Hep C Discussion Forum

I would absolutely fight for that next 4 weeks. It is expected that the virus will be undetected as long as you are taking the Harvoni, but the real test is whether or not you stay undetected after you complete treatment. If you have cirrhosis, you have to do more time on the drugs. Miss B is right with the info she quotes here. If you are still on the Harvoni, the new test will also show undetected. But with your high viral load, you may not stay undetected once you quit treatment.

Your VL was far above 6 million so you need the full 12 weeks! The Harvoni Prescribing Information says that 8 weeks can be considered, but it doesn't say that it is recommended.

* HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14)].  

But, the 8 week protocol is not endorsed by the AASLD. Please read the following from the updated AASLD HCV Guidelines & share with your doctor if he/she has any questions (or like my dr., doesn't read about hcv). The Clinical Studies (14) noted above refers to the ION-3 Trial.  The following quote explains why the AASLD is not comfortable with the post-hoc analysis from the ION-3 Trial & why the they advise caution when considering less than 12 weeks.

http://www.hcvguidelines.org/node/71

 ION-3 excluded patients with cirrhosis and investigated shortening therapy from 12 weeks to 8 weeks (with or without RBV). (Kowdley, 2014) SVR12 was 93% to 95% across all arms, with no difference in SVR in the intention-to-treat analysis. However, relapse rates were higher in the 8-week arms (20 of 431) regardless of RBV use compared with the 12-week arm (3 of 216). Post hoc analyses of the 2 RBV-free arms assessed baseline predictors of relapse and identified lower relapse rates in patients receiving 8 weeks of ledipasvir/sofosbuvir who had baseline HCV RNA levels below 6 million IU/mL (2%; 2 of 123), and was the same for patients with similar baseline HCV RNA levels who received 12 weeks (2%; 2 of 131). This analysis was not controlled and thus substantially limits the generalizability of this approach to clinical practice. Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner.

Hi Julia,

First of all congrats on the undetected status. Yes it would wise for you to complete the 12 weeks of treatment. If you are treatment naive and non-cirrhotic then

an 8 week treatment is only recommended if your viral load is <6,000,000 which yours was twice that so you need the extra 4 weeks of treatment to make sure

every single HCV RNA viral particle is eliminated.

Julia?

That's great news 8 weeks UND and no real side affects. That's treatment at its best. If you look deeper here there are lots of discussions about complying with the recommended treatment duration, and the varying factors are geno type liver damage and weather or not you have been treated and relapsed before. There are many people here much more knowledgeable than me but having relapsed 3 times myself I wouldn't chance it. The insurance companies are giving resistance to pay sometimes But there are also many people here who are fighting it and getting their meds as needed. Its expensive however if not complying opens the door to relapse who stars paying the second time? Having your doctors advocate and fight with you and appeal is where most people are going. You'll see a few individuals posting about their battles with appealing insurance and what they did and are doing. Post some questions about it you'll get as much as this group can offer telling our stories and struggles. This is a wonderful place with a lot of caring people. Good Luck

Bill s