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Avatar universal

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
"If you are at 1,000.000 treatment will be 28 weeks viral load of 2,000.000 will be the 48 week treatment, anything in-between is the Doctors call. Any feed back on that"

Starting viral load has nothing to do with response guided therapy

.5.5 Laboratory Tests
HCV-RNA levels should be monitored at Treatment Weeks 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and for other time points as clinically indicated. Use of a sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification of equal to or less than 25 IU per mL, and a limit of HCV-RNA detection of approximately 10 to 15 IU per mL. For the purposes of assessing Response-Guided Therapy milestones, a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result.

Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating VICTRELIS combination therapy. Complete blood counts should be obtained at Treatment Weeks 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.
Refer to the Package Inserts for peginterferon alfa and ribavirin, including pregnancy testing requirements.

Add VICTRELIS 800 mg (four 200-mg capsules) orally three times daily (every 7-9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following Response-Guided Therapy (RGT) guidelines to determine duration of treatment (see Table 1).

Table 1
Duration of Therapy Using Response-Guided Therapy (RGT)

Previously Untreated Patients (HCV-RNA Results) At Treatment Week 8 Undetectable At Treatment Week 24 Undetectable RECOMMENDATION
Complete three-medicine regimen at TW28.

(HCV-RNA Results) At Treatment Week 8 Detectable At Treatment Week 24 Undetectable RECOMMENDATION
1. Continue all three medicines and finish through TW36; and then
2. Administer peginterferon alfa and ribavirin and finish through
TW48.

Previous Partial Responders or Relapsers
(HCV-RNA Results) At Treatment Week 8 Undetectable At Treatment Week 24 Undetectable RECOMMENDATION
Complete three-medicine regimen at TW36.

(HCV-RNA Results) At Treatment Week 8 Detectable At Treatment Week 24 Undetectable RECOMMENDATION
1. Continue all three medicines and finish through TW36; and then
2. Administer peginterferon alfa and ribavirin and finish through
TW48.

TREATMENT FUTILITY
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen.
If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen.

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
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Avatar universal
Everything I’ve read indicates that if you are undetectable after 4 weeks of lead in time with   peginterferon, and ribavirin that your treatment with boceprevir, would be a 28 week treatment.
This is not true, the truth is that with ether drug the duration of treatment depends on your viral load before even starting any drugs. If you are at 1,000.000 treatment will be 28 weeks viral load of 2,000.000 will be the 48 week treatment, anything in-between is the Doctors call. Any feed back on that
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Avatar universal
Thanks guys!  Saw the doc today!  Seems competent lol.  Until I read this just now I did question him on the biopsy.  I asked if I should have one and he said not necessarily need since I want to do the tx rather than a question of if!  I told him I wanted one because my last one was in 2006 and it showed stage 1. I was dx in 2005 when I was 24 (prime partying age) so once tx failed I was pretty upset and just went about my ways and drank on and off (with the exception of my pregnancy) up until earlier this year!  I think I had an epiphany (or just grew up ) and decided I need to take better care of myself and that's when I quit drinking all together and decided to attempt tx.  

I did think about it on my drive home and thought maybe depending on my biopsy results, I may put off tx another yr or two and have another kid.  I will be 31 Friday and my hubby will be 35 in December. But I am pretty sure I am at a point in my life where I am ready to beat this thing and plus, my hubby only have 4 yrs left in the Army and our benefits are great so I may as well take advantage!

Thanks so much you guys!  Today was a crappy long day.  Root canal @ 7:30, female appt @ 1:30 and G.I. @ 3:00.  So the remainder of the evening I am just going to take it easy and surf the net!
Helpful - 0
1815939 tn?1377991799
I don't think my last post was very clear. This part needs further clarification:

"The degree of fibrosis will be one factor in determining length of treatment. It is recommended that anyone with cirrhosis treat for 48 weeks. I don't know if you have treated before or if this is the firt time. If you have never treated before and you attain an early virological response (Undetected at 4 weeks of Inc. or 8 weeks Vic.) you treat for 24 weeks if on Inc., 28 weeks if on Vic."

Okay, the last sentencce is only for people without cirrhosis. If one has cirrhosis, treatment is 48 weeks.


