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2. Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial

Author

Bourgeois, Stefan, Vanwolleghem, Thomas, Nevens, Frederik, Horsmans, Yves, Van Vlierberghe, Hans, Nastri, Ana Catharina, Lacerda, Marcus, Ramji, Alnoor, Conway, Brian, Coffin, Carla, Janssen, Harry, Fung, Scott, Shafran, Stephen, Hou, Jin Lin, Sperl, Jan, Urbanek, Petr, Plisek, Stanislav, Hejda, Vaclav, Samuel, Didier, Lacombe, Karine, Zoulim, Fabien, Guyader, Dominique, Raffi, Francois, Asselah, Tarik, Bourliere, Marc, Hilleret, Marie-Noelle, Wedemeyer, Heiner, Schulze zur Wiesch, Julian, Sprinzl, Kathrin, van Boemmel, Florian, Hilgard, Gudrun, Sabranski, Michael, Arasteh, Keikawus, Chan, Henry LY, Yuen, Man Fung, Wong, Vincent Ws, Brunetto, Maurizia Rossana, Taliani, Gloria, Andreone, Pietro, Lampertico, Pietro, Kurosaki, Masayuki, Yatsuhashi, Hiroshi, Fujiwara, Kei, Takehara, Tetsuo, Kawaoka, Tomokazu, Asahina, Yasuhiro, Enomoto, Hirayuki, Yabushita, Kazuhisa, Notsumata, Kazuo, Takaguchi, Koichi, Kawabe, Naoto, Kato, Naoya, Koji, Ogawa, Namisaki, Tadashi, Suzuki, Yoshiyuki, Yoon, Jung-Hwan, Ahn, SangHoon, Lim, Young-Suk, Paik, Seung Woon, Kiew, Kuang Kiat, Mohamed, Rosmawati, Tan, Soek Siam, Lee, Yeong Yeh, Hlebowicz, Maria, Berak, Hanna, Gasiorowski, Jacek, Halota, Waldemar, Janczewska, Ewa, Geyvandova, Natalia, Morozov, Viacheslav, Andreeva, Alla, Gusev, Denis, Bessonova, Elena, Osipenko, Marina, Romanova, Svetlana, Gankina, Natalia, Sagalova, Olga, Stepanova, Tatiana, Crespo Garcia, Javier, Diago, Moises, Inmaculada, Fernandez, Calleja, Jose Luis, Forns, Xavier, Buti, Maria, Tangkijvanich, Pisit, Tanwandee, Tawesak, Piratvisuth, Teerha, Leerapun, Apinya, Yilmaz, Gurdal, Tabak, Ömer Fehmi, Akarca, Ulus Salih, Akova, Murat, Idilman, Ramazan, Forton, Daniel, Bell, David, Agarwal, Kosh, Kennedy, Patrick, Felizarta, Franco, Sulkowski, Mark, Nahass, Ronald, Rojter, Sergio, Jacobson, Ira, Korenblat, Kevin, Gitlin, Norman, Yuen, Man-Fung, Jacobson, Ira M, Janssen, Harry L A, Kakuda, Thomas N, Lambrecht, Tom, Beumont, Maria, Kalmeijer, Ronald, Guinard-Azadian, Carine, Mayer, Cristiana, Jezorwski, John, Verbinnen, Thierry, Lenz, Oliver, Shukla, Umesh, and Biermer, Michael

Published
2023
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6. Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial

