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Boceprevir or Telaprevir?

Hi everyone! I haven't been on here in a long time, but I am considering starting treatment now and I have a question.  First of all, my doctor recommended Boceprevir over Telaprevir because she says she "thinks" Boceprevir is more effective and reduces Tx time more than Telaprevir does. I know there are a lot of very knowledgable people on here that I can trust so I was wondering what you thought about that.  I honestly have not spent a lot of time researching this topic. It does seem as though Telaprevir is more popular for whatever reason though.

Anyways, quick background on me: I was diagnosed 2 years ago with genotype 1a.  I've probably had the virus for 7-8 years from IV drug use.  I haven't had any labs done in about a year or so, but my VL has always been extremely low, so low once that it was undetectable. The highest it has been is a little over 13,000.  I had a biopsy about a year and a half ago (when I was first considereing Tx) which came back great. No fibrosis.  Because of that I decided to wait for the new meds to come out.

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1747881 tn?1546175878
Previously Untreated Subjects
SPRINT-2

Sustained Virologic Response (SVR)*, † and Relapse Rates‡ for Previously Untreated Subjects

Study Cohorts                    VICTRELIS-RGT    VICTRELIS-PR48     PR48
Cohort 1 Plus Cohort 2          n=368                   n=366                  n=363
SVR† %                                 63                         66                       38
Relapse‡ %                            9                           9                        27
(n/N                                      (24/257)                 (24/265)          (39/176)

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

Study 111 (ILLUMINATE)
Study 111 was a randomized, open-label trial conducted in treatment-naïve subjects. The study was designed to compare SVR rates in subjects achieving eRVR who were treated with INCIVEK for 12 weeks in combination with Peg-IFN-alfa-2a/RBV for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen).

The SVR rate for all subjects enrolled in the trial was 74%.

http://pi.vrtx.com/files/uspi_telaprevir.pdf

A head-to-head trial comparing the drugs has not been performed, so we do not yet know which one is better.

http://hepatitiscnewdrugresearch.com/boceprevir--telaprevir.html
Helpful - 0
1747881 tn?1546175878
Boceprevir or Telaprevir?

At this year’s Digestive Disease Week (DDW) meeting, prior to the FDA approval of boceprevir and telaprevir, many gastroenterologists and hepatologists were already discussing which patients should receive which drug. At this point, neither drug has been proven superior—it comes down to patient preference and risk factors, said experts.

“There’s been no head-to-head trials of these drugs, so one has not been proven significantly better than the other,” said Marcelo Kugelmas, MD, a gastroenterologist at South Denver Gastroenterology in Colorado.

The treatment regimens studied with boceprevir and telaprevir are different and the studies were not done head to head, added Dr. Kugelmas. The data for both drugs, published recently in The New England Journal of Medicine, cannot be compared (2011;364:2417-2428; 2011;364:2405-2416; 2011;364:1207-1217; and 2011;364:1195-1206).

The reported SVR rates with boceprevir are 63% on the label, whereas telaprevir has an SVR rate of 79% in treatment-naive patients. That difference has many patients asking why they wouldn’t be put on telaprevir, said Sue Simon, director of the Hepatitis C Association, a national patient advocacy and educational organization.

Experts say patients need to be told that the studies were not head-to-head trials.

“You can’t compare the results that way, although that’s sometimes difficult for patients, who aren’t aware of the nuances of clinical trials, to understand,” said Dr. Pockros.

Physicians should be familiar with both therapies and with prescribing both, said Dr. Kugelmas. “I honestly don’t think that we should be pushing one more than the other or that anyone should prescribe 100% one or the other.”

Although both agents act similarly, there are some key differences in lead-in times and side-effect profiles. The treatment period is longer with boceprevir. Boceprevir requires a four-week lead-in with pegylated interferon and ribavirin, which lowers the virus level modestly before boceprevir is added for 24 or 32 weeks. Telaprevir therapy is started at the same time as the pegylated interferon and ribavirin and given for 12 weeks as triple therapy. The pegylated interferon and ribavirin are continued for either 12 or 26 weeks thereafter.

The inclusion of pegylated interferon and ribavirin is, at this point in time, necessary to suppress any mutants that emerge over the course of treatment, explained Adrian M. Di Bisceglie, MD, co-director of the liver center and professor of internal medicine at the Saint Louis University School of Medicine, during a presentation at the DDW meeting when physicians questioned why pegylated interferon and ribavirin are needed with the new therapies.

