FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3045256412> ?p ?o ?g. }

• W3045256412 endingPage "254" @default.
• W3045256412 startingPage "239" @default.
• W3045256412 abstract "Background Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention. Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting. Findings Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints. Interpretation Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate. Funding Gilead Sciences. Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention. This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting. Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints. Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate." @default.
• W3045256412 created "2020-07-29" @default.
• W3045256412 creator A5011617429 @default.
• W3045256412 creator A5013318234 @default.
• W3045256412 creator A5013635949 @default.
• W3045256412 creator A5024710603 @default.
• W3045256412 creator A5025150770 @default.
• W3045256412 creator A5029871990 @default.
• W3045256412 creator A5033836920 @default.
• W3045256412 creator A5035679710 @default.
• W3045256412 creator A5042040728 @default.
• W3045256412 creator A5044557893 @default.
• W3045256412 creator A5046238828 @default.
• W3045256412 creator A5049071998 @default.
• W3045256412 creator A5052133090 @default.
• W3045256412 creator A5054571824 @default.
• W3045256412 creator A5057375934 @default.
• W3045256412 creator A5058306976 @default.
• W3045256412 creator A5062954288 @default.
• W3045256412 creator A5064551213 @default.
• W3045256412 creator A5065768749 @default.
• W3045256412 creator A5066658805 @default.
• W3045256412 creator A5076529428 @default.
• W3045256412 creator A5079664351 @default.
• W3045256412 creator A5087385117 @default.
• W3045256412 creator A5089993955 @default.
• W3045256412 date "2020-07-01" @default.
• W3045256412 modified "2023-10-09" @default.
• W3045256412 title "Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial" @default.
• W3045256412 cites W1413161224 @default.
• W3045256412 cites W1557238515 @default.
• W3045256412 cites W1898465070 @default.
• W3045256412 cites W1925000895 @default.
• W3045256412 cites W1970441566 @default.
• W3045256412 cites W1994036015 @default.
• W3045256412 cites W2019724200 @default.
• W3045256412 cites W2040106495 @default.
• W3045256412 cites W2050252451 @default.
• W3045256412 cites W2051116409 @default.
• W3045256412 cites W2057851884 @default.
• W3045256412 cites W2075474943 @default.
• W3045256412 cites W2101868592 @default.
• W3045256412 cites W2103920597 @default.
• W3045256412 cites W2108663710 @default.
• W3045256412 cites W2112631829 @default.
• W3045256412 cites W2113255660 @default.
• W3045256412 cites W2117057469 @default.
• W3045256412 cites W2132977017 @default.
• W3045256412 cites W2149185709 @default.
• W3045256412 cites W2168536722 @default.
• W3045256412 cites W2196190612 @default.
• W3045256412 cites W2257516528 @default.
• W3045256412 cites W2301510887 @default.
• W3045256412 cites W2319917590 @default.
• W3045256412 cites W2327535499 @default.
• W3045256412 cites W2402018016 @default.
• W3045256412 cites W2466146762 @default.
• W3045256412 cites W2467247336 @default.
• W3045256412 cites W2495049002 @default.
• W3045256412 cites W2521726183 @default.
• W3045256412 cites W2589178796 @default.
• W3045256412 cites W2593231312 @default.
• W3045256412 cites W2593423583 @default.
• W3045256412 cites W2600060125 @default.
• W3045256412 cites W2607031541 @default.
• W3045256412 cites W2738559785 @default.
• W3045256412 cites W2751592396 @default.
• W3045256412 cites W2782856081 @default.
• W3045256412 cites W2789678217 @default.
• W3045256412 cites W2789992229 @default.
• W3045256412 cites W2800324305 @default.
• W3045256412 cites W2896818093 @default.
• W3045256412 cites W2900697563 @default.
• W3045256412 cites W2902418781 @default.
• W3045256412 cites W2913553042 @default.
• W3045256412 cites W2915737634 @default.
• W3045256412 cites W2928530166 @default.
• W3045256412 cites W2945214389 @default.
• W3045256412 cites W2952934241 @default.
• W3045256412 cites W2965341020 @default.
• W3045256412 cites W2979917028 @default.
• W3045256412 cites W2983909317 @default.
• W3045256412 cites W2987833852 @default.
• W3045256412 cites W2996643654 @default.
• W3045256412 cites W3001764054 @default.
• W3045256412 cites W4238444439 @default.
• W3045256412 cites W4239743462 @default.
• W3045256412 doi "https://doi.org/10.1016/s0140-6736(20)31065-5" @default.
• W3045256412 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32711800" @default.
• W3045256412 hasPublicationYear "2020" @default.
• W3045256412 type Work @default.
• W3045256412 sameAs 3045256412 @default.
• W3045256412 citedByCount "214" @default.
• W3045256412 countsByYear W30452564122020 @default.
• W3045256412 countsByYear W30452564122021 @default.
• W3045256412 countsByYear W30452564122022 @default.
• W3045256412 countsByYear W30452564122023 @default.
• W3045256412 crossrefType "journal-article" @default.

• next