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Official Title Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
Phase Phase III
ClinicalTrials.gov NCT02201940
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015;373:2599-607.
Official Title Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Phase Phase III
ClinicalTrials.gov NCT02220998
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373:2608-17.
Official Title Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Phase Phase III
ClinicalTrials.gov NCT02201953
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373:2608-17.
Official Title Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
Phase Phase III
ClinicalTrials.gov NCT02201901
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Curry MP, O'Leary JG, Bzowej N, et al. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015;373:2618-28.
Official Title Sofosbuvir and Velpatasvir for the Treatment of HCV in Patients Coinfected with HIV-1: an Open-Label, Phase 3 Study
Phase Phase III
ClinicalTrials.gov NCT02480712
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Wyles D, Bräu N, Kottilil S, et al. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017;65:6-12.
- Younossi ZM, Stepanova M, Sulkowski M, Wyles D, Kottilil S, Hunt S. Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL-5 study. Liver Int. 2017;37:1796-1804.
Official Title A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Study
Phase Phase IV
ClinicalTrials.gov NCT03512210
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
Non-IndustryUS National Institutes of Health
References
- Solomon SS, Wagner-Cardoso S, Smeaton L, et al. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022;7:307-17.
Official Title Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials
Phase Phase III
ClinicalTrials.gov NCT02607800
Treatments
Sofosbuvir-Velpatasvir
, Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedSofosbuvir-Velpatasvir-Voxilaprevir
Sofosbuvir-Velpatasvir-Voxilaprevir
Tradename:VoseviOther Names:SOF-VEL-VOXClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017;153:113-22.
Official Title Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Phase Phase III
ClinicalTrials.gov NCT02639338
Treatments
Sofosbuvir-Velpatasvir
, Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedSofosbuvir-Velpatasvir-Voxilaprevir
Sofosbuvir-Velpatasvir-Voxilaprevir
Tradename:VoseviOther Names:SOF-VEL-VOXClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017;153:113-22.
Official Title Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis
Phase Phase II
ClinicalTrials.gov NCT02781558
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Esteban R, Pineda JA, Calleja JL, et al. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018;155:1120-7.e4.
Official Title Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial
Phase Phase III
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Takehara T, Sakamoto N, Nishiguchi S, et al. Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial. J Gastroenterol. 2019;54:87-95.
Official Title Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
Phase Phase II
ClinicalTrials.gov NCT03036852
Treatments
Sofosbuvir-Velpatasvir
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences
References
- Borgia SM, Dearden J, Yoshida EM, et al. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019;71:660-665.
Sofosbuvir-Velpatasvir Slide Deck
July 28, 2022
Clinical Trial Image Decks
ASTRAL-1 - June 30, 2022
ASTRAL-2 - June 30, 2022
ASTRAL-3 - June 30, 2022
ASTRAL-4 - June 30, 2022
ASTRAL-5 - July 28, 2022
MINMON (ACTGA5360) - June 30, 2022
POLARIS-2 - June 30, 2022
POLARIS-3 - June 30, 2022
Sofosbuvir-Velpatasvir in Patients with Compensated Cirrhosis and HCV Genotype 3 (Spain) PDF Sofosbuvir-Velpatasvir in Patients with Compensated Cirrhosis and HCV Genotype 3 (Spain) PPTX
Sofosbuvir-Velpatasvir in Patients with Compensated Cirrhosis and HCV Genotype 3 (Spain) - June 30, 2022
Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) PDF Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) PPTX
Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) - June 30, 2022
Sofosbuvir-Velpatasvir in Patients with ESRD on Dialysis PDF Sofosbuvir-Velpatasvir in Patients with ESRD on Dialysis PPTX
Sofosbuvir-Velpatasvir in Patients with ESRD on Dialysis - June 30, 2022