Drugs / Sofosbuvir
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Sofosbuvir

Small molecule

Developed for
chronic hepatitis C virus infection · hepatitis C virus infection · COVID-19 · cirrhosis of liver · hepatocellular carcinoma · hepatitis B virus infection · acute hepatitis C virus infection · indolent B-cell non-Hodgkin lymphoma
+6 more · cryoglobulinemia · hepatitis · hepatitis E virus infection · liver disorder · porphyria cutanea tarda · hepatitis C induced liver cirrhosis
Investigated by
Gilead Sciences · Bristol-Myers Squibb · Beijing 302 Hospital · Humanity and Health Research Centre · Kirby Institute · National Institute of Allergy and Infectious Diseases (NIAID)
+156 more · ANRS, Emerging Infectious Diseases · Genuine Research Center, Egypt · Janssen Scientific Affairs, LLC · Tehran University of Medical Sciences · AbbVie · Ain Shams University · Merck Sharp & Dohme LLC · Assiut University · Cairo University · Hannover Medical School · HepNet Study House, German Liverfoundation · Kawin Technology Share-holding Co., Ltd. · KawinGreen Biotech Co., Ltd. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Taiwan University Hospital · Tanta University · Tanta University · University of California, San Francisco · University of Maryland, Baltimore · Alexandria University · Duke University · Emory University · German Center for Infection Research · Ginkgopharma CO., LTD · Helwan University · Icahn School of Medicine at Mount Sinai · Janssen Infectious Diseases BVBA · Janssen R&D Ireland · Janssen Research & Development, LLC · Johns Hopkins University · National Institutes of Health Clinical Center (CC) · Peter J. Ruane, M.D., Inc. · Sanjay Gandhi Postgraduate Institute of Medical Sciences · Stanford University · University Health Network, Toronto · University of Colorado, Denver · University of Nebraska · University of Pittsburgh Medical Center · Yale University · Yassin Abdelghaffar Charity Center for Liver Disease and Research · Abbott · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Ahvaz Jundishapur University of Medical Sciences · Al-debeiky pharma · Almaza Military Fever Hospital · Almedis · Amit D Tevar, MD · Ascletis Pharmaceuticals Co., Ltd. · Bakhtar Bioshimi Co · Baqiyatallah Research Center for Gastroenterology and Liver Diseases · Benha University · Brigham and Women's Hospital · Burnet Institute · CIHR Canadian HIV Trials Network · Cairns Hinterland Health Hospital and Health Services · Catherine Anne Chappell · Catherine Chappell · Center For Hepatitis C, Atlanta, GA · Cepheid · Chang Gung Memorial Hospital · Chi Mei Medical Hospital · Chiayi Christian Hospital · China Medical University Hospital · ChromSystemsLab · Clément Sophie · Columbia University · Community Research Initiative of New England · Directorate of Health and Family Welfare, Punjab · Doctors of the World · Drugs for Neglected Diseases · Egyptian Cure Bank · Elizabeth Krans, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Federal University of São Paulo · all 162 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) SOVALDI 2017-04-07 – 2019-08-28 fda.gov
Approved EU (EMA) Sovaldi 2014-01-16 europa.eu
Approved US (FDA) SOVALDI 2013-12-06 fda.gov

