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.

[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.

[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]

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

[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.

[Dee1956]

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

[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.