Efficacy and safety of TMC278 in treatment-naïve, HIV-1-infected patients with HBV/HCV co-infection enrolled in the phase III ECHO and THRIVE trials

Table 1

	HIV/HBV and/or HCV co-infected patients		HIV mono-infected patients
	TMC278 25mg qd	EFV 600mg qd	TMC278 25mg qd	EFV 600mg qd
Efficacy (Week 48 outcomes)*	N=49	N=63	N=621	N=602
% (95% CI) with viral load <50 copies/mL, ITT-TLOVR	73.5 (60.7-86.3)	79.4 (69.1-89.6)	85.0 (82.2-87.8)	82.6 (79.5-85.6)
Mean CD4 count (95% CI)	N=48	N=63	N=621	N=602
Baseline, cells/mm³	230 (198-263)	246 (216-276)	262 (251-273)	274 (262-285)
Change from baseline, NC=F^†, cells/mm³	+137 (100-175)	+192 (147-238)	+197 (186-209)	+173 (161-185)
Change from baseline, NC=F^†, %	+6.6 (5.0-8.3)	+7.7 (6.4-9.0)	+8.6 (8.1-9.0)	+8.4 (7.9-8.8)
Safety ^‡ , ^§
Treatment-emergent hepatic AEs of interest, n (%)	N=54	N=66	N=632	N=616
Any hepatic AE	15 (27.8)	17 (25.8)	23 (3.6)	28 (4.5)
Hepatobiliary disorders^Â¶	3 (5.6)	7 (10.6)	6 (0.9)	9 (1.5)
HBV or HCV reported as an AE	3 (5.6)	5 (7.6)	-	-
Hepatic laboratory abnormalities reported as an AE	9 (16.7)	8 (12.1)	19 (3.0)	21 (3.4)
Grade 3 to 4 hepatic laboratory abnormalities, n (%)	N=54	N=66	N=631	N=604
ALT increased	9 (16.7)	11 (16.7)	1 (0.2)	12 (2.0)
AST increased	7 (13.0)	5 (7.6)	7 (1.1)	14 (2.3)
Hyperbilirubinaemia	0	0	4 (0.6)	1 (0.2)

ITT-TLOVR = intent-to-treat-time-to-loss of virologic response; CI=confidence interval; *Patients included in efficacy analysis were those with baseline HBV/HCV assessments; †NC=F = non completer = failure: missing values after discontinuation imputed with change = 0; Last observation carried forward otherwise; ‡Safety analyses performed using all available data, including beyond Week 48; §Patients who seroconverted for HBV/HCV during the study were included in the subgroup of HIV/HBV and/or HCV co-infected patients; Â¶Selection of preferred terms from System Organ Class as defined by MedDRA. Compared with HIV mono-infected patients, co-infected patients had more hepatic AEs (clinical and laboratory) and lower virologic responses, which were similar across treatment groups. Hepatic AEs rarely led to treatment discontinuation (TMC278: n=3 vs. EFV: n=9 patients). There were no fatal hepatic AEs.