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1752948 tn?1466354161

Standard of Care

Hello all.  A long time since i have posted or been at site for that matter.
I am Canadian. 9 weeks into a 12 week course of Harvoni. Fatigue headaches but manageable
I am considered treatment naive although did three weeks of Interferon back in 2012 before massive allergic reaction, . lol was not pretty.
Heavily cirrhotic. Fibrotic. Viral load 1.7 million when treatment started. Feel great for most part.
Here is the question
Is the American standard of care/treatment also 12 weeks for someone in my situation?  I have heard 24 weeks for cirrhotics with fibrosis in the States.
i have faith in my physician but with 19 pills left i would like some info upon which to base an argument if i feel i need an extension.   My viral load was 28 after four weeks. Apparently the criteria is 12 in the Staes after four weeks to suggest treatment effective. I was called borderline.

Thank you in advance for any replies
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1752948 tn?1466354161
Thank you Hector.  For your time and thoughts.  I hope that all is well for you.
Your compassion as always speaks well of you.
Helpful - 0
446474 tn?1446347682
COMMUNITY LEADER
There is no difference between treatment standards in the US and Canada.
12 weeks of Harvoni treatment is the standard duration treating for genotype 1, treatment naïve patients with or without cirrhosis as stated in the prescribing Harvoni label and the AASLD/IDSA treatment guidelines.

24 weeks without ribavirin is ONLY for treatment experienced patients.
Harvoni label - "Treatment - experienced with cirrhosis: 24 weeks"
12 weeks plus ribavirin can also be used instead of 24 weeks in most treatment experienced cirrhotic patients as well.

By the way...when you become undetectable (My viral load was 28 after four weeks) makes no difference in SVR rates.

AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C

INITIAL TREATMENT OF HCV INFECTION

Ledipasvir/sofosbuvir was approved by the FDA for the treatment of HCV genotype 1 infection in treatment-naive patients based on 2 registration trials: ION-1(865 treatment-naive patients; those with cirrhosis were included) and ION-3 (647 treatment-naive patients; those with cirrhosis were excluded).

ION-1 investigated length of treatment (12 weeks vs 24 weeks) and the need for RBV. Sustained virologic response at 12 weeks (SVR12) was 97% to 99% across all arms, with no difference in SVR based on length of treatment, use of RBV, or HCV genotype 1 subtype.

Sixteen percent of subjects enrolled were classified as having cirrhosis. There was no difference in SVR12 in those with cirrhosis (97%) versus those without cirrhosis (98%).

Harvoni Label info…

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HARVONI safely and effectively.
------------------------
DOSAGE AND ADMINISTRATION
Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food.

Recommended treatment duration:
Treatment - naïve with or without cirrhosis: 12 weeks

Good luck with achieving SVR and cure.
Hector
Helpful - 0
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