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Post Info TOPIC: New Bristol-Byers Squibb Clinical Trial NCT01979939 With Daclatasvir 30 mg, Asunaprevir 30 mg and BMS-791325 75 mg


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RE: New Bristol-Byers Squibb Clinical Trial NCT01979939 With Daclatasvir 30 mg, Asunaprevir 30 mg and BMS-791325 75 mg
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It was so good to hear from you! Thanks for replying!

I knew that all of the people that had relapsed on this BMS trial in phase 2 were 1a's.

I contracted hep C in 1977 after I was given blood after a bad car accident. I got the blood (42 units!) on May 17, 1977 (I was almost 21) after a bad car accident in the only trauma hospital (at the time) in the Washington, DC metropolitan area. I was taken to Shock Trauma in Baltimore. The blood came from inner-city Baltimore blood donors and it probably saved my life! My heart arrested twice and my lungs would not go on their own - I was on a special respirator for three weeks. They cut me open in a hurry down my belly from my chest to my legs and luckily the bleeding was only a ruptured spleen which was removed but I have a lot of scar tissue. A broke lots of bones - both clavicles, lots of ribs on both sides, lots of places in my pelvis and my left femur was broken in the middle and that piece broken away was shattered - I had a rod in my left femur for a year and then they took it out. I fought pathology to get the rod back - tee hee!!!

But look at me now - I am almost 58 and, despite this ___ virus I barely have any damage to my liver.

But I feel great and I know that even better drugs are coming so I am OK. 

Please also keep me updated about you!!!



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I am so sorry. I hope that it was a mistake. Your results have made me rethink this thing. I was feeling so positive. This is what I suspect....that although the virus is undetectable, there is still a small amount present in the body. They may have to extend the treatment time (?). I still think that they will be able to cure us soon, and I also hope that your positive test was a mistake. Let me know. I haven't heard from my trial nurse, but the results take a long time to come back to us. I don't expect my 4 week results for another week or so. I am hoping that everything will be okay with you.



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I have some bad news.

Today I received my viral count from my blood draw four weeks after I stopped the medication.

The virus is back and my viral count went from undetected to 51 IU/ml.

But there is something I don't understand: from week 2 of this trial (the third week in January) until April 2 my viral count was undetected - the results from Quintiles actually said "target not found". Now all of a sudden the virus is back.

Where was it hiding in my body for two and a half months?

Tomorrow I am going to be retested and I will post after that.



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Hi Paldendrolma, yes, I have had my cholesterol checked. Mine is fine but my Dad's family all also have genetic cholesterol problems and he has been on medication for it since he was 40. I will be 58 in August. I am 5 feet six inches and weight 123 and have never weighed more than 130 and I have worked out all of my life. I currently walk 40 minutes a day and have been doing this for years. If the hep C stays gone my only health problems are periodontal disease, migraines and rosacea.  I have all of these under control but they are still a pain in the _____.

As I have stated before my wishes are 100% SVR FOR EVERYONE!!!!!!!!!!!!!!!!!!!



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Great to hear you're doing well Lauralou, so far my labs are great too. One thing that I think you should check, if your doctor hasn't done so, is your cholesterol. If you have a family history of hyperlipidemia, now is the time that it might show up. I just got mine checked, will get the results next time I see the doctor. I know that mine will probably go up because Iwas borderline high even with a sick liver. Even though I run and work out, I will have to cut back on the junk food. Good luck, will post next results.



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Hi paldendrolma, I wanted to post an update of my results. My blood was drawn April 2 the day I took my last pill and my viral count was still undetected and the blood enzymes were excellent! I went for my week 4 post treatment blood draw on Wednesday. I got the results of the blood work (no viral count yet) yesterday and they were still the same - outstanding! the ALT, AST, GGT, etc. I will post the viral count when I get it. I think I did have side effects from the medication but they were VERY MILD. Post-treatment, I feel absolutely fantastic! I have noticed lots of changes in my body. I don't retain water like I used to and I don't bruise as easily as I used to. I am starting to sleep less and less (I used to sleep 10 hours a night) and I don't get as many migraines as I used to. I have high blood pressure which is VERY GENETIC (almost every person on my father's side of the family) but even that seems to have decreased some. I will post more information when I get it.

