Aa
Why 12 week, then 24 week?
Wondering why non-naive treatment patients with early stages of cirrhosis (like me) need to take Harvoni a full 24 weeks, rather than 16 or 20 weeks? Is it just because that's the time frame of studies?
In your situation (treatment experienced who have Cirrhosis) the SVR rate (cure rate) is much higher if you take the Harvoni for 24 weeks (as opposed to a shorter period of time). They did studies to determine the length of treatment time needed.
Recommendations from the AASLD (American Assoc. for the Study of Liver Disease):
Recommended regimens for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Ledipasvir/sofosbuvir has been evaluated in patients with and without cirrhosis in whom prior treatment with PEG-IFN and RBV, with or without HCV protease inhibitors (telaprevir or boceprevir), failed. In the ION-2 study, patients who had not responded to prior PEG-IFN and RBV were treated with ledipasvir/sofosbuvir. This regimen was given for 12 weeks or 24 weeks, with or without RBV. In the population without cirrhosis, the overall response rate was 98% (95% confidence interval [CI], 96%-99%). Specifically, in patients without cirrhosis who did not respond to PEG-IFN and RBV, 33 of 35 (94%) achieved a sustained virologic response (SVR) after treatment with ledipasvir/sofosbuvir alone, and 38 of 38 (100%) patients achieved SVR after treatment with ledipasvir/sofosbuvir and RBV. (Afdhal, 2014b) This regimen was well tolerated in all groups, with no serious adverse events reported in the 12-week regimen with or without RBV. In the population with cirrhosis, patients treated for 24 weeks had higher SVR rates than those treated for 12 weeks, supporting the recommendation that HCV treatment–experienced patients with cirrhosis receive 24 weeks of treatment without RBV.
In SIRIUS, a double-blind placebo-controlled French study, patients with cirrhosis who did not respond to PEG-IFN and RBV plus telaprevir or boceprevir, were randomized to receive placebo for 12 weeks followed by ledipasvir/sofosbuvir plus RBV for 12 weeks or ledipasvir/sofosbuvir plus placebo for 24 weeks. The SVR rate was similar in each group, 74 of 77 (96%) in the group that received ledipasvir/sofosbuvir plus RBV for 12 weeks (3 patients with relapse) and 75 of 77 (97%) in the group that received ledipasvir/sofosbuvir for 24 weeks (2 patients with relapse). This observation was further supported by a meta-analysis of treatment-naive and -experienced patients with cirrhosis who were treated with ledipasvir/sofosbuvir in phase II and III studies (including the SIRIUS study). In this analysis, ledipasvir/sofosbuvir for 12 weeks was inferior to ledipasvir/sofosbuvir for 24 weeks and ledipasvir/sofosbuvir plus RBV for 12 weeks; no difference in SVR was detected between the latter 2 groups. Safety and tolerability were similar in each group, and with the exception of anemia, reported adverse events did not differ substantially between patients treated with or without RBV. (Bourliere, 2014a); (Bourliere, 2014b)
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Recommendations from the AASLD (American Assoc. for the Study of Liver Disease):
Recommended regimens for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
Ledipasvir/sofosbuvir has been evaluated in patients with and without cirrhosis in whom prior treatment with PEG-IFN and RBV, with or without HCV protease inhibitors (telaprevir or boceprevir), failed. In the ION-2 study, patients who had not responded to prior PEG-IFN and RBV were treated with ledipasvir/sofosbuvir. This regimen was given for 12 weeks or 24 weeks, with or without RBV. In the population without cirrhosis, the overall response rate was 98% (95% confidence interval [CI], 96%-99%). Specifically, in patients without cirrhosis who did not respond to PEG-IFN and RBV, 33 of 35 (94%) achieved a sustained virologic response (SVR) after treatment with ledipasvir/sofosbuvir alone, and 38 of 38 (100%) patients achieved SVR after treatment with ledipasvir/sofosbuvir and RBV. (Afdhal, 2014b) This regimen was well tolerated in all groups, with no serious adverse events reported in the 12-week regimen with or without RBV. In the population with cirrhosis, patients treated for 24 weeks had higher SVR rates than those treated for 12 weeks, supporting the recommendation that HCV treatment–experienced patients with cirrhosis receive 24 weeks of treatment without RBV.
In SIRIUS, a double-blind placebo-controlled French study, patients with cirrhosis who did not respond to PEG-IFN and RBV plus telaprevir or boceprevir, were randomized to receive placebo for 12 weeks followed by ledipasvir/sofosbuvir plus RBV for 12 weeks or ledipasvir/sofosbuvir plus placebo for 24 weeks. The SVR rate was similar in each group, 74 of 77 (96%) in the group that received ledipasvir/sofosbuvir plus RBV for 12 weeks (3 patients with relapse) and 75 of 77 (97%) in the group that received ledipasvir/sofosbuvir for 24 weeks (2 patients with relapse). This observation was further supported by a meta-analysis of treatment-naive and -experienced patients with cirrhosis who were treated with ledipasvir/sofosbuvir in phase II and III studies (including the SIRIUS study). In this analysis, ledipasvir/sofosbuvir for 12 weeks was inferior to ledipasvir/sofosbuvir for 24 weeks and ledipasvir/sofosbuvir plus RBV for 12 weeks; no difference in SVR was detected between the latter 2 groups. Safety and tolerability were similar in each group, and with the exception of anemia, reported adverse events did not differ substantially between patients treated with or without RBV. (Bourliere, 2014a); (Bourliere, 2014b)
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
I take it that you are "Non naïve" and they want to be sure you cure. It's an individual thing. Are they just following protocol from Gilead?
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