wait for new PI or do SOC want opinions

hello all,,,taking a poll......genotype 1a...diagnosed last july...biopsy  F 1 stage 2.....have tried to get into 4 trials now but my VL stays around  7k consistently...sometimes drops to 2k...always too low to get in trials...just want some opinions and would be appreciated as to should i wait for new PI or try SOC....and a big thanks to Newleaf here shes been a great support to me and really appreciate her.

[WriteItDown]

I would wait. The PIs will up your chances of cure, and may allow you to treat for half the time. The only obstacle is the insurance issue, since no one really knows yet how it will go down. Good luck whatever you decide.

[Marcia2202]

I would also wait.

It would be stupid if there were insurance issues. It would already be 1/2 cost for the SOC drugs, since the length of treatment would most probably be 24 weeks. I guess that treatment would end up being cheaper.

[desrt]

Just a thought. If your doctor is willing and you/your insurance can afford it, try SOC and do frequent, early PCRs. Even with geno 1, a super fast early response might allow you to do a shortened course of tx without the added toxicity of a third drug. If you're not undetected by week 4, you could stop, and wait for the PIs. Some geno 1s clear early and some people don't find tx that diffucult.
Good luck whatever you decide.

[can-do-man]

desrt makes a good point, with such a low VL your tx could be alot shorter then normal, early pcr's would be a must. Ask your doctor about this. With your very low liver damage you have plenty of time to decide........Best of luck

cando

[Marcia2202]

Ahhh, I din't think of that. That is actually some very good advice from desrt! I was just reading an article today, gonna try find it and post it.

[Marcia2202]

Closely Individualized Treatment with Pegylated Interferon plus Ribavirin Is Possible Based on Baseline Viral Load and Early Response
By Liz Highleyman

Pegylated interferon plus ribavirin is an effective therapy for many people with chronic hepatitis C, but many others do not achieve a cure, and the treatment can cause difficult side effects. Researchers, therefore, have looked for ways to reduce the duration as much as possible, and to discontinue treatment early if it appears unlikely to produce a sustained response.

A 24 week course of pegylated interferon/ribavirin is standard therapy for chronic hepatitis C patients with HCV genotypes 2 or 3, but those with hard-to-treat genotype 1 are usually treated for 48 weeks. In Europe, however, shortening treatment to 24 weeks is approved for people with low baseline viral load and rapid virological response (RVR), or undetectable HCV viral load 4 weeks after starting therapy.

Christoph Sarrazin and fellow investigators with the INDIV-2 Study assessed whether more closely individualized treatment durations according to baseline viral load and initial viral decline is a feasible strategy.

This multicenter trial included more than 600 treatment-naive genotype 1 patients in Germany. Participants were randomly assigned to either undergo standard 48-week therapy or to receive pegylated interferon-alfa-2b (PegIntron) plus ribavirin for individualized treatment durations.

In the latter group, patients were treated for 24, 30, 36, 42, 48, 60, or 72 weeks, depending on whether they had high or low baseline viral load (HCV RNA > or < 800,000 IU/mL) and undetectable HCV RNA at week 4, 6, 8,12, or 24 using a highly sensitive TMA viral load assay.

Results

Overall rates of sustained virological response (SVR) -- or continued undetectable HCV RNA 24 weeks after treatment completion -- were similar in the individualized and standard treatment duration groups (53% vs 48%).
SVR rates were statistically similar between participants with individualized treatment durations and patients who had undetectable HCV RNA after the same durations but continued therapy through week 48.
Patients in the individualized therapy group who achieved RVR at week 4:
Treated for 24 weeks if low viral load: SVR 88% vs 93% in standard duration control group;
Treated for 30 weeks if high viral load: SVR 86% vs 100% in standard therapy group.
Patients with first undetectable HCV RNA at week 6:
Treated for 30 weeks if low viral load: SVR 91% vs 77% in standard therapy group;
Treated for 36 weeks if high viral load: SVR 85% vs 78% in standard therapy group
Patients with first undetectable HCV RNA at week 8:

Treated for 42 weeks if low viral load: SVR 72% vs 100% in standard therapy group;
Treated for 48 weeks if high viral load: SVR 82% vs 88% in standard therapy group.
" Patients with first undetectable HCV RNA at week 12 (complete early virological response, or EVR):
Patients with first undetectable HCV RNA at week 24 and high viral load, as well as those who first became undetectable at week 30 and had low viral load, were treated for 72 weeks: SVR 50%.

Based on these results, the researchers concluded, "For treatment of patients with chronic hepatitis C genotype 1 infection with pegylated interferon [alfa-]2b and ribavirin complete individualization and optimization of treatment duration is possible according to baseline viral load and first time HCV RNA negativity at week 4, 6, 8, 12, and 24."

They also suggested that "Complete individualized treatment durations may also be useful for STAT-C triple treatment schedules," referring to directly targeted agents such as HCV protease and polymerase inhibitors that may shorten the required duration of pegylated/interferon.

[WriteItDown]

I say hit with your best shot the first time.  I can't see any particular reason for you to do SOC now, unless you are either really anxious to just get treatment under way, or particularly worried about potential insurance issues in the future.

[Cory255]

Wait for Telaprevir or Boceprevir to be added into SOC.  It is expected to happen in 2011.

[tashka]

I am just curious, with viral load this low, are your ALT and AST elevated? Do you have any symptoms that bother you?

I am asking because it is quite unusual to have such low viral load. It is usually in the millions. Such low viral load gives you advantage when treating.

[JAY0914]

my alt and ast have been normal ...just recently they have been at the high end of normal..

[JAY0914]

i like the opinion marcia had...the cost of TX could be cheaper due to less time to treat and would have a better chance the first go round.

[nygirl7]

As you can see there are perfect pro's and con's for both sides of the issues.

I'd ask yourself some different types of questions.  Do you have good insurance now and are you sure in this present economic situation that you will still definitely have a job in 2001 oe 2112 (remember we've been hearing that these drugs would be out in 2008, 2009, 2010...there is no real guarantee).  Treatment is quite taxing and adding another drug could make it more difficult (although a shorter tx most likely) - do you have a very physically demanding job?

As a stage 2 you are just crossing the threshold where things start to get dicey.  There are good arguments for both sides but sometimes it's the simple, personal things that change the equation.  That might be of some help to you in deciding which way to go.

With a baseline VL of 7k you could probably beat this with just SOC and be done with it for good. If you did treat and did not beat it you'd have the PIs as a back up plan. If you did beat it well then you'd be done and already heading on with life.

Hard decision to make and I wish you the best of luck!!!!!