XIX International AIDS Conference


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THLBB01 - Oral Abstract

A randomized multicentre open-label trial to estimate the efficacy and safety of two doses of raltegravir (RAL) to efavirenz (EFV) for the treatment of HIV-TB co-infected patients: results of the ANRS 12 180 Reflate TB trial

Presented by Nathalie De Castro (France).

B. Grinsztejn1, N. De Castro2,3, V. Arnold4, V. Veloso1, M. Morgado5, J.H. Pilotto6, C. Brites7, J.V. Madruga8, N. Barcellos9, B. Riegel Santos10, C. Vorsatz1, C. Grondin4, M. Santini-Oliveira1, O. Patey11, C. Delaugerre2,3, G. Chêne4, J.-M. Molina2,3, ANRS 12 180 Reflate TB study group

1Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz, Laboratório de Pesquisa Clínica em DST/AIDS, Rio de Janeiro, Brazil, 2University of Paris Diderot, Sorbonne, Paris Cité, INSERM U941, Paris, France, 3Hospital Saint-Louis, AP-HP, Paris, France, 4University Bordeaux, INSERM U897, Bordeaux, France, 5Instituto Oswaldo Cruz-FIOCRUZ, Laboratory of AIDS and Molecular Immunology, Rio de Janeiro, Brazil, 6Hospital Geral de Nova Iguaçu, Departamento de DST/AIDS, Nova Iguaçu, Brazil, 7Hospital Universitário Prof. Edgar Santos, Laboratório de Pesquisa em Doenças Infecciosas, Salvador, Brazil, 8Centro de Referência e Treinamento DST/AIDS, Unidade de Pesquisa, São Paulo, Brazil, 9Health State Secretariat Hospital Sanatório Partenon, Porto Alegre, Brazil, 10Hospital Nossa Senhora da Conceição, Serviço de Infectologia, Porto Alegre, Brazil, 11C.H.G Villeneuve St George, Department of Internal and Tropical Medicine, Villeneuve St George, France

Background: Alternatives to EFV for the treatment of HIV-infection in patients with TB are warranted. Rifampin decreases RAL exposure in healthy volunteers. We estimated the safety and efficacy of two doses of RAL and EFV in HIV-1-infected adults receiving rifampin for TB.
Methods: Multicentre, open-label, randomized, phase II trial. Antiretroviral naïve HIV-1-infected adults were randomized to receive RAL (400 or 800mg bid) or EFV (600mg qd),in combination with TDF and 3TC, after starting rifampin. The primary efficacy end-point was the proportion of patients with plasma HIV-RNA level < 50 cp/ml at week 24 using a mITT TLVOR algorithm. The sample size was calculated to compare success rate in each arm to 70%. Safety was assessed by the report of adverse events using the ANRS grading scale.
Results: From July 2009 to June 2011, 179 patients were screened and 155 randomized to RAL 800 (n=52), RAL 400 (n=51) and EFV (n=52). At baseline, 73% were male, mean age: 38 yrs, median HIV-RNA level: 4.9 log10 cp/ml and median CD4 cell count:140cells/mm3.At week 24 success rates were 78%[95%CI,67-90], 76%[95%CI,65-88] and 63%[95%CI,49-76] in RAL800, RAL400 and EFV arms, respectively(mITT TLOVR).Plasma HIV RNA>50cp/ml was the main reason for failure and occurred in 6,11 and 16 patients in RAL800,RAL400 and EFV,respectively. There was a trend towards more RAL,3TC,and TDF resistance in the RAL400 than RAL800 arm. Safety of the three regimens was good with only 1,1 and 3 grade 3/4 ALT elevations in RAL800, RAL400 and EFV arms, respectively.
Conclusions: At week 24, RAL800 mg bid provided the highest success rate in HIV-1-infected patients receiving a rifampin-based therapy for TB and should be considered for further evaluation.

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