Confused... no viral load detected after 4 wks...still on tx for full time

I just got the good new that my viral load was undetected (stated at 10,900m), but I have to stay on the tx for the full time (5 more months) I have geno type 2/stage 2. My side effects (like most everyones) are horrible....no energy, blurred vision, heart papitations, leg cramps, moody. If the virus is gone, why would I have to stay on the meds? If anyone has some insight, please let me know. I dont get to talk to my hep doc, just his assistant and she just said "that's what it said in your chart, so you have to do the whole treatment".

Thanks in advance for your wisdom,
GW

[mar148]

There are people here that can put in a more technical medical context, but while the virus is clear at your 4 week test, which give you much high percentage chance of clearing the hep c virus, it does not mean the virus is eradicated for your body.  The virus is very complicated and hearty virus that needs to remain undetectable in your body with the assistance of the medication for a number of weeks (in your case 19 more) to ensure it is really gone and has lost the ability to multiple in your system.    While some type 2 and 3's have been in trials to see if this time can be reduced if you are clear at 4 weeks the percentage chance of SVR or being "cured" goes down and the ability of the virus to come back or relapse when you come off medication goes up.  While I have heard stories of people quitting the medicine early like at 16 or 18 weeks and them being VERY luck to attain SVR, 4 weeks is a very high risk of not being SVR.

[jmjm530]

The short answer is because you can still have virus in your system that is below the detection limit of the tests used and/or your immune system needs more time to reach a state where it can supress the virus permanenty. That said, there is 16 week shorter course option for those who are UND at week 4 and I believe who have a low pre-treatment viral load. Odds are about 8 percentage points less but still around 80% in your favor. A reasonable option especially for someone who has both minimal liver damage and is having a difficult time with treatment. Something to discuss with your doctor. One last thing -- do you know the sensitivity of the test used at week 4. Hopefully it goes down to at least 10 IU/ml. If not, ask your doctor for a more sensitive test.

--- Jim

[Marcia2202]

Minimum treatment for Hep C genotype 2 and 3 is 24 weeks (6 months). Minimum treatment for genotype 1 and 4 is 48 weeks.

There is no way that the virus can be killed in only 4 weeks. I'm sure that there will be several ppl replying to your post, who are much more qualified than me to explain why.

But UND at week 4 is a very positive thing, so congratulations!

There is a lot of information on the net explaining treatment...

Good luck, Marcia

[CockSparrow]

Marcia it has occured. The Japanese have done several studies treating people with as little as 4-6 weeks. There is a recent one that treated for 8 weeks if RVR and had an SVR rate of 33%. Not that high but still some people can cure with really low Tx duration.

GW1
According to ML Shiffman You should not shorten your Tx length, the relaspe rates are higher as jim mentioned.
dose reduction is prefereed if necessary but for the full term rather than shortening Tx.

CS

[Trinity4]

GW,
You are one of the more lucky to have geno2 because statics show the virus is more likely to be eradicated with standard 24 wk tx.  UND at 4 wks predicts a high probability you will achieve SVR at 24 wks.  Geno 1's have a minimum of 48 wks regardless of UND at 4 wks and generally respond less favorably than geno 2.  Your body has to have the full treatment so the virus can be killed.  I can't quote you the medical terms but that is it in a nutshell.  Keep on your course of tx, sides will lessen as tx extends and think in terms of 24 wks is a whole lot better than 48.  Good Luck and go for SVR.
Trinity

[jmjm530]

I believe Mitchell's Shiffman's commentary (or if not Shiffman other commentary on the study) was that the shorter course was a reasonable option  in cases where there were significant side effects, as the SVR rate with the shortened 16-week course was still excellent, although not as good as with 24 weeks. 80 versus 89% or thereabouts. Also, I believe there were some prior studies that showed identical rates.

[Marcia2202]

Wow. Didn't know that. Interesting!

Marcia

[Marcia2202]

I wouldn't take the risk, though...

[R Glass]

I am 2b and RVR. I almost stopped at week 16. Now that I am close to completing tx, I am glad I didn’t. All the research I did, confirms Jim’s statistics. I know that if I relapsed I would never forgive myself. In the beginning, I had a lot of problems with my insurance. If I relapsed without completing tx, I doubt they would pay for a second treatment.
I understand why it is recommended 24 weeks. I don’t understand why 2’s that are RVR, does not have the dosage is not lowered

[HectorSF]

Hi GW1.

One of the important points to keep in mind is that the virus needs to be UND for a certain period of time in order to lower the chance of relapse. If you tx for 48 weeks and become UND at week 4 that means that the virus is suppressed by the treatment for 44 weeks. For genotype 1s most (35%) reach UND before week 12. 48 weeks of treatment minus 12 weeks means the virus is suppressed for 36 weeks. That is why there are the duration protocols of 24, 48, and now 72 weeks for "slow responders" (Those that reach UND between weeks 12 and 24.
That you are a "rapid responder" give you the bests odd of beating this virus and is great news!!!