There are differences, too, in the side-effect profiles. Boceprevir causes anemia and a metallic taste; telaprevir also causes anemia, as well as skin rash and mild to moderate anorectal disorders.

In the case of boceprevir, less than 2% of patients discontinued therapy because of anemia. However, anemia was a significant factor in predicting SVR in Phase III trials of patients taking boceprevir. In the SPRINT-2 (Serine Protease Inhibitor Therapy 2) trial, 72% of patients with hemoglobin below 10 dL/g attained SVR compared with 58% of patients without anemia (Sulkowski MS et al. Presented at the 46th annual meeting of the European Association for the Study of the Liver. Abstract 476).

In patients taking boceprevir, anemia can be managed most often by reducing ribavirin and, at times, with the addition of erythropoietin, said Dr. Pockros. “Successful management of rash and anemia will allow high SVR rates,” he observed.

In the telaprevir trials, 56% of patients receiving the telaprevir combination reported rash and skin problems, 22% more than in the control arm. Of these, 4% had severe rashes and less than 1% had drug rash with eosinophilia and systemic symptoms and Stevens-Johnson syndrome. Patients with these severe symptoms should have their drug therapy stopped immediately, according to the prescribing label.

“There are some differences between these drugs that make one preferable for some patients over others. I think mostly it’s going to be a matter of individual preference and side-effect comparisons as much as anything,” said Dr. Kugelmas.

The costs of the two therapies are similar, provided patients remain on the drugs as long as permitted. The price of telaprevir is $49,200 for the course of treatment, and boceprevir costs between $26,400 and $48,400 for the full course. Those prices do not include the cost of pegylated interferon and ribavirin.

Both Merck and Vertex have established patient and co-pay assistance programs, and physicians who have started patients on the therapies say that most insurance companies are covering the therapy now that the agents have been approved by the FDA.

Experienced liver specialists are urging physicians to set up allocation systems within their practices so that the sickest patients have first access to direct-acting antiviral therapy.

In his editorial in Hepatology, Dr. Jensen proposed a “needs-based allocation system,” similar to the Model for End-Stage Liver Disease (2011;53:1789-1791). As part of the system, all patients will need to be educated about the natural history of the disease to help them understand why some patients warrant earlier treatment.

Dr. Jensen suggests that physicians host educational symposia for their patients and families in which they stress the importance of expediting treatment to the sickest patients.

“Then, patients who have previously deferred therapy and new patients will be prioritized on the basis of need, with patients with cirrhosis at one end of the spectrum and asymptomatic patients with FO-F2 fibrosis at the other end of the spectrum,” said Dr. Jensen. “This system satisfies the principle of justice while placing appropriate emphasis on medical need.”

With the two therapies now on the market, research efforts are shifting to focus on other drugs and other combinations and on patients who do not fare well with triple therapy. Some studies are looking at quadruple therapies, whereas others are looking at interferon- or ribavirin-free regimens. Many trials are also exploring other classes of drugs such as polymerase inhibitors or nonstructural protein 5A inhibitors. “Those will be the next classes of drugs and they are under investigation now,” said Dr. Pockros.

http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Clinical&d_id=50&i=August+2011&i_id=758&a_id=18855
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Avatar universal
Finally a factual explanation of INC vs VIC.  I am going to copy this to my profile.  Thanks Hrsepwrguy!

Have a great night!
Jules
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2062453 tn?1350332942
Cost may be a consideration. Telaprevir costs about $60,000 for 12 weeks of treatment. I read boceprevir costs about a quarter of that. Based on my previous treatment experience (2008-2009) Pegasys and Riba by themselves drives my virus out of my blood stream and into hiding -- I don't know where it hides. So, for me, the better choice was Telaprevir so I could "nuke" the virus before it had a chance to figure out what was happening and flee into hiding. Of course, I can't really know how the virus "thinks." I'm not a researcher/chemist/pharmacist. I just believe that for me Telaprevir was the right choice -- I guess I'll find out after I stop treatment next month.
Helpful - 0
Avatar universal
Some things to consider...

Best case incivek - 24 weeks otherwise 48
Best case victrelis - 28 weeks, otherwise 36 or 48

Prior relapsers and null responder may only have to do 36 weeks with victrelis if they respond well. 12 weeks less than on incivek.

Some folks, may do 4 weeks less on incivek than on victrelis.

http://www.natap.org/2011/PDF/NurseMary.pdf

I researched the trials (teleprevir and boceprevir) and determined based on being tx naive, with a low viral count, low liver damage, genotype 1b, I had a good shot at 24 weeks and I did finish after 24 weeks.

