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446474 tn?1446347682

Treat Now or Wait for New Therapy?

Here is a good paper to help those who are deciding whether to treat now or waiting for future hep C therapies.
You can read the complete paper at Clinical Care Options (signing up is free)

http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Pages/Page%205/Subpage%206.aspx

Hepatology - Management of Hepatitis C Infection
Authors: Jordan J. Feld, MD, MPH, Hemant Shah, MD, MScCH HPTE
Last Reviewed: 11/9/12 (What's New)

Treat Now or Wait for New Therapy?

Drug development for HCV is progressing extremely rapidly with the discovery of numerous direct-acting antivirals, some of which are in late-stage clinical development with promising early results. Future therapies hold the promise of higher efficacy, shorter duration, and improved tolerability, particularly for regimens that do not require interferon. Unlike first-generation protease inhibitors, many of the new direct-acting antiviral agents or combinations of direct-acting antiviral agents have activity against a broader spectrum of and possibly all HCV genotypes. The prospect of newer therapies raises the issue of whether to treat patients now or wait for the new treatments to arrive.


15 Responses
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1722607 tn?1335747858
So I fall into the "unclear category" Geno 1 F2. I really hope new, better, safer treatments come out soon!
Helpful - 0
446474 tn?1446347682
The fibrosis is graded on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3.

Fibrosis score:
F0 = no fibrosis
F1 = portal fibrosis without septa
F2 = portal fibrosis with few septa
F3 = numerous septa without cirrhosis
F4 = cirrhosis

Activity score:
A0 = no activity
A1 = mild activity
A2 = moderate activity
A3 = severe activity

hector
Helpful - 0
1711722 tn?1356487554
Hey Hector!

Thanks for this post!  I have no idea what category I would fall into, as I don't know what the "F" means (pardon the pun) in F0-F4, etc.  Would that have been on my labs?  If so, I will look when I get home and have more time.  Good info.

Hugs, Bee :)
(Hep C, Gen 1; 1 tx with triple t/VIC; relapsed 6 mos post)
Helpful - 0
766573 tn?1365166466
During dual therapy (the old SOC for Geno 1, Peg & Riba) both the AASLD and EASL define the treatment response

[Previous] Partial Response as:
More than 2 log10 IU/mL decrease in HCV RNA level from baseline at 12 wks of therapy but never achieve undetectable HCV RNA.

a Null Response is
Less than 2 log10 IU/mL decrease in HCV RNA level from baseline at 12 wks of therapy

That is a cut and paste straight from the article itself which defines these treatment responses as such on Table 11. http://www.medhelp.org/user_photos/show/310428?personal_page_id=1282072

It defines a Relapse as: Undetectable HCV RNA at the end of treatment, followed by reappearance of HCV RNA (and failure to achieve SVR).

______________________-

I doubt it is this complicated. I am just not seeing it :)
Helpful - 0
Avatar universal
I'm just a week into this diagnose so I don't have all the terminolgy yet. This is great information though. Thanks for posting!  Can I assume treatment niave means never been treated? Can I assume null response means been through treament but not enough response to treament?  Would that be not 2 logs?  :-)  See, I am learning!  
Helpful - 0
Avatar universal
I'm not too sure what you are asking. It looks like you want to know what the recommendation is for G1 F0-F2 with previous partial response.

There is no previous partial - there is previous relapse - which to me would mean previous partial (cause you did respond but then relapsed.)

The recommendation for that is listed as "unclear"

Is that what you were looking for?

rk
Helpful - 0
766573 tn?1365166466
This is embarrassing but sometimes I just can't focus on all this data (I'm in week 45/48).

Will someone show me the where the patient group category ★☆Genotype 1: F0-F2 with previous partial response☆★
is listed on the chart as well as the related narrative ("Therapeutic Regimens: Which Therapy for Which Patient: Genotype 1 Patients)

http://www.medhelp.org/user_photos/show/310136?personal_page_id=1282072

The introductory paragraph says the table is supposed to outline the  authors’ perspective on which patient groups should probably initiate current therapy, those who should probably wait for future options, and those for whom the decision is less clear, with a list of factors to consider in such cases.
---------------------

I noticed in an unrelated subsection that Table 11 "Response Definitions for Patients Treated With Peginterferon/Ribavirin Dual Therapy (EASL 2011)" indicates in small italics on the bottom of the table that partial response is sometimes called "nonresponders" in clinical trials. However this is in the section "Monitoring and Determining Treatment Efficacy With Peginterferon/Ribavirin Dual Therapy."

Helpful - 0
979080 tn?1323433639
The one thing clear to me is that were I not SVR for over a year already I would be in the unlcear category yet again today.....

Unclear:
"Genotypes 2-6: F0-F2, treatment naive"

b
Ex geno 4a,c
Helpful - 0
446474 tn?1446347682
Cirrhosis? No thanks! Even compensated, with no symptoms is not my idea of fun.

