Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study

Figures & data

Table 1 Baseline characteristics of the study patients

Variables	BOC (n=15)	TVR (n=102)	P-value	Total (N=117)
Age, years; mean (SD)	53.4 (8.4)	51.3 (9.7)	0.37	51.6 (9.5)
Gender, male; N (%)	12 (80.0)	63 (61.8)	0.17	75 (64.1)
HCV subtype; N (%)			0.03*	–
1a	2 (13.3)	50 (49.0)	–	52 (44.4)
1b	8 (53.3)	32 (31.4)	–	40 (34.2)
1	5 (33.3)	20 (19.6)	–	25 (21.4)
Previous treatment, n (%)			0.47	–
Treatment naïve	6 (40.0)	51 (50.0)	–	57 (48.7)
Treatment experienced	9 (60.0)	51 (50.0)	–	60 (51.3)
PegIFN type (prescribed for the TT), n (%)			0.54	–
Alfa-2a	10 (66.7)	75 (73.5)	–	85 (72.6)
Alfa-2b	5 (33.3)	26 (25.5)	–	31 (26.5)
NR	0 (0.0)	1 (1.0)	–	1 (0.9)
METAVIR score, n (%)			0.18	–
F1	1 (6.7)	1 (1.0)	–	2 (1.7)
F2	3 (20.0)	8 (7.8)	–	11 (9.4)
F3	7 (46.7)	56 (54.9)	–	63 (53.8)
F4	4 (26.7)	35 (34.3)	–	39 (33.0)
NR	0 (0.0)	2 (2.0)	–	2 (1.7)
HCV RNA			–	–
≥800,000 IU/mL, n (%)	8 (53.3)	65 (63.7)	0.38	73 (62.4)
Log10 IU/mL; median (range)	5.9 (2.3–6.6)	6.1 (3.7–7.0)	0.24	6.1 (2.3–7.0)
Hemoglobin, g/dL; median (range)	16.0 (11.0–17.5)	15.1 (9.2–18.2)	0.21	15.1 (9.2–18.2)
Neutrophil count,/mm^3; median (range)	2,944 (1,500–5,212)	3,060 (1,239–7,455)	0.90	3,056 (1,239–7,455)
Platelets, ×10^4/mm^3; median (range)	14.5 (7.7–44.8)	16.1 (5.4–34.5)	0.52	16.1 (5.4–44.8)
ALT, IU/L; median (range)	71.3 (25.0–279.0)	88.8 (17.3–325.0)	0.48	81.2 (17.3–325.0)
AST, IU/L; median (range)	51.0 (23.0–208.0)	58.5 (16.1–242.0)	0.62	57.8 (16.1–242.0)

Note:

* Statistically significant.

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BOC, boceprevir; HCV, hepatitis C virus; METAVIR, Meta-analysis of Histological Data in Viral Hepatitis; NR, not reported; PegIFN, pegylated interferon; RNA, ribonucleic acid; RVR, rapid virological response; SD, standard deviation; TT, triple therapy; TVR, telaprevir.

Table 2 RVR and changes in viral load after 4 weeks of treatment

Variables	Basal viral load, IU/mL; mean (SD)	Viral load at 4 weeks, IU/mL; mean (SD)	Viral load difference, IU/mL	RVR, n (%)
BOC (n=15)	1,326,915.67 (1,349,599.78)	34,462.73 (43,540.10)	−1,292,452.94	4 (26.7)
TVR (n=102)	2,013,227.66 (2,212,025.32)	5,850.00 (53,369.97)	−2,007,377.66	89 (87.3)
P-value	0.11#	0.03#,*	–	<0.001*
Total (N=117)	1,922,923.45 (2,126,851.25)	9,518.30 (52,925.61)	−1,913,405.15	93 (79.5)

Notes:

# Equal variances not assumed;

* Statistically significant.

Abbreviations: BOC, boceprevir; RVR, rapid virological response; SD, standard deviation; TVR, telaprevir.

Table 3 Logistic regression to identify the influence of features related to the patient and the disease on RVR rates

Variable	P-value	Odds ratio	95% CI for Exp(B)
			Lower	Upper
Protease inhibitor	<0.001*	0.011	0.001	0.119
Gender	0.134	2.658	0.740	9.541
HCV subtype	0.792	1.110	0.512	2.406
Previous treatment	0.824	1.155	0.325	4.104
PegIFN type	0.252	0.404	0.086	1.905
Baseline viral load (low/high)	0.019*	13.004	1.522	111.115
Fibrosis stage	0.239	0.262	0.028	2.429
Baseline hemoglobin	0.270	1.296	0.818	2.052
Baseline neutrophil count	0.346	1.000	1.000	1.001
Baseline platelet count	0.075	1.000	1.000	1.000
Baseline ALT	0.165	0.987	0.968	1.006
Baseline AST	0.088	1.023	0.997	1.051
Age	0.556	0.981	0.921	1.045
Baseline HCV RNA	0.120	2.032	0.831	4.970

Notes:

* Statistically significant. Exp(B) = odds ratios for the predictors.

Abbreviations: CI, confidence interval; HCV, hepatitis C virus; PegIFN, pegylated interferon; ALT, alanine aminotransferase; AST, aspartate aminotransferase; RNA, ribonucleic acid; RVR, rapid virological response.