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Week 96 efficacy an...
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
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Eron, Joseph J. (author)
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Orkin, C. (author)
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Cunningham, Douglas (author)
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show more...
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Pulido, Federico (author)
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Post, Frank A. (author)
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De Wit, Stéphane (author)
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Lathouwers, E. (author)
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Hufkens, Veerle (author)
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Jezorwski, John (author)
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Petrovic, Romana (author)
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Brown, Kimberley (author)
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Van Landuyt, E. (author)
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Opsomer, M. (author)
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De Wit, S. (author)
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Florence, E. (author)
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Moutschen, M. (author)
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Van Wijngaerden, E. (author)
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Vandekerckhove, L. (author)
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Vandercam, B. (author)
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Brunetta, J. (author)
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Conway, B. (author)
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Klein, M. (author)
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Murphy, D. (author)
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Rachlis, A. (author)
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Shafran, S. (author)
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Walmsley, S. (author)
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Ajana, F. (author)
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Cotte, L. (author)
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Girardy, P. M. (author)
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Katlama, C. (author)
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Molina, J. M. (author)
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Poizot-Martin, I. (author)
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Raffi, F. (author)
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Rey, D. (author)
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Reynes, J. (author)
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Teicher, E. (author)
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Yazdanpanah, Y. (author)
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Gasiorowski, J. (author)
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Halota, W. (author)
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Horban, A. (author)
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Piekarska, A. (author)
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Witor, A. (author)
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Arribas, J. R. (author)
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Perez-Valero, I. (author)
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Berenguer, J. (author)
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Casado, J. (author)
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Gatell, J. M. (author)
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Gutierrez, F. (author)
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Galindo, M. J. (author)
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Gutierrez, M. D.M. (author)
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Iribarren, J. A. (author)
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Knobel, H. (author)
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Negredo, E. (author)
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Pineda, J. A. (author)
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Podzamczer, D. (author)
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Sogorb, J. Portilla (author)
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Pulido, F. (author)
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Ricart, C. (author)
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Rivero, A. (author)
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Santos Gil, I. (author)
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Blaxhult, A. (author)
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Flamholc, L. (author)
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- Gisslén, Magnus, 1962 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine
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Thalme, A. (author)
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Fehr, J. (author)
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Rauch, A. (author)
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Stoeckle, M. (author)
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Clarke, A. (author)
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Gazzard, B. G. (author)
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Johnson, M. A. (author)
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Orkin, C. (author)
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Ustianowski, A. (author)
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Waters, L. (author)
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Bailey, J. (author)
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Benson, P. (author)
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Bhatti, L. (author)
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Brar, I. (author)
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Bredeek, U. F. (author)
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Brinson, C. (author)
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Crofoot, G. (author)
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Cunningham, D. (author)
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DeJesus, E. (author)
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Dietz, C. (author)
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Dretler, R. (author)
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Eron, J. (author)
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Felizarta, F. (author)
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Fichtenbaum, C. (author)
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Gallant, J. (author)
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Gathe, J. (author)
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Hagins, D. (author)
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Henn, S. (author)
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Henry, W. K. (author)
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Huhn, G. (author)
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Jain, M. (author)
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Lucasti, C. (author)
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Martorell, C. (author)
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McDonald, C. (author)
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Mills, A. (author)
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Morales-Ramirez, J. (author)
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(creator_code:org_t)
- Elsevier BV, 2019
- 2019
- English.
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In: Antiviral Research. - : Elsevier BV. - 0166-3542 .- 1872-9096. ; 170
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https://doi.org/10.1...
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https://gup.ub.gu.se...
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Abstract
Subject headings
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- © 2019 The Authors Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52–96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- Darunavir/cobicistat/emtricitabine/TAF
- Efficacy
- Safety
- Single-tablet regimen
- Switch study
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
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Eron, Joseph J.
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Orkin, C.
-
Cunningham, Doug ...
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Pulido, Federico
-
Post, Frank A.
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De Wit, Stéphane
-
show more...
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Lathouwers, E.
-
Hufkens, Veerle
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Jezorwski, John
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Petrovic, Romana
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Brown, Kimberley
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Van Landuyt, E.
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Opsomer, M.
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De Wit, S.
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Florence, E.
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Moutschen, M.
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Van Wijngaerden, ...
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Vandekerckhove, ...
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Vandercam, B.
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Brunetta, J.
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Conway, B.
-
Klein, M.
-
Murphy, D.
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Rachlis, A.
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Shafran, S.
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Walmsley, S.
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Ajana, F.
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Cotte, L.
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Girardy, P. M.
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Katlama, C.
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Molina, J. M.
-
Poizot-Martin, I ...
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Raffi, F.
-
Rey, D.
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Reynes, J.
-
Teicher, E.
-
Yazdanpanah, Y.
-
Gasiorowski, J.
-
Halota, W.
-
Horban, A.
-
Piekarska, A.
-
Witor, A.
-
Arribas, J. R.
-
Perez-Valero, I.
-
Berenguer, J.
-
Casado, J.
-
Gatell, J. M.
-
Gutierrez, F.
-
Galindo, M. J.
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Gutierrez, M. D. ...
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Iribarren, J. A.
-
Knobel, H.
-
Negredo, E.
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Pineda, J. A.
-
Podzamczer, D.
-
Sogorb, J. Porti ...
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Pulido, F.
-
Ricart, C.
-
Rivero, A.
-
Santos Gil, I.
-
Blaxhult, A.
-
Flamholc, L.
-
Gisslén, Magnus, ...
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Thalme, A.
-
Fehr, J.
-
Rauch, A.
-
Stoeckle, M.
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Clarke, A.
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Gazzard, B. G.
-
Johnson, M. A.
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Ustianowski, A.
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Waters, L.
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Bailey, J.
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Benson, P.
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Bhatti, L.
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Brar, I.
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Bredeek, U. F.
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Brinson, C.
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Crofoot, G.
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Cunningham, D.
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DeJesus, E.
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Dietz, C.
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Dretler, R.
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Eron, J.
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Felizarta, F.
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Fichtenbaum, C.
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Gallant, J.
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Gathe, J.
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Hagins, D.
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Henn, S.
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Henry, W. K.
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Huhn, G.
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Jain, M.
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Lucasti, C.
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Martorell, C.
-
McDonald, C.
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Mills, A.
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Morales-Ramirez, ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Microbiology in ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
- Articles in the publication
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Antiviral Resear ...
- By the university
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University of Gothenburg