MOAB0102 Week 96 safety and efficacy of the novel HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced participants infected with multi-drug resistant HIV-1 (BRIGHTE study) Complementary analyses are necessary to identify determinants of virologic failures in both arms. Raltegravir remains a safe option in combination with tuberculosis treatment. Twelve (5%) patients in the raltegravir arm and 14 (6%) in the efavirenz arm died (Logrank p = 0.7).Ĭonclusions: The non-inferiority of raltegravir 400 mg compared to efavirenz at week 48 was not demonstrated. Sixty-two (27%) and 77 (33%) patients experienced grade 3 to 4 adverse events in the raltegravir and efavirenz arms, respectively ( p = 0.1), including 11 (5%) and 13 (6%) IRIS ( p = 0.7). At W48, the difference between the raltegravir and efavirenz arm was -5.1% (95% CI: -13.9- +3.7), thus not meeting criteria for non-inferiority. In the mITT population, virologic success was achieved: in 134/228 (59%) pts in the raltegravir arm and 135/227 (59%) pts in the efavirenz arm at W24 (end of TB treatment) in 139/228 (61%) patients in the raltegravir arm and 150/227 (66%) patients in the efavirenz arm at W48. to 1.0) kg/m 2, median CD4 102 (IQR: 38 to 239) cells/µL, median HIV-RNA was 5.5 log (IQR: 5.0 to 5.8), 311 (68%) patients had pulmonary tuberculosis only, and 308 (68%) had bacteriologically-confirmed tuberculosis. Median age was 35 (IQR: 2 to 3) years, 40% were female, median BMI 19.1 (IQR: 17. Results: From September 2015 to January 2018, 230 patients were randomized in each trial arm: 201 (87%) and 203 (88%) completed follow-up in the EFV and RAL arms, respectively. The pre-specified non-inferiority margin was 12%. The primary endpoint was the proportion of patients with virologic success at week 48 defined as HIV-RNA ≤50 cp/ml on allocated therapy using the FDA snapshot algorithm. ART-naïve HIV1-infected patients aged ≥18 years on standard tuberculosis treatment for to weeks were randomized (1:1) to receive raltegravir 400 mg BID or efavirenz 600 mg QD both with TDF/3TC 300 mg/300 mg QD. Methods: ANRS 12300 Reflate TB2 is an open-label, phase 3, randomized trial conducted in Brazil, Côte d'Ivoire, France, Mozambique, and Vietnam. We aimed to assess non-inferiority of raltegravir 400 mg BID to efavirenz in HIV1-infected patients with tuberculosis. A previous phase 2 study showed similar efficacy of standard raltegravir 400 mg BID, raltegravir 800 mg BID, or efavirenz-based regimens. Grinsztejn 8 and for the ANRS 12300 Reflate TB2 study groupġAPHP- Hopital Saint Louis, Paris, France, 2University of Bordeaux, Bordeaux Population Health Centre Inserm U1219, Bordeaux, France, 3CEPREF, Abidjan, Cote D'Ivoire, 4SMIT, Abidjan, Cote D'Ivoire, 5Instituto Nacional de Saúde, Maracuene, Mozambique, 6CHU de Nîmes, Nîmes, France, 7Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam, 8Oswaldo Cruz Foundation - FIOCRUZ, Rio de Janeiro, Brazilīackground: Double-dose raltegravir is recommended in HIV1-infected patients with tuberculosis. efavirenz-based antiretroviral treatment in HIV1-infected adults with tuberculosis: W48 results of the ANRS 12300 Reflate TB2 trial MOAB0101 Virologic efficacy of raltegravir vs.

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