Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead - LARVOL DELTA

Delayed Multisystem Deterioration Following Large-Volume Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Overdose. (PubMed, Cureus) - "We present the case of a 35-year-old male with HIV, hypertension, and amphetamine use who presented after intentional ingestion of approximately 90 tablets of Genvoya in a suicide attempt. The patient was managed with supportive care in the medical intensive care unit and gradually improved over the following days. This case adds to the limited literature describing severe multisystem complications following large-volume Genvoya overdose."

Journal • Acute Kidney Injury • Cardiomyopathy • Cardiovascular • Critical care • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Respiratory Diseases

Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Treatment-Naive Patients Living With Human Immunodeficiency Virus (HIV) With High Viral Load: A Retrospective Observational Study. (PubMed, Cureus) - "Although high pre-treatment viral load was associated with a transient delay in early viral suppression at month six, this did not appear to compromise longer-term treatment outcomes. These findings suggest that E/C/F/TAF may represent a useful treatment option, particularly in clinical settings where second-generation integrase inhibitors are restricted or unavailable."

Journal • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Cost–utility of bictegravir/emtricitabine/tenofovir alafenamide B/F/TAF as a switch therapy for adults living with HIV from the Chilean public health system perspective (AIDS 2026) - "Comparators reflected local practice: dolutegravir/abacavir/lamivudine (ABC/3TC/DTG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and tenofovir disoproxil fumarate/emtricitabina plus darunavir/cobicistat (TDF/FTC + DRV/c). B/F/TAF is a cost-effective and dominant strategy compared to currently used TDF and ABC-based regimens in Chile. Despite the modeled economic performance of E/C/F/TAF, B/F/TAF represents the optimal switch option for long-term care, aligning with international standards for unboosted, high-genetic-barrier regimens."

Clinical • HEOR • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Orthopedics • CD4

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (clinicaltrialsregister.eu) - P4 | N=290 | Sponsor: Gilead Sciences, Inc.

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Long-term viral suppression, and cardiometabolic benefits of switch to ainuovirine coformulated with lamivudine, and tenofovir DF in virologically suppressed people with HIV-1: 144-week, open-label results from the SPRINT post-study (AIDS 2026) - "BACKGROUND: Previous 96-week results from the SPRINT extension study demonstrated that switching to the next-generation NNRTI ainuovirine coformulated with lamivudine and tenofovir DF (ANV/3TC/TDF) maintained viral suppression (VS) and improved cardiometabolic parameters in people with HIV-1 (PWH) switching from both classical NNRTI-based regimens and E/C/F/TAF. Switch to ANV/3TC/TDF maintained VS among PWH switching-off both classical NNRTIs-, and boosted INSTI-based regimens. The accompanied safety benefits included persistent improvement in LDL-C level, and ASCVD risk strata. Renal function remained stable among this population, and required general routine monitoring."

Clinical • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve adolescents and virologically suppressed children with HIV-1 (AIDS 2026) - P2/3 | "In children and adolescents with HIV, long-term treatment with E/C/F/TAF maintained viral suppression in over 90% of participants with no new safety findings."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Economic evaluation of first-line bictegravir/tenofovir alafenamide/emtricitabine (B/F/TAF) in people living with HIV (PLWHIV) with high risk of osteoporosis and renal dysfunction in Chile (AIDS 2026) - "Comparators reflected local practice: abacavir/lamivudine/dolutegravir (ABC/3TC/DTG), dolutegravir/tenofovir disoproxil fumarate/lamivudine (TDF/3TC/DTG), and elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). Positioning B/F/TAF as a first-line regimen for this population represents a cost-effective and, in some comparisons, dominant strategy. The economic evidence supports reevaluating the current prioritization of higher-toxicity regimens and the restriction of B/F/TAF to second-line use in order to optimize resource allocation and clinical outcomes."

Clinical • HEOR • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Impact on clinical biomarkers, immune recovery, and HIV reservoir dynamics of switching to EVG/c/FTC/TAF versus maintaining a non-INSTI-based regimen in virologically suppressed individuals. (PubMed, Infect Dis Immun) - "The participants were divided into two groups according to whether they received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/c/FTC/TAF)-that is, whether they switched to EVG/c/FTC/TAF (the INSTI group, n = 23) or maintained a non-nucleoside reverse transcriptase inhibitor (NNRTI)- or protease inhibitor (PI)-based regimen (the n-INSTI group, n = 36). The HIV DNA and CA HIV RNA levels significantly decreased in the INSTI group, suggesting a reduction in the HIV reservoir in these participants. The EVG/c/FTC/TAF regimen significantly improves immune recovery, enhances the CD8+ T-cell functional capacity, and reduces the HIV DNA and CA HIV RNA levels in virologically suppressed individuals."

Biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • GZMB • IFNG • LAMP1 • PRF1 • TNFA

MON-887 - A Case of Genvoya Induced Cushing Syndrome (ENDO 2026) - "Introduction: Boosted antiretroviral therapy is widely used in HIV management, the two boosting agents being ritonavir and cobicistat...The findings were consistent with iatrogenic Cushing syndrome due to elevated systemic fluticasone levels from cobicistat-mediated CYP3A4 inhibition. Genvoya was discontinued and replaced with Biktarvy, allowing continuation of fluticasone. Physiologic hydrocortisone replacement was initiated...Although recognized in the literature, this interaction can still sometimes be missed, especially since the booster is co-formulated within a single tablet, resulting in delayed diagnosis and preventable morbidity. Early recognition, adjustment of antiretroviral therapy and or co-administered drugs, and monitoring for secondary adrenal insufficiency are essential for safe management."

Clinical • Late-breaking abstract • Asthma • Cushing’s Disease • Endocrine Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases

Results of three multicenter observational studies of regimens containing tenofovir alafenamide among people with HIV in Japan. (PubMed, J Infect Chemother) - "The findings from these studies are consistent with the known safety profiles of the three TAF-containing products. No new safety issues emerged."

Journal • Observational data • Cardiovascular • CNS Disorders • Dyslipidemia • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Insomnia • Metabolic Disorders • Sleep Disorder

ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - P3 | N=360 | Terminated | Sponsor: ANRS, Emerging Infectious Diseases | Active, not recruiting ➔ Terminated; Low recruitment rate

Trial termination • Human Immunodeficiency Virus • Infectious Disease • CD4

Hyperlipidemia and associated risk factors among people living with HIV on antiretroviral therapy: a retrospective cohort study from Eastern China. (PubMed, Prev Med Rep) - "Zidovudine + lamivudine + efavirenz, tenofovir disoproxil fumarate + lamivudine + lopinavir/ritonavir, elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide had a higher risk of hyperlipidemia. A high incidence of hyperlipidemia was observed in PLWH receiving ART. Strengthening blood lipid monitoring and managing modifiable risk factors are essential to prevent hyperlipidemia in PLWH."

Journal • Retrospective data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • CD4

Refractory Dermatophytosis and Oral Hairy Leukoplakia as Sentinel Manifestations of Advanced HIV Infection. (PubMed, Cureus) - "The patient was treated with systemic terbinafine and antiretroviral therapy (ART) (Genvoya), resulting in marked improvement and the complete resolution of lesions within two months. This case emphasizes the diagnostic value of concurrent, treatment-resistant mucocutaneous manifestations as sentinel indicators of advanced HIV infection."

Journal • Dermatology • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term viral suppression, and cardiometabolic benefits of switch to ainuovirine coformulated with lamivudine, and tenofovir DF in virologically suppressed people with HIV-1: 144-week, open-label results from the SPRINT post-study (EACS 2025) - "Purpose : In the previous 96-week results of the SPRINT extensional study, switch to ainuovirine, a new-generation NNRTI, coformulated with lamivudine, and tenofovir DF (ANV/3TC/TDF) maintained viral suppression (VS), and improved cardiometabolic conditions among people with HIV-1 (PWH) switching from both classical NNRTI-based regimens, and E/C/F/TAF. The accompanied safety benefits included persistent improvement in LDL-C level, and ASCVD risk strata. Renal function remained stable among this population, and required general routine monitoring."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Preserved renal function in PWH on ainuovirine-based antiretroviral regimen: week 144 results from SPRINT study, a randomized phase 3 trial (EACS 2025) - "In the extensional study, PWH continued ANV/3TC/TDF or switched to ANV/3TC/TDF from cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF) through144 weeks. Slight reduction in eGFR through 144 weeks indicated a three-year increment in age as per the CKD-EPI equation. Routine renal function monitoring is generally recommended for this low-risk population."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Long-term Lipid Metabolism Benefits of Switching to Ainuovirine-based Regimen in People with HIV-1: 144-Week Results from the SPRINT Extensional Post-study (EACS 2025) - "Purpose : This post-hoc analysis of the SPRINT extensional post-study aimed to evaluate the 144-week lipid profile changes in virologically suppressed people with HIV-1 (PWH) who switched to ainuovirine/lamivudine/tenofovir DF (ANV/3TC/TDF) from either NNRTI- or boosted INSTI-based regimens, with particular focus on its potential to reverse INSTI-associated dyslipidemia. Method : In this open-label extensional post-study, 723 out of 762 originally randomized participants (364 continuing ANV/3TC/TDF; 359 switching from E/C/F/TAF) were followed up for through weeks...Similar significant improvements were observed for non-HDL-C (-0.62 mmol/L, -0.72 to -0.52), total cholesterol (-0.77 mmol/L, -0.87 to -0.67), and triglycerides (-0.63 mmol/L, -1.00 to -0.26) from week 48. Conclusions : ANV/3TC/TDF regimen improved lipid safety profile remarkably in virologically suppressed people with HIV-1, with a special beneficial potential for people previously exposed to INSTI-based..."

