Generic placeholder image

Infectious Disorders - Drug Targets

Editor-in-Chief

ISSN (Print): 1871-5265
ISSN (Online): 2212-3989

Review Article

Sofosbuvir: Really Meets the Unmet Needs for Hepatitis C Treatment?

Author(s): Deepti Chopra and Bharti Bhandari *

Volume 20, Issue 1, 2020

Page: [2 - 15] Pages: 14

DOI: 10.2174/1871526518666180816101124

Price: $65

Abstract

Chronic hepatitis C remains a major public health concern with a prevalence of more than 1% worldwide. Of late, with the discovery of newer drugs, chronic HCV treatment has touched new dimensions. The treatment has progressed from Interferons to Pegylated interferon (Peg IFN) based therapy, with or without ribavirin to treatment with orally active Direct Acting Antivirals (DAA) with Peg IFN and ribavirin and eventually to various combinations of DAA, without IFN.

Introduction of newer DAAs has transfigured the treatment of chronic HCV. Chronic HCV patients with advanced liver disease, psychiatric condition, anemia or autoimmune diseases, not eligible for Peg IFN based therapy have a ray of hope now. Amongst all DAAs, nucleoside inhibitors have been the most promising agent.

Thus the present review focuses on Sofosbuvir, one of the most effective nucleoside inhibitors; in terms of potency, resistance profile, activity against all genotypes of HCV and adverse effects. FDA approved Sofobuvir for clinical use in 2013. Chemically, it is 2'-deoxy-2'-α-fluoro-β-Cmethyluridine- 5'-triphosphate; a phosphoramidate prodrug that is activated by enzyme present in human liver. It is a highly potent inhibitor of HCV NS5B polymerase.

Efficacy of the Sofosbuvir has been established in various phase 2 and phase 3 clinical trials like PROTON, ELECTRON, FUSION, POSITRON etc. Sofosbuvir has a good safety profile with few mild to moderate adverse effects. Evidence reveals that sofosbuvir has substantial impact on the treatment of HCV.

Keywords: Sofosbuvir, HCV, direct acting antivirals, nucleoside inhibitors, NS5B polymerase inhibitor, chronic hepatitis C.

