Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: A randomised study

Gut

Volumn 64, Issue 6, 2015, Pages 948-956

  Hézode, Christophe ^a   Hirschfield, Gideon M ^b   Ghesquiere, Wayne ^c   Sievert, William ^d   Rodriguez Torres, Maribel ^e   Shafran, Stephen D ^f   Thuluvath, Paul J ^g   Tatum, Harvey A ^h   Waked, Imam ⁱ   Esmat, Gamal ^j   Lawitz, Eric J ^k   Rustgi, Vinod K ^l   Pol, Stanislas ^m   Weis, Nina ⁿ   Pockros, Paul J ^o   Bourlière, Marc ^p   Serfaty, Lawrence ^q   Vierling, John M ^r   Fried, Michael W ^s   Weiland, Ola ^t   Brunetto, Maurizia R ^u   Everson, Gregory T ^v   Zeuzem, Stefan ^w   Kwo, Paul Y ^x   Sulkowski, Mark ^y   Bräu, Norbert ^z   Hernandez, Dennis ^aa   McPhee, Fiona ^aa   Wind Rotolo, Megan ^aa   Liu, Zhaohui ^ab   Noviello, Stephanie ^aa   Hughes, Eric A ^aa   Yin, Philip D ^aa   Schnittman, Steven ^aa   more..

^a UNIVERSITÉ PARIS EST CRÉTEIL   (France)

^b UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d MONASH UNIVERSITY   (Australia)

^e San Juan Bautista School of Medicine   (Puerto Rico)

^f UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^g MERCY MEDICAL CENTER   (United States)

^h Options Health Research   (United States)

ⁱ National Liver Institute   (Egypt)

^j CAIRO UNIVERSITY   (Egypt)

^k UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^l Metropolitan Research   (United States)

^m INSTITUT COCHIN   (France)

ⁿ Mental Health Services CPH   (Denmark)

^o SCRIPPS CLINIC   (United States)

^p HÔPITAL SAINT JOSEPH   (France)

^q HÔPITAL SAINT ANTOINE   (France)

^r BAYLOR COLLEGE OF MEDICINE   (United States)

^s UNIVERSITY OF NORTH CAROLINA   (United States)

^t KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^u UNIVERSITY HOSPITAL OF PISA   (Italy)

^v UNIVERSITY OF COLORADO   (United States)

^w GOETHE UNIVERSITY   (Germany)

^x INDIANA UNIVERSITY   (United States)

^y JOHNS HOPKINS UNIVERSITY   (United States)

^z VETERANS AFFAIRS MEDICAL CENTER   (United States)

^aa BRISTOL MYERS SQUIBB   (United States)

^ab BRISTOL MYERS SQUIBB RESEARCH AND DEVELOPMENT   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DACLATASVIR; PEGINTERFERON ALPHA; PEGINTERFERON ALPHA2A; PLACEBO; RIBAVIRIN; ALPHA INTERFERON; BMS-790052; IMIDAZOLE DERIVATIVE; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN;

ADULT; ADVERSE OUTCOME; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; CHILL; CHRONIC HEPATITIS C; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 4; HUMAN; HYPERBILIRUBINEMIA; INSOMNIA; LIMIT OF QUANTITATION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT RESPONSE; VIRUS RESISTANCE; ADOLESCENT; CLASSIFICATION; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; GENETICS; GENOTYPE; HEPATITIS C, CHRONIC; MIDDLE AGED; REMISSION; TREATMENT OUTCOME; VIROLOGY; VIRUS LOAD; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; INTERFERON-ALPHA; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; REMISSION INDUCTION; RIBAVIRIN; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84932619401     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2014-307498     Document Type: Article

References (37)

