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TMC278 (rilpivirine), a next-generation NNRTI, demonstrates long-term efficacy and tolerability in ARV-naïve patients: 96-week results of study C204
Presented by Mario Santoscoy, Mexico.
M. Santoscoy1, P. Cahn2, C. Gonsalez3, W. Hao4, A. Pozniak5, P. Shalit6, S. Vanveggel7, K. Boven8
1Hospital Carlos Mac Gregor IMSS, Mexico City, Mexico, 2Hospital Juan A Fernández and Fundación Huesped, Buenos Aires, Argentina, 3Hospital das Clíncias, Pinheiros, Brazil, 4Beijing You’an Hospital, Beijing, China, 5Chelsea and Westminster NHS Foundation Trust and PKR/SSR, London, United Kingdom, 6Swedish Medical Center, Seattle, United States, 7Tibotec BVBA, Mechelen, Belgium, 8Tibotec Inc, Yardley, United States
Background: The 48-week primary analysis of the randomised Phase IIb study (TMC278-C204) demonstrated that all doses of the next-generation NNRTI, TMC278, provided potent, sustained efficacy in treatment-naïve patients and were well-tolerated. The 96-week results are presented.
Methods: TMC278-C204 evaluated the efficacy, safety and pharmacokinetics of three blinded TMC278 doses, 25, 75, and 150mg q.d., over 96 weeks, and included an open-label, control EFV 600mg q.d. All patients also received two NRTIs, AZT/3TC (76%) or TDF/FTC (24%).
Results: 368 patients (33% females) were randomised and treated. The potent antiviral efficacy of TMC278 at Week 48 was sustained to Week 96. All TMC278 doses resulted in >70% of patients with confirmed and sustained viral load <50 HIV-1 RNA copies/mL at Week 96, comparable to EFV. Mean changes from baseline in CD4 cell count at Week 96 further increased compared with Week 48.
[96-week C204 efficacy]
Overall, incidences of serious adverse events (AEs) (12.2% vs 14.6%), grade 3 or 4 AEs (27.2% vs 21.3%) and grade 3 or 4 laboratory abnormalities (26.5% vs 23.6%) were similar between TMC278 combined groups vs EFV, respectively. The frequency of the following AEs, any grade, irrespective of causality, was lower for TMC278 than for EFV: rashes (9.7% vs 22.5%), nervous system (36.6% vs 53.9%) and psychiatric AEs (16.1% vs 21.3%), as were increases in cholesterols and triglycerides.
Conclusions: TMC278 was generally well tolerated with less increase in serum lipids and lower incidences of rash, nervous system and psychiatric events, compared with EFV. TMC278 demonstrated a high response rate and sustained virologic response over 96 weeks.
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