 



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Hi everyone, Thanks for the kind words of support when I finished the treatment, I want to weigh in on the post treatment symptoms. For 2 to 3 weeks after completing, I had some nausea and occasional fatigue. It was also the end of a very nasty winter in the Northeast. There was always the worry of treatment failure in the back of my mind. At week 4 post treatment, I feel better. Had my bloodwork yesterday, will not know results until I go back in 4 weeks or unless they call me with irregularity. Mag, I think you will start to feel better overall. I had Hep C for probably 30 years, have a stage 3 liver biopsy, and I now feel more alert and energetic.  I think you will feel better too. This trial won't work for everyone, but I think we have an excellent chance of succeeding. I am running about 20 miles a week now, and I feel more positive and confident overall. Let us know about your lab results. I will post my progress as well.



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Hi Matt, thanks for the welcome and for the response.  I'm still learning my way around this site, so hope I'm replying in the right area..

The meds are daclatasvir, asunaprevir  and BMS 791325, there was no RIBA in the mix with my trial, and so glad it wasn't. I'm sure my HgB would have ended up in the gutter so to speak, if it was in my mix. I'm very sensitive to RIBA, but I think only 12 weeks of it would have been doable if I had to do it, but would have to recover now if that were the case.

All my labs were in normal ranges prior to the trial and remained in the norm during and at the end the 12 weeks, so that is and was really great to have. These meds are fantastic and for me I had no sx at all which still amazes me. In fact my HgB went up a whole point while on tx and I've never been as high as 13-14 on the HgB in all my history, always been down around 12. My ALT is now 8 and AST is 10, before the trial it was 36 and 38. These were the only changes and very positive changes too, can't say enough good things about this med combo. smile.gif Renal function was never affected by the meds either, and all lab values stayed the same throughout tx when compared to baseline results. VL was detected at week 1 with <25 iu/ml and at week 2 was undetected. Remained und for wk 4, 6, 8 and 12.

Don't know why I'm so fatigued now either after finishing tx. At least I got to see what it's like to have energy after so many years of not having it and after forgetting what that was like. What a great 12 weeks I had! I hope you're correct and maybe I just need more time, let's hope so. I'll have a post 4 week lab draw with the trial clinic on May 16 and I'm also going in tomorrow to my own GI and will ask for the lab work to be done through him as well. I'll post what the outcome of the PCR is when I find out. 



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GT 1a, previously treated with peg and riba for 48 wks., relapsed 4 wks post tx. Finished 12 wks in the BMS trial on April 18. 



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Hello Mag

Welcome to the forum you have found a good place with insightful and caring people.

Great to hear that you have completed your trial study BMS has a very good combo of HCV drugs. Your comments of less energy off the meds is quite unusual but it could be that your body is re-adapting to the change without the HCV virus. Its only been about two weeks so give it another two weeks and you should be feeling better. BTW was Ribavirin part of your meds.? I remember when I came off of my trial meds it took 3 weeks before I gained back some strength and felt good all day long.

Also do you know when your next blood draw for lab results will be? That will go a long way in getting insight into your current condition.       

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-24 Baby YES! 



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Hi everyone, I'm new to this site. A friend from another site that I've been on since 2006 guided me to this place, very nice site and great posts!

i just finished meds on April 18 in the BMS trial that I noticed some of you were also participating in. How's the energy level doing after finishing?

I seemed to be doing much better on the meds then off the meds. My energy was so great while on the meds and was hoping it was mainly because the virus was undetectable very early on and that it was the reason for the increase in energy. Now I'm wondering if it was the actual meds making me feel better and with energy bursts that lasted from the time I woke up till I went to bed at night. Now I'm back to feeling fatigue almost like I was feeling before starting in the trial, and not sleeping as soundly as was with the BMS meds. Those meds were fantastic while taking them, I had no negative side effects other than the positive ones I just described here... I'm really hoping this is the last time I will have treat, and hope this BMS trial was the magic ticket for us all who were in this trial. Good luck.

i hope everyone is doing well and wishing all of us SVR!

