24 or 48 weeks, respectively (Capsule Summary).[30] Among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy vs 88% with 48 total weeks of therapy. Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12). "

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx


Hang in there. He has a good chance of cure.
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1815939_tn?1377995399
Well, it took me an hour to write that post, LOL, (slow typist) and I see Advocate has responded in the meantime.

To answer your question:

Relapse means that a person has undetectable HCV-RNA at the end of treatment and then becomes detectable at some point after the end of treatment.

If a person becomes UND during treatment and then becomes DET again while still on treatment, this is called a viral breakthrough..
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Avatar_f_tn
I just want to say that though there are no guarantees that the Hep C virus will not become detectable again, the treatment meanwhile  is helping to keep his liver from become cirrhotic (and possibly cancerous) which is so much worse that fibrosis.
Congratulations on reaching UND. I know how difficult it has been to stick to the treatment. I think it sounds very promising. Stay positive and look forward to putting this nightmare behind you.

All the best,
Nan
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766573_tn?1365170066
On the Incivek site it says that 86% of Relapsers on Incivek combined with pegylated-interferon and ribavirin achieved SVR
http://www.incivek.com/hcp/rapid-viral-decline

It is possible for the virus to resurface. I worry every time I have VL done. I think a lot of us do. I mean no one wants to go through this again.
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Avatar_f_tn
  I think it is a good idea to try to stay as positive as possible, which means trying hard not to worry about stuff like the virus coming back, during a future viral load test while on Treatment, or aterwards, while waiting for the 6 month after-treatment viral load test.
  It just doesn't do us any good, to worry about
the virus coming back, and stress is hard on our already taxed immune systems/bodies.
   I just try to educate myself as much as possible, to ward of all the worry~
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Avatar_f_tn
Thank you for all the answers! Does anybody know people that did 12 weeks Triple and 24 weeks with Interferon and Riba? I understand now that not many trials has been done yet with the Triple treatment?
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Avatar_f_tn
thanks for your long answer! And 1.5 weeks to go wauw you almost did it!
I wish you really all the best.
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