- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal: Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysis. (Pubmed Central) - Feb 1, 2025
P3b
These findings support the use of the once-daily B/F/TAF single-tablet regimen for people with HIV-1 and ESKD on HD. This regimen offers a convenient treatment option for this population as it reduces the need for dose adjustment, eases pill burden and avoids potential drug-drug interactions associated with alternatives that may impact individuals on multiple medications or awaiting transplantation.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Journal, Adverse events: Signal detection and analysis of adverse events associated with Genvoya (Pubmed Central) - Dec 19, 2024
Clinicians should closely monitor these reactions and implement necessary preventive and intervention measures based on patient-specific conditions and treatment guidelines. Although this study has limitations, the analysis of FAERS database data has revealed various potential risks associated with Genvoya
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal: Clinical efficacy and safety of new compound single tablet antiviral drugs in the treatment of HIV/AIDS. (Pubmed Central) - Nov 18, 2024
Although this study has limitations, the analysis of FAERS database data has revealed various potential risks associated with Genvoya Genvoya, Biktarvy and Dovato are recommended for the treatment of HIV/AIDS and have a good safety profile.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero
SARS?CoV?2 vaccination and coronaviral disease 2019 in virologically suppressed people with HIV?1 previously on NNRTI?based antiretroviral regimen during the pandemic: the secondary longitudinal analysis of the SPRINT study, a multi?centre, randomised, active?controlled phase III trial (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_505;
The SPRINT study population, a representative subset of virologically suppressed PWH, was well vaccinated against SARS-CoV-2 during the pandemic. No severe or critical illness of COVID-19 occurred in this subpopulation, at a low incidence of testing positivity, and established or suspected diagnosis.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
The clinical utility of targeted screening for liver fibrosis/cirrhosis among people living with HIV (PLWH) (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_493;
Routine FibroScan may not be cost effective in diagnosing cirrhosis in PLWH with a single liver risk factor; however, prevalence increases in the presence of multiple risk factors. We recommend fibrosis-4 index (FIB-4) score as an inexpensive primary screening tool for fibrosis/cirrhosis, and FibroScan for those with multiple risk factors or high FIB-4 score.
- |||||||||| Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Favourable cholesterol profile in virologically suppressed people with HIV?1 switching to tenofovir DF? containing, ainuovirine?based compared to tenofovir alafenamide?containing, boosted elvitegravir? based antiretroviral regimen: normocholesterolemic subgroup analyses of the SPRINT trial, a randomised, active?controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_455;
Background: In the SPRINT trial, virologically suppressed people with HIV-1 (PWHs) switched to tenofovir DF (TDF) containing, ainuovirine (ANV, ACC008) based or tenofovir alafenamide (TAF) containing, boosted elvitegravir (EVG/c) based antiretroviral (ARV) regimen (comparator) from an efavirenz-based regimen. In PWHs with baseline normocholesterolaemia, switching to a TDF-containing, ANV-based regimen resulted in less LDL-C increase and better lipidaemic control compared to a TAF-containing, EVG/c-based regimen.
- |||||||||| Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Immunological efficacy and early response in virologically suppressed people with HIV?1 switching to tenofovir DF?containing, ainuovirine?based compared to tenofovir alafenamide?containing, boosted elvitegravir?based antiretroviral regimen: secondary immunological efficacy analyses of the SPRINT trial, a randomized, active?controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_185;
Immunological efficacy was comparable between virologically suppressed PWHs, switching to ANV/3TC/TDF and those to EVG/c/FTC/TAF, few of whom were severely immunocompromised at baseline. However, switch to ANV/3TC/TDF resulted in a favourable early immunological response within the first 12 weeks of switch, compared to that to EVG/c/FTC/TAF.
- |||||||||| tenofovir disoproxil fumarate / Generic mfg.
Virological suppression, viral blip, low?level viraemia, and confirmed viraemia in virologically suppressed people with HIV?1 switching to tenofovir DF?containing, ainuovirine?based antiretroviral regimen: secondary, and subgroup virological efficacy analyses of the SPRINT trial, a randomized, active? controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_175;
High proportion of virological suppression was achieved in virologically suppressed PWHs switching to ANV/3TC/TDF non-inferior to EVG/c/FTC/TAF. Viral blip, LLV, and confirmed viraemia occasionally occurred, which normally did not require alteration of ART regimen.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (clinicaltrials.gov) - Oct 16, 2024
P2/3, N=129, Active, not recruiting,
Viral blip, LLV, and confirmed viraemia occasionally occurred, which normally did not require alteration of ART regimen. Trial completion date: Dec 2024 --> Jun 2025
- |||||||||| Tybost (cobicistat) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
P3 data, Journal, Head-to-Head: Switch to fixed-dose ainuovirine, lamivudine, and tenofovir DF versus elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV-1: the 48-week results of the SPRINT trial, a multi-centre, randomised, double-blind, active-controlled, phase 3, non-inferiority trial. (Pubmed Central) - Aug 2, 2024
In virologically suppressed PLWH on previous NNRTI-based ARV regimen, switch to ANV/3TC/TDF resulted in less weight gain, and improved lipid metabolism while maintaining virological suppression non-inferior to that to EVG/Cobi/FTC/TAF. Jiangsu Aidea Pharmaceutical & the National "Thirteenth Five-year Period" Major Innovative Drugs Research and Development Key Project of the People's Republic of China Ministry of Science and Technology.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: Bictegravir in the Elderly Living With HIV (BICEP) (clinicaltrials.gov) - Jun 3, 2024
P=N/A, N=162, Active, not recruiting,
Jiangsu Aidea Pharmaceutical & the National "Thirteenth Five-year Period" Major Innovative Drugs Research and Development Key Project of the People's Republic of China Ministry of Science and Technology. Trial completion date: Jul 2023 --> Dec 2024 | Trial primary completion date: Jul 2023 --> Dec 2024
- |||||||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Noninferior efficacy, reduced weight gain, and improved lipid metabolism of switch to ainuovirine- versus boosted elvitegravir-based regimen in virologically suppressed people living with HIV-1: 48-week results of the SPRINT trial???? (Poster board: 086) - May 2, 2024 - Abstract #AIDS2024AIDS_1349;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Earlier Initiation of ART Reduces Intact Proviruses but Not Residual Viremia After 48 Weeks (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1323;
Surprisingly, residual plasma HIV RNA was detected in >75% of participants at week 48 with no significant differences in proportions or levels between study Groups. These results provide new evidence that earlier ART does not affect the active HIV reservoir measured by plasma HIV RNA.
