Wednesday, May 18, 2011

Getting Ready; Telaprevir or Boceprevir ?

You know folks, as I begin writing this (and I have no talent for writing by the way) I can't help but wonder if  hepatitis C patients who are preparing to treat are ready to choose between the two new drugs; Telaprevir "INCIVEK" or Boceprevir "VICTRELIS". More importantly I wonder if patients understand the dire need for an experienced physician to be on board for this complicated  three drug regimen of difficult to tolerate drugs (maybe more including rescue drugs) which will involve treating for 24 to 48 weeks.
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I ask you, are you ready ?  Do you have an experienced physician ?  Have you moved your family out of the house and into the garage in order not to hurt them, kidding. You, the patient will decide which drug to use, a difficult decision no doubt. Both drugs are so close in comparison, with each drug closely being scrutinized, your decision will be determined by the efficacy and safety provided by the recent clinical data. Although, the final decision for some patients may hinder on either enrolling in a clinical trial (when available) or taking advantage of the drug companies patient assistance programs.

Yes, boceprevir and telaprevir have both been FDA approved and the temptation to begin treatment is upon us, with two drugs to choose from you may be asking yourself what to do, which drug to use, or wishing someone would make a decision for you. Nope, that's up to you and only you. Coupled with the assistance from your physician, and your own particular scenario, you will ultimately make the final decision. That's how the medical world works today, the same is true for all medical care from cancer treatments to knee surgery, its up to you folks, so lets get started.

What we know to date is that clinical data has suggested that telaprevir is significantly more effective in comparison to boceprevir.  If  we look at patients who were not previously treated, we know that telaprevir achieved a sustained virologic response of 79 percent when used along with standard treatment. Boceprevir also used in combination with standard therapy has a 63 percent sustained virologic response in naïve patients. As for duration of treatment, in telaprevir 58% of naïve patients can shorten treatment to 24 weeks, compared to 28 weeks in 44% of boceprevir patients.

If we check out the stats in patients that have treated previously the SVR for telaprevir is 65% and boceprevir is 66%. As mentioned on the blog boceprevir did not include null responders in their trial. Vertex’s phase III REALIZE trial did test telaprevir in null responders, which produced a 31% SVR rate.
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Author Courtney McQueen from The AIDS Beacon writes;
Although the rates for telaprevir appear higher than those for boceprevir, it is not clear whether telaprevir is actually more effective.
Patients who received the standard treatment of just ribavirin plus Pegasys in the telaprevir trials had a higher cure rate than patients in the boceprevir trials who received just ribavirin plus PegIntron. As a result, it is possible that the differences in cure rates between the trials are actually due to Pegasys versus PegIntron, or other differences between the studies. Some studies have found that Pegasys is more effective than PegIntron.
Trials in which telaprevir and boceprevir are compared directly will be necessary before determining whether one drug is more effective than the other.

The concern in relation to side effects or safety in telaprevir is the significance of the rash, which was reported in 56% of patients using telaprevir. We can compare that to 32% of patients reporting a rash receiving standard of care. The rash was found to be mild to moderate although severe in 1% of patients and resulted in stopping treatment for 6% of patients. You must be aware of the symptoms of the rash, which will add to the stress often experienced with treating HCV. The drug ribavirin also causes a rash, what seasoned patients refer to as the "Riba Rash", hated it. Physicians will be on alert folks, but you must also be persistent and diligent in reporting it to your treatment nurse and doctor.
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Anemia was seen more often in patients receiving telaprevir then those treating only with standard therapy.  (36% telaprevir vs.15%  standard of care patients) and sometimes more severe. In 3% of patients telaprevir was discontinued because of anemia.(remember that 3%)
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In boceprevir anemia was seen in about 50 % of patients compared to 30% receiving standard therapy. This is important, in the telaprevir trials patients were not allowed rescue drugs, in that they were not allowed to treat the anemia with erythropoietin  (EPO)-a drug that stimulates the production of red blood cells. In comparison the boceprevir trials did allow rescue drugs and (EPO) was used, or patients were able to lower their dose of ribavirin . This raises the question of how severe the anemia could have been in the boceprevir clinical trials. So in retrospect those 3% of patients who had to discontinue telaprevir because of anemia were real numbers. This is the second time boceprevirs stats have not been clear, the same applies to those SVR numbers in previously treated patients, as mentioned null responders were not included in boceprevir trials.
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The protocol for treating with boceprevir can be viewed here and here.

The protocol for treating with telaprevir can be viewed here and here 
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The newly FDA approved boceprevir has been projected to cost around $1,100 per week, with telaprevir costing close to the same.(Not including Interferon/ribavirin).  According to consumers reports the cost of standard of care is at roughly $600 per week which breaks down to $500 for the Peginterferon and $100 for ribavirin.

Reuters reported yesterday that Merck the maker of Boceprevir made a deal with Roche to promote Victrelis/boceprevir in the US and research treatments for hepatitis c.

Related;
VICTRELIS™ ( Boceprevir)
Prescribing Information and Medication Guide
Incivek (telaprevir)
Telaprevir/Incivek Prescribing Information
Medication Guide
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20 comments:

  1. why such a big difference in anemia rates in both studies? standard of care for one is half the other

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  2. Why were the patients in the Telaprevir trials NOT allowed the use of the rescue drug(s)?

    Does this include Neupogen as well as Procrit?

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  3. Anonymous said... Hi, this is Tina/HCV new drugs, blogger will only let me reply under anonymous, go figure.
    I can only assume that Vertex/telaprevir did not want skewed results? No rescue drugs were used in the telaprevir trials. Procrit was allowed in boceprevir trials, as for neupogen, some patients did use neupogen. In the telaprevir trials ribavirin doses were lowered in some patients.

