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Post Info TOPIC: Abbvie Malachite clinical trial


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Abbvie Malachite clinical trial
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@robdbird Your story sounds so much like mine I had to reply. I am also on thyroid treatment, had 2 pregnancies, blood work every year, etc. and nothing out of the ordinary until 2 years ago. The Dr. said my liver numbers were high. I do enjoy my alcohol so I didn't panic, just cut back and started taking milk thistle. When the numbers were higher in 2013 she insisted on more tests and found the Hep C. I probably got it from an impulsive tattoo in 1978 or a blood transfusion in 1980. What a bizarre disease and I am so looking forward to it being out of my body so I can have beer again

á



-- Edited by hippiechick on Monday 21st of July 2014 11:56:34 PM

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Hey Bina

Congrats on your SVR, sounds like your clear of the virus. It may take a little longer to get back your full vigor but feel good about the being clear you can move on without all the worries that burden some of us relapsers...

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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well its been a little over 8 months since my last dose of meds so why am i still tired all the time? joint aches gone but still napping min once daily if not twice

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We go from 12 weeks post treatment to a 24 week blood draw no more weekly or bi weekly no more monthly still clear and next draw will be 24 weeks svr a cure to be sure, i am so blessed and bfor all those with muscle cramps in legs, fatigue and brain fog its part of this disease get on trials with these new meds i advocate abbvie i applaud their protocol, their clinical technicians and if i had cash would invest heavily in their stock, they are noe doing trials with cirosis patients and i pray the results are as positive. I feel like a weight has been lifted to have finally been diagnosed acurately and cured, what mystifies me with all the blood work i have had through two pregnancies, thyroid testing and hormone replcement therapy this was never picked up


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Hi Robin, that all sounds very promising.á So when do you have your next blood draw?á You were UND at 4 weeks so you responded very quickly to this Abbvie drug combo, and yes, let`s hope a lot more people will be able to have the opportunity to treat with such an amazing interferon free treatment in the future.

Good to hear how well you`re getting on now since you completed your 12 weeks, and getting away on a holiday must have given you a real boost, especially as you were able to enjoy being out in the sun without any skin sensitivity.á

Keep in touch, and thanks for the update.á Best of luck!



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Jillá

(70 yo, lives in UK)

Was Gen 3a,á

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT,á

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

á

á



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Just dropped in to stay in touch did 12 weeks and presume still svr as i havent heard otherwise. Apparently everyone in trial cured only one relapser and that was due to noncompliance with protocol. Feel stronger by the day riba definetly leaving system went away on a sun vacay and was not sun sensitive. No more daytime naps or muscle cramping lots more energy but getting in the groove gradually. Abbvie is now recruitting and doing trial with cirrosis patients. Good luck to all and gd bless for your positive support. The cure now exists without riba, lets hope it will be cost friendly

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Hello Robin

Congrats on making it to completion, it a wonderful feeling and well deserved.

You may experience a little tiredness the first week or so after being off the Meds but after that you will be floating with a weightless feeling full of joy, so indeed enjoy.

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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End of treatment Mon took last round of meds calculate I swallowed 840 pills in 12 weeks. I couldn't get out of bed 12 weeks ago and yesterday and today painted my entire apt. Sx very minor and six mos blood work follow up begins. Pray pray the dragon stays away and that dragon abbvie did slay. I hear a new trial coming up in Nov for cirosis patients in t.o msg me for info

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Hi Robin, good to hear things are going so well for you, it sounds like you`ve noticed a big improvement in your general health over the last few weeks!áá It can take up to 6 months for the ribavirin to completely clear from your system post tx, but by the sounds of it you`re already on the up, and hopefully will feel even better within a fairly short time after your tx is finished.á

Thanks for the update, keep us posted.á Best of luck with your last 3 weeks!



