Abstract | BACKGROUND & AIMS: METHODS: 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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Authors | Ira M Jacobson, Eric Lawitz, Edward J Gane, Bernard E Willems, Peter J Ruane, Ronald G Nahass, Sergio M Borgia, Stephen D Shafran, Kimberly A Workowski, Brian Pearlman, Robert H Hyland, Luisa M Stamm, Evguenia Svarovskaia, Hadas Dvory-Sobol, Yanni Zhu, G Mani Subramanian, Diana M Brainard, John G McHutchison, Norbert Bräu, Thomas Berg, Kosh Agarwal, Bal Raj Bhandari, Mitchell Davis, Jordan J Feld, Gregory J Dore, Catherine A M Stedman, Alexander J Thompson, Tarik Asselah, Stuart K Roberts, Graham R Foster |
Journal | Gastroenterology
(Gastroenterology)
Vol. 153
Issue 1
Pg. 113-122
(07 2017)
ISSN: 1528-0012 [Electronic] United States |
PMID | 28390869
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Aminoisobutyric Acids
- Antiviral Agents
- Carbamates
- Cyclopropanes
- Heterocyclic Compounds, 4 or More Rings
- Lactams, Macrocyclic
- Macrocyclic Compounds
- Quinoxalines
- Sulfonamides
- voxilaprevir
- Proline
- Leucine
- velpatasvir
- Sofosbuvir
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Aminoisobutyric Acids
- Antiviral Agents
(administration & dosage, adverse effects, therapeutic use)
- Carbamates
(administration & dosage, adverse effects, therapeutic use)
- Cyclopropanes
- Drug Therapy, Combination
- Female
- Hepatitis C, Chronic
(drug therapy)
- Heterocyclic Compounds, 4 or More Rings
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Lactams, Macrocyclic
- Leucine
(analogs & derivatives)
- Macrocyclic Compounds
(administration & dosage, adverse effects, therapeutic use)
- Male
- Middle Aged
- Proline
(analogs & derivatives)
- Quinoxalines
- Sofosbuvir
(administration & dosage, adverse effects, therapeutic use)
- Sulfonamides
(administration & dosage, adverse effects, therapeutic use)
- Sustained Virologic Response
- Young Adult
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