<15, but still detectable @wk12

1b
day1 - VL 13,500,000 IU/mL
5wk - 5,400
12wk - <15, but still detectable

This is similar what pjhep80 has posted earlier, but my questions (based on my 3.4 log drop in wk5) are:

- Are my chances for relapse after 48wk tx very high (provided I get UND @wk24)?
- And what about if I go and treat 72wk?
- What about if I don't get UND @ wk24? Will the tx be over then?

[Kristina538]

With that result I would expect you to be UND at week 13 or 14!!  I had the same result at 4 weeks (I'm a G3a) and sweated over whether it was UND or not;   my nurse said as good as, but I psychologically it just didn't feel it.

I'm sure some G1's will chime in and give better info re your chances;  I doubt very much that you'll need to take the 72 week option;  you're certainly responding well to the meds!!!

[susan400]

It's my understanding (if you aren't in a trial) that, if you clear by week 12, then, you would proceed on..., if still clear by week 24, if you're a genotype 1, then, you'd probably need to continue forward with 72 weeks to be safe.  If at week 24, you're detected again, they would probably stop treatment at that point.  All of this hinges on your week 12 though, if you're not clear by that point, my guess is that they will stop treatment..., depending on your doctor..

Susan400

[Marc1955]

This is a complicated question. The basic studies that established the cut-off points and success rates were conducted at a time when the PCR tests had a sensitivity down to 50 iu/ml. If you had been tested six years ago you would have been undetected. However, scientists have gone back and determined that a significant fraction of patients who relapsed at end of treatment had detectable virus below the 50 iu/ml threshold. So there's no question you show a good likelihood of success but it's hard to put a number on it.

It's going to be a tough question for you and your practitioner whether you consider extending to 72 weeks or stopping at 48. I do think you should push to get a test at 16 weeks. Given the rate of  your progress, I suspect that at that point you'll have cleared. I don't think you should wait for week 24 for your next test. It would be nice to have more information. The difference between treating for 48 weeks and 72 weeks is enormous.

[nygirl7]

Unfortunately the only information that exists currently does say if not UND at 12 go to 72.  Remember UND means only that it is not detectible in your BLOOD stream not elsewhere in your body though...

It's impossible for anyone to say with any value whether you will relapse if you stop at 48 or not.  That was my problem - I didn't like those 75% failure rates I kept on hearing. They do drop to about 30% if you extend. That is why I decided to go for it.

Whether or not you are UND in a week or three weeks the truth of the matter is you ARE not UND at 12.  That means that your body might not have enough time to properly train your immune system to keep on beating any occult or persistent strain that you might have left enough.  THAT is why we continue doing treatment after we are UND.

Remember, just because your blood stream shows UND does not necessarily mean it is not elsewhere.

So its a lot to think about.  I did it and never looked back and like I said before it's been 2 years and I never have to worry about it again.  For me having to restart treatment and get accustomed to those meds all over again if I had failed and then do the 72 ANYWAY was not worth it, I decided to just go for it full gusto one time and try and be done forever and it worked.

Goodl uck.

[zazza]

I went through the same dilemma as you are going through now. I was detectable at <15 IU/ml at week 12. I tried to convince myself that 48 weeks would be enough. But I had this nibbling doubt in the back of my mind. What finally made me decide to go 72 weeks was that the German hepatologist Dr. Thomas Berg, who has studied extended tx, now recommends everybody who is not UND with a test of the sensitivity of 10 IU/ml at week 12 to do 72 weeks.

I was not UND so I did the 72. I am now SVR.

I have kept an eye on all those on the forum with low viral load at week 12. Everyone I have seen who only did 48 weeks relapsed.

I preferred to do the extra 24 in my first round of tx, so I would not have to think "What if?" if I relapsed.

But that's me, I am not a gambler, I like to play it safe, or as safe as is possible in the world of hep C.

[zazza]

PS My next PCR at week 15 showed UND.

[portann]

Hi Zazza,

Nice to hear from you.

I think you've posted that Berg study before but if you have it handy, could you provide the link again?

In my case, I was only tested at week twelve with a qualitative to 50, so I'm kind of stuck here in anxiety land. All my PCR's to date have only been to 50.  I fear I'm a goner!

Hope all is well.

xoxo

Port

[zazza]

If you want the Berg study, send me an IM with your email address and I will send it to you.

It is not in that study that Berg mentions the cutoff of 10 IU/ml, it is in a German magazine article. Co said she had found this article translated to English, but when I asked her for a link, she never answered me. So if you want it in English, write to her. If you understand German, I can give it to you.

I wouldn't worry about the 50 test. That is all we have had for a long time. Did you get any PCRs prior to week 12? What was your baseline viral load? What week are you in now?

Za

[portann]

Hi Za,

Thanks for your quick reply. You can send the magazine article to me in the original. (I think I can manage.)

