Hep C Discussion Forum

"Off label" simply means it's not a recognized treatment protocol, even though it's a viable one. The trials of Sovaldi and Olysio fell short of completion and that was due to fighting between the manufacturers. The trials only progressed through phase 2 and a very small number of patients. Since the trials were incomplete, any prescribing of the combination is considered "off label" because no official approval of the combination was made. But real life use of the combination has proven it's effectiveness and people that have justified cause to use it have seen their doctors request it and their insurance approve it. It's a very effective treatment option and those prescribed it should be considered very fortunate in my opinion.

Tig

Hi there Omna

Your very lucky to on that treatment. STICK TO IT. Don't second guess "what if".  At first when I read this I thought you were pulling our legs. Just go back some pages on this on treatment thread to the old triple tx side effects and find out just how lucky you are. 

Best wishes for you.

Tig:  You are so diplomatic and thoughtful.  Me, not so much.

Omna:  Hold on for a minute while I smack you (kidding).  You are already on the Sov/Oly tx and from what you have said are doing well, but for some worries about not being able to spend as much time as you want in the sun.  

Keep taking your meds, (yes, both of them) watch out for the sun,  and consider yourself very fortunate for the opportunity to be able to get rid of this beast without the use of interferon and riba.  No point in second guessing yourself.  Btw, try getting Sovaldi a second time after you have willfully not complied with tx the first time.   Either your doctor or your insurance company may actually smack you.  I say this with love.  

I think Sov/Oly is a fantastic protocol! It's offering opportunities that we have never seen before and I think anyone that has qualified and been approved for it, has high rates of success on their side. You haven't mentioned anything other than your genotype, so any additional lab results, AST, ALT, CBC and your biopsy or fibroscan results will help us provide better informed opinions. Have you treated before and if so what and when? You may have seen the info some of us put in our signature section. It helps people relate to you and your questions when replying. That's up to you, but it helps. 

Waiting for one treatment or another depends on several factors. Until these new treatments came available, we didn't have many options. I treated first in 1996 and waited until last year for something better. I still had to go through 28 weeks of hell, so anyone that can take these new treatments for 12 weeks with minimal side effects and the high rates of success should grasp the opportunity. The decision to wait is up to you and your doctor. Yes, Sov/Led will be the next big blockbuster on the market with high rates of success. But 6 months ago, Sovaldi and Olysio with other combinations, held that same exalted position. The truth is that we're going to see continued improvements and introductions into the anti viral market. The right choice is the one that feels right to you and your doctor. You might be healthy enough to wait for Sov/Led, but when it's released, then what? There will likely be another "blockbuster" soon to be released after that. Do you wait for it? The longer you wait, the longer HCV grows inside you and the more damage is done. I would take the opportunity to treat based on the available options, rates of success and your desire to get this part of your life behind you. Good luck!

Tig

Hello, 

Ledispavir isn't approved by the FDA for use yet. It's still in trial use, but has been fast tracked for FDA approval. The current approval timeline appears to be set for this coming Fall, Oct/Nov. They will be using Ledispavir and Sovaldi together in a single, once daily oral pill. During the trial phases, they typically combine these drugs with other available medications to determine what's most effective. The use of Sovaldi and Olysio with and without Ribavirin, is currently considered off label (unapproved) but still administered to those felt to be Interferon intolerant because it is quite effective. Some insurance companies are willing to approve it while others refuse. It's all about the price. Sov/Led will be a most effective combo according to published reports.

As far as the sun sensitivity from Olysio, this is just a side effect of the drug and it affects some worse than others. I don't know if Ledispavir will have that same side effect, but I don't think the approval of either drug was/will be considered solely on that. Proper care and consideration for that side effect appears to be enough to control it.

SVR= Sustained Viral Response: it means that you maintain an undetected viral load following treatment for an established amount of time. The longer you maintain a SVR, the lower your rate of relapse. For example, I achieved SVR 12, which means I'm still undetected following the 12th week after treatment ended. The risk for relapse after SVR12 is 1% or less. They associate the term with the C word (cure)! We have a good list of abbreviations in our New Members section. You can find it on our home page or you can use the search function to find it.

Tig

Hi J,

Isis is correct, Sovaldi must not be used as a single mono therapy agent. To do so would be a waste of $84,000.00 and likely you wouldn't be able to purchase it from any pharmacy without a secondary agent. Also, Sov/Led is going to be a blockbuster agent and will be a single pill. There won't be the issue of "Off Label" prescribing that is currently being seen with Sov/Oly due to the fact they are made by different manufacturers.  The success rates of Sov/Led is without question going to offer as high or higher rates of SVR according to published trial data. But either treatment protocol is extremely effective. Many are choosing to wait for the release and approval of the Gilead combo this coming fall. Good luck...

Tig

SOVALDI MONOGRAPH 

INDICATIONS AND CLINICAL USE 

SOVALDI (sofosbuvir) is indicated for the treatment of chronic hepatitis C virus (CHC) 

infection in adult patients with compensated liver disease, including cirrhosis, as follows: 

For the treatment of genotype 1 and genotype 4 CHC infection in combination 

with pegylated interferon and ribavirin; 

For the treatment of genotype 2 and genotype 3 CHC infection in combination 

with ribavirin. 

The following points should be considered when initiating treatment with SOVALDI: 

SOVALDI must not be administered as monotherapy (see WARNINGS AND 

PRECAUTIONS, General). 

Treatment regimen and duration are dependent on both viral genotype and patient 

population (see DOSAGE AND ADMINISTRATION). 

Treatment response varies based on baseline host and viral factors. 

Omnamahshivaya wrote:

---

Thank you too! I'm wondering if I could just take Solvaldi without Olysio -- if it'd work? Then I don't have to avoid the sun with my son! :p

---

 No, please don't!  Sovaldi is not designed to be used as a monotherapy.

Hello J

Welcome to the forum from me as well, you have found a good place to gain insight to all things HCV.  Sovaldi is a powerhouse of a drug to deal with Hep-C, stay steady with the program and all will work out.

matt

Hi J,

Welcome to the forum!! So glad you're with us. We have several people on your treatment plan and I'm sure you're going to receive plenty of hello's shortly. It's a very effective treatment plan and we're seeing one early report of undetectable tests after another on these drugs. It's a great time to treat!

Olysio does warn against sun exposure and I suggest you listen carefully to the warning. I've seen some not affected as badly as others, but you can experience severe sunburns from it in short periods of time. Be very cautious outside, use a good SPF 15 or higher sunscreen if you'll be outside and most important of all, wear good UV protective sun glasses!! Limit your time in the sun and heat, as you will be susceptible to both. 

If you have any questions at all, please ask. You can also use the search function at the top of each page. We've got a lot of great information available. Talk to you soon! Good luck!

Tig