Mag

 



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GT 1a, previously treated with peg and riba for 48 wks., relapsed 4 wks post tx. Finished 12 wks in the BMS trial on April 18. 



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Hey Andrea,

I also finished my meds.

My twelve week viral count was undetectable and my twelve week labs were still great!

Keep in touch!



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Hey Andrea

Congrats on completing your Trial. BMS has a very powerful combo of drugs and you should do well in the coming weeks.

In the next couple of weeks you will be changing back to having your body adjusting to being without the meds so you might feel less energy or more. Sometimes it takes 3 weeks to enjoy the release of extra energy but you will know it and really enjoy the difference.

matt 



-- Edited by Matt Chris on Wednesday 9th of April 2014 12:26:02 AM

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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-24 Baby YES! 

Tig


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Hi Andrea,

Congratulations on completing your meds and finishing Tx! I know you're excited to be done and anxious to hear those results. I hope you're feeling better everyday and will be celebrating with you on the day we hear those 3 sweet letters, SVR. Good luck!

Tig



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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!

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I finished the meds last week, now the long wait for SVR. No change in my labs. Still undetectable VL. Let me know how you do.

 



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Great result! 

 

Thanks for your sharing

 

Lucy



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 1b, start triple treatment(incivek) on Feb 5, 2013.  UND@ 4,12,24 wks. EOT Aug 6, 2013



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Yay!!!!



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Hi Andrea,

I think you are correct in getting excited!

These new drugs are based on knowledge from the genome map of the hep C virus and they are working!

They are stopping the f____ virus from replicating!

They are not the only new drugs being made based on the knowledge of a genome map - there is also a new drug (FDA approved) for cystic fibrosis (the medical community has discovered there is more than one genome for cystic fibrosis) that STOPS one of the genomes.

100% SVR for everyone!!!!!



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Hi Everyone, Lauralou, so glad to hear that you are still testing undetected, I will probably not get week 8 test results until later. So far so good though, undetected since week 4. I am so encouraged by these new meds. I have friends with cirrhosis from this disease, people who have been doing the right thing for 20 years or more and who can't get rid of this. So far, this BMS ****tail has worked very well for people with advanced liver disease. I could never work full time as a nurse with Ifn, or even just Ribavirin. I know it's too early to get really excited, but I'm really excited!



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Hi  lauralou / Andrea 

That's great news happy for you both, thank you both for posting and taking the trial. I'm getting real restless seeing all this good news. I'll be doing something myself soon. Wishing you a speedy recovery and SRV 

Bill S 



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Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.



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Hi Andrea,

I have received my six week and eight week viral count and both are undetected.

Please let me know how you are doing!

 



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Hi Andrea I am so glad to hear your good news!

I have not had any GI discomfort on these meds but I have talked to alot of people who have.

I take the meds with a meal or a snack and I have never had any problems.

My ALT and AST were close to yours for my 4 week results.

I am told I will get my 6 week viral count and other lab work next week and I will let you know.

Keep up the good work - CONGRAGULATIONS!



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Hey Guys

Great results, keep up meds and all will be well.

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-24 Baby YES! 



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Fantastic news, Pal!! Congratulations!!!



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Gen 1b, 33yo. Started 12wk Viekira Pak on 2/28/2015. 

Baseline: VL=517K, AST=34, ALT=56. 

Wk4: VL=<15, AST=16, ALT=14.

Wk8: VL=UND, AST=17, ALT=14.

Wk12: VL=UND, Fibroscan: 3.4kPa, F0.

--->Viekira Pak financial and nurse support<---



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Hi Lauralou, I just got my week 4 results today. It is now week 7 and they just came in. The blood is sent to a lab in Georgia (USA) they are slow. I am undetected (YAY) and ALT and AST are 16 and 17, lower than they've been in years. I am happy. Most of the SEs have gone away. Just a little weakness and mild GI discomfort after taking the pill. So glad to hear that you are also doing well. I am hoping that this is the cure for everyone. Keep me posted, Andrea



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Hi Paldendrolma, I just got my 4 week results and am undetected again!

