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 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.

[Dee1956]

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

[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.

[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.

[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.

[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