Graphical Abstract
[1]
European Union HCV Collaborators. Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the European Union by 2030: a modelling study. Lancet Gastroenterol. Hepatol., 2017, 2(5), 325-336.
[http://dx.doi.org/10.1016/S2468-1253(17)30045-6] [PMID: 28397696]
[2]
Global hepatitis report, 2017. Available From : http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/
[3]
Lozano, R.; Naghavi, M.; Foreman, K.; Lim, S.; Shibuya, K.; Aboyans, V. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet, 2012, 380, 2095-2128.
[4]
Backus, L.I.; Belperio, P.S.; Shahoumian, T.A.; Mole, L.A. Direct-acting antiviral sustained virologic response: impact on mortality in patients without advanced liver disease. Hepatol., 2018, 68(3), 827-838.
[http://dx.doi.org/10.1002/hep.29811]
[5]
Gupta, V.; Kumar, A.; Sharma, P.; Arora, A. Newer direct-acting antivirals for hepatitis C virus infection: Perspectives for India. Indian J. Med. Res., 2017, 146(1), 23-33.
[http://dx.doi.org/10.4103/ijmr.IJMR_679_15] [PMID: 29168457]
[6]
Messina, J.P.; Humphreys, I.; Flaxman, A.; Brown, A.; Cooke, G.S.; Pybus, O.G.; Barnes, E. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology, 2015, 61(1), 77-87.
[http://dx.doi.org/10.1002/hep.27259] [PMID: 25069599]
[7]
Manns, M.P.; Cornberg, M. Sofosbuvir: the final nail in the coffin for hepatitis C? Lancet Infect. Dis., 2013, 13(5), 378-379.
[http://dx.doi.org/10.1016/S1473-3099(13)70074-4] [PMID: 23499157]
[8]
Manns, M.P.; Wedemeyer, H.; Cornberg, M. Treating viral hepatitis C: efficacy, side effects, and complications. Gut, 2006, 55(9), 1350-1359.
[http://dx.doi.org/10.1136/gut.2005.076646] [PMID: 16905701]
[9]
Ghany, M.G.; Nelson, D.R.; Strader, D.B.; Thomas, D.L.; Seeff, L.B. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology, 2011, 54(4), 1433-1444.
[http://dx.doi.org/10.1002/hep.24641] [PMID: 21898493]
[10]
Butt, A.A.; Kanwal, F. Boceprevir and telaprevir in the management of hepatitis C virus-infected patients. Clin. Infect. Dis., 2012, 54(1), 96-104.
[http://dx.doi.org/10.1093/cid/cir774] [PMID: 22156853]
[11]
Assis, D.N.; Lim, J.K. New pharmacotherapy for hepatitis C. Clin. Pharmacol. Ther., 2012, 92(3), 294-305.
[http://dx.doi.org/10.1038/clpt.2012.103] [PMID: 22850602]
[12]
(Sofosbuvir)FDA, 2018. Feb 24. Available from : http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
[13]
Gentile, I.; Borgia, F.; Buonomo, A.R.; Castaldo, G.; Borgia, G. A novel promising therapeutic option against hepatitis C virus: an oral nucleotide NS5B polymerase inhibitor sofosbuvir. Curr. Med. Chem., 2013, 20(30), 3733-3742.
[http://dx.doi.org/10.2174/09298673113209990178] [PMID: 23848533]
[14]
Gentile, I.; Borgia, F.; Zappulo, E.; Buonomo, A.R.; Spera, A.M.; Castaldo, G.; Borgia, G. Efficacy and safety of sofosbuvir in the treatment of chronic hepatitis c: the dawn of a new era. Rev. Recent Clin. Trials, 2014, 9(1), 1-7.
[http://dx.doi.org/10.2174/1574887108666131213120354] [PMID: 23859195]
[15]
Jacobson, I.M.; Gordon, S.C.; Kowdley, K.V.; Yoshida, E.M.; Rodriguez-Torres, M.; Sulkowski, M.S.; Shiffman, M.L.; Lawitz, E.; Everson, G.; Bennett, M.; Schiff, E.; Al-Assi, M.T.; Subramanian, G.M.; An, D.; Lin, M.; McNally, J.; Brainard, D.; Symonds, W.T.; McHutchison, J.G.; Patel, K.; Feld, J.; Pianko, S.; Nelson, D.R. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N. Engl. J. Med., 2013, 368(20), 1867-1877.
[http://dx.doi.org/10.1056/NEJMoa1214854] [PMID: 23607593]