Author

Yuen, Man-Fung, Asselah, Tarik, Jacobson, Ira M, Brunetto, Maurizia Rossana, Janssen, Harry L A, Takehara, Tetsuo, Hou, Jin Lin, Kakuda, Thomas N, Lambrecht, Tom, Beumont, Maria, Kalmeijer, Ronald, Guinard-Azadian, Carine, Mayer, Cristiana, Jezorwski, John, Verbinnen, Thierry, Lenz, Oliver, Shukla, Umesh, Biermer, Michael, Bourgeois, Stefan, Vanwolleghem, Thomas, Nevens, Frederik, Horsmans, Yves, Van Vlierberghe, Hans, Nastri, Ana Catharina, Lacerda, Marcus, Ramji, Alnoor, Conway, Brian, Coffin, Carla, Janssen, Harry, Fung, Scott, Shafran, Stephen, Hou, Jin Lin, Sperl, Jan, Urbanek, Petr, Plisek, Stanislav, Hejda, Vaclav, Samuel, Didier, Lacombe, Karine, Zoulim, Fabien, Guyader, Dominique, Raffi, Francois, Asselah, Tarik, Bourliere, Marc, Hilleret, Marie-Noelle, Wedemeyer, Heiner, Schulze zur Wiesch, Julian, Sprinzl, Kathrin, van Boemmel, Florian, Hilgard, Gudrun, Sabranski, Michael, Arasteh, Keikawus, Chan, Henry LY, Yuen, Man Fung, Wong, Vincent Ws, Brunetto, Maurizia Rossana, Taliani, Gloria, Andreone, Pietro, Lampertico, Pietro, Kurosaki, Masayuki, Yatsuhashi, Hiroshi, Fujiwara, Kei, Takehara, Tetsuo, Kawaoka, Tomokazu, Asahina, Yasuhiro, Enomoto, Hirayuki, Yabushita, Kazuhisa, Notsumata, Kazuo, Takaguchi, Koichi, Kawabe, Naoto, Kato, Naoya, Koji, Ogawa, Namisaki, Tadashi, Suzuki, Yoshiyuki, Yoon, Jung-Hwan, Ahn, SangHoon, Lim, Young-Suk, Paik, Seung Woon, Kiew, Kuang Kiat, Mohamed, Rosmawati, Tan, Soek Siam, Lee, Yeong Yeh, Hlebowicz, Maria, Berak, Hanna, Gasiorowski, Jacek, Halota, Waldemar, Janczewska, Ewa, Geyvandova, Natalia, Morozov, Viacheslav, Andreeva, Alla, Gusev, Denis, Bessonova, Elena, Osipenko, Marina, Romanova, Svetlana, Gankina, Natalia, Sagalova, Olga, Stepanova, Tatiana, Crespo Garcia, Javier, Diago, Moises, Inmaculada, Fernandez, Calleja, Jose Luis, Forns, Xavier, Buti, Maria, Tangkijvanich, Pisit, Tanwandee, Tawesak, Piratvisuth, Teerha, Leerapun, Apinya, Yilmaz, Gurdal, Tabak, Ömer Fehmi, Akarca, Ulus Salih, Akova, Murat, Idilman, Ramazan, Forton, Daniel, Bell, David, Agarwal, Kosh, Kennedy, Patrick, Felizarta, Franco, Sulkowski, Mark, Nahass, Ronald, Rojter, Sergio, Jacobson, Ira, Korenblat, Kevin, and Gitlin, Norman

Abstract

JNJ-73763989 (JNJ-3989), a small interfering RNA, targets all hepatitis B virus (HBV) RNAs, reducing all HBV proteins. JNJ-56136379 (JNJ-6379; also known as bersacapavir), a capsid assembly modulator, inhibits HBV replication. We aimed to evaluate the efficacy (ie, antiviral activity) and safety of these therapeutics in combination with nucleos(t)ide analogues in patients with chronic hepatitis B.

