Summary: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.

Top Publications

  1. Nehra V, Rizza S, Temesgen Z. Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. Drugs Today (Barc). 2017;53:177-189 pubmed publisher
    The fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, and velpatasvir, a second-generation NS5A inhibitor, has been approved by the United States Food and Drug Administration and the European Medicines ..
  2. Dalgard O, Weiland O, Noraberg G, Karlsen L, Heggelund L, Farkkila M, et al. Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study. PLoS ONE. 2017;12:e0179764 pubmed publisher
    ..We retrospectively assessed the treatment outcome of sofosbuvir (SOF) based regimes for treatment of HCV genotype 3 infections in a real life setting in Scandinavia...
  3. Jacobson I, Lawitz E, Gane E, Willems B, Ruane P, Nahass R, et al. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017;153:113-122 pubmed publisher
    ..rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir...
  4. Lin R, Moskovits T, Diefenbach C, Hymes K. Development of highly aggressive mantle cell lymphoma after sofosbuvir treatment of hepatitis C. Blood Cancer J. 2016;6:e402 pubmed publisher
  5. Chhatwal J, Kanwal F, Roberts M, Dunn M. Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States. Ann Intern Med. 2015;162:397-406 pubmed publisher
    b>Sofosbuvir and ledipasvir, which have recently been approved for treatment of chronic hepatitis C virus (HCV) infection, are more efficacious and safer than the old standard of care (oSOC) but are substantially more expensive...
  6. Bourliere M, Gordon S, Flamm S, Cooper C, Ramji A, Tong M, et al. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017;376:2134-2146 pubmed publisher NS5A inhibitor were randomly assigned in a 1:1 ratio to receive either the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the protease inhibitor voxilaprevir (150 patients) or matching placebo (150 ..
  7. Yoshida E, Kwo P, Agarwal K, Duvoux C, Durand F, Peck Radosavljevic M, et al. Persistence of Virologic Response after Liver Transplant in Hepatitis C Patients Treated with Ledipasvir / Sofosbuvir Plus Ribavirin Pretransplant. Ann Hepatol. 2017;16:375-381 pubmed publisher
    ..of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials...
  8. Hayden E. Activists sound alarm on tiered drug prices. Nature. 2014;509:412 pubmed publisher
  9. Soriano V, Benítez Gutiérrez L, Arias A, Carrasco I, Barreiro P, Pena J, et al. Evaluation of sofosbuvir, velpatasvir plus voxilaprevir as fixed-dose co-formulation for treating hepatitis C. Expert Opin Drug Metab Toxicol. 2017;13:1015-1022 pubmed publisher
    The fixed-dose combination of three direct-acting antivirals (DAA), namely sofosbuvir, velpatasvir and voxilaprevir is the first pangenotypic, single tablet regimen developed for the treatment of HCV infection...

More Information


  1. Chang C, Nguyen P, Le A, Zhao C, Ahmed A, Daugherty T, et al. Real-world experience with interferon-free, direct acting antiviral therapies in Asian Americans with chronic hepatitis C and advanced liver disease. Medicine (Baltimore). 2017;96:e6128 pubmed publisher
    ..To evaluate sustained virologic response (SVR) and adverse events (AE) in Asian Americans treated with sofosbuvir (SOF)-based, IFN-free DAA therapies...
  2. Fernández Carrillo C, Lens S, Llop E, Pascasio J, Crespo J, Arenas J, et al. Treatment of hepatitis C virus infection in patients with cirrhosis and predictive value of model for end-stage liver disease: Analysis of data from the Hepa-C registry. Hepatology. 2017;65:1810-1822 pubmed publisher
    ..In this setting, a MELD score ?18 may help clinicians to identify those patients with a higher risk of complications and to individualize treatment decisions. (Hepatology 2017;65:1810-1822). ..
