Sofosbuvir treatment and hepatitis C virus infection

Table 1 Summary of phase 3 study for hepatitis C virus genotype 1-infected patients

Study name	Population	Treatment	Duration (wk)	n	LC (%)	SVR12 (%)
						All	Non-LC	LC
NEUTRINO	Naïve	SOF/PEG-IFN/RBV	12	291	-	89	-	81
ION-1	Naïve	SOF/LDV	12	210	16	99	100	97
		SOF/LDV/RBV	12	216	15	97	97	100
		SOF/LDV	24	214	15	98	99	97
		SOF/LDV/RBV	24	214	17	99	99	100
ION-3	Naïve	SOF/LDV	8	214	0	94	94	-
		SOF/LDV/RBV	8	216	0	93	93	-
		SOF/LDV	12	216	0	95	95	-
Japanese study	Naïve	SOF/LDV	12	83	16	100	100	100
		SOF/LDV/RBV	12	83	14	96	97	92
ION-2	Experienced	SOF/LDV	12	20	94	95	86	20
		SOF/LDV/RBV	12	20	96	100	82	20
		SOF/LDV	24	20	99	99	100	20
		SOF/LDV/RBV	24	20	99	99	100	20
Japanese study	Experienced	SOF/LDV	12	32	100	100	100	32
		SOF/LDV/RBV	12	25	100	100	100	25

LC: Liver cirrhosis; SVR12: Sustained virologic response at 12 wk; Naïve: Treatment-naïve; Experienced: Treatment-experienced; SOF: Sofosbuvir; LDV: Ledipasvir; PEG-IFN: Peginterferon; RBV: Ribavirin.

Table 2 Summary of phase 3 study for hepatitis C virus genotype 2-infected patients

Study name	Population	Treatment	Duration (wk)	n	LC (%)	SVR12 (%)
						All	Non-LC	LC
FISSION	Naïve	SOF/RBV	12	70	-	97	-	-
POSITRON	IFN-ineligible/intolerant	SOF/RBV	12	109	15	93	92	94
VALENCE	Naïve	SOF/RBV	12	32	-	97	97	100
Japanese study	Naïve	SOF/RBV	12	90	9	98	97	100
FUSION	Experienced	SOF/RBV	12	36	28	86	96	60
			16	32	-	94	100	78
VALENCE	Experienced	SOF/RBV	12	41	-	90	91	88
Japanese study	Experienced	SOF/RBV	12	63	14	95	96	89

LC: Liver cirrhosis; SVR12: Sustained virologic response at 12 wk; Naïve: Treatment-naïve; Experienced: Treatment-experienced; SOF: Sofosbuvir; IFN: Interferon; RBV: Ribavirin.

Table 3 Summary of phase 3 study for hepatitis C virus genotype 3-infected patients

Study name	Population	Treatment	Duration (wk)	n	LC (%)	SVR12 (%)
						All	Non-LC	LC
FISSION	Naïve	SOF/RBV	12	183	-	56	-	-
POSITRON	IFN-ineligible/intolerant	SOF/RBV	12	98	15	61	68	21
VALENCE	Naïve	SOF/RBV	24	105	12	93	95	92
FUSION	Experienced	SOF/RBV	12	64	39	30	37	19
			16	63	-	62	63	61
VALENCE	Experienced	SOF/RBV	24	145	32	79	87	62

LC: Liver cirrhosis; SVR12: Sustained virologic response at 12 wk; Naïve: Treatment-naïve; Experienced: Treatment-experienced; SOF: Sofosbuvir; IFN: Interferon; RBV: Ribavirin.

Table 4 Summary of phase 3 study for hepatitis C virus-human immunodeficiency virus co-infected patients

Genotype	Study name	Population	Treatment	Duration (wk)	n	LC (%)	SVR12 (%)
1	PHOTON-1	Naïve	SOF/RBV	12	114	4.4	76
	PHOTON-2	Naïve	SOF/RBV	24	112	15	85
2	PHOTON-1	Naïve	SOF/RBV	12	26	-	88
		Experienced	SOF/RBV	24	24	-	92
	PHOTON-2	Naïve	SOF/RBV	12	19	5	89
		Experienced	SOF/RBV	24	6	33	83
3	PHOTON-1	Naïve	SOF/RBV	12	42	-	67
		Experienced	SOF/RBV	24	17	-	94
	PHOTON-2	Naïve	SOF/RBV	24	57	5	91
		Experienced	SOF/RBV	24	49	47	86
4	PHOTON-2	Naïve	SOF/RBV	24	31	26	84

LC: Liver cirrhosis; SVR12: Sustained virologic response at 12 wk; Naïve: Treatment-naïve; Experienced: Treatment-experienced; SOF: Sofosbuvir; IFN: Interferon; RBV: Ribavirin.