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Ira M Jacobson - One of the best experts on this subject based on the ideXlab platform.
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efficacy of 8 weeks of sofosbuvir velpatasvir and voxilaprevir in patients with chronic hcv infection 2 phase 3 randomized trials
Gastroenterology, 2017Co-Authors: Ronald Nahass, Ira M Jacobson, Sergio Borgia, Peter Ruane, Bernard Willems, Eric Lawitz, Edward Gane, Stephen D. Shafran, Kimberly A. WorkowskiAbstract:Background & Aims Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). Methods In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. Polaris-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. Polaris-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. Results In Polaris-2, 95% (95% confidence interval [CI], 93%–97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%–99%; difference in the stratum-adjusted Mantel–Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In Polaris-3, 96% of patients (95% CI, 91%–99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by patients receiving voxilaprevir. In both trials, the proportion of patients who discontinued treatment because of adverse events was low (range, 0%–1%). Conclusions In phase 3 trials of patients with HCV infection, we did not establish that sofosbuvir-velpatasvir-voxilaprevir for 8 weeks was noninferior to sofosbuvir-velpatasvir for 12 weeks, but the 2 regimens had similar rates of SVR in patients with HCV genotype 3 and cirrhosis. Mild gastrointestinal adverse events were associated with treatment regimens that included voxilaprevir. ClinicalTrials.gov numbers: Polaris-2, NCT02607800; and Polaris-3, NCT02639338.
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sof vel vox results in high svr12 rates when administered for 12 weeks in daa experienced patients or for 8 weeks in daa naive patients an integrated analysis of the Polaris 1 Polaris 2 Polaris 3 and Polaris 4 studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, Alexander J. Thompson, Stefan Zeuzem, Rajender K Reddy, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
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SOF/VEL/VOX Results in High SVR12 Rates when Administered for 12 Weeks in Daa-Experienced Patients or for 8 Weeks in Daa-Naïve Patients: An Integrated Analysis of the Polaris-1, Polaris-2, Polaris-3 and Polaris-4 Studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, K. Rajender Reddy, Alexander J. Thompson, Stefan Zeuzem, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
Swarup S. Mehta - One of the best experts on this subject based on the ideXlab platform.
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sof vel vox results in high svr12 rates when administered for 12 weeks in daa experienced patients or for 8 weeks in daa naive patients an integrated analysis of the Polaris 1 Polaris 2 Polaris 3 and Polaris 4 studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, Alexander J. Thompson, Stefan Zeuzem, Rajender K Reddy, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
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SOF/VEL/VOX Results in High SVR12 Rates when Administered for 12 Weeks in Daa-Experienced Patients or for 8 Weeks in Daa-Naïve Patients: An Integrated Analysis of the Polaris-1, Polaris-2, Polaris-3 and Polaris-4 Studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, K. Rajender Reddy, Alexander J. Thompson, Stefan Zeuzem, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
Peter Ruane - One of the best experts on this subject based on the ideXlab platform.
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efficacy of 8 weeks of sofosbuvir velpatasvir and voxilaprevir in patients with chronic hcv infection 2 phase 3 randomized trials
Gastroenterology, 2017Co-Authors: Ronald Nahass, Ira M Jacobson, Sergio Borgia, Peter Ruane, Bernard Willems, Eric Lawitz, Edward Gane, Stephen D. Shafran, Kimberly A. WorkowskiAbstract:Background & Aims Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). Methods In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. Polaris-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. Polaris-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. Results In Polaris-2, 95% (95% confidence interval [CI], 93%–97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%–99%; difference in the stratum-adjusted Mantel–Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In Polaris-3, 96% of patients (95% CI, 91%–99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by patients receiving voxilaprevir. In both trials, the proportion of patients who discontinued treatment because of adverse events was low (range, 0%–1%). Conclusions In phase 3 trials of patients with HCV infection, we did not establish that sofosbuvir-velpatasvir-voxilaprevir for 8 weeks was noninferior to sofosbuvir-velpatasvir for 12 weeks, but the 2 regimens had similar rates of SVR in patients with HCV genotype 3 and cirrhosis. Mild gastrointestinal adverse events were associated with treatment regimens that included voxilaprevir. ClinicalTrials.gov numbers: Polaris-2, NCT02607800; and Polaris-3, NCT02639338.