__________________

Jillá

(70 yo, lives in UK)

Was Gen 3a,á

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT,á

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

á

á



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Haven't posted in a while so here's the update finished week nine today heading down the homestretch with three weeks to go... undetected at week four side FAX minor sun sensitivity but no reactions however I avoided sun this summer pro actively when put on treatment ... minor hemroids and occasional funny mouth taste. Energy level remarkable increase can't wait to see difference post treatment when meds clear...anyone that knows how long this might take? Arthritis and joint pain improved. Brain fog and memory slowly but surely improving. Hang in there everyone I am convinced we have slayed the dragon and if will soon be a thing of the past. This treatment is gentle and effective. I am greatful to God and greatful to abbvie ,greatful to my Dr and my clinical trial nurse, and very greatful to all of you for posting your experiences and support. May you all be cured asap and may this disease be eradicated

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Robin

Its not quite that cut and dry, I just re-read my Abbvie information and consent form and on a similar Abbvie trial that I was on and that scenario is not outlined.

In most treatments whether your in a trial or not if you reach UND and then you have a substantial increase in viral load/count it would likely mean that you would have had a viral breakthrough and you would be pulled off treatment.

If you to get a small change like <25 it's likely that you would not be stopped but given another period 2 or 4 weeks to see what direct you are heading. I remember reading of one participant in a Abbvie study that exact scenario took place and she went on to complete the 12 weeks and achieved UND at EOT.á

So don't worry it will not likely happen.

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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so what your telling me is that even though im UND at week four if i show any virus in the next blood draw i will be removed from treatmentno

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Hi Robbin,

I would be interested to know what the addedá37 pagesá(!!) say ? One of my friend on Gilead was asked to signe few more pages, on which it was written that patients must not do the Trialáfor the purposeáto be cured (!!!) she refused to signe (she had nearly finish the trial), and is UND EOT 12.

For what purpose patients would do a Trial if it's not for the possibility to be cured ?

Any way, the fact is that she is cured, and so you will be by looking to your good results :)

á



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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Hey Robdbird
á
Sounds like your cruising along with the Meds just fine and your attitude is excellent .
á
Keep up the good reportsá
á
Matt


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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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week four blood draw today wont have results, had to sign another consent form 37 pages long all forms must be dated and initialed????? They told me I should have skipped my next dose when I accidentally did the dbl dose and sealed all my pills and gave me new ones to keep the count accurate. No change from week one to week two blood work but vrl 609000 to less than 25 is fine by me, apparently like a diet you can expect to plateau for a few weeks. The days I am exhausted are usually ones where its raining heavily and that zonks me out so it isn't the meds. I really don't feel im on any meds other than an occasional funny taste in my mouth but very minor. My nurse keeps reminding me how I told her that I wouldn't go on the trial if I was on the interferon arm b for 48 weeks and I tell her its my body and that I feel the side effects of interferon would be worse than the hepc. I don't think she gets it. Oh well otherwise she is great and very good at her job, my love and support come from all of you. Slaying dragons hope to be und by my birthday 1/3 of the way through now.

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Tuesday marks week four blood draw and results of week 2, as you all know viral load results from week one dropped significantly so is it possible I could be und at week 2? Will let you all know on tues. Thank you for your responses to my od. I made it through the night a bit dry mouthed, Still lots of energy during the day but wiped out over the weekend from running around all week. Slow and steady wins the race I suppose. It will be amazing when this drug gets to the market next year and our fellow dragon slayers wont have to suffer with interferon shots. I truly believe that this is the new generation one size fits all cure.

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posts under my user name of robdbird which I use on email addresses and other internet sites


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Hi Robin,

You'll be fine. In 1998, I was part of the first Riba trial in Australia. 3x injections of Interferon/ week and 2000 mgm Riba/day. At our centre (Royal Brisbane Hospital) there were about 20 on the trial, and the trial was supposed to go for 24 weeks.á Only one person finished the trial, as we all dropped out from anaemia- I lasted 14 weeks.á Back then, they had no idea what the Riba dose was meant to be ( and maybe they still don't). So, a double dose of Riba won't hurt! Cheers.



