might take the viekira, but not the ribavirin

[Ian]

Hello,
I have gen 1a, stage 0 fibrosis and after being denied Harvoni, I was prescribed Viekira plus Ribavirin for 12 weeks. Problem is, I'm hoping to have a child soon with my wife, and I learned that I wouldn't be able to do this for a year after finishing ribavirin treatment. Considering that skipping the ribavirin only lowers the chances of cure by 7%, and considering the potential serious side effects in terms of health, hair loss, mental focus, possible impact on my career etc I have to consider maybe taking just the Viekira and the risk might be well worth avoiding the ribavirin.

Has anyone else with 1a chosen to take only Vieira, and not the ribavirin? Are there other risks I'm not considering?

It just seems like why harm my body more then necessary? Worst case scenario, the treatment fails but in the next few years I'm hopeful it might become easier to get Harvoni and thankfully with no fibrosis I can wait.

Why would the FDA only approve Viekira with ribavirin for gen 1a? To me 90% is pretty good, especially compared to the older interferon treatments which were much less effective (but still FDA approved, interestingly).

Thanks for your insight, I am extremely grateful for these drugs and don't take them for granted but this is a tough choice.

Gen 1a
Stage 0 fibrosis
35 years old
Male
Treatment naïve
Had hep c for 15years

[Philadelphia]

I'm not a dr, nor do I play one on tv and what I say is worth exactly what you pay for it, but you might find this vid from a conference interesting. I did.

Side note, as a cirrhotic 1a, riba was a done deal. I took it, but I took a reduced amount after the first few weeks as the sx were a bit rough.

https://www.youtube.com/watch?v=vCcpES8O6P0

In fact, I recommend many of this channel's videos. A wealth of information!

[Lynn K]

Not a doctor either or even a nurse but the prescribing information sheet does not give no ribavirin as an option for GT 1a only GT 1b

http://www.rxabbvie.com/pdf/viekirapak_pi.pdf

Treatment Regimen and Duration by Patient Population
Patient Population                      Treatment*                  Duration
Genotype 1a, without cirrhosis  VIEKIRA PAK + ribavirin       12 weeks
Genotype 1a, with cirrhosis       VIEKIRA PAK + ribavirin       24 weeks**
Genotype 1b, without cirrhosis  VIEKIRA PAK                     12 weeks
Genotype 1b, with cirrhosis       VIEKIRA PAK + ribavirin      12 weeks

Viekira pak is not as effective without ribavirin if you can't take it with ribavirin you probably shouldn't take it at all but you should discuss your options with your doctor.

If you did take Viekira Pak and failed it could make you resistant to many of this new generation of meds.

One other thought it that would be off label or not as per the manufacturers recommendations so not sure your insurance would allow.

The old meds were approved because they were all we had at the time. Interferon, or later interferon and ribavirin, and later still interferon ribavirin an telapavir or no treatment at all......

Maybe your desire to have a child could be a reason you could appeal the decision and possibly be approved for Harvoni.

Good luck to you
Lynn

[Ian]

Wow, thanks for the extremely helpful information! Philadelphia, that doctor is commenting on this exact dilemma and for my specific situation he makes strong case for just taking the Viekira. I believe that for any condition, but particularly in the case of Hep C, appropriate treatment for each individual  is more nuanced than simply following FDA guidelines.

Looking at what appears to be the Pearl 4 AbbVie trials located here: https://clinicaltrials.gov/ct2/show/results/NCT01833533?sect=X4301256 it seems to show that Viekira alone was 90% effective for genotype 1A, compared to 97% for Viekira + Ribabirin. However, if you were to look at the individual participants who failed to achieve SRV my hunch is that they may have had more advanced cirrhosis, age, or other factors that made their case more difficult to treat. Therefore, based on my particular status with the virus, my likelihood of SRV could be greater than 90%.

Regardless, I plan to talk with my doctor about it because for me, increasing the chance of cure by 7% may not be worth the risk of major setbacks caused by side effects to ribavirin. The FDA is making decisions to apply to the entire US population (understandably so) but there are more nuanced options with tradeoffs that may be acceptable for individuals.

Thanks again, and I am very interested to hear any other thoughts.
Ian

[Philadelphia]

you know there's one blindingly obvious solution - fall pregnant now!

[Cal]

Ian,
I agree get pregnant now and have treatment after. Please talk to your Doctor. Doing it this way may work but if it doesn't resistance issues to the drugs in Viekira Pak will make re treating difficult or st least you may have to wait for newer drug generations. Resistance to NS3 and NS5A drugs is an emerging problem. Don't throw away a chance to SVR. It's too important. Cal 

[Cal]

Phily,
Excellent link. Thanks. Cal

[CHepCFree]

FDA has issued warning on viekira pak on October 22

http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm

[Lynn K]

Basically the warning applies to class B and C cirrhotics. Viekira Pak was already not recommended for class C cirrhosis.

"Viekira Pak is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh Class B & C).

Technivie is not indicated for use in patients with cirrhosis, and should not be used in patients with moderate and severe hepatic impairment (Child-Pugh Class B & C)."

[Ian]

Just an update, my treatment was successful I'm undetected! Also we Just had a healthy baby.  Of course everyone's situation is different, but as a type 1a I'm glad my Dr supported my choice to only take the viekira without the ribavarin. for me it was a lesson that you really do need to take an active role to ensure you're getting the right treatment for you as an individual, because sometimes the conventional thinking and FDA guidance reflects a "one size fits all" approach. Thanks for all the advice, this forum was such a valuable resource - I think doctors should tell people about this.

Thanks again!

34 years old
Gen 1a
Prior to treatment: 1.8 m viral load
6 months undetected

[Philadelphia]

Congratulations on both counts!

[andrew j]

What a lovely story!