Trials 217 · started per year

today
US approved 2013
EU approved 2014
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25
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2010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 04 trials
Phase 0 NCT06159504 Oct 2024 → Dec 2026 expected hepatitis C virus infection Doctors of the World Recruiting No outcome recorded
Phase 0 NCT03702218 Jul 2019 hepatitis C virus infection University of Maryland, Baltimore Withdrawn No outcome recorded
Phase 0 NCT03112044 Sep 2017 → Jan 2020 overdue disease related to solid organ transplantation, hepatitis C virus infection University Health Network, Toronto Active not recruiting No outcome recorded
Phase 0 NCT03249194 Aug 2017 → Mar 2020 hepatitis C virus infection Virginia Commonwealth University Completed No outcome recorded
Phase 112 trials
Phase 1 NCT04382404 Oct 2020 → Oct 2023 chronic hepatitis C virus infection Catherine Anne Chappell Completed No outcome recorded
Phase 1 NCT04358523 Mar → Dec 2020 Ascletis Pharmaceuticals Co., Ltd. Completed No outcome recorded
Phase 1 NCT03706898 Oct 2018 → Apr 2019 HIV infectious disease Viriom Completed No outcome recorded
Phase 1 NCT04039958 Apr → May 2017 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1 NCT03062423 Oct 2016 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1 NCT02683005 Sep 2016 → Feb 2020 chronic hepatitis C virus infection, pregnancy disorder Catherine Chappell Completed No outcome recorded
Phase 1 NCT02953535 May → Jun 2016 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1 NCT02605798 Aug → Sep 2015 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1 NCT02491450 Feb 2015 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1 NCT02185794 Jun → Dec 2014 hepatitis C virus infection Gilead Sciences Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04202952 Jul → Aug 2020 chronic hepatitis C virus infection Sunshine Lake Pharma Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT01565889 Mar 2012 → Aug 2013 HIV infectious disease, hepatitis C virus infection Gilead Sciences Completed No outcome recorded
Phase 1/2 NCT01441180 Sep 2011 → Mar 2013 chronic hepatitis C virus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 265 trials
Phase 2 NCT04532931 Sep 2020 → Aug 2021 COVID-19 Shin Poong Pharmaceutical Co. Ltd. Completed No outcome recorded
Phase 2 NCT03819322 Aug 2019 → Mar 2025 hepatitis C virus infection Fernanda P Silveira, MD, MS Completed No outcome recorded
Phase 2 NCT03809533 May 2019 → Apr 2026 overdue hepatitis C virus infection Amit D Tevar, MD Active not recruiting No outcome recorded
Phase 2 NCT03818308 May 2019 → Jun 2021 acute hepatitis C virus infection Hannover Medical School Completed No outcome recorded
Phase 2 NCT04246723 May 2019 → Apr 2020 chronic hepatitis C virus infection R-Pharm Completed No outcome recorded
Phase 2 NCT03794258 May 2019 → Apr 2020 hepatitis C virus infection Humanity & Health Medical Group Limited Withdrawn No outcome recorded
Phase 2 NCT04111367 Apr 2019 → Apr 2020 hepatitis C virus infection Ginkgopharma CO., LTD Unknown No outcome recorded
Phase 2 NCT03487848 Jun → Oct 2018 hepatitis C virus infection Bristol-Myers Squibb Terminated No outcome recorded
Phase 2 NCT03312023 Feb 2018 → Aug 2020 hepatitis B virus infection University of Maryland, Baltimore Completed No outcome recorded
Phase 2 NCT03236506 Jan 2018 → Aug 2020 hepatitis C virus infection University of Dundee Completed No outcome recorded
Phase 2/313 trials
Phase 2/3 NCT04885855 Mar 2021 → Dec 2023 chronic hepatitis C virus infection Muhammad Radzi Abu Hassan Completed No outcome recorded
Phase 2/3 NCT04468087 Feb → Aug 2021 COVID-19 Hospital do Coracao Completed No outcome recorded
Phase 2/3 NCT04460443 Aug 2020 → Aug 2021 COVID-19 Tanta University Unknown No outcome recorded
Phase 2/3 NCT04497649 Jul 2020 → Apr 2021 COVID-19 Tanta University Unknown No outcome recorded
Phase 2/3 NCT04443725 Jul → Oct 2020 COVID-19 Cairo University Unknown No outcome recorded
Phase 2/3 NCT03801707 Mar 2019 → Apr 2021 hepatitis C virus infection Ohio State University Completed No outcome recorded
Phase 2/3 NCT03540212 Dec 2017 → Apr 2023 chronic hepatitis C virus infection Ain Shams University Unknown No outcome recorded
Phase 2/3 NCT03490097 Dec 2017 → May 2018 chronic hepatitis C virus infection, metabolic syndrome X Ain Shams University Completed No outcome recorded
