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UND at week 10 with SOC - will 72 week tx help?
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UND at week 10 with SOC - will 72 week tx help?

Diagnosed with Hep C during early Jan 2012 - Geno 1, Baseline VL - 6.34 million, ALT - 101, AST - 60, Platelets - 165000, pre-tx

Being from India, don't have access to PIs yet.. could take a year or more for PIs to be launched here officially.

Had started with SOC during mid Jan with Pegasys 180 mcg and Riba 1000 mg (15 mg per kg of body weight)

Week 4 VL - 1770 -  3.6 log drop
Week 8 VL - 17 -      2 log drop
Weeks 10 and 12 -  UND (Less than <15 IU/ml)

Liver condition - no biopsy done - doctor's guess is it could be some Stage 3 fibrosis, going by USG report which says mild coarsening of liver echotexture, with liver and spleen being normal in size and portal vein 1.1 cm. Doctor says biopsy is only of academic interest at this stage as I am responding to SOC.. could have been done in the case of non-response.

Now, with the above data, the doctor is suggesting 72 weeks of SOC though it was cEVR. His reasoning - no RVR in my case, liver condition could be approaching Stage 4 and better chances with 72 weeks of tx.

Question: Is this really required? I am upset after listening about 72 weeks - whether I can sustain the tx this long.  By what percentage do the SVR chances increase with this? Appreciate any inputs and comments on my doctor's advice.

The riba dose increased by 200 mg to 1200 mg - 18 mg per kg of body weight.. from week 11. And the HGB stands at 11.1 at week 13, dropped by 4.9 from pre-tx level of 16. Started adding Vit D3 from week 6. Is there anything else that I can do to increase my SVR chances? Appreciate any suggestions..

Regards,
rpl
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446474_tn?1404424777
72 weeks of treatment is only for genotype 1 "slow responders". Those that  have HCV RNA at week 12 but become undetectable at week 24. You were undetectable by week 12 so this protocol would not apply to you.

Secondly, the data you present indicates you do not have cirrhosis, or more accurately you do not have cirrhosis and portal hypertension which usually are found in combination.
Why? "spleen being normal in size and portal vein 1.1 cm". And also you have a normal platelet count. None of these would be that way if you had portal hypertension due to scarring of the liver (cirrhosis).

I, personally don't see any advantage for treating for 72 instead of 48 weeks. There is no statistical data showing it would increase SVR for you.
The most important thing you can do is to stay compliant and take all your meds on time. The drugs are working fine for you so you will probably not need the addition of antivirals.

This is a very good part of an article which will explain about treating for 72 weeks for genotype 1 slow responders.

"Expert Opinion on the Treatment of Patients With Chronic Hepatitis C: Extending Treatment Duration for Slow Virological Responders"
J Viral Hepat. 2009;16(2):75-90. © 2009 Blackwell Publishing

http://www.medscape.com/viewarticle/589014_7

"Extended treatment of 72 weeks did not increase the SVR rate in the intent-to-treat population; which suggests that it is inappropriate to extend treatment for all genotype 1-infected patients. However, the study demonstrated that identifying patients with and without virological response at week 12 using a sensitive molecular test (50 IU/mL) could facilitate the decision on therapy duration for each patient on an individual basis."

"An extended treatment duration of 72 weeks can be considered in 'slow' virological responders, defined as patients who are HCV RNA positive at week 12 but become undetectable at week 24. These patients comprise approximately 20% of the HCV genotype 1-infected population, a not insubstantial proportion."

Best of luck with your treatment!
Keep up the good work!