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sof vel vox results in high svr12 rates when administered for 12 weeks in daa experienced patients or for 8 weeks in daa naive patients an integrated analysis of the Polaris 1 Polaris 2 Polaris 3 and Polaris 4 studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, Alexander J. Thompson, Stefan Zeuzem, Rajender K Reddy, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
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SOF/VEL/VOX Results in High SVR12 Rates when Administered for 12 Weeks in Daa-Experienced Patients or for 8 Weeks in Daa-Naïve Patients: An Integrated Analysis of the Polaris-1, Polaris-2, Polaris-3 and Polaris-4 Studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, K. Rajender Reddy, Alexander J. Thompson, Stefan Zeuzem, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
Eric Lawitz - One of the best experts on this subject based on the ideXlab platform.
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efficacy of 8 weeks of sofosbuvir velpatasvir and voxilaprevir in patients with chronic hcv infection 2 phase 3 randomized trials
Gastroenterology, 2017Co-Authors: Ronald Nahass, Ira M Jacobson, Sergio Borgia, Peter Ruane, Bernard Willems, Eric Lawitz, Edward Gane, Stephen D. Shafran, Kimberly A. WorkowskiAbstract:Background & Aims Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). Methods In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. Polaris-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. Polaris-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. Results In Polaris-2, 95% (95% confidence interval [CI], 93%–97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%–99%; difference in the stratum-adjusted Mantel–Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In Polaris-3, 96% of patients (95% CI, 91%–99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by patients receiving voxilaprevir. In both trials, the proportion of patients who discontinued treatment because of adverse events was low (range, 0%–1%). Conclusions In phase 3 trials of patients with HCV infection, we did not establish that sofosbuvir-velpatasvir-voxilaprevir for 8 weeks was noninferior to sofosbuvir-velpatasvir for 12 weeks, but the 2 regimens had similar rates of SVR in patients with HCV genotype 3 and cirrhosis. Mild gastrointestinal adverse events were associated with treatment regimens that included voxilaprevir. ClinicalTrials.gov numbers: Polaris-2, NCT02607800; and Polaris-3, NCT02639338.
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sof vel vox results in high svr12 rates when administered for 12 weeks in daa experienced patients or for 8 weeks in daa naive patients an integrated analysis of the Polaris 1 Polaris 2 Polaris 3 and Polaris 4 studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, Alexander J. Thompson, Stefan Zeuzem, Rajender K Reddy, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
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SOF/VEL/VOX Results in High SVR12 Rates when Administered for 12 Weeks in Daa-Experienced Patients or for 8 Weeks in Daa-Naïve Patients: An Integrated Analysis of the Polaris-1, Polaris-2, Polaris-3 and Polaris-4 Studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, K. Rajender Reddy, Alexander J. Thompson, Stefan Zeuzem, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
Steven L. Flamm - One of the best experts on this subject based on the ideXlab platform.
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sof vel vox results in high svr12 rates when administered for 12 weeks in daa experienced patients or for 8 weeks in daa naive patients an integrated analysis of the Polaris 1 Polaris 2 Polaris 3 and Polaris 4 studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, Alexander J. Thompson, Stefan Zeuzem, Rajender K Reddy, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
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SOF/VEL/VOX Results in High SVR12 Rates when Administered for 12 Weeks in Daa-Experienced Patients or for 8 Weeks in Daa-Naïve Patients: An Integrated Analysis of the Polaris-1, Polaris-2, Polaris-3 and Polaris-4 Studies
Gastroenterology, 2017Co-Authors: Steven L. Flamm, Ira M Jacobson, Peter Ruane, Eric Lawitz, Stuart K. Roberts, Curtis Cooper, K. Rajender Reddy, Alexander J. Thompson, Stefan Zeuzem, Swarup S. MehtaAbstract:Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (Polaris-1 and Polaris-4) and DAA-naive (Polaris-2 and Polaris-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified, and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA ≥800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were ≥65 years old and 10% were black. Conclusions The Polaris-1, Polaris-2, Polaris-3, and Polaris-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.