Treatment Naive Patients:

"Patients without cirrhosis treated with boceprevir, peginterferon, and ribavirin, preceded by 4 weeks of lead-in peginterferon and ribavirin, whose HCV RNA level at weeks 8 and 24 is undetectable, may be considered for a shortened duration of treatment of 28 weeks in total (4 weeks lead-in with peginterferon and ribavirin followed by 24 weeks of triple therapy)"

"Patients with cirrhosis treated with either boceprevir or telaprevir in combination with peginterferon and ribavirin should receive therapy for a duration of 48 weeks "

Hope that clarifies the unclear statemnt in the first post.
Helpful - 0
163305 tn?1333668571
I haven't read through all these replies.

What I'm going to do is tell you if it were me, and I had 0 fibrosis, I'd wait for the new non-interferon oral meds which are currently showing great promise in trials.

Helpful - 0
1815939 tn?1377991799
I can see Sentinel's point about a possible long wait for a biopsy.

However, I would still want to know what stage I was in. The degree of fibrosis will be one factor in determining length of treatment. It is recommended that anyone with cirrhosis treat for 48 weeks. I don't know if you have treated before or if this is the firt time. If you have never treated before and you attain an early virological response (Undetected at 4 weeks of Inc. or 8 weeks Vic.) you treat for 24 weeks if on Inc., 28 weeks if on Vic.

Treatment Naive Patients:
"Patients with cirrhosis treated with either boceprevir or telaprevir in combination with peginterferon and ribavirin should receive therapy for a duration of 48 weeks "

http://hepatitiscnewdrugs.blogspot.com/2011/09/2011-updated-hepatitis-c-practice.html


People with prior treatment:
Looks like they all do 48 weeks


Another article:

http://www.hepmag.com/articles/boceprevir_cirrhosis_fibrosis_2501_20205.shtml
Helpful - 0
2062453 tn?1350332942
RR: Having biopsy's before treatment are not as important as they used to be. Years ago, initiating treatment often used to (at least partly) be based on a biopsy result. Now-a-days, if treatment is going to be initiated regardless of the biopsy result then a biopsy is probably unnecessary.

I'm a data driven person and I personally like biopsy data. However, I would not want to delay treatment waiting for the VA to do a biopsy. I'm more interested in a biopsy after treatment so I know the condition of my liver for the future.

Regarding fatty foods, Pooh covered it thoroughly (as she does everything). I would like to emphasize her comment that you need some bulk in your stomach (at least with Incivek). One time I only ate 20 grams of peanut butter before taking my Incivek (I was a passenger in a car and that is all I had with me). I think the peanut butter landed on one side of my stomach and the Incivek landed on the other side -- so the Incivek passed through my system without being enveloped in the fatty food -- FIRE IN THE HOLE -- I really had pooper issues the next day. Cheers, GB
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Avatar universal
Thanks so much, Pooh!
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1815939 tn?1377991799
Personally, I would want another biopsy if I had not had one in 6 years.

Liver damage progresses at different rates in different people. Some people have gone from Stage 2 to Stage 3 or 4 in only 3 years or so. So I would definitely want to know what stage I was at now before starting treatment.

If you don't think the GI is qualified, can you ask for a Hepatologist?


Fatty foods:

I ate a lot of regular Greek yogurt, eggnog, cheese (2 ounces of Cheddar or Havarti is 20 grams), avacado (1 medium has at least 20 grams), bratwurst (cannot remember how many, read the label), cream cheese, ice cream, peanut butter (read label), nuts. If I thought I was eating something without enough fat or was not sure, I added 20 grams of fat with butter, mayo, heavy whipping cream so I was sure to get 20 grams. I always ate some solid food. Toast and the Greek yogurt, egg and toast and the eggnog, toast or bread with the ice creame if I had ice cream at 10 pm. You need some bulk in the stomach as well as the fat so drinking 20 grams of fat via olive by itself won't do the trick.  If you eat nuts eat something else too, for bulk. I used to eat chicken soup and saltimes and then add something with 20 grams of fat like berries with a lot of heavy whipping cream on them. You have to get a little creative because food is not going to taste the same as it does not. Sometimes nothing was appealing. I also found myself stocking up on cheese and avacados, only to find that I could not stand eating them the following week. Another thing I did was add some condiments to the plate to make food taste like something besides cardboard. I would have meat and add a bunch of greek olives or herbed olives or pickled beets or plain pickles as a side to help get the meat down. It worked.  