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Geno 1b, IL28B CT,á x3 prior relapser,á ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.á VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30á and 48 weeks.á EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!á Still Undet. at EOT +5 years

Malcolm



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Hi Robin,

á á á á á á don't worry.

I know somebody, who was taking 2000mg during the whole time of his triple, because he! believed that more is better.

It gave studies with Ribavarin high-dose, but stopped concerning failure.



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Hi Robin,

AbbVie gives us a card to always keep with us, with two phone numbers : one is your personnal Trial doc, from 9 am to 6 pm, the second one is for the other periods of the day, night and w.e. You will always have someoneáwho willáansweráyou directly by phone.

Have a look at the AbbVie card, you will find those phone numbers.

á

Do

á



-- Edited by ios9 on Saturday 24th of August 2013 09:18:51 AM

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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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Hello Robin

Sorry about your double dose issue. You should contact your study doctor or study sponsor nurse first, even if you have to leave a message. You should be able to handle the short term effect as the extra dose will peak out in a few hours. But monitor yourself for several hours and be aware of any abnormal functions, just take a deep breath drink some good water and relax. You should be ok.

Mattá



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á

Tig


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Your last name isn't listed on your profile here, so there isn't any way a search engine would find you here. What posts are showing up? Do you have an Abbvie forum that you're part of?



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

Hep C FAQá áLab Ref. Rangesá HCV Resistance

Signature Line Set Up/Abbreviationsá áPayment Assistance

á

Tig


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I'm not familiar with all of the Abbvie meds but I seriously doubt you have anything to worry about. I've been taking Ribavirin for months now and have doubled before on one occasion and noticed nothing different. I would explain it to your study office so they have record of it. If you have had any nausea or side effects in the past from any of them, you may notice they are a little bit more pronounced. But you're not at risk for failing the study or a serious reaction. We all have made a mistake and may do it again. Just do your best to be on time every time, but trust me its not easy. Have you set any alarms to remind yourself of medication and times? I've got two alarms set for each of the 5 times daily I have to take mine! They have saved me several times! It's called "BRAIN FOG"áconfuse



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

Hep C FAQá áLab Ref. Rangesá HCV Resistance

Signature Line Set Up/Abbreviationsá áPayment Assistance

á



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I took my evening trial meds three ribva and the trial med and had a short nap about two hrs ago when I woke up I forgot I took the meds and took them again, should I be freaking out, will I be ok or should I go to hospital? I am also very upset when I searched abbvie clinical trial on yahoo my user name came up and my posts were shown on the search engine, I wonder is there a way to avoid this as I don't want my posts showing up outside of this forum or any link to them

-- Edited by robdbird on Saturday 24th of August 2013 02:00:58 AMconfuse

-- Edited by robdbird on Saturday 24th of August 2013 02:01:37 AM

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Congrats Robin

You are responding quite well to the Meds, it's likely that your week one value is actually 25.

It's very common with the Abbvie Meds to drop the viral load very quickly.á

You have a great attitude for the trial keep it up as it's likely the Ribavirin might cause you to slow down your pace, but you will learn to rest when your body requires it.

Hoping the best for you

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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Started week 3, from someone that couldn't get out of bed I now have energy to burn. I got very good news at my appointment this week and that is that my blood draw from week one showed a decrease in viral load from in the millions to she said 25 I don't know if that means 25,000 or what. One week folks and I feel great. I wonder what this weeks draw results will be. The only side effect is after a very busy day I fall asleep at about 11 and wake up at 4 am and where I used to be able to go back to bed I am wide awake. Small price to pay. I have had no fatigue, naseau or any of the other effects and this abbvie ****tail seems to be the miracle drug. I have had this dragon they say for thirty years at least and shocked that they only discovered it three years ago at age 54. Two pregnancies, and lots of bloodwork later however that being said timing is everything and I suppose it was meant to be that I was diagnosed shortly before this new non interferon treatment arrived. I have read so many boards and posts and the struggles that people have encountered fighting this battle. I pray that these new drugs are the modality of treatment that will be a one size fits all cure.

smile



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oh I see... I noticed many country with no satisfying insurance will be on this trial, so you are very probably

But why Australia then ? they have a good health support for HCV I suppose.