Published
2023
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7. Week 96 resistance analyses of the once‐daily, single‐tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV‐1 from the phase 3 randomized AMBER and EMERALD trials

Author

Lathouwers, Erkki, primary, Weinsteiger, Shirley, additional, Baugh, Bryan, additional, Ghys, Anne, additional, Jezorwski, John, additional, Mohsine, El Ghazi, additional, Van Landuyt, Erika, additional, and De Meyer, Sandra, additional

Published
2021
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8. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

Author

Lathouwers, Erkki, Wong, Eric Y, Brown, Kimberley, Baugh, Bryan, Ghys, Anne, Jezorwski, John, Mohsine, El Ghazi, Van Landuyt, Erika, Opsomer, Magda, De Meyer, Sandra, De Wit, S, Florence, E, Vandekerckhove, L, Vandercam, B, Brunetta, J, Klein, M, Murphy, D, Rachlis, A, Walmsley, S, Ajana, F, Cotte, L, Girard, P-M, Katlama, C, Molina, J-M, Poizot-Martin, I, Raffi, F, Rey, D, Reynes, J, Teicher, E, Yazdanpanah, Y, Arasteh, K, Bickel, M, Bogner, J, Esser, S, Faetkenheuer, G, Jessen, H, Kern, W, Rockstroh, J, Spinner, C, Stellbrink, H-J, Stoehr, A, Antinori, A, Castelli, F, Chirianni, A, De Luca, A, Di Biagio, A, Galli, M, Lazzarin, A, Maggiolo, F, Maserati, R, Mussini, C, Garlicki, A, Gasiorowski, J, Halota, W, Horban, A, Parczewski, M, Piekarska, A, Belonosova, E, Chernova, O, Dushkina, N, Kulagin, V, Ryamova, E, Shuldyakov, A, Sizova, N, Tsybakova, O, Voronin, E, Yakovlev, A, Antela, A, Arribas, JR, Berenguer, J, Casado, J, Estrada, V, Galindo, MJ, Garcia Del Toro, M, Gatell, JM, Gorgolas, M, Gutierrez, F, Gutierrez, MDM, Negredo, E, Pineda, JA, Podzamczer, D, Portilla Sogorb, J, Rivero, A, Rubio, R, Viciana, P, De Los Santos, I, Clarke, A, Gazzard, BG, Johnson, MA, Orkin, C, Reeves, I, Waters, L, Benson, P, Bhatti, L, Bredeek, F, Crofoot, G, Cunningham, D, DeJesus, E, Eron, J, Felizarta, F, Franco, R, Gallant, J, Hagins, D, Henry, K, Jayaweera, D, Lucasti, C, Martorell, C, McDonald, C, McGowan, J, Mills, A, Morales-Ramirez, J, Prelutsky, D, Ramgopal, M, Rashbaum, B, Ruane, P, Slim, J, Wilkin, A, deVente, J, Moutschen, M, Van Wijngaerden, E, Vekerckhove, L, Vercam, B, Conway, B, Shafran, S, Janssen Pharmaceutica [Beerse], Janssen Pharmaceutical Research and Development Titusville, AMBER and EMERALD Study Groups: S De Wit, E Florence, L Vandekerckhove, B Vandercam, J Brunetta, M Klein, D Murphy, A Rachlis, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, K Arastéh, M Bickel, J Bogner, S Esser, G Faetkenheuer, H Jessen, W Kern, J Rockstroh, C Spinner, H-J Stellbrink, A Stoehr, A Antinori, F Castelli, A Chirianni, A De Luca, A Di Biagio, M Galli, A Lazzarin, F Maggiolo, R Maserati, C Mussini, A Garlicki, J Gasiorowski, W Halota, A Horban, M Parczewski, A Piekarska, E Belonosova, O Chernova, N Dushkina, V Kulagin, E Ryamova, A Shuldyakov, N Sizova, O Tsybakova, E Voronin, A Yakovlev, A Antela, J R Arribas, J Berenguer, J Casado, V Estrada, M J Galindo, M Garcia Del Toro, J M Gatell, M Gorgolas, F Gutierrez, Mdm Gutierrez, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, A Rivero, R Rubio, P Viciana, I De Los Santos, A Clarke, B G Gazzard, M A Johnson, C Orkin, I Reeves, L Waters, P Benson, L Bhatti, F Bredeek, G Crofoot, D Cunningham, E DeJesus, J Eron, F Felizarta, R Franco, J Gallant, D Hagins, K Henry, D Jayaweera, C Lucasti, C Martorell, C McDonald, J McGowan, A Mills, J Morales-Ramirez, D Prelutsky, M Ramgopal, B Rashbaum, P Ruane, J Slim, A Wilkin, J deVente, S De Wit, E Florence, M Moutschen, E Van Wijngaerden, L Vandekerckhove, B Vandercam, J Brunetta, B Conway, M Klein, D Murphy, A Rachlis, S Shafran, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, J Gasiorowski, W Halota, A Horban, A Piekarska, A Witor, J R Arribas, I Perez-Valero, J Berenguer, J Casado, J M Gatell, F Gutierrez, M J Galindo, Mdm Gutierrez, J A Iribarren, H Knobel, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, F Pulido, C Ricart, A Rivero, I Santos Gil, A Blaxhult, L Flamholc, M Gisslèn, A Thalme, J Fehr, A Rauch, M Stoeckle, A Clarke, B G Gazzard, M A Johnson, C Orkin, F Post, A Ustianowski, L Waters, J Bailey, P Benson, L Bhatti, I Brar, U F Bredeek, C Brinson, G Crofoot, D Cunningham, E DeJesus, C Dietz, R Dretler, J Eron, F Felizarta, C Fichtenbaum, J Gallant, J Gathe, D Hagins, S Henn, K W Henry, G Huhn, M Jain, C Lucasti, C Martorell, C McDonald, A Mills, J Morales-Ramirez, K Mounzer, R Nahass, H Olivet, O Osiyemi, D Prelutsky, M Ramgopal, B Rashbaum, G Richmond, P Ruane, A Scarsella, A Scribner, P Shalit, D Shamblaw, J Slim, K Tashima, G Voskuhl, D Ward, A Wilkin, J de Vente, and Malbec, Odile

