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220090 tn?1379170787

PIs versus SOC

Welcome to the world of spin.  A place were small eggs are large and large eggs are giant, small coffees are tall, triple A rated bonds are junk and women’s dress sizes are steadily growing.  February home sales rose says the NAR while they actually dropped 23%. Vertex says the results are great and the lawyers say they are not.

So – in this brave new world, how can you tell what new drugs are going to be worth waiting for?  Well – not without much more work that you want to put in.  I encourage everyone to look at the study released by Vertex and look at the lawsuit.  Are they comparing RVR stats between SOC and triple therapy?  Did Vertex withhold data or did they release it at the conference when they were first allowed to.

Are protease inhibitors in combination with SOC more effective than SOC alone?

Interferon and Ribaviron do not attack the virus directly; interferon stimulates our own immune responses to attack the virus while Ribaviron makes the virus unstable and causes it to mutate more rapidly than normal.   This approach is comparable to firing a 12 gauge shotgun at a mosquito; you have a good chance of killing it, but you will hit many other things along the way.

A protease inhibitor is designed to hit the virus directly and miss everything else.  It rarely achieves that goal, so side effects appear because it has impact on other cells within our bodies.  That is what caused the first PI, BILN, to be withdrawn.

Because the PI hits the virus directly, it quickly lowers the viral load by killing everything not resistant to it.  This leaves a small number of virions  for the SOC drugs to kill and making it much more likely that they will be eliminated in significantly less time.

Does that mean you should wait for the new drugs?  The answer is maybe.  The answer is dependent on whether you can afford to wait based on your biopsy result, your genotype and your predicted response profile: age, race, body density …et al.

Interferon is a very dangerous drug with serious side effects.  Here is an old warning label:

Warnings and Contraindications
Anemia associated with the use of REBETOL in combination with interferon alfa-2b (REBETRON Combination Therapy) may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated. The most common adverse experiences associated with REBETRON Combination Therapy are “flu-like” symptoms, such as headache, fatigue, myalgia and fever, which appear to decrease in severity as treatment continues. Severe psychiatric adverse events, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides), and rare instances of homicidal ideation have occurred during combination REBETOL/INTRON A therapy, both in patients with and without a previous psychiatric disorder.

And this before they discovered that it can cause psoriasis, arthritis and many other auto immune diseases – not to mention thyroid malfunction.   I believe that anything that reduces the time spent on interferon is worth it.

I am very biased towards PIs.  It appears to have worked for me after 20 years of battles.  You need to make your own decisions.  I mean this post to be a starting point.  No one should take what I say at face value.  I am not a doctor or scientist though I have tried to be as accurate as possible.
18 Responses
Avatar universal
Dear andiamo 1

The drugs really look promising but interferon is not as bad as you think. all adverse effects are reversible when you stop it. However I am intersted in PI .Are they available? By what name ? I am from India.
220090 tn?1379170787
Many of the adverse effects are not reversible.  There are plenty of people that have permanently damaged their thyroid.  Having taken interferon for 7 out of the last 20 years, I can tell you that it is devastating on the patient and the family.

They are only available in drug trials at this time, since none are FDA approved as yet.  I am not sure what the status is in India.
232778 tn?1217450711
I also think interferon is not that bad, and feel that Ribarvirin is the nasty one in the mix. That is to some extent what concerns me about the additional mix drugs.

To me, there is a fundamental difference between Hep C and HIV and that is, that many people with Hep C decide not to treat, that the side effects outweigh the benefits. Whereas with HIV, people feel they have no choice.

Accordingly, I think there will be the most benefit overall, if more people can be convinced to treatment. To that end, the focus should be on reducing the side effects of existing treatment, while looking for replacements for existing treatments, rather than add ons (which may scare away more people). In this respct, I think Albuferon could be absolutley briliant, and that similar drugs are the best way to go, along with research into some form of other future treatment not involving Ribarvirin or one day, interferon(vaccine or similar).
232778 tn?1217450711
Another way of puting it, if tommorow we had the choice between:

1. An add on drug that will raise success rates to 90% for those who can stay on treatment; or
2. A replacement for existing treatment with minimal side effects, but only a 40-50% success rate,

IMO 2 would save and improve the lives of far more people than 1. With minimal side effects, there would be far fewer dropping out of trials as well.
232778 tn?1217450711
Another way of puting it, will PI's just lead us to an HIV type blind alley - being that of maintaining a low viral count, or controlling the virus, while needing to constantly change treatment due to mutations - good for Pharmaceutical companies I guess, as many different drugs get rotated. A blind alley for Hep C I fear, because unlike HIV, many Heppers can live without virus maintenance, and hence, won't lower their standards to accept the side effects.
220090 tn?1379170787
Where did you hear that PIs lead to a low viral count when used with HCV?  All the studies show that SVR is SVR and RVR is RVR no matter if PIs are used or not.  There are plenty of Prove 1s that have been SVR for over a year now.

I see one of the world famous Docs and he couldn't disagree with you more about the desirability of continuing with SOC drugs.  I have own experience to go by: I treated for 7 out of the last twenty years and the impact of that was devastating on me and my family.  I had to do it, since I was progressing rapidly to stage 4 and by treating repeatedly, I was able to maintain stage 3 since 1992, with very little progression.

I think we both want the same thing: a cure for this disease that helps a large percentage of people.

As far as your choice  1 and 2, I certainly agree with you about 1 being optimal.  
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