Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1

Lathouwers, Erkki; Hufkens, Veerle; Jezorwski, John; Petrovic, Romana; Brown, Kimberley; Landuyt, Erika Van; Opsomer, Magda; Wit, Stéphane De; Florence, Éric; Moutschen, Michel; Wijngaerden, Eric Van; Vandekerckhove, Linos; Vandercam, Bernard; Brunetta, Jason; Conway, Brian; Klein, Marina B.; Murphy, Daniel; Rachlis, Anita; Shafran, Stephen D.; Walmsley, Sharon; Ajana, F.; Cotte, Laurent; Girardy, P.-M.; Katlama, Christine; Molina, Jean Michel; Poizot‐Martin, Isabelle; Raffi, François; Rey, David; Reynes, Jacques; Teicher, Elina; Yazdanpanah, Yazdan; Gąsiorowski, Jacek; Halota, Waldemar; Horban, Andrzéj; Piekarska, Anna; Witor, Anita; Arribas, JR; Pérez‐Valero, Ignacio; Berenguer, Juan; Casado, José L.; Gatell, José M.; Gutiérrez, Félix; Galindo, Marı́a José; Gutierrez, María del Mar; Iribarren, José Antonio; Knobel, Hernando; Negredo, Eugènia; Pineda, Juan A.; Podzamczer, Daniel; Sogorb, Joaquín Portilla; Pulido, Federico; Ricart, C; Rivero, A.; Gil, Inês; Blaxhult, Anders; Flamholc, Leo; Gisslén, Magnus; Thalme, Anders; Fehr, Jan; Rauch, Angelika; Stoeckle, Marcel; Clarke, Amanda; Bg, Gazzard; Johnson, M; Orkin, Chloe; Post, Frank A.; Ustianowski, Andrew; Waters, Laura; Bailey, Joseph; Benson, Paul M.; Bhatti, Laveeza; Brar, Indira; Bredeek, U. Fritz; Brinson, Cynthia; Crofoot, Gordon; Cunningham, Douglas; DeJesus, Edwin; Dietz, Craig; Dretler, Robin; Eron, Joseph J.; Felizarta, Franco; Fichtenbaum, Carl J.; Gallant, Joel E.; Gathe, Joseph; Hagins, Debbie; Henn, S; Henry, W. Keith; Huhn, Gregory; Jain, Mamta K.; Lucasti, Christopher; Martorell, Claudia; McDonald, Cheryl; Mills, Anthony; Morales-Ramirez, Javier O; Mounzer, Karam; Nahass, Ronald; Olivet, H; Osiyemi, Olayemi; Prelutsky, D; Ramgopal, Moti; Rashbaum, Bruce; Richmond, Gary; Ruane, P.; Scarsella, Anthony; Scribner, Anita; Shalit, Peter; Shamblaw, David; Slim, Jihad; Tashima, K.; Voskuhl, Gene W.; Ward, Douglas J.; Wilkin, Aimee M.; Vente, Jerome De

doi:10.1016/j.antiviral.2019.104543

Cited by 33 publications

(26 citation statements)

References 28 publications

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“…Darunavir/cobicistat (800/150 mg) is now available in fixed combination with TAF þ FTC (Symtuza V R ). Symtuza V R has been compared to darunavir/cobicistat þ TDF/FTC when given to treatment-naïve patients, and as switch therapy in stable patients compared to patients remaining on boosted PIs þ TDF/FTC [7,8]. The non-inferiority criteria were met in both studies.…”

Section: New Substancesmentioning

confidence: 99%

Antiretroviral treatment for HIV infection: Swedish recommendations 2019

Eriksen

Carlander

Albert

et al. 2020

Infectious Diseases

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The Swedish Reference Group for Antiviral Therapy (RAV) published recommendations for the treatment of HIV infection in this journal most recently in 2017. An expert group under the guidance of RAV here provides updated recommendations. The most important updates in the present guidelines are the following: (a) The risk of HIV transmission through condomless sex from individuals with fully suppressed HIV viral load is effectively zero. (b) Pre-exposure prophylaxis (PrEP) is recommended for groups with a high risk of HIV infection. (c) Since the last update, two new substances have been registered: bictegravir and doravirine. (d) Dual treatment may be an alternative in selected patients, using lamivudine þ dolutegravir or lamivudine þ boosted darunavir/atazanavir. As with previous publications, recommendations are evidence-graded in accordance with the Oxford Centre for Evidence Based Medicine. This document does not cover treatment of opportunistic infections and tumours.

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Section: New Substancesmentioning

confidence: 99%

Antiretroviral treatment for HIV infection: Swedish recommendations 2019

Eriksen

Carlander

Albert

et al. 2020

Infectious Diseases

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“…Methodological details for the seven clinical studies included in the previous analysis have been described. 6,[10][11][12][13][14][15][16] Detailed methods for the three recent studies of the D/C/F/TAF STR have also been reported [19][20][21][22][23] and are briefly summarized here. Key study design information for all 10 studies is shown in Supplemental Figure S1.…”

Section: Study Designsmentioning

confidence: 99%

“…Patients in this control arm were subsequently switched to D/C/F/TAF beyond Week 48. 22,23 The current analysis includes the 763 patients who immediately switched to D/C/F/TAF at baseline ("D/C/F/ TAF" group) and 352 patients who switched to D/C/F/ TAF after Week 48 ("switch to D/C/F/TAF" group; Weeks 52-96).…”

Section: Study Designsmentioning

confidence: 99%

“…Details of the resistance analyses performed in the 10 studies have been described. 6,[19][20][21][22][23] Post-baseline resistance testing was performed for patients who experienced protocol-defined virologic failure (PDVF; i.e. nonresponse, virologic rebound, and/or viremic at endpoint).…”

Section: Resistance Analysesmentioning

confidence: 99%

“…3,18 Reported here is an extension of a previous evaluation of post-baseline HIV-1 resistance data from seven phase 2 or 3 clinical studies (1686 patients) of darunavir 800 mg QD-based ARV regimens. 6 The current analysis incorporates post-baseline findings from three recent studies of the darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/ 200/10 mg QD STR [19][20][21][22][23] to evaluate resistance across a total of 10 clinical studies of darunavir 800 mg QDbased regimens.…”

Section: Introductionmentioning

confidence: 99%

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Pooled resistance analyses of darunavir once-daily regimens and formulations across 10 clinical studies of treatment-naïve and treatment-experienced patients with human immunodeficiency virus-1 infection

Lathouwers

Seyedkazemi

Luo

et al. 2020

HIV Research & Clinical Practice

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Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Saag

Gandhi

Hoy

et al. 2020

JAMA

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342

202

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ImportanceData on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices.ObjectiveTo evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV.Evidence ReviewNew evidence was collected since the previous International Antiviral (formerly AIDS) Society–USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations.FindingsFrom 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic.Conclusion and RelevanceAdvances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.

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Cited by 33 publications

References 28 publications

Antiretroviral treatment for HIV infection: Swedish recommendations 2019

Antiretroviral treatment for HIV infection: Swedish recommendations 2019

Pooled resistance analyses of darunavir once-daily regimens and formulations across 10 clinical studies of treatment-naïve and treatment-experienced patients with human immunodeficiency virus-1 infection

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

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