Subjects
0301 basic medicine, [SDV]Life Sciences [q-bio], efficacy, Human immunodeficiency virus (HIV), HIV Infections, darunavir, medicine.disease_cause, VIRALLY SUPPRESSED ADULTS, PLUS LAMIVUDINE, DOUBLE-BLIND, 0302 clinical medicine, INFECTION, Medicine and Health Sciences, Emtricitabine, 030212 general & internal medicine, Darunavir, Emtricitabine tenofovir alafenamide, Alanine, Cobicistat, Single tablet regimen, virus diseases, Viral Load, OPEN-LABEL, 3. Good health, [SDV] Life Sciences [q-bio], Drug Combinations, Infectious Diseases, NON-INFERIORITY, INITIAL TREATMENT, Reverse Transcriptase Inhibitors, Life Sciences & Biomedicine, Tablets, medicine.drug, Adult, TENOFOVIR DISOPROXIL FUMARATE, Anti-HIV Agents, Darunavir/Cobicistat, Immunology, archived RAMs, Tenofovir alafenamide, Drug Administration Schedule, single-tablet regimen, resistance, 03 medical and health sciences, deep sequencing, Virology, Drug Resistance, Viral, medicine, darunavir/cobicistat/emtricitabine/TAF, Humans, Clinical Trials/Clinical Studies, Tenofovir, emtricitabine, DRUG-RESISTANCE, Science & Technology, TREATMENT-NAIVE PATIENTS, business.industry, Adenine, cobicistat, 030104 developmental biology, TAF, HIV-1, business
Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL

