A randomized open label clinical trial to evaluate two dosages of efavirenz (600 and 800mg) in patients treated for tuberculosis with rifampicin at a reference hospital in Rio de Janeiro
F.M. Sant'Anna1, C.A.S. Schmaltz1, S.C. Neves1, C.M. Maia1, M.C. Lourenço1, J. Liporage1, M.G. Morgado2, V.C. Rolla1
1Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Laboratorio de Pesquisa Clinica em Micobacterioses, Rio de Janeiro, Brazil, 2Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Laboratorio de Imunologia, Rio de Janeiro, Brazil
Background: The ideal dose of efavirenz to be used concomitantly to rifampicin to treat tuberculosis (TB) and HIV positive patients is still unclear. The aim of this study was to compare efficacy and safety of TB and HIV therapy with rifampicin and efavirenz using two different doses (600 and 800mg).
Methods: HIV positive TB patients aging more than 18 years were recruited to participate in an open label randomized clinical trial. Primary endpoint was viral load (VL) below 80 copies at 180 days of TB therapy. TB was treated during 30 days before antiretroviral prescription of two nucleosides analogs and efavirenz after randomization for 600 (group 1) or 800mg (group 2).
Results: : We included 63 patients, 12 women and 51 men. Median age was 38 years. Disseminated TB was diagnosed among 32 cases and 33 patients used 800mg efavirenz. Both groups were similar according to baseline VL, CD4 counts and prevalence of disseminated TB. At 180 days, there were no statistical significant differences among groups 1 and 2 when comparing VL below 80 copies [17 (56.7%)/ 20 (60.6%)], deaths (0/4), abandonments (5/7), treatment failures (5/9), serious adverse events (3/5) and discontinuation due to rifampicin resistance (0/1).
Conclusions: It seems that both dosages are similar in terms of efficacy and safety at that point of the study.
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