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Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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ios9 wrote:

By the way : anyone knows why the US, Germany,áSpain and Franceáare not allowed to be on this trial ?

Seems strange to me, or I might have missed some thing ?


á Hi Do,

á á á á á áIn Germany almost all have a medical insurance, which pay for a hcv therapy. I know from other studies, which had arms with new drugs

and by way of comparison áa arm with conventionell drugs, participants, who were informed, that they were designated for the conventionel therapie,

left the therapy immediately. In a way some study doctor mention the possibility not to start, if the arm is not the favored,

because otherwise they don't get enough participants for this study. I think this problem doesn't exist in the US.

á



-- Edited by garfield on Wednesday 7th of August 2013 08:07:50 PM

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Hi Robin,

Week 6 was also the limite for Saphire and Topase for what I have heard, but on my Topase form it was not written down. They just wrote they could have to decide to stop the treatment before ending.

But do not worry that much, I had a high viral charge, but was UND week 6,á so you should be ok as you wrote your VL is low. Mine droped from 17 M and few thousands to 670 at week 1.

I am surprised the age limite for your trial is 65 years instead of 70.

Also I have been told by my docáthat withá those new drugs without Interferon the age limite could become 75.

By the way : anyone knows why the US, Germany,áSpain and Franceáare not allowed to be on this trial ?

Seems strange to me, or I might have missed some thing ?

Do



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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By the way, I`ve joined both of your threads together, Robin, so all your details and information is here in one place.á



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Jillá

(70 yo, lives in UK)

Was Gen 3a,á

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT,á

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

á

á



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Hi Robin, what it all means is that your treatment will be discontinued if any of these apply...

1) If your HCV RNA viral load increases by `more than` 1 log 10 IU/ml above your lowest vl result at any point during tx.

2) If your HCV RNA viral load fails to drop below the `lower limit of quantification ` (LLOQ) by week 6

or

3) If your HCV RNA viral load becomes `detected` again (above the LLOQ) at any point after it`s already fallen below the LLOQ, at any point during treatment.

So basically, you`ll be taken off the trial if your viral load is still detected (above the LLOQ) at 6 weeks, or your viral load increases by a certain amount from your lowest vl result at any time during treatment, or if your viral load become `detected` again after being `undetected` at any time during treatment.

These terms are very confusing, and I hope that helps!á smile

á

á



__________________

Jillá

(70 yo, lives in UK)

Was Gen 3a,á

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT,á

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

á

á



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Abbvie Malachite
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In reading the trial criteria I came upon these criteria for continuing the study but have no idea what they mean can anyone interpret this for me. I presume it means if I don't respond by week six I am removed from trial

á

á

Subjects in Arms A, C and D demonstrating any of the following will be discontinued from therapy:

  • Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment
  • Failure to achieve HCV RNA < LLOQ by Week 6 or
  • Confirmed HCV RNA LLOQ (defined as 2 consecutive HCV RNA measurements LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ

á

á



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RE: Abbvie Malachite clinical trial
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Hi Roddbird,

About Abbvie : I did not get side effects excepted some insomnia week 6, also a little anemia on week 12 (11.8). But really, what one call "anemia rage" was not there at all.

Lucky for youáto have been able to get it free. The reason people choose trials in France is to get cured, as all treatment are free when it comes to Hcv.

Let's us know how you'r doing.

