Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco - LARVOL DELTA

Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection (clinicaltrials.gov) - P=N/A | N=101 | Completed | Sponsor: University of California, Los Angeles | Active, not recruiting ➔ Completed | N=72 ➔ 101

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease

Rapid viral suppression using integrase inhibitors during acute HIV-1 infection. (PubMed, J Antimicrob Chemother) - "INSTI-based ART during AHI resulted in rapid and sustained viral suppression. Over 96 weeks, weight increased in the INSTI-based cohort but was similar to weight increase in a historical NNRTI-based AHI cohort."

Journal • Human Immunodeficiency Virus • Infectious Disease

Drug-Associated Acute Kidney Disease: Data From a World Pharmacovigilance Database. (PubMed, Cureus) - "Among the most notable medications collected, 8.3% were classified as "non-nephrotoxic," 16.7% as "potentially nephrotoxic," and 75% as "known nephrotoxic." Notable active ingredients included cobicistat + elvitegravir + emtricitabine + tenofovir disoproxil (IC025 8.7; ROR 786.96), inotersen (IC025 7.7; ROR 604.57), emtricitabine + tenofovir disoproxil (IC025 7.9; ROR 432.36), esomeprazole (IC025 6.8; ROR 184.23), and pantoprazole (IC025 6.3; ROR 109.86), with proton pump inhibitors dominating the top four positions among the most frequently involved medications. 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."

Adverse events • Journal • Nephrology • Renal Disease

Bictegravir in the Elderly Living With HIV (BICEP) (clinicaltrials.gov) - P=N/A | N=162 | Active, not recruiting | Sponsor: State University of New York at Buffalo | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Jul 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study. (PubMed, AIDS Res Ther) - "In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Bictegravir in the Elderly Living With HIV (BICEP) (clinicaltrials.gov) - P=N/A | N=162 | Active, not recruiting | Sponsor: State University of New York at Buffalo | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2022 ➔ Jul 2023

Enrollment closed • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection (clinicaltrials.gov) - P=N/A | N=72 | Active, not recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Jun 2022 ➔ Nov 2022

Trial completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

Estimated changes in price discounts for tenofovir-inclusive HIV treatments following introduction of tenofovir alafenamide. (PubMed, AIDS) - "We estimated list and net prices for tenofovir disoproxil fumarate (TDF) products Truvada, Complera, and Stribild, and their tenofovir alafenamide (TAF) versions Descovy, Odefsey, and Genvoya. This strategy encouraged patients switching from Truvada to Descovy before the availability of generic Truvada. Conversely, Gilead offered lower discounts for Odefsey and Genvoya, which resulted into higher net prices compared to Complera and Stribild."

Journal • Human Immunodeficiency Virus • Infectious Disease

"Only 28 HIV positive individuals on a Stribild regimen contracted SARS-Cov-2." (@dbdugger)

Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"https://t.co/ZpOip6YacO #stribild @AssociatedPress @GileadSciences" (@princecrichard2)

Effectiveness and safety of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet combination among HIV-infected patients in Turkey: results from a real world setting. (PubMed, Afr Health Sci) - "Adverse events were observed in 15% of the patients, and the regimen was discontinued in only six patients. Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

"@GileadSciences @US_FDA @CDCgov #Stribild #toothloss #boneloss @MikeBloomberg @JohnsHopkinsSPH @BidenCancer @kathyireland @UNAIDS @ACLU @HRC @HRC_President @AlphonsoDavid @AssociatedPress @AP" (@MrDunkleberger)

Oncology • Osteoporosis

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 (EACS 2021) - "Purpose: Based on findings from clinical studies, F/TAF-based therapies are among the recommended regimens in the EACS guidelines for HIV treatment initiation since 2016.  In this French cohort, virologic effectiveness and safety of E/C/F/TAF and R/F/TAF were confirmed after 2-year follow-up with only 1% discontinuing due to lack of efficacy and 8% due to drug-related adverse events. 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..."

Clinical • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Psychiatry • CD4

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 (EACS 2021) - "Purpose: Based on findings from clinical studies, F/TAF-based therapies are among the recommended regimens in the EACS guidelines for HIV treatment initiation since 2016.  In this French cohort, virologic effectiveness and safety of E/C/F/TAF and R/F/TAF were confirmed after 2-year follow-up with only 1% discontinuing due to lack of efficacy and 8% due to drug-related adverse events. 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..."

