- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
EVG/COBI/FTC/TAF TABLETS DISSOLVED IN TAP WATER NEAR BIOEQUIVALENT WITH WHOLE TABLETS ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_621;
EVG had a clinically insignificant reduction in concentrations (<15%) while TAF and TFV concentrations did not decline when taking a dissolved Genvoya dose. Dissolving Genvoya in water may be suitable for those with pill swallowing challenges.
- |||||||||| zidovudine / Generic mfg.
PK/PD data, Review, Journal: A Review on Pharmacokinetics properties of antiretroviral drugs to treat HIV-1 infections. (Pubmed Central) - Jan 18, 2022
These drugs are Fuzeon, Selzentry, Complera, Epivir, Retrovir, Emtriva, Ziagen, Edurant, Intelence, Pifeltro, Sustiva, Viramune, Isentress, Genvoya, Tivicay, Reyataz, Prezista, Lexiva, Invirase, Aptivus etc. classified into five major classes: fusion inhibitors, Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), Integrase Strand transfer inhibitors (INSTIs) and Protease inhibitors (PIs). This review may be helpful for the future development of potent antiretroviral drugs with improved pharmacokinetic properties.
- |||||||||| isosorbide mononitrate / Generic mfg.
[VIRTUAL] Jägermeister-Induced Pseudohyperaldosteronism () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3231;
Case Description A 54-year-old man with a history of HIV on Genvoya and CAD, HTN on metoprolol and isosorbide monoitrate was referred to nephrology for evaluation of hypokalemia and accelerated hypertension...He stopped drinking Jagermeister and on subsequent follow-up, his BP was controlled on amlodipine, carvedilol, and isosorbide mononitrate, and he no longer required potassium supplementation...According to the manufacturer, Jagermiester liquor contains under 10 mg/L of licorice, however, the amount that can cause toxicity is not certain and literature suggests that the glycyrrhizic acid content of licorice is widely variable. Physicians ought to consider dietary, non-medication causes for electrolyte abnormalities in patients with initial negative workups.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Retrospective data, Journal: A retrospective evaluation of highly active antiretroviral therapy simplification in patients with end-stage renal disease receiving hemodialysis. (Pubmed Central) - Sep 22, 2021
Recent data in PLWH with ESRD on HD demonstrate maintenance of viral suppression (82% with viral loads (VLs) <50 copies/mL) and favorable safety/tolerability profiles after ARV simplification with a fixed dose combination single tablet [elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)]...Two patients did not complete the 6- and 12-month evaluation after documented nonadherence (N = 1) and an adverse effect (pruritus) (N = 1). At 12 months, virologic suppression and tolerability resulted after a simplified ARV regimen including once daily F/TAF was initiated in PLWH with ESRD on thrice weekly HD with a reduction in pill burden.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
EVG/cobi/FTC/TAF in HIV-1 naïve patients with severe immune suppression: evolution oif weight and lipids (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_560;
E/C/F/TAF use was associated with an increase in LDL-cholesterol and triglyceride levels along with an increase in HDL-cholesterol levels. Our data suggest that EVG/cobi/FTC/TAF was not associated with excessive weight gain, all cholesterol fractions increased, but the ratio CT/HDL did not change.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Use of EVG/cobi/FTC/TAF in HIV-1 naïve patients with severe immune suppression (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_559;
Our data suggest that EVG/cobi/FTC/TAF was not associated with excessive weight gain, all cholesterol fractions increased, but the ratio CT/HDL did not change. Our data suggest that EVG/cobi/FTC/TAF is safe and effective in patients with severe immunosuppression.
- |||||||||| 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
EVG/cobi/FTC/TAF in HIV-1 naïve patients with severe immune suppression: evolution oif weight and lipids (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_93;
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 Our data suggest that EVG/cobi/FTC/TAF was not associated with excessive weight gain, all cholesterol fractions increased, but the ratio CT/HDL did not change.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Use of EVG/cobi/FTC/TAF in HIV-1 naïve patients with severe immune suppression (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_92;
Our data suggest that EVG/cobi/FTC/TAF was not associated with excessive weight gain, all cholesterol fractions increased, but the ratio CT/HDL did not change. Our data suggest that EVG/cobi/FTC/TAF is safe and effective in patients with severe immunosuppression.
- |||||||||| 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
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide as maintenance treatment in HIV/HBV-coinfected patients. (Pubmed Central) - Sep 12, 2021
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 Switch to E/C/F/TAF maintained HBV and HIV viral suppression and resulted in improvement of proteinuria and BMD of the spine and hip, but increased lipid levels in HIV/HBV-coinfected patients at week 48.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Journal: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight. (Pubmed Central) - Aug 12, 2021
Identifying who is at greatest risk and whether the unintended weight gain is reversible remain unanswered questions. We report a return to baseline weight after switching back to tenofovir disoproxil/emtricitabine/efavirenz (Atripla®) in a woman who had profound weight gain due to tenofovir alafenamide/emtricitabine/cobicistat/elvitegravir (Genvoya®).
- |||||||||| 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,
We report a return to baseline weight after switching back to tenofovir disoproxil/emtricitabine/efavirenz (Atripla®) in a woman who had profound weight gain due to tenofovir alafenamide/emtricitabine/cobicistat/elvitegravir (Genvoya®). Not yet recruiting --> Active, not recruiting
- |||||||||| 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,
CONCLUSIONS Patients treated with DTG/3TC had substantially lower (22–30%) healthcare costs compared to current standard of care STRs, although similar costs to ABC/DTG/3TC, highlighting the economic benefits of its use with sustained management of HIV infection. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Feb 2020 --> Aug 2021
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Jan 25, 2021
P2, N=195, Active, not recruiting,
Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021 Trial completion date: May 2021 --> Sep 2023
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