Phase 2/3 NCT02961426 Sep 2016 → Aug 2021 hepatitis C virus infection Drugs for Neglected Diseases Unknown No outcome recorded
Phase 2/3 NCT02825212 Feb 2016 → Jul 2019 chronic hepatitis C virus infection, cryoglobulinemia Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 358 trials
Phase 3 NCT05854511 Jun 2022 → Dec 2023 chronic hepatitis C virus infection Ain Shams University Unknown No outcome recorded
Phase 3 NCT04530422 Apr → Jul 2020 COVID-19 Almaza Military Fever Hospital Completed No outcome recorded
Phase 3 NCT04211909 Jan → Nov 2020 chronic hepatitis C virus infection Gilead Sciences Completed No outcome recorded
Phase 3 NCT04112303 Oct 2019 → Mar 2021 hepatitis C virus infection Gilead Sciences Completed No outcome recorded
Phase 3 NCT03163849 Sep 2019 → Jun 2020 chronic hepatitis C virus infection Assiut University Unknown No outcome recorded
Phase 3 NCT03883698 Mar 2019 → Aug 2020 chronic renal failure syndrome, hepatitis C virus infection Sanjay Gandhi Postgraduate Institute of Medical Sciences Completed No outcome recorded
Phase 3 NCT04001608 Oct 2018 → Jul 2019 hepatitis C virus infection Ginkgopharma CO., LTD Unknown No outcome recorded
Phase 3 NCT04353986 Jun 2018 → Apr 2023 beta-thalassemia major, hepatitis C virus infection Ain Shams University Unknown No outcome recorded
Phase 3 NCT03444272 Jan 2018 → Dec 2022 hepatitis C virus infection Tanta University Unknown No outcome recorded
Phase 3 NCT03995485 Jun 2017 → Jan 2018 chronic hepatitis C virus infection Kawin Technology Share-holding Co., Ltd. Completed No outcome recorded
Phase 446 trials
Phase 4 NCT07560046 Aug 2026 → Nov 2030 expected HIV infectious disease, hepatitis B virus infection, hepatitis C virus infection Duke University Not yet recruiting No outcome recorded
Phase 4 NCT05717400 Mar 2023 → Aug 2024 hepatocellular carcinoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 4 NCT05264558 Jul 2022 → Aug 2023 hepatitis C virus infection Macfarlane Burnet Institute for Medical Research and Public Health Ltd Completed No outcome recorded
Phase 4 NCT04695769 Nov 2020 → Oct 2021 chronic hepatitis C virus infection Helwan University Completed No outcome recorded
Phase 4 NCT04773756 Nov 2020 COVID-19 Alexandria University Completed No outcome recorded
Phase 4 NCT04498936 Jul → Oct 2020 COVID-19 Assiut University Completed No outcome recorded
Phase 4 NCT03987503 Jul 2020 → Oct 2022 chronic hepatitis C virus infection University of California, San Francisco Completed No outcome recorded
Phase 4 NCT03855917 Feb 2020 → Feb 2026 hepatitis C virus infection Kirby Institute Unknown No outcome recorded
Phase 4 NCT04169464 Apr → Nov 2019 MTI University Unknown No outcome recorded
Phase 4 NCT03537196 Nov 2018 → Nov 2020 hepatitis C virus infection, substance abuse ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase not applicable13 trials
NCT05992077 Aug 2023 → Jan 2026 overdue hepatitis C virus infection ANRS, Emerging Infectious Diseases Active not recruiting No outcome recorded
NCT03981211 Feb 2021 → Dec 2024 cirrhosis of liver, hepatitis C virus infection Kirby Institute Terminated No outcome recorded
NCT03492112 Sep 2019 → Nov 2021 hepatitis C virus infection Kirby Institute Completed No outcome recorded
NCT04039698 Aug 2019 → Dec 2020 chronic hepatitis C virus infection Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
NCT03764345 Dec 2018 → Jul 2019 chronic hepatitis C virus infection National Liver Institute, Egypt Completed No outcome recorded
NCT03646396 Aug 2018 → Aug 2025 chronic hepatitis C virus infection Tanta University Unknown No outcome recorded
NCT03603327 Feb 2018 → Dec 2020 chronic hepatitis C virus infection Soroka University Medical Center Completed No outcome recorded
NCT03483987 Feb 2018 → Apr 2022 chronic hepatitis C virus infection Sanjay Gandhi Postgraduate Institute of Medical Sciences Terminated No outcome recorded
NCT03169348 Nov 2017 → Jun 2019 hepatitis C virus infection Assiut University Unknown No outcome recorded
NCT03453346 Aug 2016 → Mar 2017 chronic hepatitis C virus infection Kawin Technology Share-holding Co., Ltd. Completed No outcome recorded
Phase not stated3 trials
NCT02161939 chronic hepatitis C virus infection Bristol-Myers Squibb No longer available No outcome recorded
NCT02097966 chronic hepatitis C virus infection Bristol-Myers Squibb No longer available No outcome recorded
