Sofosbuvir: A novel treatment option for chronic hepatitis C infection

Journal of Pharmacology and Pharmacotherapeutics

Volumn 5, Issue 4, 2014, Pages 278-284

  Bhatia, Harmeet Kaur ^a   Singh, Harmanjit ^d   Grewal, Nipunjot ^b   Natt, Navreet Kaur ^c  

^a POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH   (India)

^b Punjab Institute of Medical Sciences   (India)

^c District TB Hospital   (India)

^d ALL INDIA INSTITUTE OF MEDICAL SCIENCES   (India)

Author keywords

Hepatitis C; NS5B polymerase; Sofosbuvir; SVR

Indexed keywords

ANTIVIRUS AGENT; CYCLOSPORIN; DACLATASVIR; DARUNAVIR; EFAVIRENZ; GS 9669; LEDIPASVIR; METHADONE; NONSTRUCTURAL PROTEIN 3; NONSTRUCTURAL PROTEIN 4; NONSTRUCTURAL PROTEIN 5B; PEGINTERFERON; PSI 938; PYRIMIDINE; RALTEGRAVIR; RIBAVIRIN; RILPIVIRINE; RITONAVIR; SIMEPREVIR; SOFOSBUVIR; TACROLIMUS; TENOFOVIR; UNCLASSIFIED DRUG;

ALOPECIA; ANEMIA; ANTIVIRAL RESISTANCE; ARTICLE; BACKACHE; CHILL; CHOLELITHIASIS; CONSTIPATION; CROSS RESISTANCE; DEPRESSION; DIZZINESS; DRUG ABSORPTION; DRUG ACTIVATION; DRUG APPROVAL; DRUG EFFICACY; DRUG ELIMINATION; DRUG INDICATION; DRUG MECHANISM; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME INHIBITION; FATIGUE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPOPHOSPHATEMIA; INSOMNIA; LYMPHOCYTOPENIA; NAUSEA; NEUTROPENIA; NONCARDIAC CHEST PAIN; NONHUMAN; PANCREATITIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; UPPER RESPIRATORY TRACT INFECTION;

EID: 84908607278     PISSN: 0976500X     EISSN: 09765018     Source Type: Journal    
DOI: 10.4103/0976-500X.142464     Document Type: Article

References (27)

1. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-87.
2. Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, et al. 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: 2100-7.
3. Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368: 1867-77.
4. Zeng QL, Zhang JY, Zhang Z, Wang LF, Wang FS. Sofosbuvir and ABT-450: Terminator of hepatitis C virus? World J Gastroenterol 2013; 19: 3199-206.
5. Herbst DA Jr, Reddy KR. Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection. Expert Opin Investig Drugs 2013; 22: 527-36.
6. Gentile I, Borgia F, Buonomo AR, 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: 3733-42.
7. Soriano V, Vispo E, de Mendoza C, Labarga P, Fernandez-Montero JV, Poveda E, et al. Hepatitis C therapy with HCV NS5B polymerase inhibitors. Expert Opin Pharmacother 2013; 14: 1161-70.
8. Statement on a Nonproprietary Name Adopted by the USAN Council. Available from: Http://www.ama-assn.org/resources/doc/usan/nabiximols. pdf. [Last accessed on 2013 Oct 2].
9. Lam AM, Espiritu C, Bansal S, MicolochickSteuer HM, Niu C, Zennou V, et al. Genotype and subtype pro-ling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother 2012; 56: 3359-68.
10. Murakami E, Tolstykh T, Bao H, Niu C, Steuer HM, Bao D, et al. Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977. J Biol Chem 2010; 285: 34337-47.
11. Tseng A. Drug Interactions with Investigational Hepatitis C Nucleotide Inhibitors; Sofosbuvir. Available from: Http://www.hcvdruginfo.ca/downloads/Hepatitis%20C-int-new%20nucleotide%20inhibitors.pdf. [Last accessed on 2013 Sep 28].
12. An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination in subjects with nosocomial genotype 1 HCV infection. Available from: Http://clinicaltrials.gov/ct2/show/NCT01924949. [Last accessed on 2013 Nov 11].
13. Open-Labeled Study of PSI-7977 and RBV with and without PEG-IFN in Treatment-naive Patients with HCV GT2 or GT3. Available from: Http://clinicaltrials. gov/show/NCT01260350. [Last accessed on 2013 Oct 5].
14. Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Subjects with Chronic Genotype 1, 2, or 3 HCV Infection. Available from: Http://clinicaltrials.gov/ct2/show/NCT01826981. [Last accessed on 2013 Oct 12].
15. Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-dose Combination ± Ribavirin for the Treatment of HCV (ION-2). Available from: Http://clinicaltrials.gov/show/NCT01768286. [Last accessed on 2013 Oct 16].
16. Rodriguez-Torres M, Lawitz E, Kowdley KV, Nelson DR, Dejesus E, McHutchison JG, et al. Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naive patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial. J Hepatol 2013; 58: 663-8.
17. Lawitz E, Rodriguez-Torres M, Denning J, Cornpropst MT, Clemons D, McNair L, et al. Once daily dual-nucleotide combination of PSI-938 and PSI-7977 provides 94%HCVRNA
18. Levin J. EASL 46th Annual Meeting. PROTON Study: PSI- 7977 QD with PEG/RBV: 12-week Safety, RVR, cEVR, and SVR12 in Treatment-naïve Patients with HCV GT2 or GT3. Available from: Http://www.natap.org/2011/EASL/EASL-22.htm. http://clinicaltrials.gov/show/NCT01768286. [Last accessed on 2013 Oct 15].
19. Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013; 368: 34-44.
20. Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: A randomized clinical trial. JAMA 2013; 310: 804-11.
21. Highleyman L. DDW 2013: Interferon-free Simeprevir + Sofosbuvir Suppresses Hepatitis C with or without Ribavirin. 2013 May. Available from: Http://www. hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/4126-ddw-2013- interferon-free-simeprevir-sofosbuvir-suppresses-hepatitis-c-with-or-withoutribavirin. [Last accessed on 2013 Oct 18].
22. Levin J. High Rate of Sustained Virologic Response with the All-oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), with or without Ribavirin, in Treatment-naive Patients Chronically Infected with HCV GT 1, 2, or 3. Presented at 63rdAnnual Meeting of the American Association for the Study ofLiver diseases Boston, MA Nov 9-12 2012. Available from: Http://www.natap.org/2012/AASLD/AASLD-06.htm. [Last accessed on2013Oct 15].
23. Highlyman L. Polymerase Inhibitor PSI-7977 Works with Interferon or Companion Drug. Coverage of the 46thAnnual Meeting of the European Association for the Study of the Liver. 2011 April. Available from: Http://www. hivandhepatitis.com/2011-conference/easl2011/docs/0404-2010-d.html. [Last accessed on 2013 Oct 10].
24. Levin J. GS-7977 and HIV ARTs PK - No Clinically Significant Pharmacokinetic Interactions between Sofosbuvir (GS-7977) and HIV Antiretro virals Atripla, Rilpivirine, Darunavir/Ritonavir, or Raltegravir in Healthy Volunteers. AASLD - 63rd Annual Meeting of the American Association for the Study of Liver Diseases. 2012 Nov. Available from: Http://www.natap.org/2012/AASLD/AASLD-64.htm. [Last accessed on 2013 Oct 5].
25. Data from Phase 3 Studies of Gilead's Sofosbuvir for Hepatitis C to be Presented at 48thAnnual EASL Meeting; Findings Published Online in The New England Journal of Medicine. 2013 April. Available from: Http://www.gilead.com/news/press-releases/2013/4/data-from-phase-3-studies-ofgileads- sofosbuvir-for-hepatitis-c. [Last accessed on 2013 Oct 10].
26. Fontana RJ, Hughes EA, Bifano M, Appelman H, Dimitrova D, Hindes R, et al. Sofosbuvir and daclatasvir combination therapy in a liver transplant recipient with severe recurrent cholestatic hepatitis C. Am J Transplant 2013; 13: 1601-5.
27. FDA Approves Sovaldi for Chronic Hepatitis C. Available from: Http://www.fda.gov/News Events/Newsroom/PressAnnouncements/ucm377888. htm. [Last accessed on 2012 Dec 6].