JimmyK wrote:

 Failing is disappointing but NOT crushing. I have failed but I don't get crushed. The Dragon gets crushed not us.

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 Go Jimmy.  That's the attitude!

Skimily wrote:

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. Trying to not have super high expectations, so that I won't be crushed if this fails.

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 1. You SHOULD have "super high expectations". This is a physical AND mental battle. You go in EXPECTING to win.

 2. Failing is disappointing but NOT crushing. I have failed but I don't get crushed. The Dragon gets crushed not us.

I would encourage you to lift your head higher and approach this battle as a matter of fun. That's right FUN! It is FUN to kick a Dragons Tail.

And if ya ride a Motorcycle like I do it is even more fun to ride a Dragons Tail.

http://tailofthedragon.com/

You are going to win this one friend. Now smile!

JimmyK

Greetings,

First and foremost congrats on being clean. I got about 30 years in and know first hand it is not easy. It just keeps getting better however. Life is Beautiful!

As far as not getting your hopes up that is hogwash.

I don't know why people say that but it kind of sounds cool. Hogwash. WTH is that anyway?

Those numbers prove that the drugs are doing exactly what they are supposed to be doing, and YOU are doing GREAT!

Welcome to The Family here.

JimmyK

Hi Skimly

Those results are great.  To put in context my day 7 VL was 3000; albeit on a different trail and with a starting VL of twice yours.  

So I'd be really happy with 700 at day 3.  

Can you tell us a little about the trial and the compounds please?  For our education.

Pablo

So, 2 weeks ago I started a trial for 8 weeks of ABT 493 ABT 530. Today was my fourth visit/blood draw - the doctor got my lab results back for Day 1 and Day 3. Results showed that on day 1 my viral load was over a million, and on day 3 of medication, it had dropped to 700ish. She said this is good news and exactly the response we want. I don't go back for another 2 weeks. I'm hoping she has the blood draw results for week 2 and week 3. I am so nervous over all this.  Trying to not get my hopes too high, but this seems really good, right?

Edit: I have genotype 2B. Diagnosed December 2015 - But assuming I have had it for up to 8 years because that's when my drug use started. I have been clean for 2 1/2 years & sober for 2! :)

It just keeps getting better around here.

Hello Saundra.. what an excellent 4 wk result!  Great news that you`re responding so quickly to these drugs, you must be overjoyed! 

Sounds like you`re cruising through this trial, half way already and minimal side effects, you`re well on track for SVR!!

Keep us updated with any more news, we`re very interested in following your progress!  Congratulations! 

Wonderful news all-round for you ChinaCat!! Und at 4 weeks - miracle drugs, eh? Such good news. If you only have to do 12 weeks, you'll be done in no time!

Very glad you are actually (physically?) feeling better! You mentioned some sides, what are/were they?

Now, as you progress right along, with your new-found cured state you can look forward to more and more improvements to come. You mentioned your spleen enlargement, it will be nice to see that resolve - they, of course, will be following you and your labs well during and after the trial . Do you have any other labs to post?

REALLY nice news for you and glad your sides seem teeny! Good going!  C.

 That's great news Saundra and just what we expected. These new DAA's are not only much more effective than the old IFN / RBV based protcols, they are, as you can already tell, also easier on the mind and body. It looks like this new combination is going to work well for you and be a killer for that "persnickety" dragon. Keep up the good work and remember to stay adequately hydrated. Onward to SVR...

Congratulations! I'm pleased to hear about your quick response to the trial drugs. I like the sound of not needing to extend treatment too! The 12 week course of treatment is long enough and hopefully soon we can cut that time in half or more. Let us know how your labs turn out when you get some news. I wish you continued good luck!

Hi Mike

Thanks for the welcome. I did a trial with Lamda Interferon, Ribovirin, and 2different Protease. I was on protocol for 26 weeks and while initially my numbers looked promising My VL was detected in a big way 2weeks after tx ended. I did have to meet check points along the way to stay active in trial. But like so many folks with Genotype 1a it's persnickety. My hepatologist did do DNA testing then as well and I do have the marker that identified as harder to treat. 