Published
2019

9. 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

Author

Eron, Joseph J., primary, Orkin, Chloe, additional, Cunningham, Douglas, additional, Pulido, Federico, additional, Post, Frank A., additional, De Wit, Stéphane, additional, Lathouwers, Erkki, additional, Hufkens, Veerle, additional, Jezorwski, John, additional, Petrovic, Romana, additional, Brown, Kimberley, additional, Van Landuyt, Erika, additional, Opsomer, Magda, additional, De Wit, S., additional, Florence, E., additional, Moutschen, M., additional, Van Wijngaerden, E., additional, Vandekerckhove, L., additional, Vandercam, B., additional, Brunetta, J., additional, Conway, B., additional, Klein, M., additional, Murphy, D., additional, Rachlis, A., additional, Shafran, S., additional, Walmsley, S., additional, Ajana, F., additional, Cotte, L., additional, Girardy, P.-M., additional, Katlama, C., additional, Molina, J.-M., additional, Poizot-Martin, I., additional, Raffi, F., additional, Rey, D., additional, Reynes, J., additional, Teicher, E., additional, Yazdanpanah, Y., additional, Gasiorowski, J., additional, Halota, W., additional, Horban, A., additional, Piekarska, A., additional, Witor, A., additional, Arribas, J.R., additional, Perez-Valero, I., additional, Berenguer, J., additional, Casado, J., additional, Gatell, J.M., additional, Gutierrez, F., additional, Galindo, M.J., additional, Gutierrez, M.D.M., additional, Iribarren, J.A., additional, Knobel, H., additional, Negredo, E., additional, Pineda, J.A., additional, Podzamczer, D., additional, Sogorb, J.Portilla, additional, Pulido, F., additional, Ricart, C., additional, Rivero, A., additional, Santos Gil, I., additional, Blaxhult, A., additional, Flamholc, L., additional, Gisslèn, M., additional, Thalme, A., additional, Fehr, J., additional, Rauch, A., additional, Stoeckle, M., additional, Clarke, A., additional, Gazzard, B.G., additional, Johnson, M.A., additional, Orkin, C., additional, Post, F., additional, Ustianowski, A., additional, Waters, L., additional, Bailey, J., additional, Benson, P., additional, Bhatti, L., additional, Brar, I., additional, Bredeek, U.F., additional, Brinson, C., additional, Crofoot, G., additional, Cunningham, D., additional, DeJesus, E., additional, Dietz, C., additional, Dretler, R., additional, Eron, J., additional, Felizarta, F., additional, Fichtenbaum, C., additional, Gallant, J., additional, Gathe, J., additional, Hagins, D., additional, Henn, S., additional, Henry, W.K., additional, Huhn, G., additional, Jain, M., additional, Lucasti, C., additional, Martorell, C., additional, McDonald, C., additional, Mills, A., additional, Morales-Ramirez, J., additional, Mounzer, K., additional, Nahass, R., additional, Olivet, H., additional, Osiyemi, O., additional, Prelutsky, D., additional, Ramgopal, M., additional, Rashbaum, B., additional, Richmond, G., additional, Ruane, P., additional, Scarsella, A., additional, Scribner, A., additional, Shalit, P., additional, Shamblaw, D., additional, Slim, J., additional, Tashima, K., additional, Voskuhl, G., additional, Ward, D., additional, Wilkin, A., additional, and de Vente, J., additional

Published
2019
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12. Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment...

Author

Huhn, Gregory D., Wilkin, Aimee, Mussini, Cristina, Spinner, Christoph D., Jezorwski, John, El Ghazi, Mohsine, Van Landuyt, Erika, Lathouwers, Erkki, Brown, Kimberley, and Baugh, Bryan

