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CASL HCV is an app intended to help the user access and navigate the 2015 CONSENSUS GUIDELINES from the CANADIAN ASSOCIATION FOR THE STUDY OF THE LIVER for the management of chronic hepatitis C.
Source: Myers RP, Shah H, Burak KW, Cooper C, Feld JJ. An update on the management of chronic hepatitis C: 2015 Consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol Hepatol 2015; 29(1):1 9-34. Epub 2015 Jan 13.
IFN Free 2
SOF / LDV + RBV
The single tablet regimen of SOF/LDV has been studied in patients with HCV genotype 3 in the open-label, phase 2, ELECTRON-2 trial conducted in two centres in New Zealand . In this study, 51 treatment-naïve patients (16% with cirrhosis) were randomized to 12 weeks of SOF/LDV with or without weight-based RBV. Fifty treatment-experienced patients (44% with cirrhosis) all received SOF/LDV plus RBV. Among treatment-naïve patients, SVR12 rates were 64% (16/25) in the SOF/LDV group and 100% (26/26) in those who received SOF/LDV plus RBV. In treatment-experienced patients treated with SOF/LDV/RBV for 12 weeks, non-cirrhotic patients had higher SVR12 rates than those with cirrhosis (89% [25/28] vs. 73% [16/22]). LDV has limited activity against genotype 3 HCV in vitro , therefore, although SOF/LDV is a potential therapeutic option in these patients, additional data in diverse populations are necessary before it can be recommended as first-line therapy over other SOF-containing regimens.
PEG-IFN + RBV + SOF
SOF, PEG-IFN, and weight-based RBV administered for 12 weeks was studied in patients with HCV genotype 3 who failed prior therapy in a small, open-label phase 2 study . Among 24 patients, 12 of whom had cirrhosis, an SVR12 rate of 83% (20/24) was observed. There was no difference in response between cirrhotic and non-cirrhotic patients (83% [10/12] in both groups).
39. In cirrhotic, treatment-experienced patients with HCV genotype 3, SOF (400 mg daily) should be given with PEG-IFN and weight-based RBV for 12 weeks (Class 1, Level B).
IFN Free 1
PTV-R / OBV + RBV
The fixed-dose combination of the ritonavir-boosted, NS3/4A PI PTVR and the NS5A inhibitor OBV was studied in patients with HCV genotype 4 in the PEARL-I study . Treatment-naïve patients were randomized to receive PTVR/OBV with or without weight-based RBV for 12 weeks; all treatment-experienced patients received RBV. Nearly all patients (93%) in this study had mild fibrosis (F0-F2) and none had cirrhosis. Among subjects who received PTVR/OBV plus RBV, all treatment-naïve (42/42) and treatment-experienced patients (41/41) achieved an SVR12. However, the SVR12 rate was lower (91% [40/44]) among treatment-naïve patients randomized to the RBV-free regimen, suggesting that RBV is necessary with this drug combination. The safety profile of PTVR/OBV plus RBV was similar to that observed in patients with HCV genotype 1 who were also treated with DSV [14,15].
40. Patients with HCV genotype 4 should be treated with co-formulated PTVR/OBV plus weight-based RBV or SOF/LDV alone for 12 weeks (Class 1, Level B).
IFN Free 1
SOF + RBV
In the phase 3 FISSION trial , SOF (400 mg daily) in combination with weight-based RBV for 12 weeks or PEG-IFN/RBV (800 mg daily) for 24 weeks were administered to 359 treatment-naïve patients with HCV genotype 3. Overall, an SVR12 was observed in 56% (102/183) of patients randomized to receive SOF/RBV compared with 63% (110/176) in those treated with PEG-IFN/RBV. This difference was not statistically significant. In light of the sub-optimal responses observed with a 12-week SOF/RBV regimen in this trial, the VALENCE trial examined a 24-week course in patients with HCV genotype 3 . Among treatment-naïve patients, 94% (99/105) achieved an SVR12; responses did not differ between cirrhotic (92% [12/13]) and non-cirrhotic patients (95% [87/92]).
SOF/RBV combination therapy has also been studied in treatment-experienced patients with HCV genotype 3. In the FUSION phase 3 trial , 127 patients who had failed prior treatment were randomized to 12 or 16 weeks of SOF and weight-based RBV. Overall, SVR12 rates were 30% (19/64) and 62% (39/63) in the 12- and 16-week groups, respectively. The presence of cirrhosis was a strong negative predictor of response in patients treated for 12 weeks; only 19% (5/26) of cirrhotic patients and 37% (14/38) of non-cirrhotic patients had an SVR12 with this regimen. In the 16-week treatment arm, SVR12 rates were 61% (14/23) among patients with cirrhosis and 63% (25/40) in those without cirrhosis. In this trial, the primary mode of treatment failure was relapse, which was observed among 66% (42/64) of patients treated for 12 weeks and 38% (24/63) of those treated for 16 weeks. Therefore, the VALENCE trial examined a longer course (24 weeks) of SOF/RBV therapy in 145 treatment-experienced patients with HCV genotype 3 . Among 98 non-cirrhotic patients in this trial, an SVR12 was observed in 85 (87%). However, only 62% (29/47) of patients with cirrhosis had an SVR12. Based on this data, alternative treatment options are necessary in cirrhotic, treatment-experienced patients with HCV genotype 3.
Patients with Genotype 4, 5 and 6
There is limited data to guide treatment decision-making for patients with HCV genotypes 4, 5, or 6 due to the small numbers of patients enrolled in phase 3 clinical trials. In Canada, these genotypes are present in less than 1% of cases . Although the first generation PIs, BOC and TVR, do not have clinically significant activity against genotypes 4, 5, or 6, SOF  and SIM  have activity against all of these genotypes. However, due to a paucity of published data, Health Canada and the U.S. FDA have approved only SOF for the treatment of HCV genotype 4.
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