TOPAZ I - Viekira Pak long Term outcomes clinical trial

[OdinLovesLife]

Posting this info for anyone considering treating with Viekira Pak.

I started in an open-label clinical to measure the long-term effectiveness of this treatment 9-days ago. It's a wonderful opportunity for me as there is no prescription medication insurance where I live. Harvoni is not even approved here yet, and even if it was, it's the most expensive in a suite of treatments that are already completely unaffordable. Our government run Pharmaceutical Benefits Scheme is unlikely to list it any of the treatments soon. Like most other countries it is highly unlikely that the scheme can justify the cost of treatment subsidy until someone is on a proven path toward requiring a liver transplant.

I have seen quite a few people posting about wanting Harvoni instead of Viekira Pak. I would want it too, if it was an option. So for people in the same boat, I am happy to say that is not too bad at all! A walk in the park on a sunny day compared to IFN treatments.

For those that like lots of detail this is the study. Might still be recruiting.
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
https://clinicaltrials.gov/ct2/show/NCT02219490?term=TOPAZ+I&rank=1

Viekira Pak - FDA prescribing information, side effects and uses
http://www.drugs.com/pro/viekira-pak.html

I will post my progress and numbers as time goes on.
GT1a C/T. Failed IFN/Riba combo treatment in b2008.

[AWorriedMom]

Odin, wishing you the best in the trial. Viekira Pak cured me with minimal side effects. It was an easy treatment even with the ribavirin. I was in the Turquoise trial. I was a geno 1a, many times previous null-responder, cirrhotic, with a starting viral load of 7 million. You should do just great!

[dointime]

That is great that you have managed to get very good tx.  Best of luck.

I just want to add that the AASLD does not recommend Viekira Pak for people who have already treated with a PI.  For those people the only tx that they recommend is Harvoni,

dointime

[OdinLovesLife]

Thanks Worried. I must admit I had such a bad time with IFN/Riba that I was reluctant to believe the trial doctors and nurses when they said Ribavirin wasn't so bad without IFN. I have had some mild side effects, riba cough, a headache or two, but as long as I take it a little easy I already feel a bit better.

So glad you got treatment and cleared with the cirrhosis. I am feeling very positive about my chances this time. After about 30-years with beasties using my liver cells for mass reproduction, I am still crossing my fingers anyway.

[OdinLovesLife]

Hi dointime,
Good point about previous treatment with PIs. Fortunately Not applicable to me. The other concern is that if you have to stop early due to a bad reaction, or fail for some other reason, you may end up with resistance to all the new classes of drugs available. That concerned me and I am doing everything I can to reduce that risk. Also not the best option for women who might get pregnant.

Either way, the odds are so much better than they were with Combo.

[AWorriedMom]

Quick story....in 2008 I was on interferon and ribavirin in low doses using it as a maintenance drug. About 8 months in my bone marrow crashed and I had a hemoglobin of around 7, white blood count of .08, and an absolute neutrophil count of 0. I ended up in the hospital where they put me on procrit and neupogen. I also had heavy doses of IV antibiotics as I had an upper respiratory infection with literally no white count. I spent 5 weeks there. Even had a bone marrow biopsy to make sure it was from the interferon and ribavirin and not something else.

I was pretty scared signing up for the Turquoise trial as it used ribavirin. But I started with a hemoglobin around 12 and it only dropped one point in the trial which lasted for 6 months. My hematologist said that ribavirin without interferon is usually not a problem. So, I am hoping you have an easy time as well.

[Dee1956]

Odin, so great to see you!  I am so happy you have been able to get tx. Great news! Dee

[OdinLovesLife]

Hey there Dee. Thanks. I really do feel so lucky. It will be years before TX is affordable in Australia. This is a great trial too - all about recovery after treatment.

[OdinLovesLife]

That's really encouraging to read about your experience. So far I am finding that it's not at all bad but it's still early days. No numbers yet. I am quite optimistic though. Glad that you are past nasty experiences with the Riba and the horsepistol now. You must be so relieved.

[Dee1956]

Odin, I love that....recovery after tx.  Again, so happy for you! Dee

[OdinLovesLife]

Just posting an update on progress here for the benefit of others considering this treatment..

VL
Baseline: 6,000,000
Week 2: 42
Week 4: 20
Next test due on week 8
Have been called in for extra VL test since I didn't clear by week 4 which they expected me to do.

Sides:
Generally the Ribavirin is ripping into me. Big drop in Hgb during the first two weeks left me feeling wobbly on my feet and a bit breathless. Had some nausea and headaches, but nothing compared to IFN and Riba together. I have been able to work full time up until the near the end of week 6. I have even done an international business trip to the other side of the world - with a lot of planning and special measures. This is great compared to last time when I more or less couldn't work at all from the first night when I threw up all over the floor and felt like someone had turned down the power supply to my brain by 90%

Physically it is getting harder heading for week 7. I have to rest a lot more and of I overdo things physically I really crash out. Crash out means white as a sheet, heart palpitations, headache, sore kidneys, breathless, dizzy, nauseous... Oh **** lie down right now. It takes days to recover. I have had to inform more people at work, can't hide it. People have been great though. I can work more at home which helps a lot to keep doing a full day. When I keep everything slow and even, rest a lot, all goes well. I would say if you work a really physical job you would want to have a strategy for dealing with Ribavirin sides. I have trouble walking up the street and I am one of the lucky ones still having relatively decent levels of hgb.