I can't believe how much progress has been made to tx effectively in just a few years. im so grateful I am in a trial and I don't have to do battle with my insurance company. 

Hi Saundra.

 Welcome to the group. Our eyes will be on you as you progress in this new trial and we wish you well for a successful outcome. Please keep us up to date on how it's going. Although this is a new treatment (Tx) the same basics apply to improve your experience such as staying adequately hydrated, feed yourself healthy food, get adequate rest and some exercise.

 When looking around the forum you'll see many abbreviations used, especially in member signatures. Here is a list of definitions for those if needed. And here is help with creating your own signature if needed / desired.

 You'll likely start seeing an improvement in your enlarged spleen even before you complete Tx. That was the case for me anyway. We have been seeing many 'undetected' (UND) results @ 4 weeks after start of treatment (SOT) with the latest Direct Acting Antiviral (DAA) protocols so hopefully that will be the case for you and you'll be done with this in 12 weeks. If it takes 16 wks then that's okay too. What really counts is that we are UND 12 weeks after we complete Tx.

 You didn't mention it, but I am curious what treatment medications you tried on your first Tx attempt?

Hello Saundra,

Welcome to the group! You have met a few of the great people already and look forward to following your path to the cure. We have one other member that mentioned getting started on the same trial. There will be two, the Endurance and Expedition trials. They should be effective, lets hope they offer minimal side effects as well. It will be interesting to follow these new pan genotypic protocols. Good luck to you!

Here's a link to the other discussion we had recently:

http://hepcfriends.activeboard.com/t61104146/abbvie-abt-493-abt-530/

Good Morning Dave and Canuck. I'm looking forward to being involved in a forum. I'm very concerned discussing this with my peers in work environment and my life primarily revolves around work. I'll find my way around I'm sure.

Hi ChinaCat,

Welcome to the forum, you'll like it here, lots of great information and wonderful people.

I don't happen to know about the trial that you're on but as Canuck said others will be along that will know more ... we are fortunate to have some very informed individuals here that will, no doubt, have some information to add.

The more information that you can provide about your diagnosis, the trial, the meds you are on etc the more answers they will be able to provide.

Dave

Hi ChinaCat,

I can't recall, this very minute, whether there IS anyone else on this here - I am sure they will appear right shortly if there is.

Very interesting drugs tho - the trial stats do sound promising, and for you, all the more so, as you say they have already tested/determined it is a good choice for you.

I read a bit about the ABT drugs in prior trials and I took that info with me to discuss my options with the doc. (also took Zepitar trial info and sof/vel trial info with me) - we never really got past discussing sof/vel (I don't know why). I guess sof/vel/GS-9857 seemed to be his "trial de jour" for me as a 3a.

The ABT drugs and trial results were intriguing tho. The ABT-493 being a NS3/4A with ABT-530 being the NS5A. The last trial I was looking up on it was NCT02640157 - I assume you are on a different trial as that one was for 3's, TN, NC, 12 weeks vs sof/dac 12 weeks.

The ABT493/530 results sounded very good tho. Canuck

Hi All

i just started Abbvie trial this week. Seems like i have an excellent shot at wiping this virus out. I am having a few more side effects than I thought However, pales in comparison to my first treatment. That was just terrible.  Is anyone else in this trial?

Hi Tomekhep and welcome to the forum.

 I can certainly understand your concerns for the baby and also about not having any side effects / post-treatment results information on this new drug combo. But some things are on your side: HCV Rx trials are no longer a guinea pig experiment like they were in the past. There are documented negative Sx'S / PTx's of older, less effective - hard to tolerate drugs and, as a result, the researchers have learned a lot about what to 'not' give us and about how long it takes the drugs to clear from our systems.