[16]
Sofosbuvir., 2018. Feb 27. Available from : http://www.pubchem.ncbi.nlm. nih.gov/compound/45375808
[17]
Amidon, G.L.; Lennernäs, H.; Shah, V.P.; Crison, J.R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res., 1995, 12(3), 413-420.
[http://dx.doi.org/10.1023/A:1016212804288] [PMID: 7617530]
[18]
Kirby, B.J.; Symonds, W.T.; Kearney, B.P.; Mathias, A.A. Pharmacokinetic, pharmacodynamic, and drug-interaction profile of the hepatitis c virus ns5b polymerase inhibitor sofosbuvir. Clin. Pharmacokinet., 2015, 54(7), 677-690.
[http://dx.doi.org/10.1007/s40262-015-0261-7] [PMID: 25822283]
[19]
Cuenca-Lopez, F.; Rivero, A.; Rivero-Juárez, A. Pharmacokinetics and pharmacodynamics of sofosbuvir and ledipasvir for the treatment of hepatitis C. Expert Opin. Drug Metab. Toxicol., 2017, 13(1), 105-112.
[http://dx.doi.org/10.1080/17425255.2017.1255725] [PMID: 27797596]
[20]
Gentile, I.; Maraolo, A.E.; Buonomo, A.R.; Zappulo, E.; Borgia, G. The discovery of sofosbuvir: a revolution for therapy of chronic hepatitis C. Expert Opin. Drug Discov., 2015, 10(12), 1363-1377.
[http://dx.doi.org/10.1517/17460441.2015.1094051] [PMID: 26563720]
[21]
Desnoyer, A.; Pospai, D.; Lê, M.P.; Gervais, A.; Heurgué-Berlot, A.; Laradi, A.; Harent, S.; Pinto, A.; Salmon, D.; Hillaire, S.; Fontaine, H.; Zucman, D.; Simonpoli, A.M.; Muret, P.; Larrouy, L.; Bernard Chabert, B.; Descamps, D.; Yazdanpanah, Y.; Peytavin, G. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J. Hepatol., 2016, 65(1), 40-47.
[http://dx.doi.org/10.1016/j.jhep.2016.02.044] [PMID: 26952005]
[22]
Kirby, B.; Gordi, T.; Symonds, W.T.; Kearney, B.P.; Mathias, A. Population pharmacokinetics of sofosbuvir and its major metabolite (GS- 331007) in healthy and HCV-infected adult subjects [poster no. 1,106] 64th Annual Meeting of the American Association for the Study of Liver Diseases, 2013.Washington, DC
[23]
Cholongitas, E.; Papatheodoridis, G.V. Sofosbuvir: a novel oral agent for chronic hepatitis C. Ann. Gastroenterol., 2014, 27(4), 331-337.
[PMID: 25332066]
[24]
Cornpropst, M.T.; Denning, J.; Clemons, D.; Sale, M.; Fang, L.; Berrey, M.; Symonds, W. Effect of renal impairment and end stage Renal Disease on the Single-Dose Pharmacokinetics of GS-7977. J. Hepatic., 2012, 56, S433.
[http://dx.doi.org/10.1016/S0168-8278(12)61113-1]
[25]
Aggarwal, A.; Yoo, E.R.; Perumpail, R.B.; Cholankeril, G.; Kumari, R.; Daugherty, T.J.; Lapasaran, A.S.; Ahmed, A. Sofosbuvir use in the setting of end-stage renal disease: a single center experience. J. Clin. Transl. Hepatol., 2017, 5(1), 23-26.
[http://dx.doi.org/10.14218/JCTH.2016.00060] [PMID: 28507922]
[26]
Smolders, E.J.; de Kanter, C.T.M.M.; van Hoek, B.; Arends, J.E.; Drenth, J.P.H.; Burger, D.M. Pharmacokinetics, efficacy, and safety of hepatitis c virus drugs in patients with liver and/or renal impairment. Drug Saf., 2016, 39(7), 589-611.
[http://dx.doi.org/10.1007/s40264-016-0420-2] [PMID: 27098247]
[27]
Chen, J.; Zhang, X.; Luo, H.; Wu, C.; Yu, M.; Liu, D.; Xi, H.; Zhou, Y.; An, Y.; Xu, X. Changes in renal function indices in cirrhotic chronic hepatitis C patients treated with sofosbuvir-containing regimens. Oncotarget, 2017, 8(53), 90916-90924.
[http://dx.doi.org/10.18632/oncotarget.18701] [PMID: 29207613]
[28]
Spera, A.M.; Eldin, T.K.; Tosone, G.; Orlando, R. Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women? World J. Hepatol., 2016, 8(12), 557-565.
