Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy

Summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.

Timeline

Start

2015-11-16

Primary completion

2016-10-10

Completion

2017-01-11

Outcome

Missed primary endpoint

paper this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir PMID 28390869 ↗

registry Difference in proportions -3.2 (95% CI -6.0 to -0.4) NCT02607800 ↗

release “The POLARIS-2 study did not meet its primary endpoint” gilead.com ↗

Publications

• Results Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.
• Results Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	SOF/VEL	Unknown	100 mg	Oral
Comparator	SOF/VEL	Unknown	400 mg	Oral
Subject	SOF/VEL/VOX	Unknown	100 mg	Oral
Subject	SOF/VEL/VOX	Unknown	400 mg	Oral

Indications