  3. Lo A, Chan H, Wong V, Wong G. Cost-effectiveness of the highly effective direct-acting antivirals in the treatment of chronic hepatitis C in Hong Kong. J Gastroenterol Hepatol. 2017;32:1071-1078 pubmed publisher
    ..The cost-effectiveness of the Highly Effective DAAs was compared with sofosbuvir-PR (first-line and rescue) and boceprevir-PR therapies...
  4. Nagaty A, Abd El Wahab E. Real-life results of sofosbuvir based therapy in chronic hepatitis C -naïve and -experienced patients in Egypt. PLoS ONE. 2017;12:e0184654 pubmed publisher
    ..Treating those patients is a matter of national security. A dramatic improvement in hepatitis C virus (HCV) infection treatment was achieved in the last five years. A new era of direct-acting antivirals is now dawning in Egypt...
  5. Fabbri G, Mastrorosa I, Vergori A, Mazzotta V, Pinnetti C, Grisetti S, et al. Reactivation of occult HBV infection in an HIV/HCV Co-infected patient successfully treated with sofosbuvir/ledipasvir: a case report and review of the literature. BMC Infect Dis. 2017;17:182 pubmed publisher
    ..Herein, we report an episode of HBV reactivation in an HIV/HCV co-infected patient prescribed with sofosbuvir/ledipasvir for HCV...
  6. Nirei K, Nakamura H, Matsuoka S, Yamana Y, Yoda S, Hirayama A, et al. Ventricular Tachycardia as a Complication of Ledipasvir and Sofosbuvir Treatment for HCV Infection. Intern Med. 2017;56:787-790 pubmed publisher
    We experienced two patients with serious arrhythmias associated with the administration of ledipasvir (LDV) and sofosbuvir (SOF). Neither patient took amiodarone, an agent for which concomitant use is prohibited...
  7. Sinakos E, Kountouras D, Koskinas J, Zachou K, Karatapanis S, Triantos C, et al. Treatment of chronic hepatitis C with direct-acting antivirals in patients with β-thalassaemia major and advanced liver disease. Br J Haematol. 2017;178:130-136 pubmed publisher
    ..Five regimens were used: sofosbuvir (SOF) + ribavirin (RBV); SOF + simeprevir ± RBV; SOF + daclatasvir ± RBV; ..
  8. Hoofnagle J, Sherker A. Therapy for hepatitis C--the costs of success. N Engl J Med. 2014;370:1552-3 pubmed publisher
  9. Sultanik P, Klotz C, Brault P, Pol S, Mallet V. Regression of an HCV-associated disseminated marginal zone lymphoma under IFN-free antiviral treatment. Blood. 2015;125:2446-7 pubmed publisher
  10. Cento V, Nguyen T, Di Carlo D, Biliotti E, Gianserra L, Lenci I, et al. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens. PLoS ONE. 2017;12:e0177352 pubmed publisher
    ..8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p<0.001), reflecting higher efficacy in blocking assembly/secretion...
  11. Uchiyama N, Kamakura H, Masada S, Tsujimoto T, Hosoe J, Tokumoto H, et al. Chemical Analysis of Counterfeit Hepatitis C Drug Found in Japan. Yakugaku Zasshi. 2017;137:1265-1276 pubmed publisher
    ..We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVALDI® Tablets 400 mg (SOVALDI®), ..
  12. Miraghaei S, Mohammadi B, Babaei A, Keshavarz S, Bahrami G. Development and validation of a new HPLC-DAD method for quantification of sofosbuvir in human serum and its comparison with LC-MS/MS technique: Application to a bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2017;1063:118-122 pubmed publisher
    ..As no published method is available for quantitative HPLC analysis of sofosbuvir (SOF), an orally administered anti-hepatitis drug in human serum, this study was aimed to evaluate applicability ..
  13. Gane E, Shiffman M, Etzkorn K, Morelli G, Stedman C, Davis M, et al. Sofosbuvir-velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct-acting antiviral regimen. Hepatology. 2017;66:1083-1089 pubmed publisher
    ..this multicenter, open-label, phase 2 study, we evaluated the efficacy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjusted ribavirin administered for 24 weeks in patients who did not ..
