DAA-Experienced (Including NS5A Inhibitors), Genotype 3 Patients With or Without Compensated Cirrhosis

Recommended regimen for:

DAA-Experienced (Including NS5A Inhibitors), Genotype 3 Patients With or Without Compensated Cirrhosisa

RECOMMENDED DURATION RATING
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/ voxilaprevir (100 mg) 12 weeks I, A

For patients with prior NS5A inhibitor failure and cirrhosis, weight-based ribavirin is recommended. 12 weeks IIa, C
a For decompensated cirrhosis, please refer to the appropriate section.

 

Recommended Regimen

Sofosbuvir/Velpatasvir/Voxilaprevir ± Ribavirin

The phase 3 POLARIS-1 and POLARIS-4 trials included patients with genotype 3 infection, without cirrhosis or with compensated cirrhosis, who had previously received a DAA regimen, with or without an NS5A inhibitor. The POLARIS-4 study included treatment-experienced patients who had previously received a DAA regimen but not an NS5A inhibitor. Participants were randomized to 12 weeks of the daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100 mg) (54 with genotype 3 infection) or 12 weeks of sofosbuvir/velpatasvir (52 with genotype 3 infection). SVR rates for the genotype 3-infected patients were 96% (52/54) and 85% (44/52), respectively. The 8 patients who experienced a relapse in the sofosbuvir/velpatasvir arm were primarily white males with compensated cirrhosis (7/8) and a high BMI (>25). Although none had baseline Y93H variants, all had emergence of Y93H variants at the time of relapse (Bourliere, 2017).

The POLARIS-1 study included patients who had previously received a regimen containing an NS5A inhibitor. Participants were randomized to 12 weeks of sofosbuvir/velpatasvir/voxilaprevir (78 with genotype 3 infection) versus placebo. The SVR12 rate was 95% (74/78) for the genotype 3-infected patients. All 4 patients who experienced a relapse had cirrhosis (Bourliere, 2017). These data support the use of sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in all DAA-experienced patients. However, in NS5A inhibitor-experienced genotype 3-infected patients with cirrhosis, the relapse rate is higher and adding weight-based ribavirin is recommended to minimize relapse risk.

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Last update: 
September 21, 2017
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