Hector
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12 Comments Post a Comment
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Avatar_m_tn
To add one more data point, ALT and AST at 35 and 36 respectively at week 12 .. within normal range
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317787_tn?1373214989
Hello, I do not have statistics however wanted you to know it is early here so as people wake up the more knowledgable will have information
It is really too bad that you did not have a biopsy.  You doc can not "guess" the status of your liver.  I had blood work that did not indicate the severity of the damage.  I did 48 weeks of the SOC was UND at 7-8 weeks and stayed that way all the way till 6 weeks after tx and I relapsed.
It sounds like you are doing really well UND by week 12, 3 years ago you only had to have a 2 log drop by week 12 and you achieved that and more.  I do not know about you but I think someone casually changing your tx to 72 weeks is not responsible.  Others have had to do72 weeks however it was because they did not achieve UND until further into the tx.
I wish you the very best.
I am not a doctor just a fellow human
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446474_tn?1404424777
72 weeks of treatment is only for genotype 1 "slow responders". Those that  have HCV RNA at week 12 but become undetectable at week 24. You were undetectable by week 12 so this protocol would not apply to you.

Secondly, the data you present indicates you do not have cirrhosis, or more accurately you do not have cirrhosis and portal hypertension which usually are found in combination.
Why? "spleen being normal in size and portal vein 1.1 cm". And also you have a normal platelet count. None of these would be that way if you had portal hypertension due to scarring of the liver (cirrhosis).

I, personally don't see any advantage for treating for 72 instead of 48 weeks. There is no statistical data showing it would increase SVR for you.
The most important thing you can do is to stay compliant and take all your meds on time. The drugs are working fine for you so you will probably not need the addition of antivirals.

This is a very good part of an article which will explain about treating for 72 weeks for genotype 1 slow responders.

"Expert Opinion on the Treatment of Patients With Chronic Hepatitis C: Extending Treatment Duration for Slow Virological Responders"
J Viral Hepat. 2009;16(2):75-90. © 2009 Blackwell Publishing

http://www.medscape.com/viewarticle/589014_7

"Extended treatment of 72 weeks did not increase the SVR rate in the intent-to-treat population; which suggests that it is inappropriate to extend treatment for all genotype 1-infected patients. However, the study demonstrated that identifying patients with and without virological response at week 12 using a sensitive molecular test (50 IU/mL) could facilitate the decision on therapy duration for each patient on an individual basis."

"An extended treatment duration of 72 weeks can be considered in 'slow' virological responders, defined as patients who are HCV RNA positive at week 12 but become undetectable at week 24. These patients comprise approximately 20% of the HCV genotype 1-infected population, a not insubstantial proportion."

Best of luck with your treatment!
Keep up the good work!

Hector
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Avatar_f_tn
All that imfo looks very good, and hopeful!  You were UND and normal enzymes, at 12 weeks, crongrats!  Hector up there is much more knowledgable than I, but I would say, keep it up for 48 weeks, you have a good chance, and good luck!
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2062453_tn?1350336542
Hi Rpl: If it was me, instead of spending an extra 24 weeks on treatment now, I would stop at 48 weeks and if I relapsed I would spend the 24 weeks I saved on duel therapy treating with triple therapy including one of the protease inhibitors Cheers, GB
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Avatar_m_tn
Agree with all the above ..given the data from studies the benefit would not seem to outweigh the risk.


..http://www.hivandhepatitis.com/2009icr/easl/docs/050809_b.html


Best..
Will
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1130586_tn?1316269892
Hi Rpl ,

Great to hear you got your Und !

Your doc is "sort of" correct imo , though you are not a "slow responder" .

I do not entirely agree with the statements made above , though made with good intentions .. allot of that data is outdated .

Most of the older studies 2009 and before did not take into account "Individualized Tx" & did not include a PCR at Wk. 8 in their studies ...

You might want to check CCO , PubMed etc for published peer reviewed studies on Individual Tx from 2010 to present that include a 8 wk PCR ...

As you know I decided to extend to 60 wks. even though I achieved cEVR somewhere between wk 8-12 Und like you ...

This is a very personal choice ... I weighed many factors and choose what I deemed to be appropriate for me ..

One factor was I thought adding 12 wks might help reduce the chance of relapse and having to do 2x Tx like many G1a's (overall 56% relapse) .. which would come to a total of 96 wks ...

If I had achieved - Und at my Wk. 8 PCR .. I would have only choose 48 Wks Tx ... you were very close to that with a sensitive PCR ... so a bit difficult to choose .. I had 6000 IU/ml @ Wk. 8 ....

