Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco 
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  • ||||||||||  Tybost (cobicistat) / Gilead, Tegsedi (inotersen) / Ionis, SOBI, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Journal, Adverse events:  Drug-Associated Acute Kidney Disease: Data From a World Pharmacovigilance Database. (Pubmed Central) -  Aug 2, 2024   
    We also highlight the potential nephrotoxic role of less suspected medications. This study emphasizes the need to consider AKD as a condition potentially associated with iatrogenic etiology, highlighting various medications and their respective involvement in the various possible manifestations of AKD.
  • ||||||||||  Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Trial primary completion date:  Bictegravir in the Elderly Living With HIV (BICEP) (clinicaltrials.gov) -  Nov 1, 2022   
    P=N/A,  N=162, Active, not recruiting, 
    Conversely, Gilead offered lower discounts for Odefsey and Genvoya, which resulted into higher net prices compared to Complera and Stribild. Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2022 --> Jul 2023
  • ||||||||||  Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Trial completion date:  Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection (clinicaltrials.gov) -  Oct 26, 2022   
    P=N/A,  N=72, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2022 --> Jul 2023 Trial completion date: Jun 2022 --> Nov 2022
  • ||||||||||  Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J, Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) / J&J, Gilead
    Effectiveness, persistence and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and rilpivirine/emtricitabine/tenofovir alafenamide (R/F/TAF) in treatment-naïve and treatment-experienced people living with HIV (PLWH) - 24-month results of the French TARANIS cohort (eLibrary) -  Sep 18, 2021 - Abstract #EACS2021EACS_546;    
    Discontinuations were mainly attributed to non-treatment-related reasons. Emergence of resistance was rare (100,000 cp/mL, n (%) HIV-1-RNA 5%, n (%)hypertension: 52 (16.0)hyperlipidemia: 39 (12.0)neuropsychiatric disorder: 38 (11.7)cardiovascular: 21 (6.5)chronic hepatitis C: 20 (6.2)diabetes mellitus: 18 (5.5)hypertension: 4 (5.7)hyperlipidemia: 2 (2.9)neuropsychiatric disorder: 3 (4.3)cardiovascular: 3 (4.3)chronic hepatitis C: 1 (1.4)diabetes mellitus: 2 (2.9)hypertension: 48 (18.8)hyperlipidemia: 37 (14.5)neuropsychiatric disorder: 35 (13.7)cardiovascular: 18 (7.1)chronic hepatitis C: 19 (7.5)diabetes mellitus: 16 (6.3)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)149 (45.8)45 (13.8)0 (0)123 (37.8)34 (48.6)8 (11.4)0 (0)17 (24.3)115 (45.1)37 (14.5)0 (0)106 (41.6)TDF-based ART prior to E/C/F/TAF----N/A220 (86.3)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI information missing----N/A146 (57.3); [E/C/F/TDF: 103 (40.4)]49 (19.2)61 (23.9)3 (1.2)IQR, inter quartile range; N/A, not applicable; *most common M184V/I (n=16), D67N (n=10), K219Q/E/N/R (n=10); **overlap possibleTable 2. Baseline characteristics of the R/F/TAF analysis population for TE patientsTE (n=313, 100%)Male gender, n (%)236 (75.4)Age, years, median (IQR)50 (41-56)Time since diagnosis, years (IQR)12.0 (6.5-21.0)CDC stage C, n (%)44 (14.1)CD4 count, cells/µl, median (IQR)689 (497-879)HIV-1-RNA 5%, n (%) hypertension: 48 (15.3) hyperlipidemia: 43 (13.7) neuropsychiatric disorders: 42 (13.4) chronic hepatitis C: 26 (8.3) osteopathic disorders: 24 (7.7) cardiovascular: 21 (6.7) diabetes mellitus: 18 (5.8)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)131 (41.9)29* (9.3)8** (2.6)127 (40.6)TDF-based ART prior to E/C/F/TAF288 (92.0)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI 16 (5.1)272 (86.9); [R/F/TDF: 214 (68.4)]19 (6.1)IQR: inter quartile range; *most common M41L (n=12), T215Y/F (n=12), M184V/I (n=9); **E138K (n=1), G190A/S/E (n=2), K101E/P (n=1), K103N/S (n=3), Y181C/I/V (n=1); ***overlap of groups possible​
  • ||||||||||  Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J, Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) / J&J, Gilead