Subjects
EMTRICITABINE, RITONAVIR, DRUG efficacy, HIV, DARUNAVIR, TENOFOVIR, EMERALDS, CD4 lymphocyte count
Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated in AMBER (treatment-naïve adults; NCT02431247) and EMERALD (treatment-experienced, virologically-suppressed adults; NCT02269917). To describe a Week 96 pre-planned subgroup analysis of D/C/F/TAF arms by demographic characteristics (age ≤/>50 years, gender, black/non-black race), and baseline clinical characteristics (AMBER: viral load [VL], CD4+ count, WHO clinical stage, HIV-1 subtype and antiretroviral resistance; EMERALD: prior virologic failure [VF], antiretroviral experience, screening boosted protease inhibitor [PI], and boosting agent). Patients in D/C/F/TAF and control arms could continue on/switch to D/C/F/TAF in a single-arm, open-label extension phase after Week 48 until Week 96. Efficacy endpoints were percentage cumulative confirmed VL ≥50 copies/mL (virologic rebound; EMERALD), and VL <50 (virologic response), or ≥50 copies/mL (VF) (FDA snapshot; both trials). D/C/F/TAF demonstrated high Week 96 virologic responses (AMBER: 85% [308/362]; EMERALD: 91% [692/763]) and low VF rates (AMBER: 6% [20/362]; EMERALD: 1% [9/763]). In EMERALD, D/C/F/TAF showed low virologic rebound cumulative through Week 96 (3% [24/763]). Results were consistent across subgroups, including prior antiretroviral experience in EMERALD. No darunavir, primary PI, or tenofovir resistance-associated mutations were observed post-baseline. Study-drug-related serious adverse events (AEs) and AE-related discontinuations were <1% and 2%, respectively (both D/C/F/TAF arms), and similar across subgroups. eGFRcyst and bone mineral density improved or were stable and lipids increased through Week 96 across demographic subgroups, with small changes in total-cholesterol/HDL-cholesterol ratio. D/C/F/TAF was effective with a high barrier to resistance and bone/renal safety benefits, regardless of demographic or clinical characteristics for treatment-naïve and treatment-experienced, virologically-suppressed adults. [ABSTRACT FROM AUTHOR]

Published
2020
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13. Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril) When Administered Concomitantly With a Tetravalent Dengue Vaccine Candidate in Healthy Toddlers at 12–13 Months of Age in Colombia and Peru

Author

López, Pio, primary, Lanata, Claudio F., additional, Zambrano, Betzana, additional, Cortés, Margarita, additional, Andrade, Teresa, additional, Amemiya, Isabel, additional, Terrones, Cynthia, additional, Gil, Ana I., additional, Verastegui, Hector, additional, Marquez, Viviana, additional, Crevat, Denis, additional, Jezorwski, John, additional, and Noriega, Fernando, additional

Published
2016
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15. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials.

Author

Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, and De Meyer S

Subjects
Adenine administration & dosage, Adult, Alanine, Anti-HIV Agents administration & dosage, Drug Administration Schedule, Drug Combinations, HIV Infections epidemiology, HIV-1 drug effects, Humans, Reverse Transcriptase Inhibitors administration & dosage, Tablets administration & dosage, Tenofovir analogs & derivatives, Viral Load drug effects, Adenine analogs & derivatives, Cobicistat administration & dosage, Darunavir administration & dosage, Drug Resistance, Viral, Emtricitabine administration & dosage, HIV Infections drug therapy
Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL <50 copies/mL) in EMERALD. Through week 48 across both studies, no darunavir, primary PI, or tenofovir resistance-associated mutations (RAMs) were observed in HIV-1 viruses of 1,125 participants receiving D/C/F/TAF or 629 receiving boosted darunavir plus emtricitabine/tenofovir-disoproxil-fumarate. In AMBER, the nucleos(t)ide analog reverse transcriptase inhibitor (N(t)RTI) RAM M184I/V was identified in HIV-1 of one participant during D/C/F/TAF treatment. M184V was detected pretreatment as a minority variant (9%). In EMERALD, in participants with prior VF and genoarchive data ( N  = 140; 98 D/C/F/TAF and 42 control), 4% had viruses with darunavir RAMs, 38% with emtricitabine RAMs, mainly at position 184 (41% not fully susceptible to emtricitabine), 4% with tenofovir RAMs, and 21% ≥ 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL <50 copies/mL at week 48 or prior discontinuation. D/C/F/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response.

Published
2020
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