RESUMO
BACKGROUND: The MERIT study evaluated maraviroc versus efavirenz, both with zidovudine/lamivudine, in treatment-naïve patients with CCR5-tropic (R5) HIV-1. Post hoc analyses previously assessed week 48 outcomes in patients rescreened with R5 virus by a more sensitive tropism assay. METHODS: Week 96 efficacy (post hoc, n = 614) and safety (n = 721) were assessed. RESULTS: Proportions of subjects <50 copies/mL (58.8% maraviroc, 62.7% efavirenz) and time to loss of virologic response (TLOVR) responders (<50 copies/mL: 60.5% vs 60.7%) were similar. Maraviroc recipients had greater CD4 increases (+ 212 vs + 171 cells/mm(3)) and fewer adverse event discontinuations (6.1% vs 15.5%), malignancies, and category C events. CONCLUSION: Week 96 data confirm week 48 observations in MERIT.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Benzoxazinas/uso terapêutico , Cicloexanos/uso terapêutico , Inibidores da Fusão de HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , HIV-1 , Lamivudina/uso terapêutico , Triazóis/uso terapêutico , Zidovudina/uso terapêutico , Adolescente , Adulto , Idoso , Alcinos , Fármacos Anti-HIV/efeitos adversos , Benzoxazinas/efeitos adversos , Antagonistas dos Receptores CCR5 , Cicloexanos/efeitos adversos , Ciclopropanos , Quimioterapia Combinada , Feminino , Inibidores da Fusão de HIV/efeitos adversos , Infecções por HIV/imunologia , Infecções por HIV/virologia , Humanos , Lamivudina/efeitos adversos , Masculino , Maraviroc , Pessoa de Meia-Idade , Resultado do Tratamento , Triazóis/efeitos adversos , Zidovudina/efeitos adversosRESUMO
The next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI) etravirine (TMC125) has demonstrated durable virologic efficacy in clinical trials involving >1000 treatment-experienced, NNRTI-resistant, HIV-1-infected patients. In this clinical safety review, we show etravirine to be well tolerated with a proven safety record. The nature and magnitude of adverse events observed during treatment suggest that etravirine may offer improved tolerability over existing antiretrovirals, including NNRTIs. Notably, adverse events reported with etravirine treatment are generally mild to moderate in severity. Rash has been shown to occur with a higher incidence in etravirine-treated patients versus placebo, but cases are generally mild to moderate, occur within the first few weeks, and resolve with continued use. In addition, the rate of adverse event-related discontinuations is low with etravirine. In summary, the safety and tolerability profile of etravirine, combined with its virologic efficacy, suggest that the drug may be a valuable option for treatment-experienced patients with HIV-1 infection.