Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study

Bonaventura Clotet, Judith Feinberg, Jan Van Lunzen, Marie Aude Khuong-Josses, Andrea Antinori, Irina Dumitru, Vadim Pokrovskiy, Jan Fehr, Roberto Ortiz, Michael Saag, Julia Harris, Clare Brennan, Tamio Fujiwara, Sherene Min

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Abstract

Background Dolutegravir has been shown to be non-inferior to an integrase inhibitor and superior to a non-nucleoside reverse transcriptase inhibitor (NNRTI). In FLAMINGO, we compared dolutegravir with darunavir plus ritonavir in individuals naive for antiretroviral therapy. Methods In this multicentre, open-label, phase 3b, non-inferiority study, HIV-1-infected antiretroviral therapy-naive adults with HIV-1 RNA concentration of 1000 copies per mL or more and no resistance at screening were randomly assigned (1:1) to receive either dolutegravir 50 mg once daily or darunavir 800 mg plus ritonavir 100 mg once daily, with investigator-selected tenofovir.emtricitabine or abacavir.lamivudine. Randomisation was stratifi ed by screening HIV-1 RNA (.100 000 or >100 000 copies per mL) and nucleoside reverse transcriptase inhibitor (NRTI) selection. The primary endpoint was the proportion of patients with HIV-1 RNA concentration lower than 50 copies per mL (Food and Drug Administration [FDA] snapshot algorithm) at week 48 with a 12% non-inferiority margin. This trial is registered with ClinicalTrials.gov, NCT01449929. Findings Recruitment began on Oct 31, 2011, and was completed on May 24, 2012, in 64 research centres in nine countries worldwide. Of 595 patients screened, 484 patients were included in the analysis (242 in each group). At week 48, 217 (90%) patients receiving dolutegravir and 200 (83%) patients receiving darunavir plus ritonavir had HIV-1 RNA of less than 50 copies per mL (adjusted diff erence 7E1%, 95% CI 0E9.13E2), non-inferiority and on pre-specifi ed secondary analysis dolutegravir was superior (p=0E025). Confi rmed virological failure occurred in two (

Original languageEnglish
Pages (from-to)2222-2231
Number of pages10
JournalLancet
Volume383
Issue number9936
DOIs
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Medicine(all)

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    Clotet, B., Feinberg, J., Van Lunzen, J., Khuong-Josses, M. A., Antinori, A., Dumitru, I., Pokrovskiy, V., Fehr, J., Ortiz, R., Saag, M., Harris, J., Brennan, C., Fujiwara, T., & Min, S. (2014). Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet, 383(9936), 2222-2231. https://doi.org/10.1016/S0140-6736(14)60084-2