I am going to try to find a link to another thread. I should have bookmarked it, lol: This link has some good ideas in it for fatty foods. Scroll down to 80mecheng's very long post with many, many foods to choose from.

http://www.medhelp.org/posts/Hepatitis-C/Are-these-fats-okay/show/1694773
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Avatar universal
Thanks so much, Pooh!  That makes sense.  What type of "fatty" food should the PI be taken with?  A burger and fries or something as simple as nuts with a high fat content?  

I am going to my Dr. tomorrow.  Unfortunately but fortunately, we are Army and on a base so I don't get to pick my Dr.  I have to see a G.I. from the VA hospital and I hope is knowledgeable of the new HCV tx.  I haven't had a biopsy since Jan 06.  Do you think I should get one before tx?  I do, just from all I've heard and all I've read!  I am so scared this Dr. will be a quack.  When I was first dx in 2005 the first Dr. I was referred to was a total quack and the only reason I knew that was because I had done so much research.  I went to his office.  He said I should probably get an ultrasound and I said, "shouldn't I have a biopsy?"  He said, "No."  He proceeded to write me a script for Interferon and Riba and sent me on my way.  That really put up some flags since I read how bad tx can be.  So I told my PCM to get me another Dr. and they sent me to The Liver Associates of Texas and my Dr. was THEE best!  I always felt comfortable and all of the staff could answer questions and if not get me an answer in a timely fashion.

I just hope the new Dr. is near that good.  I have a feeling I will be coming to this forum for help a lot!

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1815939 tn?1377991799
The literature says 7-9 hours, but personally, I always aimed for 8 hours on the dot.

I set my alarms for every 8 hours and my timers for every 8 hours.I carried the timer everywhere I went even at home (room to room).

This was my schedule:
5:30 am get up, fix fatty food, eat fatty food
6 am take Incivek and Riba
go back to bed for awhile
1:30 pm fix fatty food, eat fatty food
2 pm take Incivek
6 pm eat again and take Riba
9:30 pm fix fatty food, eat fatty food
10 pm take Incivek

If you aim for every 8 hours you are more likely not to screw up your Incivek dosing. It takes time to fix the food and then to eat it and then to take the Incivek. No, I was not always right on the dot with the Incivek because some foods took longer to cook or fix, but I was never more than 15-20 min. longer than 8 hours (so I was still well within the 7-9 hour time frame).  

This is from the Vertex site:

"The recommended dose is 750 mg (two 375-mg tablets) taken 3 times a day (7–9 hours apart) with food (not low-fat)"

http://www.incivek.com/hcp/patient-counseling
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Avatar universal
So it would be OK if you are a few minutes late of taking the dose?  I was just concerned it had to be 8 hours ON THE DOT... that's what she made it seem like!
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1815939 tn?1377991799
They both have to be taken every 8 hours (leeway 7-9 hours).

http://www.drugs.com/mtm/boceprevir.html

http://www.drugs.com/incivek.html

So either way, you will be taking the PI every 8 hours regardless of which one it is. This is a must. They have very short half lives so the blood level drops and is not as effective if too much time passes between doses. If you do not take it properly and too much time passes between doses, you can get resistant strains of the virus and place your entire treatment in jeopardy.
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Avatar universal
I have heard that one of the inhibitors HAS to be taken EVERY 8 hours on the dot or the patient may develop resistant strains to any tx... is that true?  I am also on Webmd and one of the doctors that responses to the page has a youtube video about tx and she mentioned that.  Any thoughts?
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Avatar universal
Thank you everyone for all the info. It has really helped. I might try it without the PI and just do the victrelis if needed. Still thinking about if I even want to treat now. I am pretty busy, but then again, I'll probably always be pretty busy, so I don't know if there will ever be a "good" time to go on tx. Anyways, thanks again. Still have a lot to think about, but you have all helped.
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1835200 tn?1427460238
A lot of good information has been provided. The studies lumped all geno 1's without consideration of 1a or 1b. 1b's are responding much better than 1'a to protease inhibitors. Also nothing is mentioned of INF response with regard to IL28B markers- CC, CT, or TT. I would agree with desrt, "no brainer", a 4 week lead in with INF/Riba to determine your initial response. If RVR add Vic.- if you decide to treat now.