    May 29, 2011 5:40 PM

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  4. Does anyone know of any doctors who are going to start treatment for HIV/HCV coninfected patients now instead of waiting for the trial studies to be completed before next June 2012.

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  5. I must say that this is the best ever thing i've read related to new HCV drugs. Very good and clinically relevant comparisons have been made here. I am very much thankful to the author for such thought provoking write-up

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  6. I have HCV and went through the 44 week 2 drug cocktail back in 2003 - 2004. It was unsuccessful and I have less energy now than before taking the treatments with sores on my forearms that won't heal. Felt great with no sores before taking the treatments but I still decided to try this 3 drug cocktail; although I am less than optimistic. I am hopeful for myself and all of the folks who are infected. I will add VICTRELIS/boceprevir to my treatments next week (week 5) and I am a little nervous about the side effects. I would like to wish all of you'll who are also infected the best of luck and if my experience(s) can be helpful, I wouldn't mind talking to anyone who is faced with the decision of whether or not to try the treatment(s). Ultimately, the decision will still be 100% yours. I can tell you that I watched a good friend die of complications from HCV and it was a hard, slow death. She was diagnosed too late to try the treatments. She is the reason I chose the treatments. May God bless you all!

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  7. I have been diagnosed with Stage 2/III Liver Disease from Hep C. I am going on the 3 drug cocktail in December but have to choose between boceprevir and teleprevir. Hepatologist said rashes "could" be severe enough to stop treatment with teleprevir but he likes the fact that all the drugs are started at the same time. With boceprevir the treatment is 1 month longer and the side effect is severe anemia but he said he could give me EPO for that. The choice is mine. From what I can glean, teprevir has a higher cure rate? Confused. I know you can't decide for me but any input would be appreciated. I am a "naiive" (love that) patient. Thanks.

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  8. If you have never treated before, then both drugs would be equally beneficial. Good Luck

    HCV New Drugs/Tina

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  9. Thanks Tina. I am leaning toward the boceprevir.
    Lynda

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  10. Scooter in NJ. Just started 3 drug combo today 9/23/11 using Telaprevir (Incivek). In my case it was my Doctor (UPenn) who made the choice of Telaprevir. I've been on so many studies since 1999 it's hard to keep track. I generally respond well but then the virus skyrockets once I'm done. Fingers crossed, hoping and praying for the best. Good luck to to the rest of you!

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  11. Wishing You The BEST!
    Tina

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  12. Any studies you know of that compare boceprevir vs. telaprevir results for type 1 genotype?

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  13. That is the million dollar question. No, not at this time. But there are many study results on both drugs. Click on the links located on the blog.
    Good luck
    Tina

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  14. dont be scared about side effects. don't let it put you of treatment. i'm on my last week of telaprevir{12w}. no sever side effects, just tired all the time. good luck everybody with hcv.

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  15. Well after having HepC and B antibodies for I don't know how long, probably 30 years or more, I am now going to have to treat it. 2 biopsies in the past have shown very little damage to my liver and I had no symptoms, except maybe a little joint pain. This June (2011), I had to have breast cancer surgery along with radiation. I think my body decided that that was more important to fight than the Hep C. I breezed through the cancer treatments, but now am in the throes of the Hep C taking control. I am now sick, sick with fatigue, bad joint pain, and my cryogobulins are very high. I have genotype 1b and was supposed to start the telaprevir in June as well, but had to put it off because of the cancer. My doc recommends the telaprevir and he's been involved with Hep C since 1991, so I'm going to follow his advice. If I can get rid of this and have a normal life, I will endure whatever it takes to finish it. Best of luck to all of you. I'll say a prayer for you!

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  16. Hello. I have tried to treat my HepC with traditional treatment two years ago. It took me a year and a half to be virus-free but unfortunately the virus came back after 6 months. I'll start new treatment whit Telaprevir tomorrow. My doctor advised me not to wait for the next development of medicine. I have not much left of my liver. In the case of side effects may I say that my last treatment has absolutely not been painless, but I think it is individual. some have more and some less side effects. The main thing is that you stay virus-free after treatment. I wish you all good luck. V. from Sweden

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  17. Wishing you the best of luck- From the U.S. To Sweden

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  18. Hi everyone...I am a 61 yr old female. I was diagnose in the late fall 2007 with HCV genotype 1a. I waited until after the holidays I started the traditional 48 week treatment in 2008. Duriing that time my doctor had to reduce both meds due to skin and scalp rash and anemia, I ended up needing transfustion. I had to start procrit injections. I completed the treatment, There was no detection of virus. In Jan 2009 I had my last lab work, the virual load had returned. Now it 2012 and I'm about to start the triple cocktail (incivek) in April. My recent biopsy shows my liver is in stage 3. Note: I was also diagnosed with sarcoidosis 2011. I had numerous grandulomas (non benign) total 7 tumors that grow on the back of both wrists. They were removed and biosped results sarcoidosis of my lungs, 2 in my liver. I was told by my Pulmo and my Gastro doctors that this is a side effect of the interferon. My Pulmoary doctor treated me with predisone 20 MG, for 90 days weaning down to 10 MG for life. If the grandulomas start growing again during treatment, I will be taken off. I had a moderate amt of hair lost, it grew back with the help of a liquid tropical steroid & rogaine. You are all in my prayers.

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  19. Hello Everyone
    51, female, three traials so far, last one Telaprevir - was withdrawn from trial due to severe rash everywhere.

    I would love to hear if anyone who has had a negative response to Telaprevir has gone on to be succesfully treated with Boceprevir.

    Good luck to all of you who are 'in treatment' I've always taken the view that the standard ribo & ped caused me more autoimmune problems and a higher viral load and that I should have left alone until a better approach came along.

    Healing Thoughts from the UK

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