Thursday, May 18, 2017

The Changing HCV Landscape: Pangenotypic Regimens

Review Articles
MAY 18, 2017

The Changing HCV Landscape: Update on Treatment

Toward the Future: Pangenotypic Regimens

A novel once-daily RBV-free doublet regimen of ABT-493 (a protease inhibitor) and ABT-530 (an NS5A inhibitor) was studied in an intent-to-treat population of treatment-naive and treatment-experienced patients for 8 to 12 weeks (phase 2 SURVEYOR-1 and SURVEYOR-2). Both drugs are second-generation members of their respective classes, with pangenotypic coverage and coverage of most or all known RAVs relevant to their classes. The results are summarized as follows: SVR12 by 97% to 98% with 8 weeks of treatment in GT1 and GT2 noncirrhotic patients by intention-to-treat analysis,64 96% SVR12 in GT1 patients with cirrhosis treated for 12 weeks,65 and 100% SVR4 for patients with GT4-6 without cirrhosis treated for 12 weeks.66 Additional studies in GT3 patients yielded SVR12 in 97% of noncirrhotics treated for 8 weeks,67 and 100% in cirrhotics treated for 12 weeks.68 These data from phase 2 trials reflect the potential for this regimen to be available in the future as a truly pangenotypic regimen without RBV if phase 3 trials recapitulate these results. A fixed-dose coformulated regimen consisting of SOF-VEL and GS-9857 (a second-generation NS5A inhibitor) received breakthrough therapy designation by the FDA for the treatment of chronic GT1 patients who have previously failed an NS5A-containing regimen. Lawitz et al treated 128 GT1-6 patients, mostly with GT1-3, including 48% with cirrhosis for 12 weeks with the triplet regimen.69 Nearly 80% of patients had prior DAA exposure, including 63 of 63 GT1 patients (100%), and 60% had baseline RAVs. Overall, 127 of 128 (99%) attained SVR12, with the only virologic failure in a GT3 patient. Of 35 patients with prior NS5A exposure, all had SVR12.

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