Clinical • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Psychiatry • CD4

"$GILD#Stribild #FDA approval @AndyBiotech @BertrandBio @megtirrell - #Biktarvy" (@SolomonDoug)

FDA event

ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - P3; N=360; Active, not recruiting; Sponsor: ANRS, Emerging Infectious Diseases; Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

[VIRTUAL] Persistence of drug-drug interaction problems with contemporary antiretroviral therapy. The case of ergotism (IAS-HIV 2021) - "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."

Clinical • Pain

SABES: HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (clinicaltrials.gov) - P4; N=223; Completed; Sponsor: Fred Hutchinson Cancer Research Center; Active, not recruiting ➔ Completed; Trial primary completion date: Mar 2019 ➔ Nov 2020

Clinical • Trial completion • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Suppressive combination antiretroviral therapy in people infected with HIV-1 is associated with a decrease of the reactive dicarbonyl methylglyoxal. (ECCMID 2021) - "Twenty nine patients used Triumeq®, nine Stribild® and one Genvoya® . Suppressive INSTI-STR is associated with a decrease of plasma concentration of MGO, sICAM-1 and sVCAM-1 . Since MGO is associated with age-related diseases, it is clinically relevant to further investigate MGO in (ageing) hiv infected patients."

Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • CD4 • VCAM1

Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection (clinicaltrials.gov) - P=N/A; N=72; Active, not recruiting; Sponsor: University of California, Los Angeles; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Feb 2020 ➔ Aug 2021

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

"When my love of makeup and HIV content collide 💊💋💄#hiv #hivpositive #gilead #stribild #uequalsu .⁦@GileadSciences⁩ let’s collaborate and do a pallet! 💀 https://t.co/neW70oxDh7" (@JaneliAlejandra)

Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Efficacy and durability of elvitegravir/cobicistat/emtricitabine/tenofovir plus darunavir in the treatment of resistant HIV: a multi-center chart review (ASHP 2020) - "Purpose: To evaluate the efficacy and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/c/FTC/TDF or EVG/c/FTC/TAF) and darunavir (DRV) in persons living with HIV. Due to the broad description of failure in this analysis, the efficacy of Stribild or Genvoya plus Prezista or Triumeq plus Prezcobix was difficult to assess. Although there were many treatment failures, the primary causes of failure included nonadherence, advanced immunosuppression, and changes in therapy due to drug interactions. Further prospective research with a larger sample size must be conducted to evaluate the long-term effects of this therapeutic combination."

Clinical • Review • Human Immunodeficiency Virus • Immunology • Infectious Disease

Effects of Integrase Inhibitor-Based ART on the NLRP3 Inflammasome Among ART-Naïve People With HIV. (PubMed, Open Forum Infect Dis) - P=N/A | "Six months of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate significantly decreased caspase-1 levels in association with CD4+/CD8+ ratio recovery. Trial registration. ClinicalTrials.gov NCT01766726."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • CD8

Single-tablet regimen of emtricitabine/tenofovir disoproxil fumarate plus cobicistat-boosted elvitegravir increase adherence for HIV postexposure prophylaxis in sexual assault victims. (PubMed, Sex Transm Infect) - "Sexual assault victims who were prescribed an STR based on EVG/COBI/FTC/TDF were more likely to complete PEP than those who were prescribed an MTR."

Journal • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Persistence of Guideline-Recommended Antiretroviral Therapy Regimens among Persons Living with HIV Newly Initiating Treatment in the US (IDWeek 2020) - "The proportion remaining on their index regimen at 6 months of follow-up was 79% for BIC/FTC/TAF, 73% for EVG/COBI/FTC/TAF, 71% for DTG/ABC/3TC, 69% for DTG + FTC/TAF, 67% for EFV/FTC/TDF, 62% for EVG/COBI/FTC/TDF, and 38% for DTG + FTC/TDF. Among US adult PLWH, STRs were associated with longer persistence on first-line therapy compared to MTRs. Among STRs, persistence was highest for BIC/FTC/TAF."

Human Immunodeficiency Virus • Infectious Disease