In addition, all of my liver enzymes (even the AST, GGT, etc.) are all down in the middle of the acceptable range.

Please let me know how you are doing!

 



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Hi Paldendrolma, your results sound great! And you sound like you are doing great!

Before I began my liver enzymes were always still in the normal range but the high end of the normal range. Now they are all very, very low.

I went in for my week 4 visit today and the research nurse gave me more information. She said that most people in the trial (over 95 percent) were undetected at four weeks. The medical community seems to think the results of this trial will be as good as those of Abbvie. So I think we have a outstanding chance at SVR but my hep C doc lectured me to take care of myself (for me this is mostly plenty of sleep) even after I stop the medication at 12 weeks for the 24 weeks after that. My hep C doc says the percent relapsing has been small but there is still that small chance.

But I also feel very, very positive about this trial. And my body feels BETTER in lots of small ways (bruises healing faster, less water retention in my middle, etc.) but sometimes I wonder if this is just psychological. But who cares!

I am still a little bit in shock about the rapid viral response (really rapid!) for, as I said before, I expected positive results from this trial but not as fast as they came!

Please keep me posted and, as soon as I get my four week results, I will psot them.

 



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Hi Pal~,

Congrats on the low VL. At two weeks a drop that significant indicates treatment is working as desired. Remember it wasn't too long ago, the VL tests didn't detect that low and you would've been undetectable. Just recently they only detected down to 43 IU/ml on the quantification tests. The qualitative tests go down to 5 IU/ml, but only indicate a positive or negative result and were very expensive to perform. Now the quantified tests are reaching levels as low as 7 IU/ml. The sensitivity of today's tests are quite good and really provide you with an accurate picture of your VL and treatment performance. I think the odds of you reaching UND by your next VL is quite high! Good luck....

Tig

 



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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!

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Hi Lauralou, I got my results for week 2, Viral load is less than 25, not quite undetectable yet, but I think my week 4 results will be. My liver enzymes are all back to normal, actually, all labs (except of course Hep C) Are normal. I am very happy. My enzymes were elevated prior to starting this study. I really hope that we will be cured. Keep up the good work!!



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Hey Lauralou

That is fantastic news! Wow to be UND that quick is a real good sign. Keep up the meds and don't slack off you have a long way to go.

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-24 Baby YES! 



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Thank you, Paldendrolma!

Please post your results after your get them - I will be thinking of you!



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That is great, Laura Lou. I do not get my results for a few more days. I will let you know, Congratulations!

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Hi Laura,

Wow! That's absolutely fantastic news biggrin, WOOT!! The future is looking very bright    for one lady I know, yeah!!! Keep up the good work, your attention to protocol and your desire to succeed has just been proven worthy! Continued good luck Lauralou....

Tig



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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!

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Hi Paldendrolma, I got the results of my two week viral count this morning. The research nurse sent me an email saying I was undetected. The lab results from Bristol-Myers Squibb came also as a separate attachment. For HCV RNA the result reads "Target not detected". 

I am in a state of shock. I knew these new emdications were good but I did not expect such good results so soon!

I think I will just let myself be in the state of shock  for awhile. When I come out of my state of shock I will post more.



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That is amazing Lauralou, I won't have my week 2 test results until next week, the week 4 visit, unless of course I badger the trial nurse. I am encouraged by your liver enzyme results. I have some significant fibrosis and I worry about that. I am thinking positive thoughts for both of us. Stay well!



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I just got my week 2 lab results without the viral count.

Most of my pertinent (pertinent according to my hep C doc) lab results have always been close to normal (even the ALT) but the ALT has now dropped down to 17 and I don't ever remember it being this low before.

In addition, my AST has ALWAYS been higher than normal and it is now in the normal range - it is 28.

I do not have the week 2 viral count but I will post it when I get it.

Many thanks to everyone for their support!