So I am clinging to hope that week 8 VL test results won't be bad news. Have read the info about time to clear not being a strong predictor of SVR with DAAs, and the news from some others of clearing later than 4 weeks and still achieving SVR.

Good luck to all.

[OdinLovesLife]

EASL conference report on the study I am participating in.
http://www.natap.org/2015/EASL/EASL_43.htm

[SurfsideGal]

Odin, many people at my Abbvie  (Viekira Pak) trial site did not clear by week 4 and every last one got an SVR. We also had people who were undetected and then had a low level of viremia and then went undetected again. They cleared. Hang in there.

[OdinLovesLife]

Hey thanks. I have heard of some cases but not many. That's great news :-)

I am staying positive. The trial people are great. Can't help worrying a little bit though. I know the chances of success are very good.

[Dee1956]

Hey there, thanks for updating!  I am so happy to see!  I found this article I hope might help you.  The new tx's aren't like the old ones where they wanted to you be UND by 4 or 8 weeks.  I don't know if you have seen this, I hope it helps you.

http://www.medhelp.org/posts/Hepatitis-C/HCV-UND---SVR-NEW-INFO/show/2527772

[OdinLovesLife]

Thanks Dee. Have seen it, but good to be reminded and good to share :-)

[OdinLovesLife]

Got my undy!

Baseline: 6,000,000
Week 2: 42
Week 4: 20
Week 8: ZERO ZERO ZERO!!!

I am starting week 10 tomorrow. Coping a bit better with the haemoglobin drop but can't wait until this is over now. Sides are mostly more of the same but manageable. Slightly sore joints, and muscles, weakness. From week 9 the dizziness (normal without swordfish trombones) has eased up enough to walk a short distance without feeling like I am going to roll into the gutter. To celebrate I took myself and my undy out for a banquet with friends.

[SurfsideGal]

Woo Hoo. I had no trouble with Viekira Pak and have been clear for over two years now.

[OdinLovesLife]

Did you have Ribavirin? I have been able to work the whole time during TX which was good. Certainly a breeze compared to Interferon. The trial nurse said the 1b's have no side effects.

[SurfsideGal]

I did have ribavirin and was scared to death as my hemoglobin dropped horrifically on Peg and riba. This time it dropped a little bit...not enough to make me feel it. I was a cirrhotic 1a and did 24 weeks in Turquoise II.

[OdinLovesLife]

I was pretty scared too after the Interferon and Riba experience. So good that you could achieve SVR. I remember when that when things were bad enough just trying to get rid of HCV with little liver damage. The choices were far  tougher once cirrhosis set in. How's your recovery going?

[brian53222]

well, after having an artery blockage and having it fixed in Nov 2014. . I was given the news 1 hour before being released from the hospital. Everything looks good, you do not have any heart muscle damage, but....."you have tested positive for Hepatitis C". I am/was 1B. My side effects were fatique and loss of motivation. Guess I"m more sensitive than others and I did not have to take RIBO with my V-Pak. My load was 5 million and I believe in 3 weeks it was undetectable. I still have to wait a few months to see if i have achieved SVR. My problem is I do have some post fatique and fogginess. AM i the only one, it has been two weeks off the V-Pak.

[OdinLovesLife]

Hi Brian,
I can't speak from personal experience yet. I still have 4-days left until EOT. Will find out soon. I have heard people saying it took varying amounts of time before they felt better.

Unlike the last time when I treated, I have been able to work the whole time - with a little understanding from colleagues. I would have liked to take a few weeks off but it wasn't a good time. No brain fog at all. Maybe felt a bit less mentally alert due to fatigue some of the time.

How did you feel before treatment? Is the fogginess worse? Two weeks isn't very long. There's so much going on mentally and physically when getting rid of HCV. More than just nuking critters in your liver!

[OdinLovesLife]

I finished treatment just over a week ago. Went off for the EOT tests. I was stir crazy with the limitations on life and really ready to move on. Part of the trial was to do an EOT Fibroscan. The results were really positive. The Fibroscan results show a significant drop already down to 4.8 KPa. Amazing, since last year it was around the 5.8 KPa mark, three years ago 6.3 KPa. (The slight slow drop over 2-years was due to lifestyle, diet and herbs). So, I was mentally primed for a quick improvement...

Within a half a day of stopping treatment I felt the heaviness lifting from my chest. I could breathe more easily. I was less dizzy when walking. For the first few days I woke in up in the morning feeling like I was getting better and better. Then about 3-days into the recovery process I stupidly went for a gentle walk and bang! I realised the anaemia is still there, the battery power disappeared suddenly at the bottom of a small hill. By the time I got back to the top I was trembling, nauseous and pale. Had to lie down for a few hours. Too much too soon.

Since then I have been feeling pretty low. Borderline depressed and worried about when, or if, I will get better. I was quite clear-headed during treatment except for a short period when affected by insomnia. Now I am definitely fuzzy, demotivated, and irritable. While I was taking Ribavirin I wasn't irritable most of the time! My digestive system is whacky too. Things were flowing quite nicely from about the second month. Now I feel bloated and like my guts are going on strike. All this has been getting worse over the past week not better!

I know that I have to give recovery more time. I just didn't expect to start feeling like I am going backwards. I wonder what is actually going on? It is easier to cope with things that make sense.

[OdinLovesLife]

Hey Brian, how are you feeling now? I definitely experienced the same thing as you.