ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV

New England Journal of Medicine

Volumn 370, Issue 21, 2014, Pages 1983-1992

  Ferenci, Peter ^a   Bernstein, David ^b   Lalezari, Jacob ^c   Cohen, Daniel ^h   Luo, Yan ^h   Cooper, Curtis ⁱ   Tam, Edward ^j   Marinho, Rui T ^k   Tsai, Naoky ^l   Nyberg, Anders ^d   Box, Terry D ^m   Younes, Ziad ⁿ   Enayati, Pedram ^e   Green, Sinikka ^f   Baruch, Yaacov ^o   Bhandari, Bal Raj ^p   Caruntu, Florin Alexandru ^q   Sepe, Thomas ^r   Chulanov, Vladimir ^s   Janczewska, Ewa ^t   Rizzardini, Giuliano ^u   Gervain, Judit ^v   Planas, Ramon ^w   Moreno, Christophe ^x   Hassanein, Tarek ^g   Xie, Wangang ^h   King, Martin ^h   Podsadecki, Thomas ^h   Reddy, K Rajender ^y   more..

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

^c Quest Clinical Research   (United States)

^d KAISER PERMANENTE   (United States)

^e California Liver Institute   (United States)

^f EStudySite   (United States)

^g Southern California Research Center   (United States)

^h ABBVIE INC   (United States)

ⁱ UNIVERSITY OF OTTAWA   (Canada)

^j Liver and Intestinal Research Centre   (Canada)

^k Centro Hospitalar Lisboa Norte   (Portugal)

^l Queen's Medical Center   (United States)

^m Clinical Research Centers of America   (United States)

ⁿ Gastro One   (United States)

^o Rambam Health Care Campus ^*  (Israel)

^p Delta Research Partners   (United States)

^q Matei Bals National Institute for Infectious Diseases   (Romania)

^r University Gastroenterology   (United States)

^s CENTRAL RESEARCH INSTITUTE OF EPIDEMIOLOGY   (Russian Federation)

^t ID Clinic   (Poland)

^u UNIVERSITY OF MILAN   (Italy)

^v Department of Internal Medicine   (Hungary)

^w HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^x ERASME HOSPITAL   (Belgium)

^y UNIVERSITY OF PENNSYLVANIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABT 450; BILIRUBIN; DASABUVIR; HEMOGLOBIN; OMBITASVIR; PLACEBO; RIBAVIRIN; RITONAVIR; VIRUS RNA;

ADULT; AGED; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEMALE; GENOTYPE; HEADACHE; HEPATITIS C; HUMAN; HYPERBILIRUBINEMIA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; TREATMENT DURATION; TREATMENT OUTCOME;

ADULT; AGED; ANILIDES; ANTIVIRAL AGENTS; CARBAMATES; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEMOGLOBINS; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MACROCYCLIC COMPOUNDS; MALE; MIDDLE AGED; RECURRENCE; RIBAVIRIN; RNA, VIRAL;

EID: 84901044326     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1402338     Document Type: Article

References (28)

1. Hepatitis C: fact sheet no. 164. Geneva: World Health Organization (http://www.who.int/mediacentre/factsheets/fs164/en).
2. Rosen HR. Chronic hepatitis C infection. N Engl J Med 2011;364:2429-38.
3. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-74.
4. Global Alert and Response (GAR): hepatitis C. Geneva: World Health Organization (http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/ index2.html).
5. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405-16.
6. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195-206.
7. McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009;360:1827-38.
8. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR study. Hepatology 2013;58:1918-29.
9. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368:1878-87.
10. Chung RT. A watershed moment in the treatment of hepatitis C. N Engl J Med 2012;366:273-5.
11. Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360:1839-50.
12. Lok AS, Gardiner DF, Hezode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol 2014;60:490-9.
13. Sun SC, Bae A, Qi X, et al. Natural variation in drug susceptibility to HCV polymerase inhibitors in treatment-naïve HCV patient isolates. J Viral Hepat 2011;18:861-70.
14. Sarrazin C, Zeuzem S. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology 2010;138:447-62.
15. Susser S, Welsch C, Wang Y, et al. Characterization of resistance to the protease inhibitor boceprevir in hepatitis C virus-infected patients. Hepatology 2009;50:1709-18.
16. Zeuzem S, Soriano V, Asselah T, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med 2013;369:630-9.
17. Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366:216-24.
18. Kowdley KV, Lawitz E, Poordad F, et al. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 2014;370:222-32.
19. Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013;368:34-44.
20. Lawitz E, Poordad FF, Pang PS, et al. 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; 383:515-23. [Erratum, Lancet 2014;383:870.]
21. Jacobson IM, Kowdley KV, Kwo PY. Anemia management in the era of triple combination therapy for chronic HCV. Gastroenterol Hepatol (N Y) 2012;8:Suppl 6:1-16.
22. Menon RM, Klein CE, Lawal AA, et al. Pharmacokinetics and tolerability of the HCV protease inhibitor ABT-450 following single ascending doses in healthy adult volunteers with and without ritonavir. In: Program and abstracts of Hep-DART 2009, Kohala Coast, HI, December 6-10, 2009.
23. Pilot-Matias T, Koev G, Krishnan P, et al. In vitro combinatory effect of HCV NS3/4A protease inhibitor ABT-450, NS5A inhibitor ABT-267, and non-nucleoside NS5B polymerase inhibitor ABT-333. In: Program and abstracts of the 47th Annual Meeting of the European Association for the Study of the Liver, Barcelona, April 18-22, 2012.
24. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011;365:1014-24. [Erratum, N Engl J Med 2011;365:1551.]
25. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1594-603.
26. Poordad F, Hezode C, Trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014;370:1983-92.
27. Jacobson IM, Ghalib RH, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study. In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases, Washington, DC, November 1-5, 2013.
28. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014;370:211-21.