  14. Dolatimehr F, Karimi Sari H, Rezaee Zavareh M, Alavian S, Behnava B, Gholami Fesharaki M, et al. Combination of sofosbuvir, pegylated-interferon and ribavirin for treatment of hepatitis C virus genotype 1 infection: a systematic review and meta-analysis. Daru. 2017;25:11 pubmed publisher
    ..Some studies have shown that adding Sofosbuvir (SOF), an HCV polymerase inhibitor to the conventional therapy of Pegylated-interferon (PegIFN) plus Ribavirin (..
  15. Shah R, Maize K, Zhou X, Finzel B, Wagner C. Caught before Released: Structural Mapping of the Reaction Trajectory for the Sofosbuvir Activating Enzyme, Human Histidine Triad Nucleotide Binding Protein 1 (hHint1). Biochemistry. 2017;56:3559-3570 pubmed publisher
    ..e., proTides), such as the FDA approved hepatitis C drug, sofosbuvir. The active site of hHint1 comprises an ensemble of strictly conserved histidines, including nucleophilic His112...
  16. Liao J, Fischer M. Restrictions of Hepatitis C Treatment for Substance-Using Medicaid Patients: Cost Versus Ethics. Am J Public Health. 2017;107:893-899 pubmed publisher
    ..Facing constrained budgets, most states adopted prior authorization criteria for sofosbuvir, the first of these agents...
  17. Uemura H, Tsukada K, Mizushima D, Aoki T, Watanabe K, Kinai E, et al. Interferon-free therapy with direct acting antivirals for HCV/HIV-1 co-infected Japanese patients with inherited bleeding disorders. PLoS ONE. 2017;12:e0186255 pubmed publisher
    ..While several studies have reported the high efficacy and safety of direct acting antivirals (DAA) in HIV-1 co-infected patients, such data are limited in hemophiliacs...
  18. Pillai A, Maheshwari R, Vora R, Norvell J, Ford R, Parekh S, et al. Treatment of HCV infection in liver transplant recipients with ledipasvir and sofosbuvir without ribavirin. Aliment Pharmacol Ther. 2017;45:1427-1432 pubmed publisher
    Ledipasvir and sofosbuvir is a well-tolerated regimen with high sustained virological response (SVR) rates in pre-liver transplant patients infected with chronic hepatitis C virus (HCV), but data in liver transplant recipients outside of ..
  19. Lacombe K, Fontaine H, Dhiver C, Metivier S, Rosenthal E, Antonini T, et al. Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort. J Acquir Immune Defic Syndr. 2017;75:97-107 pubmed publisher
    ..This was a subanalysis of HIV/HCV coinfected ATU patients treated with DCV plus sofosbuvir (SOF)...
  20. Rice C, Saeed M. Hepatitis C: Treatment triumphs. Nature. 2014;510:43-4 pubmed publisher
  21. Wang W, Hakim M, Nair V, De Ruiter P, Huang F, Sprengers D, et al. Distinct Antiviral Potency of Sofosbuvir Against Hepatitis C and E Viruses. Gastroenterology. 2016;151:1251-1253 pubmed publisher
  22. Langness J, Tabano D, Wieland A, Tise S, Pratt L, Harrington L, et al. Curing Chronic Hepatitis C: A Cost Comparison of the Combination Simeprevir Plus Sofosbuvir vs. Protease-Inhibitor-Based Triple Therapy. Ann Hepatol. 2017;16:366-374 pubmed publisher
    ..The multi-DAA regimen of simeprevir plus sofosbuvir (SMV/SOF) was compared to the triple therapy regimen consisting of peginterferon and ribavirin, with either ..