[http://dx.doi.org/10.4254/wjh.v8.i12.557] [PMID: 27134703]
[29]
Study of hepatitis C treatment during pregnancy. Available From : http://www.clinicaltrials.gov/ct2/show/NCT02683005 [2018 Feb 28];
[30]
Indolfi, G.; Hierro, L.; Dezsofi, A.; Jahnel, J.; Debray, D.; Hadzic, N.; Czubkowski, P.; Gupte, G.; Mozer-Glassberg, Y.; van der Woerd, W.; Smets, F.; Verkade, H.J.; Fischler, B. Treatment of Chronic Hepatitis C Virus Infection in Children: A position paper by the hepatology committee of european society of paediatric gastroenterology, hepatology and nutrition. J. Pediatr. Gastroenterol. Nutr., 2018, 66(3), 505-515.
[http://dx.doi.org/10.1097/MPG.0000000000001872] [PMID: 29287014]
[32]
Lawitz, E.; Lalezari, J.P.; Hassanein, T.; Kowdley, K.V.; Poordad, F.F.; Sheikh, A.M.; Afdhal, N.H.; Bernstein, D.E.; Dejesus, E.; Freilich, B.; Nelson, D.R.; Dieterich, D.T.; Jacobson, I.M.; Jensen, D.; Abrams, G.A.; Darling, J.M.; Rodriguez-Torres, M.; Reddy, K.R.; Sulkowski, M.S.; Bzowej, N.H.; Hyland, R.H.; Mo, H.; Lin, M.; Mader, M.; Hindes, R.; Albanis, E.; Symonds, W.T.; Berrey, M.M.; Muir, A. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect. Dis., 2013, 13(5), 401-408.
[http://dx.doi.org/10.1016/S1473-3099(13)70033-1] [PMID: 23499158]
[33]
Kowdley, K.V.; Lawitz, E.; Crespo, I.; Hassanein, T.; Davis, M.N.; DeMicco, M.; Bernstein, D.E.; Afdhal, N.; Vierling, J.M.; Gordon, S.C.; Anderson, J.K.; Hyland, R.H.; Dvory-Sobol, H.; An, D.; Hindes, R.G.; Albanis, E.; Symonds, W.T.; Berrey, M.M.; Nelson, D.R.; Jacobson, I.M. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet, 2013, 381(9883), 2100-2107.
[http://dx.doi.org/10.1016/S0140-6736(13)60247-0] [PMID: 23499440]
[34]
Gane, E.J.; Stedman, C.A.; Hyland, R.H.; Ding, X.; Svarovskaia, E.; Symonds, W.T.; Hindes, R.G.; Berrey, M.M. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N. Engl. J. Med., 2013, 368(1), 34-44.
[http://dx.doi.org/10.1056/NEJMoa1208953] [PMID: 23281974]
[35]
Gane, E.J.; Stedman, C.A.; Hyland, R.H.; Ding, X.; Svarovskaia, E.; Subramanian, G.M.; Symonds, W.T.; McHutchison, J.G.; Pang, P.S. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology, 2014, 146(3), 736-743.e1.
[http://dx.doi.org/10.1053/j.gastro.2013.11.007] [PMID: 24262278]
[36]
Lawitz, E.; Poordad, F.F.; Pang, P.S.; Hyland, R.H.; Ding, X.; Mo, H.; Symonds, W.T.; McHutchison, J.G.; Membreno, F.E. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet, 2014, 383(9916), 515-523.
[http://dx.doi.org/10.1016/S0140-6736(13)62121-2] [PMID: 24209977]
[37]
Lawitz, E.; Sulkowski, M.S.; Ghalib, R.; Rodriguez-Torres, M.; Younossi, Z.M.; Corregidor, A.; DeJesus, E.; Pearlman, B.; Rabinovitz, M.; Gitlin, N.; Lim, J.K.; Pockros, P.J.; Scott, J.D.; Fevery, B.; Lambrecht, T.; Ouwerkerk-Mahadevan, S.; Callewaert, K.; Symonds, W.T.; Picchio, G.; Lindsay, K.L.; Beumont, M.; Jacobson, I.M. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet, 2014, 384(9956), 1756-1765.
[http://dx.doi.org/10.1016/S0140-6736(14)61036-9] [PMID: 25078309]
[38]
Sulkowski, M.S.; Gardiner, D.F.; Rodriguez-Torres, M.; Reddy, K.R.; Hassanein, T.; Jacobson, I.; Lawitz, E.; Lok, A.S.; Hinestrosa, F.; Thuluvath, P.J.; Schwartz, H.; Nelson, D.R.; Everson, G.T.; Eley, T.; Wind-Rotolo, M.; Huang, S.P.; Gao, M.; Hernandez, D.; McPhee, F.; Sherman, D.; Hindes, R.; Symonds, W.; Pasquinelli, C.; Grasela, D.M. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N. Engl. J. Med., 2014, 370(3), 211-221.
