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

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

Cardiac, liver, renal, and other safety profiles in PWH on ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 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) until 96 weeks. Out of 762 randomized participants, 376 participants originally assigned to ANV/3TC/TDF (376/381, 98.7%), and 371 participants originally to E/C/F/TAF (371/381, 97.4%) completed the extensional study, respectively. Switch to ANV/3TC/TDF is well tolerated in VS PWHs, without clinically significant changes in organ-associated biochemical measures observed. Routine safety laboratory monitoring is generally recommended in PWHs on switching therapy."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Profiles of body weight, glucose, and uric acid in PWH on ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 2025) - "Continuation of ANV/3TC/TDF treatment resulted in constant profiles of BW, FSG and SUA for VS PWH. However, switch from E/C/F/TAF favored profiles of BW and SUA in the SPRINT extensional period in contrast to that to E/C/F/TAF in the randomized study."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

Favorable lipid profile in people with HIV-1 switching to ainuovirine-based antiretroviral regimen: week 96 results from SPRINT, a randomized phase 3 trial (IAS-HIV 2025) - "Switch to ANV/3TC/TDF from E/C/F/TAF is favored for improved serum lipid profile and ASCVD risk-associated dyslipidemia in VS PWH."

Clinical • P3 data • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Safety and efficacy of ANV/3TC/TDF vs E/C/F/TAF for maintaining virologic suppression in adults living with HIV-1: week 96 results from the phase 3, noninferiority SPRINT randomized trial (IAS-HIV 2025) - "Both immediate and delayed switches to ANV/3TC/TDF maintained high viral suppression through 96 weeks. Delayed switch could offset weight gain, and lipid dysmetabolism associated with previous exposure to E/C/F/TAF."

Clinical • Head-to-Head • P3 data • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Diabetic Striatopathy Presenting With Hemiballism: An Unusual Neurologic Complication Of Uncontrolled Type 2 Diabetes Mellitus (ENDO 2025) - "She is on aspirin 81 mg daily, atorvastatin 40 mg daily, carvedilol 25mg twice daily, chlorthalidone 50 mg daily, spironolactone 100 mg daily, losartan 50 mg daily and the combination of elvitegravir- cobicistat- emtricitabine-tenofovir alafenamide as 1 tablet daily.Physical exam showed dry mucous membranes, tachycardia, intermittent left upper extremity abduction and adduction movements, with no other motor or sensory deficits. Diabetic striatopathy is a rare neurologic complication of uncontrolled hyperglycemia, characterized by abnormal movement (hemichorea/ hemiballism). The most common radiologic finding is hyperdensity in the contralateral putamen and/or caudate nucleus on CT scan. Management relies on the correction of hyperglycemia and the administration of antipsychotics (haloperidol, risperidone) or benzodiazepines(clonazepam)."

Late-breaking abstract • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Diabetes • Dyslipidemia • Hematological Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Movement Disorders • Pain • Type 2 Diabetes Mellitus

A rare case of high grade carcinoma presenting as unilateral adrenal metastasis with PTH related Peptide hypercalcemia and possible ectopic ACTH secretion (ENDO 2025) - "61 year old incarcerated male with HIV on genvoya, treated syphilis, diabetes mellitus type 2, left nephrectomy for donation presented as a transfer from outside hospital for adrenal mass...However, ACTH was significantly elevated at 300 pg/ml, 1 mg dexamethasone suppression test with 8am cortisol of 16.75 mcg/ml and elevated 24 urine free cortisol at 172 mcg raising concern for ectopic ACTH secretion...PTHrP mediated hypercalcemia accounts for 90% of hypercalcemia in malignancy, usually presents in late stages of cancer and carries poor prognosis with mean survival of 4 to 6 months. Presence of PNS at advanced stages can be indicative of poor prognosis."

Clinical • Adrenal Cortex Carcinoma • Cardiovascular • Diabetes • Endocrine Cancer • Endocrine Disorders • Esophageal Cancer • Gastric Cancer • Human Immunodeficiency Virus • Infectious Disease • Melanoma • Metabolic Disorders • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombosis • Type 2 Diabetes Mellitus

Silent Threats Unveiled: The Hidden Pneumothorax in a Chronic Marijuana User (ATS 2025) - "A 52-year-old male with a history of HIV managed on Genvoya and daily marijuana use for 20 years, presented to the ER with sudden-onset, sharp left-sided chest pain...It was observed that in comparison to tobacco cigarettes, one cannabis joint had obstructive adverse effects equivalent to 2.5 - 5 tobacco cigarettes (12). The risk of complications including the development of tension pneumothorax seen in spontaneous pneumothorax is also higher in those who smoke cannabis (4,2,13,14)."

Human Immunodeficiency Virus • Infectious Disease • Nicotine Addiction • Pain • Pulmonary Disease • Respiratory Diseases

A CASE OF PRESUMABLY CONGENITAL, LATE-DIAGNOSED HIV AND SYPHILIS COINFECTION, RECURRENT HERPES ZOSTER WITH ATYPICAL SKIN MANIFESTATIONS IN A 8-YEAR-OLD GIRL. (ESPID 2025) - "After a course of benzylpenicillin, she received 1 dose of long-acting intramuscular benzathine penicillin. Due to Herpes zoster relapse, received i/v Aciclovir empirically...Due to the development of hypersensitivity to the initiated ART therapy, changed to Genvoya. The clinical condition improved after therapy and patient was discharged home in stable condition. Learning Points/Discussion Regular screening for HIV/syphilis-first step toward treatment and prevention of transmission."

Clinical • Herpes Zoster • Human Immunodeficiency Virus • Infectious Disease • Tuberculosis • Varicella Zoster • CD4

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

Efficacy of Switching to Ainuovirine-Based Antiretroviral Regimen in Virologically Suppressed PWH (CROI 2025) - "Background In the SPRINT study, switch to ainuovirine, a novel non-nucleoside reverse transcriptase inhibitor, combined with lamivudine and tenofovir DF (ANV/3TC/TDF), was non-inferior to that to cobicistat-boosted elvitegravir with emtricitabine and tenofovir alafenamide (E/C/F/TAF) for virologically suppressed (VS) people with HIV-1 (PWH) in 48-week virologic efficacy endpoint. Conclusions VS was well preserved in PWH with second- or third-line switch to ANV/3TC/TDF through 96 weeks. Immunologic outcomes might favor a "same-class" switch to ainuovirine-based regimen, and warranted further investigation into the changes in the viral reservoir and immune functionality of VS PWH switching antiretroviral regimen."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Pharmacokinetics, safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in children with HIV aged from 2 years and weighing at least 14 kg. (PubMed, J Int AIDS Soc) - P2/3 | "These data support the use of single-tablet E/C/F/TAF (90/90/120/6 mg) regimen for the treatment of HIV in children aged ≥2 years and weighing ≥14-<25 kg."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases • CD4

Signal detection and analysis of adverse events associated with Genvoya® based the FAERS database. (PubMed, Front Pharmacol) - "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®, providing important safety references for HIV treatment."

Adverse events • Journal • CNS Disorders • Cognitive Disorders • Developmental Disorders • Human Immunodeficiency Virus • Infectious Disease

B-free Multistage Trial (clinicaltrials.gov) - P4 | N=210 | Enrolling by invitation | Sponsor: Insel Gruppe AG, University Hospital Bern | Trial completion date: Dec 2027 ➔ Sep 2027 | Trial primary completion date: Nov 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4