  23. Sheridan C. FDA approvals usher in the post-interferon era in HCV. Nat Biotechnol. 2014;32:3-5 pubmed publisher
  24. Meissner E, Wu D, Osinusi A, Bon D, Virtaneva K, Sturdevant D, et al. Endogenous intrahepatic IFNs and association with IFN-free HCV treatment outcome. J Clin Invest. 2014;124:3352-63 pubmed publisher
    ..METHODS. We conducted a clinical trial using the DAA sofosbuvir plus ribavirin (SOF/RBV) and performed detailed mRNA expression analysis in liver and peripheral blood from ..
  25. Brennan T, Shrank W. New expensive treatments for hepatitis C infection. JAMA. 2014;312:593-4 pubmed publisher
  26. Liu S, Watcha D, Holodniy M, Goldhaber Fiebert J. Sofosbuvir-based treatment regimens for chronic, genotype 1 hepatitis C virus infection in U.S. incarcerated populations: a cost-effectiveness analysis. Ann Intern Med. 2014;161:546-53 pubmed publisher
    ..To assess the cost-effectiveness of sofosbuvir for HCV treatment in incarcerated populations. Markov model. Published literature and expert opinion...
  27. Barua S, Greenwald R, Grebely J, Dore G, Swan T, Taylor L. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Ann Intern Med. 2015;163:215-23 pubmed publisher systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States...
  28. Lawitz E, Poordad F, Wells J, Hyland R, Yang Y, Dvory Sobol H, et al. Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus. Hepatology. 2017;65:1803-1809 pubmed publisher
    ..SVR) on a DAA-based regimen were randomized to receive treatment with a fixed-dose combination tablet of sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin (RBV) for 12 weeks...
  29. . A combination of ledipasvir and sofosbuvir (Harvoni) for hepatitis C. Med Lett Drugs Ther. 2014;56:111-2 pubmed
  30. Phelan M, Cook C. A treatment revolution for those who can afford it? Hepatitis C treatment: new medications, profits and patients. BMC Infect Dis. 2014;14 Suppl 6:S5 pubmed publisher
  31. Jayasekera C, Perumpail R, Chao D, Pham E, Aggarwal A, Wong R, et al. Task-Shifting: An Approach to Decentralized Hepatitis C Treatment in Medically Underserved Areas. Dig Dis Sci. 2015;60:3552-7 pubmed
    ..after treatment completion (SVR-12), adverse events, and treatment discontinuations in patients who received sofosbuvir-based DAA regimens between December 2013 and November 2014...
  32. Donnelly M, Imlach S, Abravanel F, Ramalingam S, Johannessen I, Petrik J, et al. Sofosbuvir and Daclatasvir Anti-Viral Therapy Fails to Clear HEV Viremia and Restore Reactive T Cells in a HEV/HCV Co-Infected Liver Transplant Recipient. Gastroenterology. 2017;152:300-301 pubmed publisher
  33. Ollendorf D, Tice J, Pearson S. The comparative clinical effectiveness and value of simeprevir and sofosbuvir for chronic hepatitis C virus infection. JAMA Intern Med. 2014;174:1170-1 pubmed publisher
  34. Stokes W, Fenton C, Clement F, James M, Ronksley P, Tang K. The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis. Can J Gastroenterol Hepatol. 2017;2017:6468309 pubmed publisher
    ..with chronic hepatitis C (CHC), genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF), ledipasvir (LDV), and ribavirin (RBV)...
  35. Wirth S, Rosenthal P, Gonzalez Peralta R, Jonas M, Balistreri W, Lin C, et al. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017;66:1102-1110 pubmed publisher
    ..We evaluated the all-oral combination of sofosbuvir and ribavirin in adolescents aged 12-17 with hepatitis C virus genotype 2 or 3 ( NCT02175758)...
  36. Linas B, Barter D, Morgan J, Pho M, Leff J, Schackman B, et al. The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection. Ann Intern Med. 2015;162:619-29 pubmed publisher
    Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used...