    Effectiveness, persistence and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and rilpivirine/emtricitabine/tenofovir alafenamide (R/F/TAF) in treatment-naïve and treatment-experienced people living with HIV (PLWH) - 24-month results of the French TARANIS cohort (eLibrary) -  Sep 18, 2021 - Abstract #EACS2021EACS_79;    
    Discontinuations were mainly attributed to non-treatment-related reasons. Emergence of resistance was rare (100,000 cp/mL, n (%) HIV-1-RNA 5%, n (%)hypertension: 52 (16.0)hyperlipidemia: 39 (12.0)neuropsychiatric disorder: 38 (11.7)cardiovascular: 21 (6.5)chronic hepatitis C: 20 (6.2)diabetes mellitus: 18 (5.5)hypertension: 4 (5.7)hyperlipidemia: 2 (2.9)neuropsychiatric disorder: 3 (4.3)cardiovascular: 3 (4.3)chronic hepatitis C: 1 (1.4)diabetes mellitus: 2 (2.9)hypertension: 48 (18.8)hyperlipidemia: 37 (14.5)neuropsychiatric disorder: 35 (13.7)cardiovascular: 18 (7.1)chronic hepatitis C: 19 (7.5)diabetes mellitus: 16 (6.3)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)149 (45.8)45 (13.8)0 (0)123 (37.8)34 (48.6)8 (11.4)0 (0)17 (24.3)115 (45.1)37 (14.5)0 (0)106 (41.6)TDF-based ART prior to E/C/F/TAF----N/A220 (86.3)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI information missing----N/A146 (57.3); [E/C/F/TDF: 103 (40.4)]49 (19.2)61 (23.9)3 (1.2)IQR, inter quartile range; N/A, not applicable; *most common M184V/I (n=16), D67N (n=10), K219Q/E/N/R (n=10); **overlap possibleTable 2. Baseline characteristics of the R/F/TAF analysis population for TE patientsTE (n=313, 100%)Male gender, n (%)236 (75.4)Age, years, median (IQR)50 (41-56)Time since diagnosis, years (IQR)12.0 (6.5-21.0)CDC stage C, n (%)44 (14.1)CD4 count, cells/µl, median (IQR)689 (497-879)HIV-1-RNA 5%, n (%) hypertension: 48 (15.3) hyperlipidemia: 43 (13.7) neuropsychiatric disorders: 42 (13.4) chronic hepatitis C: 26 (8.3) osteopathic disorders: 24 (7.7) cardiovascular: 21 (6.7) diabetes mellitus: 18 (5.8)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)131 (41.9)29* (9.3)8** (2.6)127 (40.6)TDF-based ART prior to E/C/F/TAF288 (92.0)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI 16 (5.1)272 (86.9); [R/F/TDF: 214 (68.4)]19 (6.1)IQR: inter quartile range; *most common M41L (n=12), T215Y/F (n=12), M184V/I (n=9); **E138K (n=1), G190A/S/E (n=2), K101E/P (n=1), K103N/S (n=3), Y181C/I/V (n=1); ***overlap of groups possible​
  • ||||||||||  Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment closed:  ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) -  Aug 9, 2021   
    P3,  N=360, Active, not recruiting, 
    Emergence of resistance was rare (100,000 cp/mL, n (%) HIV-1-RNA 5%, n (%)hypertension: 52 (16.0)hyperlipidemia: 39 (12.0)neuropsychiatric disorder: 38 (11.7)cardiovascular: 21 (6.5)chronic hepatitis C: 20 (6.2)diabetes mellitus: 18 (5.5)hypertension: 4 (5.7)hyperlipidemia: 2 (2.9)neuropsychiatric disorder: 3 (4.3)cardiovascular: 3 (4.3)chronic hepatitis C: 1 (1.4)diabetes mellitus: 2 (2.9)hypertension: 48 (18.8)hyperlipidemia: 37 (14.5)neuropsychiatric disorder: 35 (13.7)cardiovascular: 18 (7.1)chronic hepatitis C: 19 (7.5)diabetes mellitus: 16 (6.3)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)149 (45.8)45 (13.8)0 (0)123 (37.8)34 (48.6)8 (11.4)0 (0)17 (24.3)115 (45.1)37 (14.5)0 (0)106 (41.6)TDF-based ART prior to E/C/F/TAF----N/A220 (86.3)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI information missing----N/A146 (57.3); [E/C/F/TDF: 103 (40.4)]49 (19.2)61 (23.9)3 (1.2)IQR, inter quartile range; N/A, not applicable; *most common M184V/I (n=16), D67N (n=10), K219Q/E/N/R (n=10); **overlap possibleTable 2. Baseline characteristics of the R/F/TAF analysis population for TE patientsTE (n=313, 100%)Male gender, n (%)236 (75.4)Age, years, median (IQR)50 (41-56)Time since diagnosis, years (IQR)12.0 (6.5-21.0)CDC stage C, n (%)44 (14.1)CD4 count, cells/µl, median (IQR)689 (497-879)HIV-1-RNA 5%, n (%) hypertension: 48 (15.3) hyperlipidemia: 43 (13.7) neuropsychiatric disorders: 42 (13.4) chronic hepatitis C: 26 (8.3) osteopathic disorders: 24 (7.7) cardiovascular: 21 (6.7) diabetes mellitus: 18 (5.8)Any baseline resistance associated mutation (RAM), n (%) Any NRTI RAM, n (%)* Any major INSTI RAM, n (%) No resistance data, n (%)131 (41.9)29* (9.3)8** (2.6)127 (40.6)TDF-based ART prior to E/C/F/TAF288 (92.0)Components/drug classes used in previous ART**, n (%) INSTI NNRTI PI 16 (5.1)272 (86.9); [R/F/TDF: 214 (68.4)]19 (6.1)IQR: inter quartile range; *most common M41L (n=12), T215Y/F (n=12), M184V/I (n=9); **E138K (n=1), G190A/S/E (n=2), K101E/P (n=1), K103N/S (n=3), Y181C/I/V (n=1); ***overlap of groups possible​ Not yet recruiting --> Active, not recruiting