- |||||||||| Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Cytovene (ganciclovir) / Roche, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Cytomegalovirus Colitis Causing Hemorrhagic Shock and Ileocolic Intussusception in a Patient With Acquired Immunodeficiency Syndrome (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_3530;
The patient was started on broad-spectrum antibiotics, Genvoya and prophylaxis with atovaquone and azithromycin...Etoposide and dexamethasone were started for HLH...Blood transfusion with packed red blood cells, platelets and fresh frozen plasma was started and inotropic support with nor-epinephrine infusion was started...Ganciclovir was started for CMV colitis...Post-operatively, the patient improved remarkably and was discharged with itraconazole for disseminated histoplasmosis and valganciclovir for CMV colitis with outpatient clinic follow-up...The patient had a stormy course with multiple complications of disseminated histoplasmosis, HLH, and CMV Colitis, causing refractory lower gastrointestinal bleeding and ileocecal intussusception, for which the patient underwent right hemicolectomy. The multidisciplinary expert involvement and the timely intervention of the complications with rapid escalation to higher levels of care resulted in the successful outcome of the patient with a guarded prognosis.
- |||||||||| Pifeltro (doravirine) / Merck (MSD), Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
Enrollment status, Trial completion date, Trial primary completion date: B-free Multistage Trial (clinicaltrials.gov) - Nov 30, 2023
P4, N=210, Enrolling by invitation,
The multidisciplinary expert involvement and the timely intervention of the complications with rapid escalation to higher levels of care resulted in the successful outcome of the patient with a guarded prognosis. Recruiting --> Enrolling by invitation | Trial completion date: Aug 2027 --> Dec 2027 | Trial primary completion date: Aug 2025 --> Nov 2025
- |||||||||| Pifeltro (doravirine) / Merck (MSD), Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
Enrollment open: B-free Multistage Trial (clinicaltrials.gov) - Oct 23, 2023
P4, N=210, Recruiting,
Recruiting --> Enrolling by invitation | Trial completion date: Aug 2027 --> Dec 2027 | Trial primary completion date: Aug 2025 --> Nov 2025 Not yet recruiting --> Recruiting
- |||||||||| Pifeltro (doravirine) / Merck (MSD), Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
New P4 trial: B-free Multistage Trial (clinicaltrials.gov) - Sep 14, 2023
P4, N=210, Not yet recruiting,
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Journal, Real-world evidence, Real-world: Lipid profile changes associated with antiretroviral therapies in a real-world cohort. (Pubmed Central) - Sep 8, 2023
with no residual viremia through 48w in arm E/C/F/TAF The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in na
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare
Journal, HEOR, Real-world evidence, Real-world: Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens. (Pubmed Central) - Aug 8, 2023
The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in na Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.
- |||||||||| Tybost (cobicistat) / Gilead, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Journal: Overdose of the HIV Medicine Genvoya (Pubmed Central) - Feb 27, 2023
Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). We present a case report of two independent suicide attempts by self-administered overdose with the same antiretroviral medicine Genvoya
- |||||||||| 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) - Feb 6, 2023
P2, N=195, Active, not recruiting,
Trial completion date: Dec 2023 --> Dec 2024 Trial completion date: Sep 2023 --> Apr 2025
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion: CTN289: HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection (clinicaltrials.gov) - Nov 14, 2022
P3, N=25, Completed,
Conversely, Gilead offered lower discounts for Odefsey and Genvoya, which resulted into higher net prices compared to Complera and Stribild. Unknown status --> Completed
- |||||||||| 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,
Unknown status --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2022 --> Jul 2023
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
THE GREAT MASQUERADER: A CASE OF SYPHILITIC HEPATITIS, A DERMATOLOGICAL AND LIVER BIOPSY PROVEN CASE () - Oct 23, 2022 - Abstract #AASLD2022AASLD_570;
With our case report and extensive research of the literature, we hope to shed light on the importance of maintaining a broad differential diagnosis and contemplating the high likelihood of associated conditions with certain diseases, in order to reach a definitive accurate diagnosis. Because of how rarely seen syphilitic hepatitis is, it is often a missed diagnosis, but we are hopeful our case report helps physicians better understand the disease, as well as consider it on the differential in patients with high-risk features, and an elevated alkaline phosphatase
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Switch to bictegravir in real-life settings in the ANRS-CO3-AquiVIH-NA cohort () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_224;
Virological failure was observed in 3% of patients. The switch to BIC/FTC/TAF in virologically suppressed patients is a safe and effective strategy.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
The Great Masquerader: A Case of Syphilitic Hepatitis (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_2954;
Here, we highlight a case of an undomiciled 40-year-old male with HIV (on Genvoya) and chronic hepatitis B, who presented with tachycardia to 107...Figure: Image 1. Skin Findings
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