lower your expenses [LLOQ:<1% (1/263) 1% (1/101) 0/45 1% (1/150) 0/5 0/78 0/22 0/1 0/6 Relapse 2% (6/261) 1% (1/100) 0/45 1% (1/149) 0/5 5% (4/78) 5% (1/21) 0/1 0/6 Other 1% (3/263) 2% (2/101) 0/45 1% (2/150) 0/5 0/78 5% (1/22) 0/1 0/6 DAA-Experienced Adults Without Cirrhosis or With Compensated Cirrhosis Who Had Not Received An NS5A Inhibitor (POLARIS-4) POLARIS-4 was a randomized, open-label trial that evaluated 12 weeks of treatment with Vosevi and 12 weeks of treatment with SOF/VEL in subjects with genotype 1, 2, 3, or 4 HCV infection without cirrhosis or with compensated cirrhosis who had previously failed a HCV DAA-containing regimen that did not include an NS5A inhibitor. Subjects whose only DAA exposure was an NS3/4A protease inhibitor were excluded. Subjects with genotype 1, 2, or 3 HCV infection were randomized 1:1 to each group. Randomization was stratified by HCV genotype and by the presence or absence of cirrhosis. Subjects with genotype 4 HCV infection were enrolled to the Vosevi group. No subjects with genotype 5 or 6 were enrolled. Demographics and baseline characteristics were generally balanced across treatment groups. Of the 333 treated subjects, the median age was 58 years (range: 24 to 85); 77% of the subjects were male; 87% were White, 9% were Black; 8% were Hispanic or Latino; 35% had a baseline body mass index at least 30 kg/m 2 ; 81% had non-CC IL28B genotypes (CT or TT); 75% had baseline HCV RNA levels at least 800,000 IU/mL; and 46% had compensated cirrhosis. In the POLARIS-4 trial, prior DAA regimens contained sofosbuvir (85%) with the following: peginterferon alfa and ribavirin or ribavirin (69%), HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir; 15%) and investigational DAA (> <1%). Of the 15% of subjects without prior sofosbuvir exposure, most received investigational HCV DAAs or approved HCV NS3/4A protease inhibitors, with or without peginterferon alfa and ribavirin. Treatment with Vosevi for 12 weeks resulted in numerically higher SVR12 rates than treatment with sofosbuvir/velpatasvir for 12 weeks in subjects with HCV genotype 1a and 3 infection. Comparable SVR12 rates were observed in subjects with HCV genotype 1b and 2 infection treated with Vosevi for 12 weeks or with sofosbuvir/velpatasvir for 12 weeks. No comparison data are available for HCV genotypes 4, 5, and 6. Given these data, the additional benefit of Vosevi has not been shown over sofosbuvir/velpatasvir for these genotypes and Vosevi is only indicated for the treatment of HCV genotypes 1a or 3 infection in adults who previously received sofosbuvir without an NS5A inhibitor. Table 10 presents the comparative virologic outcome data for HCV genotype 1, 2, and 3 subjects with prior exposure to a sofosbuvir-containing regimen. Table 10 POLARIS-4 Trial: Virologic Outcomes by HCV Genotype in Vosevi-Treated Subjects* and SOF/VEL-Treated Subjects* Without Cirrhosis or With Compensated Cirrhosis (12 Weeks After Treatment) *Subjects with prior exposure to a SOF-containing regimen Vosevi 12 Weeks (N=139) SOF/VEL 12 Weeks (N=125) * The denominator for relapse is the number of subjects with HCV RNA>
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