Hepatitis C in human immunodeficiency virus co-infected individuals: Is this still a “special population”?

Table 1 Trials of direct-acting antivirals for chronic hepatitis C infection in human immunodeficiency virus co-infected patients

Study	GT	Tx regimen	Tx duration (wk)	Hepatitis C characteristics	SVR12
					GT	Fibrosis stage	Treatment status
P05411[100]	1	PegIFNα-2b + RBV	BOC: 44	Tx naïve	BOC
		wb (600-1400 mg) +	PegIFN/RBV: 48	Metavir F0-4	GT1: 42/64 (66%)
		BOC vs placebo		Cirrhosis: 3%	GT1a: 32/51 (63%)
					GT1b: 7/12 (58%)
					Placebo GT1: 9/34 (26%)
VX08-950-110[101]	1	PegIFNα-2a + RBV	TPV: 12	Tx naïve	TPV
		800 mg or wb	PegIFN/RBV: 48	Metavir F0-4	GT1: 28/38 (74%)
		(1000-1200 mg) +			GT1a: 20/27 (74%)
		TVR vs placebo			GT1b: 7/11 (64%)
					Placebo
					GT1: 10/22 (45%)
					GT1a: 4/14 (29%)
					GT1b: 4/6 (67%)
ANRS HC26	1	PegIFNα-2a + RBV	TPV: 12	Tx exp	GT1: 55/69 (80%)	F1-2	Relapse
TelapreVIH[95]		wb (1000-1200 mg)	PegIFN/RBV (RGT): 44 or 72	Metavir F0-4	GT1a: 36/48 (75%)	34/42 (81%)	20/27 (74%)
		+ TVR		Both cirrhosis and prior	GT1b: 19/21 (90%)	F3-4	Breakthrough
				null-response excluded		21/27 (78%)	5/6 (83%)
							Partial response
							15/15 (100%)
							Null response
							15/21 (71%)
P7977-1910[102]	1-4	SOF + PegIFNα-2a	12	Tx naïve	All GTs: 21/23 (91%)
		+ RBV wb		No cirrhosis	GT1: 17/19 (89%)
		(1000-1200 mg)			[GT1a: 13/15 (87%)
					GT1b: 4/4]
					GT2: 1/1
					GT3: 2/2
					GT4: 1/1
STARTVerso4[103,104]	1	FDV 240 mg (EFV) or 120 mg	FDV: 24 or (12 vs 24),	PegIFN/RBV Tx naïve	GT1: 221/308 (72%)	No Cirrhosis	Tx naïve
		(ATV/r or DRV/r) or 120 vs 240 mg	PegIFN/RBV (RGT): 48 or	or prior relapse	GT1a: 171/242 (71%)	187/261 (72%)	164/239 (69%)
		(RAL or MVC or no ART) +	24 wk vs 48 wk	Compensated cirrhosis: 15%	GT1b: 50/66 (76%)	Cirrhosis	Relapse
		PegIFNα-2a + RBV wb (1000-1200 mg)				33/45 (73%)	57/69 (83%)
C212[105]	1	SMV + PegIFNα-2a + RBV wb	SMV: 12	PegIFN/RBV Tx naïve	GT1: 78/106 (74%)	F0-2	Tx naïve
		(1000-1200 mg)	PegIFN/RBV RGT: (24 vs 48)	or Tx exp	GT1a: 62/88 (70%)	36/45 (80%)	42/53 (79%)
			for Tx naïve or prior relapse	Metavir F0-4; Cirrhosis:	GT1b: 16/18 (89%)	F3-4	Relapse
			or 48 for partial-	6%-30% by Tx arm		14/22 (64%)	13/15 (87%)
			or null-response or cirrhosis				Partial response
							7/10 (70%)
							Null response
							16/28 (57%)
PHOTON-1[106]	1-3	SOF + RBV wb (1000-1200 mg)	GT 1: 24	Tx naïve (GT1-3) or exp (GT2-3)	GT1: 87/114 (76%)	No Cirrhosis	Tx naïve
			GT 2-3 Tx naïve: 12	Cirrhosis ≤ 20%	[GT1a: 74/90 (82%)	GT1: 84/109 (77%)	GT1: 87/114 (76%)
			GT 2-3 Tx exp: 24		GT1b: 13/24 (54%)]	GT2: 22/25 (88%)	GT2: 23/26 (88%)
					GT2: 44/50 (88%)	GT3: 24/36 (67%)	GT3: 28/42 (67%)
					GT3: 44/59 (75%)	Cirrhosis	Tx exp
						GT1: 3/5 (60%)	GT2: 22/24 (92%)
						GT2: 1/1	GT3: 16/17 (94%)
						GT3: 4/6 (67%)
PHOTON-2[107]	1-4	SOF + RBV wb (1000-1200 mg)	GT 1, 3, 4: 24	Tx naïve (GT1-4) or exp (GT 2-3)	GT1: 95/112 (85%)	No Cirrhosis	Tx naïve
			GT 2 Tx naïve: 12	Compensated cirrhosis: 20% of patients	[GT1a: 84/100 (84%)	GT1: 84/95 (88%)	GT 1: 95/112 (85%)
			GT 2 Tx exp: 24		GT1b: 10/11 (91%)]	GT2: 19/22 (86%)	GT2: 17/19 (89%)
					GT2: 22/25 (88%)	GT3: 73/80 (91%)	GT3: 52/57 (91%)
					GT3: 94/106 (89%)	GT4: 19/23 (83%)	GT4: 26/31 (84%)
					GT4: 26/31 (84%)	Cirrhosis	Tx exp:
						GT1: 11/17 (65%)	GT2: 5/6 (83%)
						GT2: 3/3	GT3: 41/49 (84%)
						GT3: 21/26 (81%)
						GT4: 7/8 (88%)
TURQUOISE-I[108]	1	Paritaprevir/r/Ombitasvir +	12 or 24	Tx naïve or PegIFN/RBV exp	Tx for 12 wk
		Dasabuvir + RBV wb (1000-1200 mg)		Cirrhosis ≤ 30%	GT1: 29/31 (94%)
					Tx for 24 wk
					19/20 (95%)
ERADICATE[109]	1	SOF/LDV	12	Tx naïve	Untreated HIV Infection
				Knodell F0-3	GT1: 10/10
C-WORTHY[110]	1	Grazoprevir + MK-8742 +/- RBV	12	Tx naïve	With RBV
				No cirrhosis	28/29 (97%)
				Metavir F0-3	Without RBV
					26/29 (90%)

/: Indicates co-formulation; +/-: With or without; GT: HCV genotype and subtype; RGT: Response guided therapy; Tx (exp): Treatment (experienced); vs: Indicates randomisation; wb: Weight based; ATV: Atazanavir; BOC: Boceprevir; DRV: Darunavir; EFV: Efavirenz; FDV: Faldaprevir; LDV: Ledipasvir; PegIFN: Pegylated Interferon; r: Ritonavir boosted; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir; TVR: Telaprevir.