Best wishes.
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Avatar universal
True Jasmine but many other things to consider also like skin conditions.  And also you said low viral count....what do you consider a low viral count.  I am GT lb also.  Just curious

Have a great day!
Jules
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Avatar universal
Thank you for the great information! Of course, now I am wondering why the heck she recommended Victrelis. My gut tells me I will finish in a shorter time period (If my own body can make the virus undetectable, I'm sure the drugs would cure me, right?) and if I could do 4 less weeks on Incivek I'd rather do that. Hmm... I think the Dr. did mention side effects as well, that they may be a little less severe with Victrelis.  I also just remembered that she liked that Victrelis gets added later to give the body time to adjust instead of going all out right from the get go. Or something to that effect. My head was probably spinning by that time thinking about feeling like crap for 6 months straight, possibly longer.
Helpful - 0
2062453 tn?1350332942
You might find my data point interesting. I started triple therapy treatment (Incivek) at 22,000,000 VL (high viral load). After 1 week my VL was 65. After 2 weeks my VL was UND.

The choice of which protease inhibitor is best for each individual depends on many factors that the doctor will consider.

There are many success stories with Telaprevir/Incivek and many success stories with Boceprevir/Victrelis.

You may find interesting the 5-page table frijole posted as photos on her page (http://www.medhelp.org/personal_pages/user/223152). It contains a list of our User IDs, the treatment we are undergoing (or have undergone), how well our treatment is working, and some of the more serious side effects we have experienced.
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Avatar universal
Hi Jules, viral load of > 200k.
Helpful - 0
Avatar universal
I tried to find the publication I had found with a 1b reference before I treated but could not.  I did find this instead, published after I started tx.  It says odds for 1b are better in Vic,  thought I should share.  http://viralmatters.blogspot.com/2011/07/genotype-1b-hcv-patients-fare-better-on.html

Sorry Missy, more thread stealing.  See you are 1a.
Helpful - 0
Avatar universal
This was posted yesterday re. Bocevir being used in the NHS UK:

http://hepatitiscnewdrugs.blogspot.com/2012/03/victrelis-mercks-hepatitis-c-drug-wins.html
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1148619 tn?1332010984
I chose Vic because, 1, I did not want to try and eat all the fat with Inc.   2. I have very sensitive skin and get rashes.   She made me very aware of the possiblity of Anemia. I was undetectable before I added the Victrelis at four weeks, then 8 and 12. Now waiting for 24 VL test.

I became Anemic early in tx, I think week 6, 9.2 and have stayed there all of treatment without helper drugs.

Good luck with your decision, its not an easy one to make. I asked for a few weeks to weight out the pros and cons. And, I also tried eating fat meals 3x a day. That did not work so there was my answer.

mo
Helpful - 0
Avatar universal
Prior to discussing treatment with my doctor, all the press info suggested to me he would put me on Incivick.  He recommended Vic for me for the following reasons:
1.  "Fire in the hole" (anal pain) was common and did stop treatment for some.  With either, once you stop they currently do not think you can redo like prior Pega/Riba treatment alone.
2.  Severe and serious rash for some.  A few on here actually ended up in the hospital as a result and stopped treatment.
3.  Vic is cheaper but if you have insurance it is a small consideration.
4.  Merck has a support system called Be In Charge with nurses available 24-7 for questions and concerns.  I have used them and they have been helpful.
5.  I am Geno type 1, first treatment, white (blacks are less responsive to treatment in general) and modest liver damage.  The success rate is about 90% for my conditions.

He felt though it might be longer, I had the best change of success without some of the side effects.  I am in week 25 of 28 and the anemia which got quite bad at week 18 resulting in the addition of Procrit.  I have been undetectable since week 8 (4 weeks of Vic).  

Best of luck.
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1747881 tn?1546175878
855-546-2483 Vertex (incivek) nurse 24/7 hotline
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Avatar universal
In July when I reviewed options with my doctor, Vertex did not have a helpline set up.  At least the rep could not provide one when asked.
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1747881 tn?1546175878
The success rate is about 90% for my conditions.

