Daclastasvir /sovaldi compared to simeprevir/ sovaldi

[Aldora]

Anyone know which is more difficult in terms of secondary effects..tolerance and efficacy?

[Mike]

Unfortunately, these are both new drug combinations and haven't been around long enough for research studies to determine which combination is more tolerable (less side effects).Preliminary data suggests that both are well tolerated.

The same holds true with efficacy. While clinical trails report 90%+ effectiveness for both combinations, they are still being prescribed off label.

It wont be until the first large group off label participants is available that true efficacy results will be available for comparison

Currently, only data from clinical trials has been analyzed, which were small samples for comparison/extrapolation.

Here's some research links:

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0CC4QFjAC&url=http%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa1306218&ei=R-n7U-jKK8LhsASTjICICQ&usg=AFQjCNFi5WOgGtT3NcRwRzdzrsHPMuDA7g&bvm=bv.73612305,d.cWc

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CCAQFjAA&url=http%3A%2F%2Fwww.hepmag.com%2Farticles%2FOlysio_Sovaldi_2501_25501.shtml&ei=2un7U8HbMaLLsAT2vIGgBg&usg=AFQjCNFqeF0EYjft0Y4poQrumiuTTVLd4w&bvm=bv.73612305,d.cWc

Best wishes, Mike

[tebrlovesherpets]

Hi....brand new person to this forum!!
Are you cured of Hep C?
Which treatment did you have?
Thanks!

[Mike]

I was treated with Sovaldi, Interferon and Ribavirin x 12 weeks. I was genotype 1a, 9 million viral load, partial responder to prior treatment with grade 2 fibrosis (moderate).

Cleared the virus in February, 2014 and declared cured by my GI July 2014.

Sovaldi is a miracle drug!

Best wishes, Mike

[tebrlovesherpets]

Hi....brand new person to this forum!!
Are you cured of Hep C?
Which treatment did you have?
Thanks!

Unfortunately, these are both new drug combinations and haven't been around long enough for research studies to determine which combination is more tolerable (less side effects).Preliminary data suggests that both are well tolerated.

The same holds true with efficacy. While clinical trails report 90%+ effectiveness for both combinations, they are still being prescribed off label.

It wont be until the first large group off label participants is available that true efficacy results will be available for comparison

Currently, only data from clinical trials has been analyzed, which were small samples for comparison/extrapolation.

Here's some research links:

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0CC4QFjAC&url=http%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa1306218&ei=R-n7U-jKK8LhsASTjICICQ&usg=AFQjCNFi5WOgGtT3NcRwRzdzrsHPMuDA7g&bvm=bv.73612305,d.cWc

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CCAQFjAA&url=http%3A%2F%2Fwww.hepmag.com%2Farticles%2FOlysio_Sovaldi_2501_25501.shtml&ei=2un7U8HbMaLLsAT2vIGgBg&usg=AFQjCNFqeF0EYjft0Y4poQrumiuTTVLd4w&bvm=bv.73612305,d.cWc

Best wishes, Mike

Hi....brand new person to this forum!!
Are you cured of Hep C?
Which treatment did you have?
Thanks!

[tebrlovesherpets]

Congratulations, Mike!  You are a wonderful success story!!
I have genotype 1a also but not to " up " on the current treatment available, as I have been " waiting " for the new treatment that is possibly going to be available in the fall of 2014??
Was told I have a slow progressing disease .... stage 2 to 3 so not a lot of time to put treatment off.
Hard decision to make .... I'm scared and worried.

[Mike]

Hi  tebrlovesherpets,

Being scared is understandable and normal.

There are some great treatments coming down the pike that don't involve Interferon or Ribavirn - both of which can cause significant side effects.

Of these, Sovaldi and Ledipasvir shows great promise, and should be released/approved as a single-pill combination in October/November.

This combination was specifically developed to treat geneotype 1 and, clinical trials have demonstrated a 90%+ cure rate. Treatment duration is 12 weeks.

This will be well worth the wait and will put you on the path for a cure!!!

Time to be happy and a time to get pumped.

This will be a real game changer for genotype 1 (especially 1a) which has always been considered the hardest to treat!

Had this combo been available last January, I would have jumped on it.

Hang in there, you'll slay this dragon!

Best wishes, Mike

[tebrlovesherpets]

Hi Mike,

Great information and words of encouragement!!

Is Sovaldi the same as Sofasbuvir?

I " think " I was told a combination pill of:  Sofasbuvir  and  Ledipasvir  ??

Yes I heard the treatment you had had a lot of side affects and I hope you endured that not too badly ... the main thing is you are cured.  Great hope for others ....

I did not want to go through the former treatment, as I would have to travel far to Clinic once a week, and was worried about being sick all the time.  I know everyone is different, but was not for me.

Hopefully this new drug will be approved in the Fall of 2014.  We all need to cross our fingers and have faith / be positive!!

Thanks ... tebrlovesherpets

[iana5252]

Hi tebrlovesherpets,

Yes, Sovaldi is the same as sofosbuvir. Sovaldi is the brand name while sofosbuvir is the generic name. Here's a page that breaks down all the drugs approved or in phase III clinical trials...
http://www.hepmag.com/drug_list_hepatitisc.shtml

The sofosbuvir/ledipasvir combo was submitted to the FDA for approval on Feb 10, 2014 (http://www.hepmag.com/articles/gilead_fixed_dose_sovaldi_ledipasvir_2501_11455.shtml). The expected decision date is early October. The FDA usually releases their approvals on Friday evenings.

There are several other drug approvals expected later this year and early 2015 so you should have plenty of choices available very soon.

Best of luck.
Ian

[tebrlovesherpets]

Hi iana 5252 .... thanks for the explicit info.  Thanks for the sites.  All the best to you.   

[Scooter]

Has Daclatasvir been approved ?

(sorry this stuff is very hard to follow)

[lporterrn]

not yet Scooter - approval anticipated in late 2014 (with asunaprevir)

[Suma]

Hi everyone,
I'm new to this forum and have been reading post on hepatitis C treatment from past few days and now need some urgent advice.
My mum has HepatitisC genotype3a from last 6 years and been cured with ribaviran n interferone injections but remained non respondent. Her liver is healthy and she is 59. She now been advised by her Doctor to start sovaldi+Ribavirin for 24 weeks she just started. We are quite scared n confused as heard some bad reviews about sovaldi but we don't have any other option. Now problem her hb level is 8 while her platelets are normal and she been advised of EPOKINE 2000 injections to avoid blood transfusion. She's been prescribed 5 injections. Now i am so confused that she should have these injections or not or are they safe? I googled and couldnt find any info on having epokine while on sovaldi+Ribaviran treatmentand according to her Doc she should start ASAP. Please help. Any help will be greatly appreciated as we are so confused and don't really know what to do?My mum is not overweight and don't have any other complications just wondering if some one already had these injections EPOKINE 2000 and are they safe for her during this treatment.Any help will be greatly appreciated
Many Thanks
Suma

[Mike]

Hi Suma,

I used a similar drug when I was on Interferon and Ribavirin (Epongen). I had 1 weekly injections over a month to increase my red blood cell count, which allowed me to continue treatment.

It worked and raised my blood count.

Best wishes, Mike

[Suma]

Thank you ever so much Mike. Can i ask is she going with right treatment? and also what diet one should have in HepatitisC as she's been told not to eat meat at all and also lots of other things just salad n fruits she's surviving on? Is sovaldi a safe treatment i've read post of one user with devastating loss of her mum i felt so sad n we all got so scared that i stopped my mum not to take this medicine but her viral load shooted just in few days from 8 million to 10million now so we haven't got any option left and to go with this treatment. I'll keep everyone updated it may help someone who are unsure like me to go with this treatment or not. I really appreciate your quick response.I hope I'll get more supportive info specially what precautions can make this treatment more manageable for her and also about side effects in this regard and ofcourse i will keep every1 updated how her treatment is going it may help others to decide who are unsure about this treatment .we will be getting first blood test after 4 weeks according to Doctors  but I insisted she sould have one after 10 days just on safe side Is it ok? Many thanx
Regards,
Suma

[Mike]

Hi Suma,

It sounds like your mom is on the right treatment and her doctor is monitoring things. As far as diet, I didn't have any restrictions, though I did lose my appetite and would drink protine shakes if I skipped a meal.