NCT01779518 hepatitis C virus infection Gilead Sciences Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 46 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03882307 Comparator Oct → Nov 2022 chronic hepatitis C virus infection Assiut University Unknown No outcome recorded
Phase 0 NCT03188276 Comparator Feb 2016 → May 2017 chronic hepatitis C virus infection Third Affiliated Hospital, Sun Yat-Sen University Completed No outcome recorded
Phase 11 trial
Phase 1 NCT03005210 Comparator Nov 2016 Genuine Research Center, Egypt Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT03146741 Background May 2017 → Sep 2019 heart failure University of Pennsylvania Completed No outcome recorded
Phase 1/2 NCT04387539 Comparator Mar → Oct 2017 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 1/2 NCT04391985 Comparator Mar → Oct 2017 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 1/2 NCT04382339 Comparator Mar → Nov 2015 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 26 trials
Phase 2 NCT04561063 Comparator Dec 2020 → Feb 2022 COVID-19 University of Witwatersrand, South Africa Completed No outcome recorded
Phase 2 NCT05091008 Comparator Mar 2018 → Aug 2019 chronic hepatitis C virus infection Mansoura University Children Hospital Completed No outcome recorded
Phase 2 NCT02551861 Comparator Dec 2015 → Jun 2016 chronic hepatitis C virus infection Bristol-Myers Squibb Withdrawn No outcome recorded
Phase 2 NCT02541409 Comparator Sep 2015 → Dec 2016 chronic hepatitis C virus infection Johns Hopkins Bloomberg School of Public Health Completed No outcome recorded
Phase 2 NCT02421211 Background May → Nov 2015 chronic hepatitis C virus infection Janssen Sciences Ireland UC Completed No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT05616598 Comparator Mar → Nov 2022 hepatitis C virus infection, male infertility Benha University Completed No outcome recorded
Phase 2/3 NCT03480932 Comparator Feb → Nov 2018 chronic hepatitis C virus infection Johns Hopkins Bloomberg School of Public Health Completed No outcome recorded
Phase 2/3 NCT02985281 Comparator Dec 2016 → Jun 2017 National Liver Institute, Egypt Unknown No outcome recorded
Phase 2/3 NCT04387526 Comparator Apr 2016 → May 2017 chronic hepatitis C virus infection Beni-Suef University Completed No outcome recorded
Phase 2/3 NCT02483156 Comparator Jul → Aug 2015 chronic hepatitis C virus infection Egyptian Liver Hospital Completed No outcome recorded
Phase 311 trials
Phase 3 NCT07037277 Comparator Jun 2025 → Dec 2026 expected chronic hepatitis C virus infection Atea Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 3 NCT06868264 Comparator Apr 2025 → Sep 2026 expected chronic hepatitis C virus infection Atea Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 3 NCT04535869 Comparator Dec 2020 → Apr 2021 COVID-19 Mansoura University Unknown No outcome recorded
Phase 3 NCT03343444 Comparator Apr 2017 → Nov 2018 chronic hepatitis C virus infection Egyptian Liver Hospital Unknown No outcome recorded
Phase 3 NCT03186313 Comparator Sep 2016 → May 2017 chronic hepatitis C virus infection Egyptian Liver Hospital Completed No outcome recorded
Phase 411 trials
Phase 4 NCT05467826 Background Sep 2022 → Nov 2023 cirrhosis of liver, hepatitis C virus infection Peking University People's Hospital Unknown No outcome recorded
Phase 4 NCT06306300 Comparator Jul 2022 → Dec 2025 hepatitis C virus infection Oswaldo Cruz Foundation Unknown No outcome recorded
Phase 4 NCT03296930 Comparator Oct 2017 → Sep 2018 poisoning Assiut University Unknown No outcome recorded
Phase 4 NCT02938013 Background Jan 2017 → Sep 2019 HIV infectious disease, hepatitis C virus infection Johns Hopkins University Completed No outcome recorded
Phase 4 NCT02347345 Comparator Nov 2016 hepatitis C virus infection Rockefeller University Completed No outcome recorded
Phase not applicable6 trials
NCT05248919 Comparator Jun 2023 → Sep 2027 expected hepatitis C virus infection Queen Mary University of London Enrolling by invitation No outcome recorded
NCT03669835 Background Mar 2018 → Sep 2019 hepatitis C virus infection Asfendiyarov Kazakh National Medical University Completed No outcome recorded
NCT03549832 Comparator Jan 2018 → Jan 2019 hepatitis C virus infection Assiut University Completed No outcome recorded
NCT03481036 Comparator Jun 2016 → Dec 2020 chronic hepatitis C virus infection Post Graduate Institute of Medical Education and Research, Chandigarh Unknown No outcome recorded
NCT03547895 Comparator Jun 2015 → May 2016 cirrhosis of liver Zagazig University Completed No outcome recorded