I have included an except of and article by Dr. Shiffman that discusses chances of achieving SVR and a few other articles that speak to the duration of treatment.

Understanding HCV Nonresponse and Identifying Candidates for Retreatment
By: Mitchell L. Shiffman, MD

Rapid virologic response occurs in approximately 15% of patients with HCV genotype 1 and 66% of patients with HCV genotypes 2 or 3 treated with peginterferon alfa and ribavirin (Figure 4).[3,7] It is critically important to identify patients with RVR because these patients have up to a 90% SVR rate if they remain on treatment for 48 weeks for HCV genotype 1 infections[4] (and 24 weeks for HCV genotype 2 and 3 infections.[3]
Several small studies have suggested that patients with HCV genotype 2 or 3 who achieve an RVR can be treated for a shorter duration (12-16 vs 24 weeks) without any significant decrease in the number of patients achieving SVR.[16-18] In addition, a single retrospective analysis has evaluated the impact of reducing the duration of therapy from 48 weeks to 24 weeks in patients with genotype 1 who achieved an RVR.[19]

Unfortunately, in each of these studies, reducing the duration of therapy was associated with approximately a doubling in the relapse rate. In addition, a large, randomized controlled trial in patients with genotypes 2 and 3 demonstrated that SVR was significantly reduced in patients with RVR—from 90% to 82%—when the duration of therapy was shortened from 24 to 16 weeks.[3]

Based on these observations, it is apparent that patients who achieve an RVR are highly sensitive to the duration of interferon-based therapy. Taken together, these studies also suggest that patients with genotype 2/3 with RVR should be treated for 24 weeks and those with genotype 1/4 for 48 weeks and that doing so is associated with high rates of SVR. As a result, the management strategy for patients with RVR who develop adverse events should be to consider reduction of the doses of ribavirin and/or peginterferon alfa so that these patients have a better chance to complete the current standard-of-care duration of therapy.

3. Shiffman ML, Suter F, Bacon BR, et al. Peginterferon alfa 2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007;357:124 134.
4. McHutchinson JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med. 1998;339:1485-1492.
7. Ferenci P, Fried MW, Shiffman ML, et al. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa 2a (40 KD)/ribavirin. J Hepatol. 2005;43:425-433.
16. von Wagner M, Huber M, Berg T, et al. Peginterferon alpha 2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology. 2005;129:522 527.
18. Mangia A, Santoro R, Minerva N, et al. Peginterferon alfa 2b and ribavirin for 12 vs 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005;352:2609 2617.
19. Jensen DM, Morgan TR, Marcellin P, et al. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha 2a (40 kd)/ribavirin therapy. Hepatology. 2006;43:954 960.

In the July 12, 2007 New England Journal of Medicine, for example, Mitchell Shiffman and colleagues reported results from the ACCELERATE trial, in which 1,469 genotype 2 or 3 patients were randomly assigned to receive Pegasys plus 800 mg ribavirin for either 16 or 24 weeks. The overall SVR rates were 62% in the 16-week group and 70% in the 24-week group, and the relapse rate was significantly higher in the shorter treatment arm (31% vs 18%). However, among participants who achieved RVR at Week 4, the SVR rates were 79% and 85%, respectively. And among those with a low baseline viral load, SVR rates were similar in both treatment arms (82% vs 81%). The researchers concluded that “16 weeks may be adequate for a carefully selected subset of patients.”

Similarly, in the January 2008 issue of Hepatology, Olav Dalgard and colleagues reported that among 428 genotype 2 or 3 patients treated with PegIntron plus 800-1400 mg ribavirin who cleared HCV by Week 4, 81% achieved SVR with a 14-week course of treatment, compared with 91% of those treated for 24 weeks, which did not meet the non-inferiority criteria. “However,” they wrote, “the SVR rate after 14 weeks of treatment is high, and although longer treatment may give slightly better SVR, we believe economical savings and fewer side effects make it rational to treat patients with genotype 2 or 3 and RVR for only 14 weeks.”

You are doing great keep up the good work!!!

