[P2] 48-WEEK DURABLE EFFICACY AND SAFETY RESULTS OF TMC-125 IN HIV PATIENTS WITH NNRTI AND PI RESISTANCE: STUDY TMC-125-C223

12th Annual Conference of the British HIV Association

29 March–1 April 2006, Brighton, UK

48-WEEK DURABLE EFFICACY AND SAFETY RESULTS OF TMC-125 IN HIV PATIENTS WITH NNRTI AND PI RESISTANCE: STUDY TMC-125-C223

HIV Med 2006; 7(Suppl. 1):11 (abstract no. P2)

Cal Cohen¹, Corklin Steinhart², Doug Ward³, Peter Ruane⁴, Monika Peeters⁵ and Brian Woodfall⁵
¹Community Research Initiative of New England, Boston, MA, ²Mercy Hospital, Miami, FL, ³Dupont Circle Physicians Group, Washington DC, ⁴Lightsource Medical, Los Angeles, CA, USA, ⁵Tibotec BVBA, Mechelen, Belgium

METHODS: TMC-125–C223 is a randomised, controlled, partially-blinded study of TMC-125 in 199 patients with documented NNRTI resistance and ≥3 primary PI mutations (median 4). Patients received TMC-125 (400 mg or 800 mg bid) with an investigator-selected background, or a standard-of-care control regimen.

RESULTS: Median baseline viral load was 4.7 log₁₀ copies/ml and CD4 count 100 cells/µl.


48 week results ITT (NC = F)	400 mg	800 mg	Control
Mean ΔVL (log₁₀ copies/ml)	–0.88**	–1.01*	–0.14
%>1 log₁₀ decrease	31%*	34%*	8%
% <50 copies/ml	23%	22%	0%
Δ CD4 cell count	+58	+61	+13

P-value versus control at week 48 – *P<0.01 **P=0.02)

At week 48 in the combined TMC-125 groups, 88% of those patients with a viral load <50 at 24 weeks remained <50 copies/ml; an additional six patients also achieved <50. Virological failure on TMC-125 400 and 800 mg bid was 9% in both groups. In the control arm, 98% of patients discontinued study, 78% due to virological failure. The high rate of premature discontinuations on the control arm confounded the comparison of safety given the lower median duration of treatment in the control arm of 17.9 weeks, versus 47.7 weeks in both TMC-125 groups. Grade 3/4 AEs (all causes) were reported in 43% of patients on TMC-125; 17% discontinued due to AEs.

CONCLUSION: In this study, TMC-125 showed high rates of sustained efficacy in heavily pre-treated patients with substantial NNRTI and PI resistance. These data are the first to show durable efficacy at 48 weeks with an NNRTI in subjects with NNRTI resistance.

2006-03-29
P2

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