I'm in week 41 of 48. I'm embarrassed to admit how much went wrong at the start of my tx. The NP accidentally forgot to order the baseline PCR, so I only have an old one.  It was a mishap. Maybe we were chatting too much about her vacation but it slipped her mind and I didn't know better at the time.

I got the qualitative 50 at four weeks and my NP was visibly disturbed that I was detectable, since my old load (get this, from 2001!!) was 196,000 and she'd really expected me to be UND. I had to gently twist her arm (due to policy) to get the 24 week PCR and then was just too worn out to twist her arm to get a 36 week one. (I honestly love this nurse.)

The hard part for which I only have myself to blame is that I could have travelled four hours and paid out of pocket to get the better test. Between the cold weather and my inertia, I stayed put and hibernated. Oh, oh - hunkering down may prove costly!  I guess I can face anything after a humongous cry.

I'll send you my email  address for the Berg study. Thanks again.

Port

[all_is_well]

Thanks to all for your input! It's really very informative given the fact that is based on your own experience.

My hepatologist already mentioned that I may have to go for 72 weeks, which I wouldn't mind if this increases my chances (and like nygirl said 30% or 75% is quite a difference) - there is no doubt that I will fight to treat for 72wk. And since I am doing relatively well up to now (I am now in wk15), I hope I would be able to manage 72wks. But who knows...

They will test me at wk24, but I can't see how I could force them to check my VL at an earlier time. They just have their protocol and wouldn't do it.

Now I'll pray to be UND at wk24 and have my tx extended.

Thanks again!
A.

[skersj]

The only way I talked my doctor into a 16 wk PCR was to agree to pay for it myself if my insurance didn't pay. I was never billed for it and I am week 28 now. I found the following study:    (The link is listed at the bottom of this post)

....All participants were treated with 1.5 mcg/kg/week pegylated interferon alpha-2b (PegIntron) plus 800-1400 mg/day ribavirin. They were randomly assigned in a 1:1 manner to complete 48 weeks (standard of care) or 72 weeks of therapy.

Results

End-of-treatment response rates were similar in the 48-week and 72-week groups (45% versus 48%; P = non-significant).
The overall SVR rate was greater in patients treated for 72 weeks versus 48 weeks (38% versus 18%, respectively; P = 0.026).
Dose reductions and treatment discontinuations due to adverse events or laboratory abnormalities were similar in the 2 treatment arms.
“Extending the treatment duration from 48 weeks to 72 weeks in genotype 1-infected patients with slow virologic response to peginterferon alpha-2b and weight-based ribavirin significantly improves SVR rates,” the researchers concluded. “Treatment extension does not seem to increase the rate of dose reduction or therapy discontinuation.”
While the end-of-treatment response rates were comparable in the 2 duration arms, slow responders who received extended therapy were less likely to experience relapse after completing therapy.
Treatment Length Based on Rapid Response
In the second study, Italian researchers tested the hypothesis that variable treatment duration individualized on the basis of first undetectable HCV RNA is as effective as standard 48-week treatment.
This study included 696 genotype 1 chronic hepatitis C patients treatment with either 180 mcg/week pegylated interferon alfa-2a (Pegasys) or 1.5 mcg/kg/week PegIntron plus 1000-1200 mg/day ribavirin. One group (n = 237) was treated for the standard 48-week duration. The other group (n = 459) received variable durations of treatment based on early response:

24 weeks if HCV RNA became undetectable at 4 weeks;

48 weeks if HCV RNA became undetectable at 8 weeks;

72 weeks if HCV RNA became undetectable at 12 weeks.

Results
45% of patients in the standard duration group and 49% in the variable duration group achieved SVR (P = 0.37).
27% first achieved undetectable HCV RNA at 4 weeks, 28% at 8 weeks, and 11% at 12 weeks.
In the standard duration group, 87%, 70%, and 38% of patients who first achieved undetectable HCV RNA at 4, 8, and 12 weeks, respectively, achieved SVR.
In the variable duration arm, the corresponding SVR rates were 77%, 72%, and 64%.
Low baseline HCV RNA levels and younger age were independent predictors of rapid virological response (RVR) at week 4.
Patients with RVR who had a high baseline viral load ≥ 400,000 IU/mL had a higher SVR rate when treated for 48 rather than 24 weeks (87% vs 73%; P = 0.14).
The only predictive factor for SVR in patients with RVR was advanced liver fibrosis.
In conclusion, the authors wrote, “Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs.”
01/04/08
References
BL Pearlman, C Ehleben, and S Saifee. Treatment extension to 72 weeks of peginterferon and ribavirin in hepatitis C genotype 1-infected slow responders.Hepatology 46(6): 1688-1694. December 2007.


http://www.hepctrust.org.uk/news/2008/January/Duration+of+pegylated+interferon+plus+ribavirin+may+be+tailored+based+on+early+patient+response.htm

[skersj]

I apologize for my earlier post. It didn't apply to the question. I misread the question. Oh, if I only had a brain.