Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin: SOUND-C3, a Phase 2b study

Liver International

Volumn 35, Issue 2, 2015, Pages 417-421

  Zeuzem, Stefan ^a   Dufour, Jean François ^b   Buti, Maria ^c   Soriano, Vicente ^d   Buynak, Robert J ^e   Mantry, Parvez ^f   Taunk, Jawahar ^g   Stern, Jerry O ^h   Vinisko, Richard ^h   Gallivan, John Paul ⁱ   Böcher, Wulf ⁱ   Mensa, Federico J ^h   Cobert, Barton ^j   Gonzalwz Peralta, Regino ^k   Ray, Stuart C ^l   Talal, Andrew ^m  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b UNIVERSITY OF BERN   (Switzerland)

^c INSTITUTO DE SALUD CARLOS III   (Spain)

^d HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^e Northwest Indiana Center for Clinical Research   (United States)

^f METHODIST DALLAS MEDICAL CENTER   (United States)

^g Think Composites LLC   (United States)

^h BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

ⁱ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^j BLCMD Associates LLC   (United States)

^k UNIVERSITY OF FLORIDA   (United States)

^l DEPARTMENT OF PATHOLOGY   (United States)

^m WEILL CORNELL MEDICAL COLLEGE   (United States)

more..

Author keywords

Genotype 1; Interferon free; SVR12; Treatment na ve

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; DELEOBUVIR; FALDAPREVIR; HEMOGLOBIN; INTERLEUKIN 28B; RIBAVIRIN; ACRYLIC ACID DERIVATIVE; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; N-((CYCLOPENTYLOXY)CARBONYL)-3-METHYLVALYL-4-((8-BROMO-7-METHOXY-2-(2-((2-METHYLPROPANOYL)AMINO)-1,3-THIAZOL-4-YL)QUINOLIN-4-YL)OXY)-N-(1-CARBOXY-2-ETHENYLCYCLOPROPYL)PROLINAMIDE; OLIGOPEPTIDE; THIAZOLE DERIVATIVE; VIRUS RNA;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; DEHYDRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FATIGUE; GASTROINTESTINAL DISEASE; GENOTYPE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HUMAN; LIVER CIRRHOSIS; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PHOTOSENSITIVITY; PRURITUS; TREATMENT DURATION; VOMITING; BLOOD; CLINICAL TRIAL; DRUG COMBINATION; HEPATITIS C, CHRONIC; TREATMENT OUTCOME;

ACRYLATES; ANTIVIRAL AGENTS; BENZIMIDAZOLES; DRUG THERAPY, COMBINATION; HEPATITIS C, CHRONIC; HUMANS; OLIGOPEPTIDES; RIBAVIRIN; RNA, VIRAL; THIAZOLES; TREATMENT OUTCOME;

EID: 84921453842     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/liv.12693     Document Type: Article

References (15)

1. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-87.
2. 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.
3. 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.
4. Ferenci P, Asselah T, Foster GR, et al. Faldaprevir plus pegylated interferon alfa-2a and ribavirin in chronic HCV genotype-1 treatment-naïve patients: final results from STARTverso1, a randomised, double-blind, placebo-controlled phase III trial. J Hepatol 2013; 58: S569-70.
5. Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; doi: 10.1016/S0140-6736(14)60494-3. [Epub ahead of print].
6. Ogawa E, Furusyo N, Kajiwara E, et al. Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: results from Kyushu University Liver Disease Study. J Gastroenterol Hepatol 2012; 27: 1233-40.
7. Zeuzem S, Soriano V, Asselah T, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med 2013; 369: 630-9.
8. Zeuzem S, Soriano V, Asselah T, et al. SVR4 and SVR12 with an interferon-free regimen of BI201335 and BI207127, +/- ribavirin, in treatment-naive patients with chronic genotype-1 HCV infection: interim results of SOUND-C2. J Hepatol 2012; 56: S45.
9. Zeuzem S, Asselah T, Angus P, et al. Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection. Gastroenterology 2011; 141: 2047-55.
10. Zeuzem S, Asselah T, Angus P, et al. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther 2013; 18: 1015-9.
11. McCarthy JJ, Li JH, Thompson A, et al. Replicated association between an IL28B gene variant and a sustained response to pegylated interferon and ribavirin. Gastroenterology 2010; 138: 2307-14.
12. Kumada H1, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014; 59: 2083-91.
13. Lawitz E, Sulkowski MS, Ghalib R, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet 2014; doi: 10.1016/S0140-6736(14)61036-9. [Epub ahead of print]
14. Merck Sharp & Dohme Corp. Victrelis (boceprevir) prescribing information, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. Revised February 2013. (accessed 3 September 2014).
15. Vertex Pharmaceuticals Inc. Incivek (telaprevir) prescribing information, Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA. Revised April 2013. (accessed 3 September 2014).