[http://dx.doi.org/10.1056/NEJMoa1306218] [PMID: 24428467]
[39]
Lawitz, E.; Poordad, F.; Gutierrez, J.A.; Kakuda, T.N.; Picchio, G.; Beets, G.; Vandevoorde, A.; Van Remoortere, P.; Jacquemyn, B.; Luo, D.; Ouwerkerk-Mahadevan, S.; Vijgen, L.; Van Eygen, V.; Beumont, M. Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease. J. Viral Hepat., 2017, 24(4), 287-294.
[http://dx.doi.org/10.1111/jvh.12645] [PMID: 27878906]
[40]
Sulkowski, M.S.; Feld, J.J.; Lawitz, E.; Felizarta, F.; Corregidor, A.M.; Khalid, O.; Vandevoorde, A.; Van Remoortere, P.; Jacquemyn, B.; Luo, D. Ouwerkerk-Mahadevan, S.; Vijgen, L.; Van Eygen, V.; Beumont, M. Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection. J. Viral Hepat., 2017, 24, 287-294.
[41]
Lawitz, E.; Mangia, A.; Wyles, D.; Rodriguez-Torres, M.; Hassanein, T.; Gordon, S.C.; Schultz, M.; Davis, M.N.; Kayali, Z.; Reddy, K.R.; Jacobson, I.M.; Kowdley, K.V.; Nyberg, L.; Subramanian, G.M.; Hyland, R.H.; Arterburn, S.; Jiang, D.; McNally, J.; Brainard, D.; Symonds, W.T.; McHutchison, J.G.; Sheikh, A.M.; Younossi, Z.; Gane, E.J. Sofosbuvir for previously untreated chronic hepatitis C infection. N. Engl. J. Med., 2013, 368(20), 1878-1887.
[http://dx.doi.org/10.1056/NEJMoa1214853] [PMID: 23607594]
[42]
Zeuzem, S.; Dusheiko, G.M.; Salupere, R.; Mangia, A.; Flisiak, R.; Hyland, R.H.; Illeperuma, A.; Svarovskaia, E.; Brainard, D.M.; Symonds, W.T.; Subramanian, G.M.; McHutchison, J.G.; Weiland, O.; Reesink, H.W.; Ferenci, P.; Hézode, C.; Esteban, R. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N. Engl. J. Med., 2014, 370(21), 1993-2001.
[http://dx.doi.org/10.1056/NEJMoa1316145] [PMID: 24795201]
[43]
Sulkowski, M.S.; Naggie, S.; Lalezari, J.; Fessel, W.J.; Mounzer, K.; Shuhart, M.; Luetkemeyer, A.F.; Asmuth, D.; Gaggar, A.; Ni, L.; Svarovskaia, E.; Brainard, D.M.; Symonds, W.T.; Subramanian, G.M.; McHutchison, J.G.; Rodriguez-Torres, M.; Dieterich, D. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA, 2014, 312(4), 353-361.
[http://dx.doi.org/10.1001/jama.2014.7734] [PMID: 25038354]
[44]
Molina, J.M.; Orkin, C.; Iser, D.M.; Zamora, F.X.; Nelson, M.; Stephan, C.; Massetto, B.; Gaggar, A.; Ni, L.; Svarovskaia, E.; Brainard, D.; Subramanian, G.M.; McHutchison, J.G.; Puoti, M.; Rockstroh, J.K. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet, 2015, 385(9973), 1098-1106.
[http://dx.doi.org/10.1016/S0140-6736(14)62483-1] [PMID: 25659285]
[45]
Kwo, P.; Gitlin, N.; Nahass, R.; Bernstein, D.; Etzkorn, K.; Rojter, S.; Schiff, E.; Davis, M.; Ruane, P.; Younes, Z.; Kalmeijer, R.; Sinha, R.; Peeters, M.; Lenz, O.; Fevery, B.; De La Rosa, G.; Scott, J.; Witek, J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology, 2016, 64(2), 370-380.
[http://dx.doi.org/10.1002/hep.28467] [PMID: 26799692]
[46]
Lawitz, E.; Matusow, G.; DeJesus, E.; Yoshida, E.M.; Felizarta, F.; Ghalib, R.; Godofsky, E.; Herring, R.W.; Poleynard, G.; Sheikh, A.; Tobias, H.; Kugelmas, M.; Kalmeijer, R.; Peeters, M.; Lenz, O.; Fevery, B.; De La Rosa, G.; Scott, J.; Sinha, R.; Witek, J. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2). Hepatology, 2016, 64(2), 360-369.
[http://dx.doi.org/10.1002/hep.28422] [PMID: 26704148]
[47]
Feld, J.J.; Jacobson, I.M.; Hézode, C.; Asselah, T.; Ruane, P.J.; Gruener, N.; Abergel, A.; Mangia, A.; Lai, C.L.; Chan, H.L.; Mazzotta, F.; Moreno, C.; Yoshida, E.; Shafran, S.D.; Towner, W.J.; Tran, T.T.; McNally, J.; Osinusi, A.; Svarovskaia, E.; Zhu, Y.; Brainard, D.M.; McHutchison, J.G.; Agarwal, K.; Zeuzem, S. ASTRAL-1 Investigators. Sofosbuvir and velpatasvir for HCVgenotype 1, 2, 4, 5 and 6 infection. N. Engl. J. Med., 2015, 373, 2599-2607.
