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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World Journal of Gastroenterology

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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.

Table 2 Efficacy of pangenotypic 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
Lawitz et al[60] (FISSION)	256	SOF + RBV, 12 wk	1-3	147/204 (72.1)		23/49 (46.9)
Jacobson et al[61] (FUSION)	201	SOF + RBV, 12 wk (n = 103)	2, 3		25/26 (96.2), 14/38 (36.8)		6/10 (60.0), 5/26 (19.2)
Jacobson et al[61] (FUSION)	201	SOF + RBV, 16 wk (n = 98)	2, 3		23/23 (100), 25/40 (62.5)		7/9 (77.8), 14/23 (60.9)
Jacobson et al[61] (POSITION)	207	SOF + RBV, 12 wk	2		85/92 (92.0%)		16/17 (94.0%)
Jacobson et al[61] (POSITION)	207	SOF + RBV, 12 wk	3		57/84 (68.0%)		3/14 (21.0%)
Zeuzem et al[81] (VALENCE)¹	323	SOF + RBV, 12 wk (n = 73)	2	29/30 (96.7)	30/32 (93.8)	2/2 (100)	7/9 (77.8)
Zeuzem et al[81] (VALENCE)¹	323	SOF + RBV, 24 wk (n = 250)	3	87/92 (94.6)	85/98 (86.7)	12/13 (92.3)	29/47 (61.7)
Omata et al[82]	153	SOF + RBV, 12 wk	2	80/82 (95.0)	52/54 (100)	8/8 (100)	8/9 (89.0)
Foster et al[62] (BOSON)¹	363	SOF + RBV, 16 wk	3	58/70 (83.0)	41/54 (76.0)	12/21 (57.0)	17/36 (47.0)
Foster et al[62] (BOSON)¹	363	SOF + RBV, 24 wk	3	65/72 (90.0)	44/54 (81.0)	18/22 (82.0)	26/34 (76.0)
Satsangi et al[83]	105	SOF + RBV, 24 wk	3	49/49 (100)	1/1 (100)	22/23 (95.6)	3/3 (100)
Nelson et al[65] (ALLY-3)	152	DCV + SOF, 12 wk	3	105/109 (96.0)		20/32 (63.0)
Nelson et al[65] (ALLY-3)	152	DCV + SOF, 12 wk	3	73/75 (97.0)	32/34 (94.0)	11/19 (58.0)	9/13 (69.0)
Feld et al[67] (ASTRAL-1)	624	SOF/VEL, 12 wk	1, 2, 4, 5, 6	496/501 (99.0)		120/121 (99.2)
Foster et al[68] (ASTRAL-2)	266	SOF/VEL, 12 wk (n = 134)	2	133/134 (99.0)
Foster et al[68] (ASTRAL-2)	266	SOF + RBV, 12 wk (n = 132)	2	124/132 (94.0)
Foster et al[68] (ASTRAL-3)	552	SOF/VEL, 12 wk (n = 277)	3	160/163 (98.0)	31/34 (91.0)	40/43 (93.0)	33/37 (89.0)
Foster et al[68] (ASTRAL-3)	552	SOF + RBV, 24 wk (n = 275)	3	141/156 (90.0)	22/31 (71.0)	33/45 (73.0)	22/38 (58.0)
Curry et al[69] (ASTRAL-4)	267	SOF/VEL, 12 wk (n = 90)	1-6			75/89 (84.3)
		SOF/VEL + RBV 12 wk (n = 87)				82/87 (94.0)
		SOF/VEL, 24 wk (n = 90)				77/87 (88.5)
Forns et al[73] (EXPEDITION-1)	146	GLE/PIB, 12 wk	1, 2, 4, 5 or 6			145/146 (99.0)
Zeuzem et al[81] (ENDURANCE-1)	703	GLE/PIB, 8 wk (n = 351)	1	343/344 (99.7)
Zeuzem et al[81] (ENDURANCE-1)	703	GLE/PIB, 12 wk (n = 352)	1	345/345 (100)
Zeuzem et al[72] (ENDURANCE-3)	505	GLE/PIB, 12 wk (n = 233)	3	214/217 (99.0)
		SOF + DCV, 12 wk (n = 115)		110/111 (99.0)
		GLE/PIB, 8 wk (n = 157)		143/149 (96.0)
Asselah et al[74] (ENDURANCE-2)	202	GLE/PIB, 12 wk	2	192/192 (100)
Asselah et al[74] (ENDURANCE-4)	121	GLE/PIB, 12 wk	4-6	120/120 (100)
Brown et al[76] (EXPEDITION-8)	343	GLE/PIB, 8 wk	1-6			334/335 (99.7)
Gane et al[78] (EXPEDITION-4)	104	GLE/PIB, 12 wk	1-6	102/104 (98.0)
Bourlière et al[84] (POLARIS-1)¹	263	SOF/VEL/VOX, 12 wk	1-6	253/263 (96.0)²
Bourlière et al[84] (POLARIS-4)¹	182	SOF/VEL/VOX, 12 wk	1-4	178/182 (98.0)²

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

²All analyzed patients were previously treated with a direct-acting antiviral-containing regimen.

DCV: Daclatasvir; GLE: Glecaprevir; GT: Genotype; mITT: Modified intention-to-treat; PIB: Pibrentasvir; RBV: Ribavirin; SOF: Sofosbuvir; SVR: Sustained virological response; VEL: Velpatasvir; VOX: Voxilaprevir.

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