The influence of HAART on the efficacy and safety of pegylated interferon and ribavirin therapy for the treatment of chronic HCV infection in HIV-positive individuals

Table 5 Post-hoc analysis treatment arm C1 with regard to SVR

	SVR	No SVR	p-value
	n = 21	n = 28
Age [years]	41 (31 - 47)	42 (27 - 47)	0.732
Male sex [%]	81	71	0.733
Transmission risk IVDU [%]	19	29	0.844
HCV genotype 1 or 4 [%]	43	79	0.007
HCV-RNA [IU/ml, log10]
HCV-RNA ≥ 500 000 IU/ml [%]	5.1 (4 - 6)	5.7 (4.7 - 7.2)	0.001
	24	54	0.019
ALT [IU/l]	72 (31 - 206)	71 (27 - 243)	0.949
Weight adapted RBV, GT 1/4 infections only [%]	100	68	0.141
Tx duration 48 wks, GT 2/3 infections only [%]	42	20	0.600
Enrollment period 2002 - 2004 [%]	52	57	0.771
HAART [%]
3 × NRTI	10	14	0.688
AZT	24	39	0.359
d4T	19	18	1.000
ABC	19	39	0.210
TDF	52	43	0.572
HIV-RNA > Lod [%]	4	14	0.369
CD4-cellcount [/μl]	470 (268 - 685)	524 (222 - 781)	0.521
Elevations serum ALT [%]
Grade 1/2	76	79	1.000
Grade 3/4	-	11	0.250
Anemia [%]
Grade 1/2	24	21	1.000
Grade 3/4	-	-	-
Leucopenia [%]
Grade 1/2	57	61	1.000
Grade 3/4	14	11	1.000
Thrombocytopenia [%]
Grade 1/2	57	46	0.567
Grade 3/4	9	11	1.000
Clinical adverse events [%]
Grade 1/2	67	61	0.769
Grade 3/4	10	7	1.000
Dose reduction PegIFN [%]†	10	18	0.436
% of total dose received	87	81
Dose reduction RBV [%]†	14	32	0.179
% of total dose received	91	78
Treatment discont. AEs [%]	-	14	0.125

†Percent of patients who were dose reduced for pegylated interferon (PegIFN) or ribavirin (RBV) and respective percent of the cumulative dose received.
Data shown as percent of patients (95% Confidence Interval) or median (95% range). SVR sustained virological response, IVDU intravenous drug abuse, ALT serum alanine aminotransferase, RBV ribavirin, GT HCV genotype, Tx Treatment, wks weeks, NRTI nucleos(t)ide reverse transcriptase inhibitor, AZT zidovudine, d4T stavudine, ABC abacavir, TDF tenofovir DF, Lod Level of detection, Treatment discont. AEs Treatment discontinuation due to adverse events.

ISSN: 2047-783X