Sofosbuvir-Velpatasvir (Epclusa)

Other Names: SOF-VEL

All Clinical Trials

All Clinical Trials
Resistance/Virological Failure
Pharmacology
- Adverse Effects

ASTRAL-1 Industry

Official Title Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection

Phase Phase III

ClinicalTrials.gov NCT02201940

Treatments

Sofosbuvir-Velpatasvir

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

ASTRAL-2 Industry

Official Title Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection

Phase Phase III

ClinicalTrials.gov NCT02220998

Treatments

Sofosbuvir-Velpatasvir

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

ASTRAL-3 Industry

Official Title Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection

Phase Phase III

ClinicalTrials.gov NCT02201953

Treatments

Sofosbuvir-Velpatasvir

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

ASTRAL-4 Industry

Official Title Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis

Phase Phase III

ClinicalTrials.gov NCT02201901

Treatments

Sofosbuvir-Velpatasvir

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

ASTRAL-5 Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]
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.
[PubMed Abstract]

MINMON (ACTGA5360) Non-Industry Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

POLARIS-2 Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Sofosbuvir-Velpatasvir-Voxilaprevir

Tradename:VoseviOther Names:SOF-VEL-VOXClass:FDA-Approved

Funding

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.
[PubMed Abstract]

POLARIS-3 Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Sofosbuvir-Velpatasvir-Voxilaprevir

Tradename:VoseviOther Names:SOF-VEL-VOXClass:FDA-Approved

Funding

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.
[PubMed Abstract]

Sofosbuvir-Velpatasvir in Patients with Compensated Cirrhosis and HCV Genotype 3 (Spain) Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

Sofosbuvir-Velpatasvir in Patients with ESRD on Dialysis Industry

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

Tradename:EpclusaOther Names:SOF-VELClass:FDA-Approved

Funding

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.
[PubMed Abstract]

Sofosbuvir-Velpatasvir Slide Deck

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July 28, 2022

Clinical Trial Image Decks

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ASTRAL-1 - June 30, 2022

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ASTRAL-2 - June 30, 2022

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ASTRAL-3 - June 30, 2022

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ASTRAL-4 - June 30, 2022

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ASTRAL-5 - July 28, 2022

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MINMON (ACTGA5360) - June 30, 2022

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POLARIS-2 - June 30, 2022

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POLARIS-3 - June 30, 2022

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Sofosbuvir-Velpatasvir in Patients with Compensated Cirrhosis and HCV Genotype 3 (Spain) - June 30, 2022

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Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) - June 30, 2022

PDF PPTX

Sofosbuvir-Velpatasvir in Patients with ESRD on Dialysis - June 30, 2022

HCV Test and Cure

Screening and Diagnosis of Hepatitis C Infection

Evaluation, Staging, and Monitoring of Chronic Hepatitis C

Evaluation and Preparation for Hepatitis C Treatment

Treatment of Hepatitis C Infection

Treatment of Key Populations and Unique Situations

HCV Test and Cure

HCV Test and Cure Training Certificate

Screening and Diagnosis of Hepatitis C Infection

Evaluation, Staging, and Monitoring of Chronic Hepatitis C

Evaluation and Preparation for Hepatitis C Treatment

Treatment of Hepatitis C Infection

Treatment of Key Populations and Unique Situations

Elbasvir-Grazoprevir

Glecaprevir-Pibrentasvir

Ledipasvir-Sofosbuvir

Ribavirin

Sofosbuvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir (Epclusa)

All Clinical Trials

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir Slide Deck

Clinical Trial Image Decks

HCV Test and Cure

Screening and Diagnosis of Hepatitis C Infection

Evaluation, Staging, and Monitoring of Chronic Hepatitis C

Management of Cirrhosis-Related Complications

Evaluation and Preparation for Hepatitis C Treatment

Treatment of Hepatitis C Infection

Treatment of Key Populations and Unique Situations

HCV Test and Cure

HCV Test and Cure Training Certificate

Screening and Diagnosis of Hepatitis C Infection

Evaluation, Staging, and Monitoring of Chronic Hepatitis C

Management of Cirrhosis-Related Complications

Evaluation and Preparation for Hepatitis C Treatment

Treatment of Hepatitis C Infection

Treatment of Key Populations and Unique Situations

Elbasvir-Grazoprevir

Glecaprevir-Pibrentasvir

Ledipasvir-Sofosbuvir

Ribavirin

Sofosbuvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir (Epclusa)

All Clinical Trials

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir Slide Deck

Clinical Trial Image Decks

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