Also agree with willbb, that finally mentioned the option of waiting, since you are young and have little liver damage. The INF/Riba tx is harsh for many. I'm sure you know, there are many, many, trials currently ongoing without INF. In addition, if you have a poor response in the lead in phase of INF/Riba it makes little since to add the protease, particuIarly if you are a 1a. Another thing to conisider-many of the new DAA combo trials are using protease and you may not be able to re-treat with a protease, for some period of time still unknown, as resistant mutations are present.  It appears you have the option of waiting. The 3x tx will still be available if the new DAA combos prove to be a failure. Best of luck, God bless.
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Avatar universal
http://www.ncbi.nlm.nih.gov/pubmed/18508296

CONCLUSION:  Both 24 and 48 weeks of therapy can achieve high SVR rates (>96%) in HCV-1 patients with low viral loads and an RVR.




http://www.medscape.com/viewarticle/708930_4

The majority of studies that have measured RVR have done so using the lower limit of quantification of 50 IU/ml. To use a more stringent cutoff would likely change the predictive values. This needs to be borne in mind when trying to compare across studies. Table 1 summarizes several genotype 1 studies where RVR was assessed in Peg IFN alfa 2a and alfa 2b. The overall predictability of SVR when RVR is achieved ranges from 72.5% to 100%.  When shortening therapy to 24 weeks in RVR patients, the PPV ranges from 74.2% to 88.9%, whereas PPV with 48 weeks ranges from 72.5% to 100%.




http://www.intmedpress.com/serveFile.cfm?sUID=246a4a78-2a19-4926-a77e-3011cf5e450c

In this study ...it basically says in table 1 about 3/4 of the way down the page that if there is low vral load and an RVR there is basically no difference in success rates 24 weeks vs. 48.  

Best..
Will
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Avatar universal
Hi missy...As desrt and I have said and cando has copied  the" Predict" study..

You are in an excellent position to  start therapy using just PEG/RIBA and if at 4 weeks you are UND.(RVR) then if in fact you have low VL (less than 400K) with no liver damage ..your chances of success are approx.  90% doing jut 24 weeks  by the data from studies(I will post them when I have more time)

At worst ..if you don't RVR you can then add Vic at that time(in line with what your doctor has suggested) to the mix(which is prescribed after 4 weeks anyway) and if UND at week 8(considered an RVR) then you still have about the same chance of success ..and the total time  treating would be 28 weeks.

As desrt ..so succinctly put it above...just about a no brainer.

There is anemia effects with approx.45 - 50 % of patients on both Inci. and Vic  and studies showed somewhat more severe for those on Vic(also what we see on the forum) in.(likely due to the longer time taking it),however this may be alleviated in most by slight Riba reduction and /or introduction of the growth factor "procrit..

Good luck..
Will
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148588 tn?1465778809
" Wouldn't I still have to go through the 48 weeks without it?"
No. As willbb posted, there's no significant difference between 24 and 48  -  provided you're UND at week 4  -  given a low viral load and little to no damage. The Europeans have been using this protocol for geno 1s for years. But there is no gaurantee you'll be UND at week 4, in which case you go ahead with the PI. But given the fact that the PIs have caused the % of people who have to discontinue tx entirely to roughly double (from 4% to 6-8%) it's an approach I'd give some serious thought to.
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Avatar universal
Genotype 1 Chronic Hepatitis C Patients with Low Viral Load Can Achieve Sustained Response with 24 Weeks of Pegylated Interferon plus Ribavirin
      
  SUMMARY: Final results from the PREDICT study showed that genotype 1 chronic hepatitis C patients with low baseline viral load and rapid virological response at week 4 can achieve good outcomes with just 24 weeks of pegylated interferon plus ribavirin, researchers reported at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009) this month in Boston.  
    
    

By Liz Highleyman

Standard therapy for chronic hepatitis C virus (HCV) infection consists of pegylated interferon plus ribavirin for 24 weeks in patients with HCV genotypes 2 or 3, and for 48 weeks in patients with hard-to-treat genotype 1. But the shorter treatment duration may be adequate for certain genotype 1 patients with favorable characteristics.
PREDICT was a Phase 4 open-label post-marketing study conducted in Europe to evaluate shortened therapy for treatment-naive genotype 1 patients with low baseline viral load (< 600,000 IU/mL) and rapid virological response (RVR), or undetectable HCV RNA at week 4 of therapy. A majority of participants (62%) were men, most (97%) were white, the mean age was about 38 years, and the mean estimated duration of HCV infection was 13 years.
A total of 187 enrolled participants were treated with 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 800-1200 mg/day weight-based ribavirin. Patients who had undetectable HCV RNA at week 24 were given the option to stop therapy at that point, and were followed for 24 weeks post-treatment.

