Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1

doi:10.3748/wjg.v22.i12.3418

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Trials Study

World J Gastroenterol. Mar 28, 2016; 22(12): 3418-3431
Published online Mar 28, 2016. doi: 10.3748/wjg.v22.i12.3418

Table 4 Overall on-treatment safety in GT1-infected patients

Event, n (%)	*DCV + pegIFN/RBV (n =* 402)**	*TVR + pegIFN/RBV (n =* 200)¹**
Death	1 (0.2)²	1 (0.5)²
SAEs	26 (6.5)²	20 (10.0)²
AEs leading to discontinuation of any study drug	28 (7.0)²	37 (18.5)²
AEs leading to discontinuation of all 3 study drugs	25 (6.2)	25 (12.5)
AEs (grade 1-4) ≥ 20%
Fatigue	140 (34.8)	81 (40.5)
Headache	137 (34.1)	57 (28.5)
Asthenia	109 (27.1)	53 (26.5)
Pruritus	107 (26.6)	75 (37.5)
Anemia	96 (23.9)	99 (49.5)
Rash	93 (23.1)	69 (34.5)
Nausea	88 (21.9)	74 (37.0)
Neutropenia	87 (21.6)	27 (13.5)
Alopecia	86 (21.4)	32 (16.0)
Influenza-like illness	85 (21.1)	38 (19.0)
Dry skin	84 (20.9)	34 (17.0)
Pyrexia	80 (19.9)	42 (21.0)
Grade 3 or 4 emergent laboratory abnormalities
Hemoglobin	26 (6.5)	41 (20.5)
Absolute neutrophil count	104 (25.9)	41 (20.5)
Lymphocytes	67 (16.7)	44 (22.0)
^{Platelet count}	15 (3.7)	8 (4.0)
ALT	3 (0.7)	4 (2.0)
AST	7 (1.7)	1 (0.5)
Total bilirubin	4 (1.0)	6 (3.0)
Serum creatinine increased	1 (0.2)	0

¹n = 198 for grade 3/4 laboratory abnormalities;

²Further information provided in supplementary material. AE: Adverse event; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; DCV: Daclatasvir; GT: Genotype; pegIFN: Peginterferon alfa-2a; RBV: Ribavirin; SAE: Serious adverse event; TVR: Telaprevir.

Citation: Jacobson I, Zeuzem S, Flisiak R, Knysz B, Lueth S, Zarebska-Michaluk D, Janczewska E, Ferenci P, Diago M, Zignego AL, Safadi R, Baruch Y, Abdurakhmanov D, Shafran S, Thabut D, Bruck R, Gadano A, Thompson AJ, Kopit J, McPhee F, Michener T, Hughes EA, Yin PD, Noviello S. Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1. World J Gastroenterol 2016; 22(12): 3418-3431
URL: https://www.wjgnet.com/1007-9327/full/v22/i12/3418.htm
DOI: https://dx.doi.org/10.3748/wjg.v22.i12.3418