Decade of optimizing therapy with direct-acting antiviral drugs and the changing profile of patients with chronic hepatitis C

doi:10.3748/wjg.v29.i6.949

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Feb 14, 2023 (publication date) through May 15, 2024

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World Journal of Gastroenterology

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1007-9327

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World J Gastroenterol. Feb 14, 2023; 29(6): 949-966
Published online Feb 14, 2023. doi: 10.3748/wjg.v29.i6.949

Table 1 Efficacy of genotype-specific regimens in phase III of clinical trials

Ref.	Number of participants	Regimen	GT	SVR (mITT analysis) n/N (%)
				Patients without cirrhosis		Patients with cirrhosis
				Treatment-naïve	Treatment-experienced	Treatment-naïve	Treatment-experienced
Afdhal et al[40] (ION-1)	865	LDV/SOF, 12 wk (n = 214)	1	179/179 (100)		32/33 (97.0)
		LDV/SOF + RBV, 12 wk (n = 217)		178/178 (100)		33/33 (100)
		LDV/SOF, 24 wk, (n = 217)		181/182 (99.5)		31/32 (96.9)
		LDV/SOF + RBV, 24 wk (n = 217)		179/179 (100)		36/36 (100)
Afdhal et al[41] (ION-2)	440	LDV/SOF, 12 wk (n = 109)	1		83/87 (95.4)		19/22 (86.4)
		LDV/SOF + RBV, 12 wk (n = 111)			89/89 (100)		18/22 (81.8)
		LDV/SOF, 24 wk, (n = 109)			86/87 (98.9)		22/22 (100)
		LDV/SOF + RBV, 24 wk (n = 111)			88/89 (98.9)		22/22 (100)
Kowdley et al[42] (ION-3)	647	LDV/SOF, 8 wk (n = 215)	1	202/214 (94.4)
		LDV/SOF + RBV, 8 wk (n = 216)		201/211 (95.3)
		LDV/SOF, 12 wk (n = 216)		206/209 (98.6)
Feld et al[45] (SAPPHIRE-I)	473	OBV/PTV/r + DSV + RBV, 12 wk	1	455/473 (96.2)
Zeuzem et al[46] (SAPPHIRE-II)	297	OBV/PTV/r + DSV + RBV, 12 wk	1		286/297 (96.3)
Ferenci et al[47] (PEARL-III)	419	OBV/PTV/r + DSV + RBV, 12 wk (n = 210)	1b	209/210 (99.5)
		OBV/PTV/r + DSV + placebo, 12 wk (n = 209)		207/207 (100)
Ferenci et al[47] (PEARL-IV)	305	OBV/PTV/r + DSV + RBV, 12 wk (n = 100)	1a	97/99 (98.0)
		OBV/PTV/r + DSV + placebo, 12 wk (n = 205)		185/204 (90.7)
Welzel et al[48] (GARNET)	163	OBV/PTV/r + DSV, 8 wk	1b	160/162 (99.0)
Asselah et al[49] (AGATE-I)	120	OBV/PTV/r + RBV, 12 wk (n = 59)	4			57/58 (98.0)
		OBV/PTV/r + RBV, 16 wk (n = 61)				60/60 (100)
Asselah et al[50] (AGATE-I Part II)	64	OBV/PTV/r + RBV, 24 wk	4			60/60 (100)
Waked et al[51] (AGATE-II)	160	OBV/PTV/r + RBV, 12 wk (n = 131)	4	94/98 (96.0)	30/31 (97.0)
		OBV/PTV/r + RBV, 24 wk (n = 29)				27/28 (96.0)
Zeuzem et al[58] (C-EDGE treatment naïve)	421	GZR/EBR ± RBV, 12 wk	1, 4, 6	68/70 (97.0)¹		231/246 (94.0)¹
Kwo et al[59] (C-EDGE treatment-experienced)	420	GZR/EBR ± RBV, 12 or 16 wk	1, 4, 6		255/264 (96.6)		135/144 (93.8)

¹Intent-to-treat analysis (no data for modified intent-to-treat analysis).

DSV: Dasabuvir; EBR: Elbasvir; GT: Genotype; GZR: Grazoprevir; LDV: Ledipasvir; mITT: Modified intention-to-treat; OBV: Ombitasvir; PTV/r: Paritaprevir; RBV: Ribavirin; SOF: Sofosbuvir; SVR: Sustained virological response.

Citation: Brzdęk M, Zarębska-Michaluk D, Invernizzi F, Cilla M, Dobrowolska K, Flisiak R. Decade of optimizing therapy with direct-acting antiviral drugs and the changing profile of patients with chronic hepatitis C. World J Gastroenterol 2023; 29(6): 949-966
URL: https://www.wjgnet.com/1007-9327/full/v29/i6/949.htm
DOI: https://dx.doi.org/10.3748/wjg.v29.i6.949