  • ||||||||||  Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Trial completion, Trial primary completion date:  SABES: HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (clinicaltrials.gov) -  Jul 14, 2021   
    P4,  N=223, Completed, 
    Not yet recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Mar 2019 --> Nov 2020
  • ||||||||||  ritonavir / Generic mfg.
    [VIRTUAL] Persistence of drug-drug interaction problems with contemporary antiretroviral therapy. The case of ergotism () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_1343;    
    BACKGROUND: Drug-drug interaction (DDI) potential of protease inhibitors (PI) based antiretroviral therapy (ART), especially if boosted by ritonavir, became a problem early on after its rollout, with increasing reports of harmful effects, resulting in a large and growing list of drugs and natural substances no to be used concomitantly. Adequate identification of ergotamine containing drugs, better counseling of patients and increased awareness in the health care personnel seem necessary to avoid its occurrence in a context of contemporary antiretroviral therapy.
  • ||||||||||  Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Enrollment closed, Trial completion date, Trial primary completion date:  Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection (clinicaltrials.gov) -  Mar 10, 2021   
    P=N/A,  N=72, Active, not recruiting, 
    No virologic failure or significant NC changes were detected following the switch.Clinical Trials Rwegistration: NCT02251236. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Feb 2020 --> Aug 2021
  • ||||||||||  [VIRTUAL] Evaluating the IMPACT on Pharmaceutical Expenditure of HIV in the USA between 2017-2020 () -  Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1797;    
    Price rises in ARVs are, therefore, the majority driver of HIV pharmaceutical expenditure surges. This is also reflected in Medicaid expenditure increases, in which ARVs are consistently amongst the costliest drug classes.Unwarranted price increases may cause further patient access barriers and expand the population of HIV+ individuals who do not receive regular treatment.
  • ||||||||||  Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  SABES: HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (clinicaltrials.gov) -  Jan 15, 2020   
    P4,  N=223, Active, not recruiting, 
    Our data show a favorable effect of EVG/c/FTC/TDF switch to preserve immune activation-driven damage to T cell homeostasis, restore the multifunctional properties of effector T cells, and possibly contain cell-associated HIV viral burden in already virologically suppressed patients. Recruiting --> Active, not recruiting | N=150 --> 223 | Trial completion date: Aug 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Mar 2019
  • ||||||||||  Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Infections of the Kidney/Genitourinary Tract - Palmer (LACC 408 B) -  Dec 3, 2019 - Abstract #USCAP2020USCAP_297;    
    He has a past medical history of HIV on Stribild (cobicistat, elvitegravir, emtricitabine, tenofovir)...Pertinent Laboratory Data: Vitals: Afebrile, BP 121/77, HR 62, RR 18 Lower extremities with 2+ edema bilateral, otherwise physical exam is unremarkable. BUN/Cr = 17/0.97 Albumin 1.7 UA +protein, negative blood, negative WBC Urine protein:creatinine ratio = 12.44 CD4 count 488 HIV VL undetected HAV, HBV, HCV negative
  • ||||||||||  Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
    Stribild (Twitter) -  Nov 23, 2019