[http://dx.doi.org/10.1056/NEJMoa1512610] [PMID: 26571066]
[48]
Foster, G.R.; Afdhal, N.; Roberts, S.K.; Bräu, N.; Gane, E.J.; Pianko, S.; Lawitz, E.; Thompson, A.; Shiffman, M.L.; Cooper, C.; Towner, W.J.; Conway, B.; Ruane, P.; Bourlière, M.; Asselah, T.; Berg, T.; Zeuzem, S.; Rosenberg, W.; Agarwal, K.; Stedman, C.A.; Mo, H.; Dvory-Sobol, H.; Han, L.; Wang, J.; McNally, J.; Osinusi, A.; Brainard, D.M.; McHutchison, J.G.; Mazzotta, F.; Tran, T.T.; Gordon, S.C.; Patel, K.; Reau, N.; Mangia, A.; Sulkowski, M. ASTRAL-2 Investigators. ASTRAL-3 Investigators. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N. Engl. J. Med., 2015, 373(27), 2608-2617.
[http://dx.doi.org/10.1056/NEJMoa1512612] [PMID: 26575258]
[49]
Curry, M.P.; O’Leary, J.G.; Bzowej, N.; Muir, A.J.; Korenblat, K.M.; Fenkel, J.M.; Reddy, K.R.; Lawitz, E.; Flamm, S.L.; Schiano, T.; Teperman, L.; Fontana, R.; Schiff, E.; Fried, M.; Doehle, B.; An, D.; McNally, J.; Osinusi, A.; Brainard, D.M.; McHutchison, J.G.; Brown, R.S., Jr; Charlton, M. ASTRAL-4 Investigators. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N. Engl. J. Med., 2015, 373(27), 2618-2628.
[http://dx.doi.org/10.1056/NEJMoa1512614] [PMID: 26569658]
[50]
Wyles, D.; Bräu, N.; Kottilil, S.; Daar, E.S.; Ruane, P.; Workowski, K.; Luetkemeyer, A.; Adeyemi, O.; Kim, A.Y.; Doehle, B.; Huang, K.C.; Mogalian, E.; Osinusi, A.; McNally, J.; Brainard, D.M.; McHutchison, J.G.; Naggie, S.; Sulkowski, M. ASTRAL-5 Investigators. Sofosbuvir and velpatasvir for the treatment of HCV in patients coinfected with HIV-1: an open-label, phase 3 study. Clin. Infect. Dis., 2017, 65, 6-12.
[http://dx.doi.org/10.1093/cid/cix260] [PMID: 28369210]
[51]
Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO network - Academic and community treatment of a realworld, heterogeneous population 2018, Mar 12. Available from : http://www.natap.org/2014/AASLD/AASLD_09.htm
[52]
Safety and efficacy of sofosbuvir-containing regimens for hepatitis c: real-world experience in a diverse, longitudinal observational cohort. 2018, Mar 12. Available from : http://www.natap.org/2014/AASLD/AASLD_10.htm
[53]
Kaur, K.; Gandhi, M.A.; Slish, J. Drug-Drug Interactions Among Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Medications. Infect. Dis. Ther., 2015, 4(2), 159-172.
[http://dx.doi.org/10.1007/s40121-015-0061-2] [PMID: 25896480]
[54]
Verma, N.; Singh, S.; Sawatkar, G.; Singh, V. Sofosbuvir induced steven Johnson Syndrome in a patient with hepatitis C virus-related cirrhosis. Hepatol Commun, 2017, 2(1), 16-20.
[http://dx.doi.org/10.1002/hep4.1126] [PMID: 29404508]
[55]
German, P.; Mathias, A.; Brainard, D.M.; Song, Q.; Ling, J.; Kearney, B.P. A thorough QT Study to Evaluate the Effects of Supratherapeutic Doses of Ledipasvir on the QTc Interval in Healthy Subjects. Clin. Pharmacol. Drug Dev., 2018, 7(6), 641-651.
[http://dx.doi.org/10.1002/cpdd.390] [PMID: 29058821]
[56]
Lenz, D.U.; Crutcher, E.L.; Greene, E.M. Sexual dysfunction in a patient taking ledipasvir/sofosbuvir for the treatment of hepatitis C: A case report. J. Pharm. Pract., 2017., 897190017744421
[http://dx.doi.org/10.1177/0897190017744421] [PMID: 29183252]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy