Simeprevir for the treatment of hepatitis C virus infection

Figures & data

Table 1 Data from Phase III trials conducted in HCV genotype 1 patients with simeprevir in combination with pegylated interferon and ribavirin

Trial name	Patient characteristics	Study location	Number of patients	SMV dose (mg)	Treatment duration (weeks)	Genotype 1a% (placebo arm/SMV arm)	SVR12 SMV arm (%)	SVR 12 placebo arm (%)	% relapse SMV arm/placebo arm	% viral breakthrough SMV arm/placebo arm
CONCERTO-1	Genotype 1 naïve	Japan	183	100	24 or 48 (RGT)	1.7/1.6	88.6	61.7	7.6/30.6	0.8/3.3
CONCERTO-2	Genotype 1 prior nonresponders	Japan	106	100	24 or 48 (RGT)	NA/2.8	44.3	No arm	44.9/NA	12.3/NA
CONCERTO-3	Genotype 1 prior relapsers	Japan	49	100	24 or 48 (RGT)	NA/2	95.9	No arm	8.2/NA	0/NA
QUEST 1 and 2	Genotype 1 naïve	Europe, US	785	150	24 or 48 (RGT)	30.1†	80.4	50	8.1/24.2	5.8/29.6
PROMISE	Genotype 1 prior relapsers	Europe,US	393	150	24 or 48 (RGT)	40.6/42.3	79.2	36.1	18.5/48.4	3.1/27.1

Note:

† Represents global data.

Abbreviations: HCV, hepatitis C virus; NA, not applicable; PROMISE, PROtease inhibitor TMC435 In patientS who have previously rElapsed on IFN/RBV; RGT, response-guided therapy; SMV, simeprevir; SVR, sustained virologic response.

Figure 1 SVR rates in genotype 1a patients treated with simeprevir in Phase II and III trials.

Abbreviations: ASPIRE, Antiviral STAT-C Protease Inhibitor Regimen in Experienced patients; ND, no data; PILLAR, Protease Inhibitor TMC435 trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen; PROMISE, PROtease inhibitor TMC435 In patientS who have previously rElapsed on IFN/RBV; SMV, simeprevir; SVR, sustained virologic response.

Table 2 Baseline characteristics and treatment responses of naïve and nonnaïve patients included in Phase III studies arm with boceprevir, telaprevir, and simeprevir

Drugs	Naïve patients			Nonnaïve patients
	Boceprevir	Telaprevir	Simeprevir	Boceprevir	Telaprevir	Simeprevir
Study name	SPRINT-2	ADVANCE	QUEST 1 and 2	RESPOND-2	REALIZE	PROMISE
Ribavirin dosage (mg/d)	600–1,400	1,000–1,200	ND	600–1,400	1,000–1,200	ND
Type of pegylated interferon	2b	2a	2a and 2b	2b	2a	2a
Previous type of response (%)
Relapse				65	55	100
No response				35	45	0
Stage of fibrosis (%)
F0–F2	90.6	79.9	75	78.6	50.4	70
F3	5	14.3	15	10	22.6	15
F4	4.4	5.8	10	11.4	27	15
HCV genotype 1a (%)	64	59	48.8	58.8	49.4	42
SVR control arm (%)	38	44	50	21	17	37
SVR according to IL28B polymorphism (%)
CC	82	ND	95	79	76	89
CT	65	ND	78	61	72	78
TT	55	ND	61	55	55	65
SVR according to fibrosis stage (%)
F0–F2	67	78	84	66	70	82
F3–F4	41	62	68	44	58	73
Relapse rate (%)	9	9	8	15	12	18

Abbreviations: HCV, hepatitis C virus; ND, no data; PROMISE, PROtease inhibitor TMC435 In patientS who have previously rElapsed on IFN/RBV; SPRINT, Serine PRotease INhibitor Therapy; SVR, sustained virologic response.