 It's important that HCV treatment be addressed as top priority. That sometimes requires putting other important things on hold. In your case, having a baby will also need to be top priority. We can only have one 'top' priority at a time. So your choice depends on #1 what condition your liver health is, which in your case, it sounds like you can possibly delay treatment if having a baby is that urgent but you still need to consider that HCV is still damaging your liver even if it is a slowly progressing process. #2 The chance of infecting your wife or baby is remote, but it exist. Considering that the chance of treatment rendering you infertile is almost nil, does being cured of HCV give you better odds of having a healthy baby? I think so, but that's your decision.

 Whatever you decide we will be here to cheer you on, in both ridding yourself of HCV and bringing a new life into this world. I personally don't know much about baby's but I'm a good cheerleader. On the other hand myself and many of our other members know plenty about successfully treating the HCV virus so you'll have a good source of support and information here. So make yourself at home, ask all the questions you like, and know that there is a solution.

Hi Tomekhep,

Welcome to the forum. The study and research on these drugs have been going on for years. One of the first things they determine are the adverse effects a single drug or combination of them have, which includes teratogenic effect. If there is a possibility, the warnings are loud and clear. The drug Ribavirin, that so many of us have had to take, is one such drug and the warnings are clearly stated. The warnings also explain the need for effective birth control during its use and provide instructions on waiting to become pregnant for at least 6 months after the last dose taken. These drugs don't stay with you forever and do clear your system. 

Many of us have or had been infected for decades before we found out. We lived normal lives during those years, had families and very rarely was a child born with the disease as a result of an infected mother (or father). Since you are infected and not your wife, the chance of passing the virus to either of them is almost nil. It's passed through blood contact. If that's not an option you would consider taking, then treatment should be seriously considered. I believe that treating the disease, and waiting the recommended amount of time to become pregnant will provide you with safety you desire. It's important to discuss this with your doctor, but I'm sure they will tell you the same thing.

I wouldn't dwell on this and wouldn't let it stop me from seeking treatment. The drugs are safer than before, shorter courses of treatment, which mean shorter exposures to the medication themselves. HCV very often has no symptoms, but is slowly chewing away at your liver and the rest of you as it continues to damage everything it touches. 

Good luck, let us know what you decide. If you have any other questions, don't hesitate to ask.

Hello Everyone!

I have an opportunity to participate in Abbvie clinical trial for ABT 493- ABT 530. I m not sure what to do.

The most important thing for me is that after treatment (plus half a year) me and my wife will try to have a baby. And I am very afraid that something will go wrong. It is still experimental treatment so we cant be sure about effects. Is it possible that one of them will be infertility? Or problems with baby?
I know it may sounds crazy but it is very important for me so if you have any information please let me know because I dont know what to do.

I feel good, I do not have any symptoms because of my hcv.

Hey Alexandra

Great to hear you were selected for the trial, it should be a life changing event.

I participated in one of Abbvie Hep-C trials in 2013 (Turqousie II) and the key is having a knowledgeable Doctor and nurse that can train you on the do & don't s while on the trial.

Don't hold back on asking any and all questions on every area of concern including diet to sleep and side effects, and dosing schedule. Once your enrolled in the trial Abbvie wants you to complete the trial so don't be intimidated by a doctor or nurse.

Hoping the best for you, go ! Alexandra

matt 

I'm looking for additional information on this protocol, but thus far there's not a lot of concrete evidence provided. Such is the case when trials are underway. I'll post a few things as I find them, but what I've read so far indicates they are very effective. As Matt mentioned, online searches will mine most of your info right now. The trial results are still being compiled and until they've got their T's crossed and I's dotted, they aren't going to release too much data. But one thing seems evident, this is effective stuff...

"AbbVie's ongoing HCV pipeline development program focuses on investigating a pan-genotypic, ribavirin (RBV)-free, once-daily treatment that may also allow for treatment durations of as little as eight weeks. Preliminary results from a Phase 2b study (n=79) of ABT-493 and ABT-530 in non-cirrhotic GT1 patients receiving the RBV-free recommended regimen for 12 weeks demonstrated a sustained virologic response rate at four weeks post treatment (SVR4) of 99 percent (n=78/79). These results, announced for the first time today, included both GT1a and GT1b, treatment-naïve and pegylated-interferon and RBV prior null responders. Patients across both study arms were randomized to receive ABT-493 (200mg) and either 120mg or 40mg of ABT-530. To date, the most common (>5 percent) adverse reactions were fatigue, headache, nausea, diarrhea and anxiety. Data from these Phase 2b studies of ABT-493 and ABT-530 will not be presented at ILC 2015, and will be released at future medical congresses."