That success rate is based on the fact that you were UND at wk 8 not your conditions.
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1747881 tn?1546175878
Patients Who Have Never Received Therapy
(Treatment-Naı¨ve Patients) Boceprevir. The SPRINT-2 trial

The SVR rates among Caucasian patients were 67% in the RGT, 69% in the fixed duration, and 41% in the SOC arms, respectively.12 In black
patients, the SVR rates were 42% in the RGT, 53% in the fixed duration, and 23% in the SOC arms, respectively (Fig. 1).12 A total of 54% of Caucasian recipients of BOC experienced a rapid virological response
(RVR; HCV RNA undetectable, <10-15 IU/mL at week 8, this interval selected because of the 4 week lead-in). By contrast, only 20% of black recipients of BOC experienced an RVR. Regardless of race, among
those patients who became HCV RNA negative at week 8 (57% in both BOC arms and 17% in SOC arm), the SVR rates were 88% in the RGT arm, 90% in the fixed duration arm and 85% in the arm treated
by SOC, compared to SVR rates of 36%, 40%, and 30%, respectively, if HCV RNA remained detectable at week 8

http://www.aasld.org/practiceguidelines/Documents/2011UpdateGenotype1HCVbyAASLD24641.pdf
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Avatar universal
Don't take telepravil. Its too expensive and from experience the insurance companies won't send it to you in time. Iy cost my husband his life. Go with the other. Also your body can build immunity so you want to do it hard and quick!
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Avatar universal
He recommended Vic for me for the following reasons:

1)with either, once you stop they currently do not think you can redo like prior Pega/Riba treatment alone.
-------------------------
Why would your doctor recommend Vic for this reason when both protease's resistance issues are still unknown???


2)A few on here actually ended up in the hospital as a result and stopped treatment.
----------------
Your doctor recommended Vic because some MH members ended up in the hospital??


3) Merck has a support system called Be In Charge with nurses available 24-7 for questions and concerns.  I have used them and they have been helpful.
------------------------------

Why would your doctor be concerned with a drug companies support line..they all have 24 hr lines???


4)I am Geno type 1, first treatment, white (blacks are less responsive to treatment in general) and modest liver damage.  The success rate is about 90% for my conditions.
--------------------------------------------------------
Your doctor knew you would RVR before you started??---

I don't see how any knowledgeable doctor experienced in the treatment of HCV could make any recommendations  based on what you have told us..

Missy114:

Both of these drugs are excellent ..and this link gives DR.Shiffman's(noted Hepatologist) take on both  as an adjunct to what hrsepwrguy has copied above.

http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02718.x/full


Good luck with your decision..
Will






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1747881 tn?1546175878
Thanks for the advice but I have already finished with telaprevir and am in wk 29 of treatment and undetectable.

I am very sorry to hear about your husbands situation though and wish you all the best moving foward
Helpful - 0
1815939 tn?1377991799
I took Incivek and I would do it again (but only if I had to, lol).

Incivek does have more rashes and it also has some anal problems in some people. Both Incivek and Victrellis can cause anemia but Victrelis seems to cause anemia in a higher percentage of people than does Incivek. They both have a lot of side effects so neither is a picnic, but generally, unless one gets life threatening side effects, both are doable (is that a word, lol).

One really good thing is Incivek is done in 12 weeks time (and I found that a big plus). A person takes Victrellis for 24 weeks or longer.

Incivek is expensive for 12 weeks of treatment. Victrelis costs less if one does the 28 weeks of treatment but the costs are similar if one has to treat longer on Victrellis.

Some insurance companies are not as good as others. Having a good doctor who has a good team and who fills out the proper insurance approval paperwork on time is imperative. Having a specialty pharmacy that takes care of the medication approvals and arrangements helps immensely.

I have actually not had top do a thing about insurance other than to give the insurance information to the doctor and clinic. The doctor and his team did the rest by filling out the paperwork and contacting the specialty pharmacy. The specialty pharmacy  contacts the ins. co. and gets all of the approvals a couple of weeks in advance and they stay on top of it. I receive my box of meds via United Parcel a week before I need them so I never run out.

In the end, since the SVR rates seem to generally be similar, the decision concerning which to use is a personal decision that a person makes based on his/her own situation and circumstances. I know you are picking our brains for experience and information and I think it is helpful for people to offer their knowledge and experience.  

I wish you the best whichever med you decide to use.
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1815939 tn?1377991799
My comment, " I took Incivek and I would do it again (but only if I had to, lol). " is not very clear. What I mean is, if I had it alll to do over again I would still choose Incivek. Tthe "but only if I had to" part was sort of a joke because obviously I would not take it if I did not have to. No one would.
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1747881 tn?1546175878
doable adjective
Definition of DOABLE
capable of being done or carried out <the assignment will be just barely doable in the time allowed

http://www.merriam-webster.com/thesaurus/doable
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1815939 tn?1377991799
Thanks, lol.

I saw people using it so I started using it because it fits well with what we are talking about, but it sounds odd to me.
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