Hector


Understanding HCV Nonresponse and Identifying Candidates for Retreatment
By: Mitchell L. Shiffman, MD

Rapid virologic response occurs in approximately 15% of patients with HCV genotype 1 and 66% of patients with HCV genotypes 2 or 3 treated with peginterferon alfa and ribavirin (Figure 4).[3,7] It is critically important to identify patients with RVR because these patients have up to a 90% SVR rate if they remain on treatment for 48 weeks for HCV genotype 1 infections[4] (and 24 weeks for HCV genotype 2 and 3 infections.[3]
Several small studies have suggested that patients with HCV genotype 2 or 3 who achieve an RVR can be treated for a shorter duration (12-16 vs 24 weeks) without any significant decrease in the number of patients achieving SVR.[16-18] In addition, a single retrospective analysis has evaluated the impact of reducing the duration of therapy from 48 weeks to 24 weeks in patients with genotype 1 who achieved an RVR.[19] Unfortunately, in each of these studies, reducing the duration of therapy was associated with approximately a doubling in the relapse rate. In addition, a large, randomized controlled trial in patients with genotypes 2 and 3 demonstrated that SVR was significantly reduced in patients with RVR—from 90% to 82%—when the duration of therapy was shortened from 24 to 16 weeks.[3]
Based on these observations, it is apparent that patients who achieve an RVR are highly sensitive to the duration of interferon-based therapy. Taken together, these studies also suggest that patients with genotype 2/3 with RVR should be treated for 24 weeks and those with genotype 1/4 for 48 weeks and that doing so is associated with high rates of SVR. As a result, the management strategy for patients with RVR who develop adverse events should be to consider reduction of the doses of ribavirin and/or peginterferon alfa so that these patients have a better chance to complete the current standard-of-care duration of therapy.

[Marcia2202]

Superb piece of information. Thanks.

Marcia

[Trinity4]

Hector,

Your articles boggle my mind sometimes but I certainly appreciate the vast knowledge you share with us.  You express your opinions in a way that does not cast judgement nor does it make me feel stupid because I don't have the facts exactly correct.  Thank you again for all you share and the way in which you share it.
Trinity

[HectorSF]

Thank you both for your positive feedback I really appreciate it.

I try to provide medical articles and data from recent studies so people they can find the entire articles online and find out further details for themselves. Being educated about HCV and liver disease has given me some feeling of control and has allowed me to make the best choices for my own treatment. I hope it can help others also.

I'm glad if I can in any way turn this "bad" disease into something positive.

Regards,

Hector

[comeagain]

I`m a geno 3 and i think we should have vl tests w 1 w2 and w 4,  how many of them so-called 4week RVR responders were in fact UND before week 2 .

This HCV is so new so I dare to say, the docs hasn`t learned to do the proper tests, give the proper doses neither determen the proper tx time for some paitent, and you dont know if you are among them some, that didn´t got the optimal tx strategi, because you hasn´t got enough tests to know.

If I were you I`ll play it safe!! go the whole 24w don´t make any dose reduction exept in extreme cases.

I did my first tx between sept. 06 and feb07 24w. they didn´t do any vl test until w12 the same all over the word, and gave every geno2 and 3  the same doses no mater what weight they had. My doc told me two weeks ago that that decision was based on a study made in sout and central europe where the population are smaller and lighter then most countrys, and that guidline they been following until just recently.

Con to your UND 4w result what test did they use how sensitive?

The tx is tuff but doable for most of us, welcome aboard here, its a great support for heppers.

[pigeonca]

If you are suffering intolerable side effects and are UND at week 4, using a test that goes down to less than 10, you definitely can consider shortening your treatment.

I had autoimmune problems prior to treating.  These were so exacerbated by treatment - along with anemia and fatigue - that my doctor made me quit the riba after 12 weeks and the interferon after another week, totaling 13 weeks of treatment in total.  BUT I was UND at week 4.  Now, a year later, I'm still UND.  

As I understood it at the time, my odds of SVR would have been 90% going the full 24 weeks, versus 82% at 13 weeks.  Fortunately I did not have to make a decision; my doctor made it for me.  And it was the right decision for me, as time has told.

If I had not SVR'd, at least I only treated for 3 months before failing - and I would have waited for the new meds before trying again.  Be well.
pigeon

[merryBe]

the virus is not gone, only barely detectable. Unless they used the Labcore >2 test, there could still be a dozen or more virions per teaspoon of blood....and those virions are replicating happiply in the liver.
the liver turns over ever cell in an average of ONE and ONE HALF years. That means less chance of relaspe as old viral infected cells are replaced with new healthy cells.
Over time, on tx less and less liver cells will be infected as the INF/Riba kills virus particularly while it circulates in the blood.

the main thing is the above Shiffman stats show your SVR rate goes down with each month you cut back on tx.
So maybe try to use meds for side effects and plow through or lower doses    now that you are UND...but still stay on enough to give you some advantage.

I'm in month 7 with 11 months to go....and all the symptoms you describe.

but hang in there, you don't want to do the treatment over again later if you could kick it with a little fortitude now, especially if you want to preserve or rebuild all healthy liver tissue, treating early in the stages has an advantage.....waiting 3  years for better drugs when they may still make you as sick anyway...and your chances are 80 % now... may not prove to be wisdom.

[GW1]

Thank you for ALL the info. I will stay the course. ONE DAY AT A TIME! Thanks you all again!!!!!!!!!!  ((((((((HUGZ))))))))))))))))
GW