Results
93% of participant completed the study.  
3% were lost to follow-up, 2% discontinued due to adverse events, 2% elected not to continue, and 1% did not meet eligibility requirements.  
In an efficacy analysis of 170 patients, the sustained virological response (SVR) rate was 87.6% and the relapse rate was 9.7%.
In a per-protocol analysis of 156 patients, the SVR rate was 90.4% and the relapse rate was 9.6%.
Looking at 153 patients who were deemed adherent to therapy, the corresponding rates were 90.8% and 9.2%, respectively.
14% of participants reported adverse events.
The most common side effect was flu-like symptoms, reported by 3%.

Based on these findings, the PREDICT investigators concluded, "In HCV genotype 1 low viral load treatment-naive subjects who attain RVR, pegylated interferon alfa-2b and weight-based ribavirin for 24 weeks is well-tolerated and results in a high rate of SVR with a low likelihood of relapse."

http://www.hivandhepatitis.com/2009icr/aasld/docs/111709_a.html
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Avatar universal
*nausea is the scariest side effect after anemia I should say.
Also my anemia isn't usually too serious. Doesn't it also effect WBCs and platelets? If so those are usually low for me too.
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Avatar universal
Lots to think about! Thank you everyone. I should add here that I am usually anemic as it is, so that side effect is a big concern. However, it seems as though more people experience nausea with Incivek. That for me is probably the scariest symptom. Plus the rash and anal pain don't sound too pleasant either.

dsrt and willbb:  Not using a PI at all is a thought. I think there is a very good chance that the virus would be undetectable after 4 weeks of peg/riba. I thought that adding inc or vic would make the treatment time shorter though? Wouldn't I still have to go through the 48 weeks without it?

I don't know if I would want to wait for newer treatment options. I was thinking I might try to have another baby if possible in the next few years and if I don't get rid of this virus now then that's not an option. I know the chances of giving this to the baby are small (both children I had before I knew I had Hep C do not have it), but I still don't want to take that chance.
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Avatar universal

desrt ..brings up a good point . Having a low VL(especially if it is <200,000 ) being of younger age,low body weight and no fibrosis are all predictors of attaining an RVR( no virus at week4)   doing just Peg/Riba.

With an RVR data shows the chances of success are approx. 85  -90% without adding the third drug (and studies show that no significant difference in those circumstances doing 24 or 48 weeks)

Also ...have you and your doctor discussed  waiting to treat until possibly even better modalities are available(there are many drug companies experimenting currently with" Inteferon free" treatments),that may be on the market in the next few years?
Being you are young and and have possibly only been infected for 7 years or so and have no liver damage ..this certainly might be something to consider...

Best to you on any decison you make.......
Will


80mecheng:

There is significant data given the thousands that participated in many trials over a span of approx. 8 years. There was "no " difference in "drop out" rates " due to "adverse events" of either drug ..... 13 vs. 14 %

Fourteen percent of subjects discontinued INCIVEK due to adverse drug reactions. Rash, anemia, fatigue, pruritus, nausea, and vomiting were the most frequent adverse drug reactions leading to discontinuation of INCIVEK

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm


During the entire course of treatment, the proportion of subjects who discontinued treatment due to adverse reactions was 13% for subjects receiving the combination of VICTRELIS with PegIntron/REBETOL
. Events resulting in discontinuation were similar to those seen in previous studies with PegIntron/REBETOL.

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm255413.htm



80meching:
It should be noted that we are basically less than a year into the usage of either drug so our understanding is incomplete IMO.
-----------------------------------------------------------------------

The data is very complete from the thousands of patients that took part in carefully analyzed trials over approx. 8 years

And the fact is that there was" no "difference between either drug for their "drop out "rate .



Helpful - 0
148588 tn?1465778809
Low viral load and no fibrosis? That's a no brainer. Do the course of tx with a 4 week lead in of Peg/riba and if UND at 4 weeks don't bother with a PI.
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