Overall efficacy and safety results of sofosbuvir-based therapies in Phase II and III studies

Digestive and Liver Disease

Volumn 46, Issue S5, 2014, Pages S179-S185

  Mangia, Alessandra ^a   Piazzolla, Valeria ^a  

^a CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

Author keywords

DAAs; HCV

Indexed keywords

PEGINTERFERON ALPHA2A; RIBAVIRIN; SOFOSBUVIR; ALPHA INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN; URIDINE PHOSPHATE;

ANEMIA; CHILL; COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FLU LIKE SYNDROME; GENOTYPE; HUMAN; INSOMNIA; LOSS OF APPETITE; MYALGIA; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RETREATMENT; REVIEW; TREATMENT FAILURE; ANALOGS AND DERIVATIVES; DRUG COMBINATION; FEMALE; GENETICS; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; MALE; MIDDLE AGED; TREATMENT OUTCOME;

ANTIVIRAL AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG THERAPY, COMBINATION; FEMALE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RIBAVIRIN; TREATMENT OUTCOME; URIDINE MONOPHOSPHATE;

EID: 84919442958     PISSN: 15908658     EISSN: 18783562     Source Type: Journal    
DOI: 10.1016/j.dld.2014.09.026     Document Type: Review

References (23)

1. FDA approves Sovaldi for chronic hepatitis C. FDA news release US food and Drug administration. 2013-12-06.
2. European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C EMA/717004/2013.
3. Sofia M.J., Bao D., Chang W., et al. Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus. Journal of Medicinal Chemistry 2010, 53:7202-7218.
4. Lam A.M., Espiritu C., Bansal S., et al. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrobial Agents and Chemotherapy 2012, 56:3359-3368.
5. Gane E.J., Stedman C.A., Hyland R.H., et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. New England Journal of Medicine 2013, 368:34-44.
6. Cheng W., Shafran S., Beavers K., et al. Long-term follow-up of patients treated with sofosbuvir in the Phase 3 studies FISSION, POSITRON, FUSION, and NEUTRINO. Journal of Hepatology 2014, 50(Suppl. 1):S449.
7. Rodriguez-Torres M., Lawitz E., Kowdley K.V., et al. Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: a randomized, 28-day, dose-ranging trial. Journal of Hepatology 2013, 58:663-668.
8. Kowdley K.V., Lawitz E., Crespo I., et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naïve patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomized, multicenter phase 2 trial. Lancet 2013, 38:2100-2107.
9. Lawitz E., Lalezari J.P., Hassanein T., et al. 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 Infectious Diseases 2013, 13:401-408.
10. Gane E.J., Stedman C.A., Hyland R.H., et al. Once daily sofosbuvir/ledipasvir fixed dose combination with or without ribavirin: the ELECTRON trial. Hepatology 2013, 58(Suppl. 1):243A.
11. Lawitz E., Poordad F., Brainard D.M., et al. Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides high SVR rates in HCV-infected genotype 2 or 3 treatment experienced patients with or without compensated cirrhosis: results from the LONESTAR-2 study. Hepatology 2013, 58(Suppl. 1):1380A.
12. Osinusi A., Meissner E.G., Lee Y-J., et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics. A randomized clinical trial. Journal of American Medical Association 2013, 310:804-811.
13. EASL HCV recommendations presented by Prof. Jean-Michel Pawlotsky at the International Liver Congress™ 2014, London: . http://www.easl.eu/_newsroom/latest-news/easl-recommendations-on-treatment-of-hepatitis-c-2014.
14. Lawitz E., Mangia A., Wyles D., et al. Sofosbuvir for previously untreated chronic hepatitis C infection. New England Journal of Medicine 2013, 368:1878-1887.
15. Jacobson I.M., Gordon S.C., Kowdley K.V., et al. Sofosbuvir for hepatitis C genotype 2 or 3 patients without treatment options. New England Journal of Medicine 2013, 368:1867-1877.
16. Mangia A., Kugelmas M., Everson G.T., et al. Virologic response rates to sofosbuvir-containing regimens are similar in patients with and without traditional negative predictive factors: a retrospective analysis of phase 3 data. Program and abstracts of the 64th annual meeting of the American Association for the Study of Liver Diseases; November 1-5 2013, Abstract 1115.
17. Zeuzem S., Dusheiko G., Salupere R., et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. New England Journal of Medicine 2014, 370:1993-2001.
18. Jacobson I.M., McHutchison J.G., Dusheiko G., et al. Telaprevir for previously untreated chronic hepatitis C virus infection. New England Journal of Medicine 2011, 364:2405-2416.
19. Poordad F., McCone J., Bacon B.R., et al. Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine 2011, 364:1195-1206.
20. Ruane P.J., Ain D., Riad J., et al. Sofosbuvir plus ribavirin in the treatment of chronic HCV genotype 4 infection in patients of Egyptian ancestry. Hepatology 2013, 58(Suppl.):736A.
21. Pol S., Sulkowski M., Hassenein T., et al. Successful retreatment with sofosbuvir of HCV genotype 1 infected patients who failed prior therapy with pegInterferon plus ribavirin plus 1 or 2 additional direct-acting antiviral agents. Journal of Hepatology 2014, 60:S23-S44.
22. Esteban R., Nyberg L., Lalezari J. Successful retreatment with sofosbuvir containing regimens for HCV genotype 2 and 3 infected patients who failed prior sofosbuvir plus ribavirin therapy. Journal of Hepatology 2014, 60:S4.
23. Gordon S., Contai S., Tournee W., et al. Integrated safety analysis of sofosbuvir-based HCV treatment regimens from phase III studies. Journal of Hepatology 2014, 60:S361-S522.