Regarding the posts about the person who lost her mother, which was very sad. There are a few things that need to be pointed out. First, her mother was 80 years old and recently completed a course of chemotherapy for cancer. Although the daughter indicated the cancer was in remission, she didn't discuss any of the residuals and/or damage the cancer caused. Additionally, the daughter didn't appear to know much about her mother's Hep-C infection, extent of liver damage, viral load and so on.

In short, it seems like there were other factors that complicated the picture, such as age, cancer, overall health and so on.

Sovaldi is a safe drug; but with all mediucations there can be some risks. I completed a Sovaldi based treatmnent protocol in April and had no issues with the drug (the Ribavirin made my red blood cell count drop; but that was manageble).

Best wishes, Mike

[BattleTheBeast]

Hi Suma,

I think at this point anyone on treatment today is getting Sovaldi (it's in Harvoni too). If you mom has a good doctor and it sounds like she does I think you can trust he will make the best decisions for her. It doesn't hurt at all to question, in fact its a good thing but it really does sound like he has her best interests in mind.

I was originally on the Sovaldi and Olysio combination and my issue was all with an allergic reaction from the Olysio and had nothing at all to do with the Sovaldi. In fact, I stayed on it for 9 weeks anyway and then we moved my treatment to Harvoni.  So I've been taking Sovaldi for over 11 weeks now with no issues. My starting VL was over 8 million GT1a and I was a sick girl. At week 9 I was Undetected and moved to the Harvoni. At week 11 of treatment including Sovaldi, I am starting to feel like a human being after over 9  months of being really sick.

Please don't let the person who lost her Mom get to you. She was grieving a loss and chose to blame the Hep C treatment, she even sent me some personal messages that were way scary when I first started my treatment plan. I can share with you that my ID doctor has been participating in many of the clinical trials and he has told me numerous times that over 90% of the people on all his new trials did not have any side effects and the ones who did it was mostly due to another underlying condition and had nothing to do with the treatment.

Your Mom is lucky to have a daughter like you helping her, we will all be here to support both of you. Keep asking the questions and keep holding her hand through this. Keeping her spirits up with really help.

Mel

[Suma]

Thank you Mike and Mel for your kind and helpful responses. I really appreciate it. Thanks for taking time to explain me so well and giving me the confidence which i was lacking somewhere to go ahead with my mum's treatment. I am feeling quite positive now.

[BattleTheBeast]

That's awesome Suma,

So glad we could help you feel more comfortable with the treatment plan. Mike and Lucinda both have a ton of clinical knowledge and both of them do a great job of explaining things so even I can understand them

Me, well I am full of long stories and details about my own experiences and I am happy to share and be an open book. Please keep asking the questions, they are all good ones and really valid. Just think now someone could look on the forum and search it for EPOKINE and find your questions and Mike's responses.

When I was diagnosed I searched a ton on this forum and it really really helped me so much.

Have a wonderful Sunday and keep in touch,

Mel

[Suma]

Hi,

I hope everyone is doing well and I wish you all Merry Christmas.

Just want to know about Hepamin and Silver (not sure about spells) supplements as my mum's doctor prescribed her these supplements to take with Sovaldi and ribavirin. Anyone used them before and are they safe?

Many Thanks,

Suma

[Suma]

Hi everyone,

I got my mum's PCR report today after 4weeks been on Sovaldi and Ribaviran treatment.
We all are surprised to see the reports virus load is 0 and it says "specific fluorescence was not detected on real time PCR system"it  further says viral load not detected.
Does it mean it's negative now and cured. she's continuing the course but is it something experienced before?
I'm sorry i'm not very regular on this forum as i work full time and look after my mum also I'm mum of two little boys as well. But I make sure I update you on everything about my mum's ongoing treatment. She's on week5 treatment and I updated before she is taking some sort of vitamins as well prescribed by her doctor.

Regards,
Suma

[BattleTheBeast]

Hi Suma,

It looks like she is Undetected which is what you want to see during treatment. She will not be considered cured until you get those same results 24 weeks after treatment though some say 12 weeks. That is what is called SVR12 and SVR24 or Sustained Virology Response which means after treatment is over they can't find any of the infection left.

It's all positive for now, keep Mom going on the treatment and let's hope it continues to stay away!

Mel