Human Immunodeficiency Virus • Infectious Disease

Long-term changes in triglyceride-glucose index and insulin resistance in virologically suppressed people with HIV-1 switching to ainuovirine coformulated with lamivudine, and tenofovir DF: 144-week, open-label results from the SPRINT post-study (EACS 2025) - "Purpose : In the SPRINT study, switch to ainuovirine, a novel NNRTI, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), resulted in noninferior virological efficacy and improved cardiometabolic conditions, compared to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF), in virologically suppressed (VS) people with HIV-1 (PWH) previously on classical NNRTI-based antiretroviral (ARV) regimen. This increase was reverted in E/C/F/TAF arm through 144 weeks following re-switch to ANV/3TC/TDF. Conclusions : Switch to ANV/3TC/TDF from preceding classical NNRTI-, and boosted integrase transfer inhibitor-based ARV regimens resulted in a favorable change in TyG index and IR among virologically suppressed PWH through 144 weeks."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Improved atherosclerotic cardiovascular disease risk-associated dyslipidemia strata in people with HIV-1 switching to ainuovirine-based antiretroviral regimen: week 144 results from SPRINT, a randomized phase 3 trial (EACS 2025) - "Purpose : In the SPRINT study, switch to ainuovirine, a novel NNRTI, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), resulted in favorable changes in body weight and serum lipids, compared to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF), in virologically suppressed people with HIV-1 (PWH). Non-HDL-C, TC, and TG demonstrated similar trends in proportions of people with normal, borderline high, and high strata through 144 weeks (Figure 1). Conclusions : Switch to ANV/3TC/TDF favored ASCVD risk-associated with dyslipidemia strata in virologically suppressed PWH previously on classical NNRTI- or boosted integrase strand transferase inhibitor-based antiretroviral regimen as per the primary prevention target."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Efficacy, and safety of ainuovirine-based antiretroviral regimen in women with HIV-1: the pooled analysis of the RACER, and SPRINT studies, two multicenter, randomized, active controlled phase 3 trials (EACS 2025) - "Method : In the RACER study (N=34), 18, and 16 treatment-naïve WWH were medicated with ANV/3TC/TDF, and EFV/3TC/TDF, respectively. In the SPRINT study (N=22), 11, and 11 virologically suppressed WWH were medicated with ANV/3TC/TDF, and E/C/F/TAF, respectively...Conclusions : At a small sample size, ANV/3TC/TDF regimen showed high viral suppression comparable to the comparators in women. Accompanied benefits included less neuropsychiatric symptoms for treatment-naïve women, and improved lipid metabolism for both subpopulations."

P3 data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

Efficacy, and safety of ainuovirine plus lamivudine, and tenofovir DF in young people with HIV-1: pooled analyses of RACER, and SPRINT studies, two randomized, active-controlled phase 3 trials (EACS 2025) - "This study evaluated ainuovirine (ANV), a next-generation NNRTI with demonstrated non-inferior efficacy to efavirenz (EFV) and elvitegravir/cobicistat (E/C) in phase 3 trials, focusing on young people with HIV-1 (YPWH) across treatment-naïve (TN), and virologically suppressed (VS) populations. Method : We pooled data from two randomized trials: RACER (TN, N=219; ANV/3TC/TDF vs EFV/3TC/TDF) and SPRINT (VS, N=107; ANV/3TC/TDF vs E/C/F/TAF)...The combination of maintained viral suppression, improved CD4 cell recovery, attenuated weight gain, better lipid control, and preserved renal function positions ANV/3TC/TDF as an optimized treatment option for YPWH, particularly in Asia-Pacific regions where metabolic complications are of growing concern. These findings support ANV's role as a valuable alternative to the antiretroviral armamentarium for this vulnerable population."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • CD4

Immediate and delayed switches to tenofovir DF-containing, ainuovirine-based antiretroviral regimen: the SPRINT extensional study. (PubMed, BMC Med) - P3 | "Both ISG and DSG maintained high viral Suppression in PLWH through 96 weeks. DSG could offset weight gain and dyslipidemia associated with previous exposure to E/C/F/TAF."

Clinical • Journal • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Psychiatry

Research on the Psychological Status of Patients With HIV-1 Infection (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Shanxi Bethune Hospital

New trial • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - P2 | N=195 | Completed | Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

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) - P2/3 | N=129 | Completed | Sponsor: Gilead Sciences | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Efficacy, and safety of ainuovirine-based antiretroviral regimen in women with HIV-1: the pooled analysis of the RACER, and SPRINT studies, two multicenter, randomized, active controlled phase 3 trials (IAS-HIV 2025) - "This integrated analysis aimed to evaluate the virological outcomes, and safety profile of ANV/3TC/TDF in women with HIV-1 (WWH) at week 48. In the RACER study (N=34), 18, and 16 treatment-naïve WWH were randomized, and medicated with ANV/3TC/TDF, and EFV/3TC/TDF, respectively. In the SPRINT study (N=22), 11, and 11 virologically suppressed WWH were randomized, and medicated with ANV/3TC/TDF, and E/C/F/TAF, respectively... Although at a small sample size, ANV/3TC/TDF regimen showed high viral suppression comparable to the comparators in both treatment-naïve, and virologically suppressed women."

P3 data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4