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Hey Lauralou

WOW! Fantastic reduction, your body is responding very well and that is the best news you could possible have. The next step / goal will be RVR by week 4 but at your of reduction rate you might reach week 2 or 3 with less than 25 (<25) or even RVR

Keep up the great results it a joy to hear that news

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-24 Baby YES! 



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This morning I got my week1 viral count.

I went from a viral count of 10,224,974 to 60!

I am waiting to get the other lab results (ALT, AST, etc.) for week 1.

I will post those when I get them.

Paldendrolma, please let me know your future labs also.

SVR here I come!



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Matt, Thanks for the support.



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Paldenrolma, thank you for getting back to me. I will post my results as I get them. Many thanks!



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Hello Andrea

Welcome to the forum we are very happy to have you as a member. You have found a good place with caring people. BMS has several goods trials this year, the one you are on has had very good results so far, we are pulling for both you and Lauralou to make it to the finish. Its nice to have someone who you can share your journey with that is near to the time range as yourself.  

Laurallou its good to hear you have a work schedule that allows for better balance, maybe Andrea can find a way to relax her schedule to have a better pace.

Hoping you both can keep to 100% adherence and enjoy the ride to better health.

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-24 Baby YES! 



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Thanks for getting back to me. I am feeling very positive about this trial, but the side effects keep coming. I have had elevated temperatures and real fevers for days now. I just came back from Puerto Rico though, that might have something to do with it. I am a hospital nurse, I work crazy 12 hour shifts, so after the interferon failure in 2006, I gave up on treatment. I have hope now and feel I have some control over the situation. I will post my next viral load, I think it will be good news.



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Paldendrolma, thank you for your response to my post.

I am so sorry to hear about your side effects but pleased about your first week viral count.

I am been on this trial since January 8 also but I have not yet received my viral load for the end of week one. I will post it when I do. But all of my other blood work was also OK. I have been told by the trial nurse and others, my hep C doc, etc. that your week one viral drop is not uncommon and that many people in this trial have a viral count that is undetected in four weeks.

I still do not have any side effects from the medication I am taking in this trial. And, as I posted below, I actually feel better - I am noticing that my bruises are healing faster and that my body is retaining less fluid than it did before I started the trial.

I am not experiencing fatique as a side effect of this trial. But I have experienced fatique as a side effect of hepatitis C for years. When I was younger and did not have hep C I would sleep 7 hours a night. Now I need to sleep 10 hours a night to feel OK. But if I get ten hours of sleep I am fine and I can function on my job. I talked to my hep C doc about this. I am lucky because I have a good government job doing technical work (computational mathematical statistics) on the computer and the agency I work for has telework as an option. So my hep C doc wrote me a letter justifying medical telework because of the hep C (I got a disability lawyer in case I had a problem) and I requested a medical telework schedule at work. I was granted this and started this several years ago. Of course, this helped me greatly!

I will update this post when I get some further results.

Thanks you so much for your response!



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I am on this trial since 08 January. Am having some side effects. Fatigue, chills, feeling of disconnectedness. Insomnia. I am going to stick it out though it has already affected me at work. All blood work okay. Viral load went from 7.5 million to 120 (that's right, just 120) At the end of week one. Let me know if you start to have side effects. I want to learn to cope with them.

 



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Hey Laurallou

That is great news that you started, soak in that first month and enjoy the change. Sounds like your body and mind agree with the Meds. BMS is really being aggressive in 2014 in the HCV trials, hope a lot more enter your trial and the others during the coming year.

Keep us up to date the members are keen on the latest trial info.

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-24 Baby YES! 



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I just started this trial and I have been taking the medication for one week.

The medication is daclatasvir (NS5A inhibitor) 30 mg, asunaprevir (NS3 inhibitor) 30 mg and BMS-791325 (NS5B inhibitor) 75 mg all in one tablet taken twice a day.

So far I feel no side effects.

In addition, I FEEL BETTER. For example, my body is not retaining water like it used to. And my bruises are healing faster - I noticed this the first day of the medicine. I don't know if this is psychological or the medicine.

If anyone else is in this trial please post and share your experiences with me.



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