Assessment, by Transcription-Mediated Amplification, of Virologic Response in Patients with Chronic Hepatitis C Virus Treated with Peginterferon α-2a

DOI: 10.1128/JCM.39.8.2850-2855.2001

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Fig. 1.
ALT levels of sustained virologic responders, virologic relapse patients, and nonresponders measured during baseline (before initiation of therapy), end-of-treatment (ETR, week 48), and end-of-follow-up (EFU, week 72) visits. Horizontal bars indicate median values of the cohorts. Dotted lines indicate the upper limit of normal of ALT levels for men (43 U/liter) and women (34 U/liter). Open circles in the panel of virologic relapse patients at the end of treatment (ETR) indicate patients who had HCV RNA detectable by the TMA-based assay (VERSANT HCV RNA Qualitative Assay).
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Fig. 2.
Proposed model of virologic relapse after the end of treatment in a representative patient treated with standard IFN α-2a (standard IFN) and peginterferon α-2a (PEG-IFN). TW, treatment week. FU, follow-up week.

Table 1.

Pretreatment clinical, virologic, biochemical, and histological characteristics of patients^a

Category and no. of patients^b	Sex (male/ female)	Age (yr)	Wt (kg)	Body surface area (m²)	No. (%) of patients belonging to genotype^c:					Amt of pretreatment HCV RNA (copies/ml)	Amt of ALT^d (U/liter) at:			Total HAI^e score	No. (%) of patients at histological stage of:
Category and no. of patients^b	Sex (male/ female)	Age (yr)	Wt (kg)	Body surface area (m²)	1a/b	2	3	4	Other/ untypeable	Amt of pretreatment HCV RNA (copies/ml)	Baseline	End of treatment (week 48)	End of follow-up (week 72)	Total HAI^e score	Non-cirrhosis	Bridging fibrosis	Cirrhosis
Virologic sustained responders (78)	46/32	39 ± 9.8	71 ± 14.2	1.8 ± 0.2	35 (45)	13 (17)	27 (35)	2 (2)	1 (1)	(4.2 ± 6.9) × 10⁶	156 ± 137	44 ± 22	22 ± 16	9.1 ± 3.2	65 (83)	9 (12)	4 (5)
Virologic relapse patients (60)	43/17	43 ± 9.7	77 ± 12.7	1.9 ± 0.2	44 (73)	3 (5)	10 (17)	2 (3)	1 (2)	(9.2 ± 9.1) × 10⁶	107 ± 73	38 ± 19	94 ± 70	9.1 ± 3.0	51 (85)	5 (8)	4 (7)
Virologic nonresponders (39)	22/17	44 ± 11	79 ± 18.3	1.9 ± 0.2	31 (79)	1 (3)	7 (18)	0	0	(11.5 ± 17.2) × 10⁶	97 ± 59	77 ± 48	98 ± 80	8.0 ± 3.3	36 (92)	2 (5)	1 (3)

↵a All ± values represent means ± standard deviations.
↵b Sustained responders, HCV RNA undetectable on week 72 (24 weeks after discontinuation of therapy; relapsers (end of treatment responders), HCV RNA undetectable on week 48 (end of treatment) but with virologic relapse thereafter; nonresponders, HCV RNA positive at end of treatment and thereafter. Classification of the three groups was based on results of Cobas Amplicor HCV version 2.0.
↵c Genotyping was performed with a reverse hybridization assay (INNO LiPA HCV-II; Innogenetics, Ghent, Belgium).
↵d Normal ranges for ALT: male patients, 6 to 43 U/liter; female patients, 6 to 34 U/liter.
↵e HAI, histology activating index.