Press releases naming this drug 71 releases

DateIssuerRelease
2020-03-19 Gilead Sciences U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.com
2019-12-20 Gilead Sciences China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment gilead.com
2019-01-08 Gilead Sciences Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.com
2018-12-04 Gilead Sciences China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com
2018-09-24 Gilead Sciences Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com
2018-05-30 Gilead Sciences China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com
2017-09-25 Gilead Sciences China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection gilead.com
2017-08-01 Gilead Sciences U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.com
2017-07-28 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com
2017-07-18 Gilead Sciences U.S. Food and Drug Administration Approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus gilead.com
2017-06-23 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes gilead.com
2017-04-21 Gilead Sciences Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 284 sources stand behind the page.

FieldValueCited text
Known as sofosbuvir “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601
252

“The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for...” NCT02300103

“This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549

“Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from...” NCT03062423

“Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 Jul 2016

“After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the...” NCT03126370

“For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and...” NCT03669835

“Participants will be treated with the pan-genotypic therapeutic regimen "single-pill daily," at a fixed dose and duration: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead...” NCT06306300

“patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or...” PMID 26575258 Nov 2015

“This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated...” NCT01687257

“determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human...” NCT02491450

“Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per...” NCT03146741

“Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease” NCT02691728

Sofosbuvir (SOVALDI®) is a nucleotide analog directed against HCV NS5B polymerase, clinically approved with potent antiviral effects on the hepatitis C virus with several genotypes21.” NCT04468087

“This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.” NCT04387526

“At 20 sites, 37 individuals with chronic HCV infection of any genotype and compensated cirrhosis received sofosbuvir-velpatasvir (400 mg/100 mg) daily for 12 weeks.” PMID 35802063 Aug 2022

“voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794

“We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.” PMID 28369210 Jul 2017

“Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.” PMID 27198664 May 2016

“Relapse occurred post treatment in a single case of a non-cirrhotic male with genotype 3, who was treated with sofosbuvir/velpatasvir for 6 weeks.” PMID 33082372 Oct 2020

“a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).” NCT03222531

“For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection” NCT03764345

Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial.” PMID 26551051 Nov 2015

Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.” PMID 23982366 Aug 2013

“One hundred patients aged 12-17 years received a combination tablet of 90 mg ledipasvir and 400 mg sofosbuvir once daily for 12 weeks.” PMID 27997679 Jun 2017

“Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.” NCT05264558

“Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539

“In this study, we evaluated the efficacy and safety of sofosbuvir/velpatasvir for 12 weeks in patients from Russia and Sweden.” PMID 30499360 Nov 2018

“Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients” NCT04391985

“Patients were given ledipasvir (90 mg) plus sofosbuvir (400 mg) as a fixed-dose combination tablet once daily for 6 weeks.” PMID 28029529 Oct 2016

“the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857” PMID 27486034 Jul 2016