Kindest regards,

Do

á



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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so official week one complete, not a side effect at all, still somewhat fatigued but I don't think as much so as before the trial, perhaps hope of a solution is giving me an extra lift , perhaps the drugs or the funk of acceptance from my loss and moving forward. It amazes me however that when first diagnosed three years ago the dr said that I have probably had the virus for over thirty years. I have had blood work for thyroid, blood work monthly for hormone replacement and blood work for pregnancies and this was never detected. How it was detected in a random hormone test one time but not others confounds me. All things for a reason I suppose and greatful that I am not a drinker per se and that Abvie and other companies have come out with the triple therapy combo and that it has such a high success rate. If all continues to go as week one I should sail through this and be SVR12 by my birthday. I was told that the government here in Canada will not cover these drugs once they are approved and treatment could run as high as 15,000.00. I have no insurance other than social medicine and see no way that I would be able to afford that ticket if I weren't on the trial. If there is anyone on the board who did get side effects from the Ribvarin when did they kick in immediately or after a few weeks of treatment?? It was great to log in today and see all the welcoming comments from the group.



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Hello Robin,

Welcome to theágroup, and .. to theáAbbVie club !

We are a few here who have been or still are on an AbbVie trial too.

I understand your past of brain fog, depression and exhaustion as I have been in the same state after the lost of a loved one last end of September. This is how my doc has found out few months ago that Iáhad Hep C.

AbbVie drugs does not have bad side effects to my knowledge.

Matt is right : great friends here, it helps much more than one could think.

All the best,

á

Do

á



-- Edited by ios9 on Wednesday 31st of July 2013 09:18:48 AM

__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

á

á

á



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Hello Robin

Welcome to the Forum, they is much to be gained by learning from the resources of this forum.

Also the friends you make can be the greatest support you will find.

Matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24áBabyáYES!á



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Hi Robin, welcome!á This looks like the trial you`ll be doing, as you are treatment naive...

http://www.clinicaltrials.gov/ct2/show/NCT01854697?term=Abbvie+malachite&rank=1

You`re lucky to be on Arm 1, with no interferon injections or telaprevir, and you should do well on it.á

Sorry to hear about the loss of your parent, it`s not an easy thing to go through, I know, and can take a long while to come to terms with.á Some of those symptoms you`re getting could well be caused by the Hep C too, and hopefully once you`ve completed the trial you`ll feel a lot better altogether.

As Garfield mentioned, we do have a section called `Clinical Trial Participants` which is for people to post their trial details and progress updates, so do feel free to start a new thread there.á You`ll find it interesting to browse through the other trial threads there too.

A lot of us here can trace our Hep C infections back to too much partying in our youth, you`re not alone!á Main thing is you`re moving forward and I wish you all the best of luck.á

Keep us posted!á ~ Jillá smile



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Jillá

(70 yo, lives in UK)

Was Gen 3a,á

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT,á

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

á

á



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Hi,

á áwelcome in the forum.

Specially in the forum clinical trial participants you will find postings from guys who have participated or are participating in abbvie studies,

and you will get there answers to your questions and support.

á

á



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Hi all new to the board, diagnosed with HCV 1a 2010 while doing routine blood work for hormone therapy, apparently have had it since the 70s and not sure how I got it but was doing a lot of partying back then. Anyways my original dr had me slated for clinical trial with bocevir and interferon but I didn't qualify as they were looking for fast responders and I was ct normal responder. I am treatment na´ve. I recently was accepted for the Abbvie Malachite study which is comparing telapravir with interferon to Abbvies new experimental drugs. It is a randomized study and you don't know what arm you will be randomized to. I am thrilled to say that I received Arm A today and took my first dose of pills this morning. Fortunately no advanced liver disease and low viral load. I have had brain fog and depression and exhaustion for a long time now however some of it can be attributed to the loss of a parent. I pray that 12 weeks from now I will be virus free and want to hear if anyone else is on this trial or similar Abbvie non interferon. I will keep you all posted about the fx and treatment. Its great to have support. I am fortunate to receive these meds on trial as I could never afford them and hope that this will be the new modality of treatment as from my research it is highly effective with minimal side effects. Took my first course of pills this a.m so far so good.



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