Abbvie, ILC 2015

Abbvie, Next Generation DAA Combo

Hello Alexandra

I am very familiar with these Abbvie trial Hep-C drugs, they are the the latest 2nd/3rd generation Protease (NS3-4) and (NS5A) Inhibitors.

They boast to having a very high barrier to resistance or RAV's. Abbvie have had several trials of these in the US in the past year and will likely being reporting on them at the AASLD (Liver Convention) in just a few days, so watch for the latest late breaking abstracts about Abbvies studies on these drugs.

These two drugs ABT-493 & ABT-530 are so highly regarding in defeating Hep-C that they have trialed them for patients that have relapsed on other Hep-C DAA's protocols.

If you Google those two drugs and Abbvie you will be able to read more about the trial results.

matt

Hey people...I don't qualify for treatment where I live, bc of not enough damage. But I was offered an Abbvie clinical trial for ABT 493- ABT 530 (taken together). The trial evaluates treatment length, 8 vs 12 weeks...I believe it's called ENDURANCE. No placebos, apparently high cure rate. Anyone have any info on this? Anyone done it?

charly,

You won't find much on the non-nucleoside NS-5B inhibitors. They are basically useless as they are extremely prone to resistant variants.

The only one being used is Dasabuvir (formerly ABT-333), which is part of Viekira Pak from AbbVie. It's usefulness has been questioned, but combined with Ombitasvir and Paritaprevir, it seems pretty effective for some patients, but Ribavirin may be required as well. Cheers.

Thanks for the info!  I am still learning but it sounds like you are saying that drugs that block the NS-5B site are the most effective.  I have noticed that there are nucleotide polymerase inhibitors (Sovaldi/sofosbuvir) and Non-nucleoside inhibitors.  I can not find much on the Non-nucleoside and if they are more effective.  Any thoughts?

Also it looks like Gilead has a triple therapy coming as well:  SOF/GS-5816/GS9857.  This should take care of the NS5B (nucleotide) / NS5A / NS3/4.

Hi Charly8,

I agree with Tig.  AbbVie is almost as bad as Merck in the PR/Marketing Departments.

AbbVie have been sitting on ABT-493 for some years, yet they persisted in using their very average antiprotease, ABT-450 (which needed Ritonavir for adequate blood levels) in order to get Viekira Pak approved.

These days, it seems any treatment protocol without a nucleoside NS-5B inhibitor will create little interest. As far as NS-3 and NS-5A RAV's are concerned, Gilead's GS-5816, the Merck duo and even Achillion's drugs are further along the development path.

It was rumoured that AbbVie had struck a deal with Australia's Federal Government for substantial discounting, yet they did not bother applying for Viekira Pak to be approved by our PBAC. Slack.

Hi Charly,

Welcome to the forum! I think Abbvie is playing catch up and I'm not sure at the rate they are progressing if they will catch Gilead, if they stay this course. The thought of using ABT 493, another (NS3/4)Protease Inhibitor, combined with ABT 530, (NS5A) among other options, is behind the eight ball already. The thought of the emergence of RAV's being better addressed by this still trialed combo, has already been addressed by Harvoni. Any potential for Ledipasvir NS5A RAV's are easily defeated by the NS5B  Sovaldi (Sofosbuvir), which provides its pan genotypic action at extremely high rates of SVR. Whether the investors want to keep at this remains to be seen. Gilead already has another blockbuster set to release later this year or early next. It's the combination of Sovaldi and GS5816, another pan genotypic protocol. I'm just not sure Abbvie is looking far enough ahead. 

With all this talk about resistance it looks like the best drugs of the future are these two:

http://www.natap.org/2014/AASLD/AASLD_51.htm

Looks like they are resistant to all the variants.