Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1:96 week results from the NEAT001/ANRS143 randomised non-inferiority trial

2014-11-29

BACKGROUND: Standard first-line antiretroviral therapy for HIV-1 infection includes two nucleoside or nucleotide reverse transcriptase inhibitors (NtRTIs), but these drugs have limitations. We assessed the 96 week efficacy and safety of an NtRTI-sparing regimen.METHODS: Between August, 2010, and September, 2011, we enrolled treatment-naive adults into this randomised, open-label, non-inferiority trial in treatment-naive adults in 15 European countries. The composite primary outcome was change to randomised treatment before week 32 because of insufficient virological response, no virological response by week 32, HIV-1 RNA concentration 50 copies per mL or higher at any time after week 32; death from any cause; any new or recurrent AIDS event; or any serious non-AIDS event. Patients were randomised in a 1:1 ratio to receive oral treatment with 400 mg raltegravir twice daily plus 800 mg darunavir and 100 mg ritonavir once daily (NtRTI-sparing regimen) or tenofovir-emtricitabine in a 245 mg and 200 mg fixed-dose combination once daily, plus 800 mg darunavir and 100 mg ritonavir once daily (standard regimen). This trial was registered with ClinicalTrials.gov, number NCT01066962.FINDINGS: Of 805 patients enrolled, 401 received the NtRTI-sparing regimen and 404 the standard regimen, with median follow-up of 123 weeks (IQR 112-133). Treatment failure was seen in 77 (19%) in the NtRTI-sparing group and 61 (15%) in the standard group. Kaplan-Meier estimated proportions of treatment failure by week 96 were 17·8% and 13·8%, respectively (difference 4·0%, 95% CI -0·8 to 8·8). The frequency of serious or treatment-modifying adverse events were similar (10·2 vs 8·3 per 100 person-years and 3·9 vs 4·2 per 100 person-years, respectively).INTERPRETATION: Our NtRTI-sparing regimen was non-inferior to standard treatment and represents a treatment option for patients with CD4 cell counts higher than 200 cells per μL.FUNDING: European Union Sixth Framework

Adenine; Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Cholesterol, HDL; Cholesterol, LDL; Deoxycytidine; Drug Resistance, Viral; Drug Therapy, Combination; Female; HIV Infections; HIV-1; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Organophosphonates; Pyrrolidinones; Ritonavir; Sulfonamides; Treatment Outcome; article

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DAV oai:pure.atira.dk:publications/6bb84690-61de-488d-a3b6-66f05916cd75
https://curis.ku.dk/portal/da/publications/ritonavirboosted-darunavir-combined-with-raltegravir-or-tenofoviremtricitabine-in-antiretroviralnaive-adults-infected-with-hiv1(6bb84690-61de-488d-a3b6-66f05916cd75).html
https://doi.org/10.1016/S0140-6736(14)61170-3
916713070

UNIV OF COPENHAGEN
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