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

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

The clinical utility of targeted screening for liver fibrosis/cirrhosis among people living with HIV (PLWH) (HIV-Glasgow 2024) - "The antiretroviral combination of TAF and INI (excluding Genvoya) had statistically significant association with ≥S1 steatosis (OR 3.4)... Our data show a low prevalence of liver cirrhosis. 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."

Clinical • Fibrosis • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatotic Liver Disease • CD4

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 (HIV-Glasgow 2024) - "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."

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

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 (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. 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."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease

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 (HIV-Glasgow 2024) - "This study compared efficacy and safety of switch to ainuovirine plus lamivudine and tenofovir DF (ANV/3TC/TDF) and that to cobicistat-boosted elvitegravir plus emtricitabine and tenofovir alafenamide (E/C/F/TAF) in virologically suppressed PWH previously on NNRTI-based antiretroviral (ARV) regimen. 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."

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Improved uric acid metabolism in virologically suppressed people with HIV‐1 switching to tenofovir DF‐ containing, ainuovirine‐based compared to tenofovir alafenamide‐containing, boosted elvitegravir‐ based antiretroviral regimen: the secondary analyses of 48‐week results of the SPRINT trial, a randomised, active‐controlled phase III study (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. Switching to tenofovir DF-containing, ANV-based regimen resulted in constant glucose but improved uric acid metabolism in virologically suppressed PWHs compared to that to TAF-containing, boosted EVG-based regimen. Glucose or uric acid dysmetabolism should be well addressed although diabetes or gout occasionally emerges in virologically suppressed PWHs."

Clinical • P3 data • Diabetes • Gout • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Rheumatology

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 (HIV-Glasgow 2024) - "ANV/3TC/TDF, ainuovirine/lamivudine/tenofovir disoproxil; E/C/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. 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."

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

Prevalence of integrase strand transfer inhibitor resistance in people living with HIV and virological failure. (PubMed, J Chin Med Assoc) - "INSTI resistance was uncommon when used as the first-line single tablet regimen in Taiwan. The results confirmed the robustness of ABC/DTG/3TC and BIC/FTC/TAF regarding integrase resistance in cases of virological failure in routine clinical care."

Journal • Human Immunodeficiency Virus • Infectious Disease

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study. (PubMed, HIV Med) - "Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART."

Journal • Patient reported outcomes • Chronic Kidney Disease • Human Immunodeficiency Virus • Infectious Disease • Nephrology • Renal Disease • CD4