Sofosbuvir and velpatasvir for HCV Genotype 2 and 3 infection

New England Journal of Medicine

Volumn 373, Issue 27, 2015, Pages 2608-2617

  Foster, G R ^a   Afdhal, N ^a   Roberts, S K ^a   Br, N ^a   Gane, E J ^a   Pianko, S ^a   Lawitz, E ^a   Thompson, A ^a   Shiffman, M L ^a   Cooper, C ^a   Towner, W J ^a   Conway, B ^a   Ruane, P ^a   Bourlie, M ^a   Asselah, T ^a   Berg, T ^a   Zeuzem, S ^a   Rosenberg, W ^a   Agarwal, K ^a   Stedman, C A M ^a   Mo, H ^a   Dvory Sobol, H ^a   Han, L ^a   Wang, J ^a   McNally, J ^a   Osinusi, A ^a   Brainard, D M ^a   McHutchison, J G ^a   Mazzotta, F ^a   Tran, T T ^a   Gordon, S C ^a   Patel, K ^a   Reau, N ^a   Mangia, A ^a   Sulkowski, M ^a   more..

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; HEMOGLOBIN; INTERLEUKIN 28B; RIBAVIRIN; SOFOSBUVIR; SOFOSBUVIR PLUS VELPATASVIR; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; DRUG COMBINATION; FUSED HETEROCYCLIC RINGS; NS-5 PROTEIN, HEPATITIS C VIRUS; VELPATASVIR; VIRAL PROTEIN;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; AGED; ANXIETY; ARTHRALGIA; ARTICLE; BEHAVIOR DISORDER; COGNITIVE DEFECT; CONTROLLED STUDY; COUGHING; DEPRESSION; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; ENTERITIS; FATIGUE; FEMALE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 2; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; HYPERBILIRUBINEMIA; INSOMNIA; IRRITABILITY; LIVER CIRRHOSIS; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MENTAL CONCENTRATION; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; THROMBOCYTE COUNT; ANTAGONISTS AND INHIBITORS; ANTIVIRAL RESISTANCE; CLINICAL TRIAL; COMPLICATION; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; TREATMENT OUTCOME; VERY ELDERLY; VIROLOGY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; CARBAMATES; DRUG COMBINATIONS; DRUG RESISTANCE, VIRAL; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 4 OR MORE RINGS; HUMANS; LIVER CIRRHOSIS; MALE; MIDDLE AGED; SOFOSBUVIR; TREATMENT OUTCOME; VIRAL NONSTRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84952909361     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1512612     Document Type: Article

References (18)

1. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol, 2014, 61: Suppl, S45-S57.
2. Hepatitis C fact sheet no. 164. Geneva: World Health Organization, 2015 (http://www .who .int/mediacentre/factsheets/fs164/en).
3. Ampuero J, Romero-Gez M, Reddy KR. Review article: HCV genotype 3 the new treatment challenge. Aliment Pharmacol Ther 2014; 39: 686-98.
4. Goossens N, Negro F. Is genotype 3 of the hepatitis C virus the new villain? Hepatology 2014; 59: 2403-12.
5. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C (http://www .hcvguidelines .org).
6. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63: 199-236.
7. Rebetol (ribavirin) prescribing information. Whitehouse Station, NJ: Merck, 2013 (package insert) (http://www .merck.com/product/usa/pi-circulars/r/rebetol/rebetol-pi .pdf).
8. Sovaldi (sofosbuvir) prescribing information. Foster City, CA: Gilead Sciences, 2014 (package insert) (http://www .gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi-pi .pdf).
9. Cheng G, Yu M, Peng B, et al. GS-5816 A second generation HCV NS5A inhibitor with potent antiviral activity, board genotypic coverage and a high resistance bar- rier. Presented at the 48th Annual Meeting of the European Association for the Study of the Liver, Amsterdam, April 24 28, 2013. abstract.
10. Doehle B, Dvory-Sobol H, Hebner C, et al. Deep sequencing of HCV NS5A from a 3-day study of GS-5816 monotherapy confirms the potency of GS-5816 against pre-existing genotype 13 NS5A resistance- associated variants. Presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases, Washington DC, November 15, 2013. abstract.
11. Lawitz E, Freilich B, Link J, et al. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat 2015 July 16 (Epub ahead of print).
12. Everson GT, Towner WJ, Davis MN, et al. Sofosbuvir with velpatasvir in treatment-nae non-cirrhotic patients with genotype 1-6 hepatitis C virus infection: a randomized trial. Ann Intern Med 2015 November 10 (Epub ahead of print).
13. Pianko S, Flamm SL, Shiffman ML, et al. Sofosbuvir-velpatasvir combination therapy for treatment-experienced patients with genotype 1 and 3 hepatitis C virus infection: a randomized trial. Ann Intern Med 2015 November 10 (Epub ahead of print).
14. Feld JJ, Jacobson IM, Hode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med 2015;373:2599-607.
15. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993-2001.
16. Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61: 1127-35.
17. Foster GR, Pianko S, Brown A, et al. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with HCV genotype 3 infection and treatmentexperienced patients with cirrhosis and HCV genotype 2 infection. Gastroenterology 2015 August 4 (Epub ahead of print).
18. Curry MP, OLeary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373:2618-28.