As far as the safety of Sofosbuvir, I am one of the canaries in the mine.
If I stop singing... best hightail it over to Abbott!
I figure if any of us trial folk kick the bucket we 50 with the constellation of hep C, cirrhosis, liver cancer awaiting transplantation are high on the list of most likely to fail. Not only will I be dead (and that could ruin my whole day) but to add insult to injury my stock portfolio will take a real beating too.

Que sera sera.
Hector
Helpful - 0
766573 tn?1365166466
On table 7: I am unclear what the categorization is for the Patient Group:

Genotype 1: F0-F2 with previous partial response


I can't really scroll through the whole document on my phone but what you pasted looks identical to the table - will look again when I am on my home PC.

Helpful - 0
Avatar universal
Waiting at stage three would really scare me, to short of a jump to being cirrhotic. seen to many here make that jump in a short span and I think we both agree nobody wants to become cirrhotic.

People should keep in mind what doctor foster said as there was three and now only one.
"The suspension of this drug family leaves only 1 nucleotide at an advanced stage of development (sofosbuvir, previously known as GS-7977), and I am now crossing
my fingers and hoping that its current impressive safety record continues. The failure of drugs in late-
stage clinical trials has reminded me that unexpected safety concerns are common, and despite the best
efforts of companies and regulators, clinical trials remain challenging."
Helpful - 0
446474 tn?1446347682
Cando -

The only way that makes sense to me is they have plenty of time to wait for newer treatments with shorter durations, less side effects and higher SVR rates?
These are usually the easiest patients to treat.

Stage 3 I am not so sure why they can't wait. Although someone who is stage 3/4 I think should try treatment at least. What have they to lose bu their hepatitis C. If they fail then wait for new treatment(s).

Surely stage F0-F2 can wait 2-3 years if genotype 1 for Sofosbuvir + GS-5885 and maybe ribavirin.
For genotypes 2/3 waiting a year is for most people a non-issue.

But again we are all individuals so treatment should always be based on the patient's situation.

Hector
Helpful - 0
Avatar universal
"Unclear:
F3 or F4 with previous partial or null response
Genotype 1: F0-F2, treatment naive or previous relapse
Genotypes 2-6: F0-F2, treatment naive"

What I find odd is this doctor is saying even people with no or very little damage its unclear whether they should wait or treat.... Where i totally agree anyone past stage 2 no matter their genotype should treat now, except those that are prior null responders as interferon is not their friend.
Helpful - 0
446474 tn?1446347682
There are several factors to consider in making the decision to treat vs wait, but ultimately it is an individualized decision that must be made between the physician and patient depending on the specific circumstances of the person’s HCV infection. Relevant issues to consider are the severity of liver fibrosis, the probability of sustained virologic response with current therapies, the tolerability of and willingness to accept interferon-based treatment, and the local timeline for approval and reimbursement of new therapies. Additional factors that may also be considered include the age and stage of life of the patient and the presence of extrahepatic manifestations of HCV. Patients with advanced fibrosis who are treatment naive or who have relapsed following peginterferon/ribavirin therapy need treatment and will likely do well with current protease inhibitor–based regimens. By contrast, previous null responders to peginterferon/ribavirin have a low likelihood of response and may benefit from waiting for newer therapies. For patients with genotype 2 or 3 HCV infection, sustained virologic response rates are high with current peginterferon/ribavirin therapy, but all-oral, well-tolerated regimens are currently in phase III development.
Helpful - 0
446474 tn?1446347682
Table 7 outlines the authors’ perspective on which patient groups should probably initiate current therapy, those who should probably wait for future options, and those for whom the decision is less clear, with a list of factors to consider in such cases.

Table 7. Categorization of Patient Groups Suitable for Current Therapy vs Waiting for Newer Therapies

Treat Now:
Genotype 1: F3 or F4, treatment naive or previous relapse
Genotype 2-6: F3 or F4, treatment naive
Extrahepatic manifestations of HCV

Wait for New Therapy:
Genotype 1: F0-F2 with previous null response
Genotype 2/3: previous relapse or nonresponse
Poor adherence to or tolerability of peginterferon/ribavirin
Relative contraindication to peginterferon/ribavirin

Unclear:
F3 or F4 with previous partial or null response
Genotype 1: F0-F2, treatment naive or previous relapse
Genotypes 2-6: F0-F2, treatment naive

Issues to Consider:
Severity of liver fibrosis
Previous response to and tolerability of peginterferon/ribavirin
HCV genotype
Age
Comorbidities
Nonmedical factors (eg, patient willingness, family planning, employment)
Local timeline for approval, reimbursement, and availability of newer direct-acting antiviral agents
IL28B genotype

' Hope this helps to clarify your thoughts.
Hector
Helpful - 0
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