“53 PATIENTS were treated after 6 months of transplantation with sofosbuvir 400mg and weight based ribavirin for 24 weeks.” NCT03133065

“Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks.” NCT02480166

“Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection” NCT02175758

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection” NCT03074331

“Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks.” PMID 30555048 Dec 2018

“Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)” NCT04211909

“treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks” NCT03118843

“One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks” NCT03118674

“Patients with HBV and genotype-1 HCV received 90 mg ledipasvir and 400 mg sofosbuvir daily for 12 weeks.” PMID 27367295 Jul 2016

“the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvirPMID 25863559 Apr 2015

sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants” NCT04382339

“Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg).” NCT03743727

“Fixed dose combination of sofosbuvir 400 mg plus ledipasvir 90 mg once daily plus ribavirin 1000 mg” NCT03483987

Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily” NCT01565889

“the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir once daily” PMID 26569658 Nov 2015

“the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir.” PMID 28390869 Apr 2017

“All patients received 12 weeks of treatment that included 400 mg of sofosbuvir once daily.” PMID 26551263 Nov 2015

“Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks.” NCT03987503

“the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir” PMID 26571066 Nov 2015

“the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir” PMID 26575258 Nov 2015

“1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day” NCT03080415

Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.” PMID 28564569 Jun 2017

“Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir” NCT04039958

“Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR\>30” NCT03702218

Sofosbuvir (400mg/day) and Velpatasvir(100mg/day) for 12 weeks or 24 weeks” NCT05248919

“patients received once daily for 12 weeks either sofosbuvir-velpatasvir” PMID 38644678 Apr 2024