We don't have the choice of triple Tx where we live .. that also weighed into my decision making process ..

I Tx for 44 weeks & then decided I was still fit enough to add 12 more ... you might want to wait and see how you feel too .. do some research on Individualized P/R Tx response & then make the very personal choice ...

I still have until end of June - 24 Wk PCR to go ... but as you know I was Und at Wk. 12 post Tx PCR : )

These meds are harsh & do have risks associated with them ... the less taken the better !  

Either way you are having real good results & I wish you the best .

Cheers , Aaron

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Avatar_m_tn
Thanks much for all the responses which helped me understand the 72 week treatment is not warranted in my case. I will discuss with my doctor about this during my next appointment.

Another aspect that my doctor had brought about during the last discussion was that baseline VL was high - 6.34 million. Going through the articles presented here, I guess high VL may not be the factor to be considered here, but the it is the time it took for VL to go to UND levels
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1130586_tn?1316269892
SVR rates in patients receiving individualized treatment durations (INDIV-2) similar to controls (INDIV-1 48-week peginterferon/ribavirin)

SVR: 61% vs 41% with extended vs 48-week therapy, respectively, among patients with high baseline HCV RNA

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Vienna%202010/Tracks/HCV/Capsules/54.aspx

P.S. you can find the studies INDIV-2 & INDIV-1 in goggle or CCO
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Avatar_m_tn
Hi Hector,

Thanks much for your observation that my data is not suggestive of Cirrhosis or portal hypertension. In the absence of liver biopsy, I was quite in the dark whether it is cirrhosis or not.

To be precise, the relevant part of my Ultrasound report pre-tx reads like this:

-------------------------------
"Liver is normal in size and appears mildly coarse in echotexture. No obvious focal lesion identifiable.
No intrahepatic biliary radicle dilatation. Visualised hepatic veins are patent.
Portal vein is 1.1 cm, patent and shows hepatopetal flow.

Spleen is normal in size (10.0 cm) and echotexture. No focal lesion.
SMV measures 1.0 cm
Splenic vein is not dilated

No free fluid in the abdomen

Impression: Mild coarsening of liver echotexture suggestive of probable chronic liver disease with mild dilatation of SMV. Portal vein and splenic veins are normal in caliber."
-------------------------------------------

Also platelets were 165000 pre-tx, dropping to 95000 during first 2 weeks of tx and stabilizing between 130000 and 155000 later during tx.

Though I am not sure what mild dilatation of SMV would mean.

Hope all this data is not suggestive of cirrhosis yet.
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979080_tn?1323437239
Once UND relapse risk becomes your biggest enemy.
Extending tx can reduce relapse but not very much only a few percentage points.Nobody can say with certainty if you fall within that group.
If you tolerate tx well you might want to consider it since you are geno1
with high baseline viral load , no RVR and possibly some liver damage.
You still have lots of time to decide.

My first UND was wk10 as well and I followed the advice of a well known
hepatologist who also used to post here years ago Dr. Douglas Dietrich.
He recommended 48wks of tx after true UND by sensitive PCR is achieved.
I took that rule and rounded it up to an even 60wks. BTW , I was geno4 a,c
with low baseline VL 234K .

The 72wk SOC rule stems from being a slow responder UND by wk24.
24+48=72.

I agree with Aaron , we both did 60wks.
He is now SVR12 and I am SVR36.

b
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Avatar_m_tn
Hello Aaron,

It seems we both posted at the same time here.

Thanks much for giving me a different perspective here. Like you suggested, I need to review the the published peer reviewed studies from 2010 to see how it is relevant for me to extend to 72 weeks. If it is going to help, I need to definitely consider the 72-week option.

As of now, I am able to tolerate the treatment somewhat with normal side effects without major issues. Like Bali said, it is still a long time to complete 48 weeks and to decide about further 24-week treatment. Hopefully if the tolerance level continues to be the same, I can definitely extend my treatment to increase the odds by a few percentage points.

Regards
rpl
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