1. Negro F, Alberti A. The global health burden of hepatitis C virus infection. Liver Int 2011;31(Suppl 2):1-3.
2. Lavanchy D. The global burden of hepatitis C. Liver Int 2009;29(Suppl 1):74-81.
3. World Health Organization. Hepatitis C key facts. WHO factsheet No 164. July 2012. 2012; http://www.who.int/mediacentre/factsheets/fs164/en/ (accessed 19 Mar 2014).
4. Armstrong GL, Wasley A, Simard EP, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006;144:705-14.
5. World Health Organization. Global Alert and Response (GAR)-Hepatitis C. 2012. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html (accessed 19 Mar 2014).
6. Sievert W, Altraif I, Razavi HA, et al. A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int 2011;31(Suppl 2):61-80.
7. Cornberg M, Razavi HA, Alberti A, et al. A systematic review of hepatitis C virus epidemiology in Europe, Canada and Israel. Liver Int 2011;31(Suppl 2):30-60.
8. Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-74.
9. Kamal SM. Hepatitis C virus genotype 4 therapy: progress and challenges. Liver Int 2011;31(Suppl 1):45-52.
10. Thompson AJ, Muir AJ, Sulkowski MS, et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology 2010;139:120-9.
11. Ochi H, Maekawa T, Abe H, et al. ITPA polymorphism affects ribavirin-induced anemia and outcomes of therapy-a genome-wide study of Japanese HCV virus patients. Gastroenterology 2010;139:1190-7.
12. Janssen Therapeutics. OLYSIO™ (simeprevir) Prescribing Information. 2014.
13. Gilead Sciences Inc. SOVALDITM (sofosbuvir) Prescribing Information. 2014.
14. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol 2014;60:392-420.
15. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. 2014. http://www.hcvguidelines.org/ (accessed 29 May 2014).
16. Wang C, Jia L, Huang H, et al. In vitro activity of BMS-790052 on hepatitis C virus genotype 4 NS5A. Antimicrob Agents Chemother 2012;56:1588-90.
17. Fridell RA, Qiu D, Valera L, et al. Distinct functions of NS5A in hepatitis C virus RNA replication uncovered by studies with the NS5A inhibitor BMS-790052. J Virol 2011;85:7312-20.
18. Nettles RE, Gao M, Bifano M, et al. Multiple ascending dose study of BMS-790052, an NS5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology 2011;54:1956-65.
19. Qiu D, Lemm JA, O'Boyle DR II, et al. The effects of NS5A inhibitors on NS5A phosphorylation, polyprotein processing and localization. J Gen Virol 2011;92:2502-11.
20. Lee C, Ma H, Hang JQ, et al. The hepatitis C virus NS5A inhibitor (BMS-790052) alters the subcellular localization of the NS5A non-structural viral protein. Virology 2011;414:10-18.
21. Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 2010;465:96-100.
22. Pol S, Ghalib RH, Rustgi VK, et al. Daclatasvir for previously untreated chronic hepatitis C genotype 1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis 2012;12:671-7.
23. Ge D, Fellay J, Thompson AJ, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009;461:399-401.
24. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368:1878-87.
25. Moreno C, Hezode C, Marcellin P, et al. Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype 4-infected patients: final results of a phase III trial [Abstract]. J Hepatol 2014;60(Suppl 1):S535.
26. Kwo PY, Lawitz EJ, McCone J, et al. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet 2010;376:705-16.
27. 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.
28. Jacobson I, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: Results from QUEST-1, a phase III trial [Abstract]. J Hepatol 2013;58(Suppl 1):S574.
29. Belda O, Targett-Adams P. Small molecule inhibitors of the hepatitis C virus-encoded NS5A protein. Virus Res 2012;170:1-14.
30. Vezali E, Aghemo A, Colombo M. A review of the treatment of chronic hepatitis C virus infection in cirrhosis. Clin Ther 2010;32:2117-38.
31. Manns M, Marcellin P, Fred Poordad FP, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype-1 infection in treatment-naive patients: Results from QUEST-2, a phase III trial [Abstract]. J Hepatol 2013;58(Suppl 1):S568.
32. Lawitz E, Zeuzem S, Nyberg LM, et al. Boceprevir (BOC) Combined with Peginterferon alfa-2b/ribavirin (P/RBV) in Treatment-Naïve Chronic HCV Genotype 1 Patients with Compensated Cirrhosis: Sustained Virologic Response (SVR) and Safety Subanalyses from the Anemia Management Study [Abstract]. Hepatology 2012;56 (Suppl):216A.
33. Vertex Pharmaceuticals Inc. INCIVEK™ (telaprevir) Prescribing Information. 2014.
34. Merck & Co. Inc. VICTRELISTM (boceprevir) Prescribing Information. 2014.
35. 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.
36. Everson GT, Sims KD, Rodriguez-Torres M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 2014;146:420-9.
37. Chan P, Tafoya E, Bifano M, et al. Exposure-response analysis of daclatasvir in patients with genotype 1 chronic HCV infection: dose selection for phase 3 clinical trials [Abstract]. Rev Antiviral Ther Infect Dis. 2012;6:14.