“ASC18:ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg” NCT04358523

“Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.” PMID 26196665 Jul 2015

Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.” NCT01604850

Sofosbuvir (SOF) 400 mg tablet is administered orally once daily” NCT02480686

Sofosbuvir (SOF) 400 mg tablet administered orally once daily.” NCT02482077

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01682720

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01808248

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01667731

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01838590

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01896193

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01542788

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01713283

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT02932293

“1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir” NCT03005210

sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination” NCT02781571

Sofosbuvir (SOF) tablets administered orally once daily” NCT01260350

“Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)” NCT02673489

Sofosbuvir (SOF) 400 mg administered orally once daily” NCT03794258

sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks” NCT01958281

Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks” NCT03488485

“the nucleotide polymerase inhibitor sofosbuvirPMID 27486033 Jul 2016

sofosbuvir/velapatasvir combination (Epclusa)” NCT03520660

SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead)” NCT03249194

“1 tablet contains 400 mg sofosbuvirNCT02953535

“1 tablet contains 400 mg sofosbuvirNCT02605798

sofosbuvir (SOF) + ribavirin (RBV)” NCT02738333

Sofosbuvir and Daclatasvir” NCT03481036

sofosbuvir (SOF; GS-7977)” NCT01625338

Sofosbuvir + Ribavirin” NCT02469012

“Drug: SofosbuvirNCT02074514

“Drug: SofosbuvirNCT02168361

NCT03549832

NCT01687270

NCT03801707

NCT03105349

NCT06868264

NCT04497649

NCT02705534

NCT02319031

NCT02421211

NCT04498936

NCT01532908

NCT04695769

NCT02021643

NCT02339038

NCT02156570

NCT02206932

NCT03235154

NCT02175966

NCT02253550

NCT03061032

NCT02250807

NCT02961426

NCT07560046

NCT04246723

NCT03855917

NCT04530422

NCT04532931

NCT03093740

NCT02292719

NCT03961828

NCT03819322

NCT02464631

NCT03236506

NCT02032875

NCT02478229

NCT02399345

NCT03343444

NCT01329978

NCT02781649

NCT02858180

NCT01783678

NCT02596880

NCT03200184

NCT02032901

NCT01805882

NCT04535869

NCT02262728

NCT03163849

NCT03250910

NCT03296930

NCT01435044

NCT04169464

NCT03086044

NCT03416491

NCT04382404

NCT02125500

NCT05854511

NCT05895448

NCT03261349

NCT02959359

NCT03453346

NCT02097966

NCT01910636

NCT03186313

NCT02771405

NCT04561063

NCT07037277

NCT02128217

NCT03312023

NCT02483156

NCT02371408

NCT04039698

NCT03188276

NCT02985281

NCT02551861

NCT02468648

NCT02349048

NCT02161939

NCT03112044

NCT03169348

NCT01779518

NCT02405013

NCT03282474

NCT02768961

NCT03402165

NCT04353986

NCT02717949

NCT02032888

NCT03818308

NCT03537196

NCT02601573

NCT01188772

NCT02938013

NCT02576314

NCT04385407

NCT05467826

NCT01054729

NCT01641640

NCT05616598

NCT02760355

NCT02214420

NCT02220868

NCT02702739

NCT02723084

NCT03480932

NCT02133131

NCT01994486

NCT03646396

NCT03063879

NCT04001608

NCT02336139

NCT06159504

NCT02358044

NCT02836925

NCT02128542

NCT03981211

NCT03369327

NCT02683005

NCT04773756

NCT03995485

NCT05717400

NCT03547895

NCT02640157

NCT03883698

NCT02455167

NCT03540212

NCT02624063

NCT04460443

NCT02347345

NCT02556086

NCT03882307

NCT03069001

NCT04885855

NCT03057847

NCT02081079

NCT02114151

NCT03490097

NCT05992077

NCT03721627

NCT01559844

NCT04202952

NCT03487848

NCT02278419

NCT03492112

NCT02114177

NCT01497366

NCT04457050

NCT03706898

NCT02473211

NCT02745535

NCT02485080

NCT02555943

NCT02647632

NCT02363517

NCT02541409

NCT04111367

NCT03809533

NCT03444272

NCT02356562

NCT02165189

NCT02304159

NCT02939989

NCT02992457

NCT04443725

NCT02804386

Known as GS-7977 “Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection” NCT02804386
2

“Sofosbuvir is also known as GS-7977 or PSI-7977.” NCT02125500

NCT01878799

Known as Harvoni ClinicalTrials.gov intervention name — accepted as the source's own label NCT02825212
2

NCT02533934

NCT02759861

Known as Heterosofir “determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human...” NCT02491450
Known as Ledipasvir-Sofosbuvir ClinicalTrials.gov intervention name — accepted as the source's own label NCT05091008
1

NCT02660905

Known as LPV-SOF “The availability of interferon (IFN)-free HCV Direct Acting Antiviral (DAA) antiviral therapy such as Ledipasvir-Sofosbuvir (LPV-SOF) allows for broad provision of treatment...” NCT02660905
Known as PSI-7977 “Sofosbuvir is also known as GS-7977 or PSI-7977.” NCT02125500
3

NCT01466790

NCT01359644

NCT01497327

Known as Psi-7977, gs-7977 ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059
Known as SOF “This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549
62

“The proposed study will quantify hepatic improvement and antiviral efficacy of the open-label interferon-free combination of 12 weeks of simeprevir (SMV, Simeprevir),...” NCT02455167

“METHODS: A subanalysis of efficacy and safety for a daclatasvir (DCV) and sofosbuvir (SOF) regimen, with or without ribavirin (RBV), was undertaken in HIV-HCV-coinfected...” PMID 27845298 Nov 2016

“This phase III study (ALLY-3; ClinicalTrials.gov: NCT02032901) evaluated the 12-week regimen of daclatasvir (DCV; pangenotypic nonstructural protein [NS]5A inhibitor) plus...” PMID 25614962 Mar 2015

“This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated...” NCT01687257

“containing the NS5B polymerase inhibitor sofosbuvir (SOF) 90 mg and the NS5A inhibitor ledipasvir (LDV) 400mg, marked a new era of IFN and ribavirin free, directly acting...” NCT02683005

“The C-ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants...” PMID 29473975 Apr 2018

sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.” NCT01858766

“The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)” NCT01909804

“This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.” NCT04387526

“This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3.” NCT02133131

“voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794

“To investigate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or simeprevir (SMV) in a randomized, open-label, noninferiority trial” PMID 29906601 Jun 2018

“The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV).” PMID 33930223 May 2021

“Velpatasvir (VEL) is an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B nucleotide polymerase inhibitor.” NCT03250910

“Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539

“Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection” NCT03487848

“In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]).” NCT03483987

sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX)” NCT05467826

“Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)” NCT04211909

“Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV)” NCT02292719

sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants” NCT04382339

Sofosbuvir (SOF) and ribavirin (RBV) will be taken orally once daily for the entire study period.” NCT02541409

Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily” NCT01565889

“Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily” NCT02309918

sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks” NCT02671500

“voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC)” NCT02378935

“combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4” NCT03743727

“combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks” NCT02556086

Sofosbuvir (SOF) 400 mg tablet is administered orally once daily” NCT02480686

Sofosbuvir (SOF) 400 mg tablet administered orally once daily.” NCT02482077

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT02470858

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01713283

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT02932293

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01542788

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01838590

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01896193

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01682720

Sofosbuvir (SOF) 400 mg tablet administered orally once daily” NCT01808248

“Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)” NCT02858180

sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination” NCT02201901

Sofosbuvir (SOF) tablets administered orally once daily” NCT01260350

Sofosbuvir (SOF) 400 mg administered orally once daily” NCT03794258

“group 1: sofosbuvir (SOF)+ribavirin (RBV) for 24 weeks” PMID 29727383 Aug 2018

“Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)” NCT02673489

“combination of sofosbuvir plus ledipasvir (SOF + LDP)” NCT02363517

“combination of sofosbuvir (SOF) and simeprevir (SMV)” PMID 27782373 Dec 2016

sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks” NCT01958281

Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks” NCT03488485

SOF 400 mg tablet administered orally once daily” NCT01826981

Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks” NCT03481036

Sofosbuvir tablet (SOF) 400 mg - once daily” NCT02483156

sofosbuvir (SOF) + ribavirin (RBV)” NCT02201953

sofosbuvir (SOF)/ledipasvir (LDV)” NCT01975675

sofosbuvir/velpatasvir (SOF/VEL)” NCT06159504

sofosbuvir (SOF; GS-7977)” NCT01625338

Sofosbuvir (SOF)/GS-5816” NCT02336139

sofosbuvir (SOF)” PMID 29546644 Mar 2018

Sofosbuvir (SOF)” NCT02421211

sofosbuvir (SOF)” PMID 30598598 Nov 2018

sofosbuvir (SOF)” NCT02723084

sofosbuvir (SOF)” NCT02399345

NCT02220998

Known as Sofosbuvir (GS-7977) Sofosbuvir (GS-7977)NCT01805882
Known as Sofosbuvir component of epclusa ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059
Known as Sofosbuvir component of harvoni ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059
Known as Sofosbuvir component of vosevi ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059
Known as Sofosbuvir/ Ledipasvir “This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg...” NCT05091008
Known as Solvaldi (Sofosbuvir); Solvaldi (Sofosbuvir);NCT02455167
Known as sovaldi “Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per...” NCT03146741
7

“Sofosbuvir (SOVALDI®) is a nucleotide analog directed against HCV NS5B polymerase, clinically approved with potent antiviral effects on the hepatitis C virus with several genotypes21.” NCT04468087

“daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight” NCT04382339

“using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).” NCT02455167

“treated with Sofosbuvir 400 mg (Sovaldi) + Daclatasvir 60mg (Daklinza) + Ribavirin 200 mg (Rebetol)” NCT03547895

SOVALDI (Sofosbuvir) (400mg QD)” NCT02214420

“Sofosbuvir 400 MG [Sovaldi]” NCT03312023

“Sofosbuvir, SovaldiNCT02304159

Known as Sovaldi (sofosbuvir) Sovaldi (sofosbuvir)NCT01532908
Known as Sovaldi is a trade name of sofosbuvir Sovaldi is a trade name of sofosbuvirNCT04387539
1

Sovaldi is a trade name of sofosbuvirNCT04385407

Action Inhibit “nucleotide polymerase inhibitor sofosbuvir” PMID 24262278 Nov 2013
Modality Small molecule “sofosbuvir, a uridine nucleotide analogue” PMID 23499158 Mar 2013
Route Oral “Sofosbuvir tablet(s) administered orally once daily” NCT01054729