Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead - LARVOL DELTA

Therapeutic drug monitoring uncovering incorrect antiretroviral drug intake in a patient with swallowing difficulties. (PubMed, IDCases) - "Treatment with darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza®) was initiated, with the patient choosing to chew the tablet before swallowing because of her swallowing difficulties. After correction of the drug intake conditions, darunavir exposure increased to therapeutic levels. This case highlights the clinical value of therapeutic drug monitoring in identifying medication intake errors and optimising antiretroviral therapy in patients with swallowing difficulties."

Journal • Human Immunodeficiency Virus • Infectious Disease

Prevalence and Severity of Potential Drug-Drug Interactions in People Living with HIV on Antiretroviral Therapy in the United States. (PubMed, Infect Dis Ther) - "In this large, real-world claims analysis, pDDIs between ART and non-ART medications were not uncommon in routine clinical practice. As the HIV population continues to age, systematic screening for drug interactions (particularly with comedications for chronic conditions such as diabetes and cardiovascular disease) and thoughtful, individualized ART selection may help mitigate interaction risk and support safe, effective long-term HIV management."

Journal • Cardiovascular • Diabetes • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

A Silent Collapse: HIV-Induced Adrenal Insufficiency - A Case Report (ENDO 2026) - "A 39-year-old man with multidrug-resistant HIV/AIDS on darunavir/cobicistat/emtricitabine/tenofovir/alafenamide (Symtuza) and fostemsavir, (Rukobia), chronic respiratory failure requiring tracheostomy, and percutaneous endoscopic gastrostomy tube dependence was admitted for recurrent septic shock...Stress-dose corticosteroid therapy with intravenous methylprednisolone 50 mg every 8 hours was initiated in the setting of ongoing sepsis, resulting in stabilization of blood glucose levels and hemodynamic status...This case underscores HIV infection as a potential contributor to adrenal insufficiency through multifactorial mechanisms, including chronic immune activation with cytokine-mediated HPA axis suppression and direct adrenal injury from opportunistic infections. Although rare, recognition of this association is important, as corticosteroid therapy may rapidly reverse metabolic and hemodynamic instability in affected patients."

Case report • Clinical • Endocrine Disorders • Human Immunodeficiency Virus • Hypoglycemia • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases • Septic Shock

When Local Isn't Local: Systemic Complications from Intra-Articular Steroids in A Patient on Cobicistat (ENDO 2026) - "Cobicistat is a pharmacokinetic enhancer in the combined antiretroviral formulation Symtuza® (darunavir, cobicistat, emtricitabine, tenofovir alafenamide), which is commonly used to treat HIV...He then presented to the ED with bilateral multi-segmental pulmonary embolism treated with apixaban...Antiretroviral treatment was then switched to Biktrvy® (bictegravir/ emtricitabine/ tenofovir)...In this case the cobicistat- glucocorticoid interaction appears to have caused glucocorticoid excess leading to insomnia, hypomanic behavior and possibly pulmonary embolism followed by adrenal insufficiency. Given the widespread use of inhaled and injectable steroids by patients who can also be receiving cobicistat, early recognition of this interaction can potentially prevent complications related to glucocorticoid excess and adrenal insufficiency."

Clinical • Cardiovascular • CNS Disorders • Endocrine Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Insomnia • Nephrology • Osteoarthritis • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Sleep Disorder

A crucial role for novel miR-12137-3p in supporting weight gain in treatment naïve HIV-infected patients on antiretroviral therapies. (PubMed, J Transl Med) - P4 | "The study reports for the first time a role for novel miRNA, miR-12137-3p, in ARV-associated weight gain/obesity. Further understanding the biology of miR-12137-3p may offer novel therapeutic approaches to treating weight gain in general."

Journal • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity • PPARG • WNT3A

Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial. (PubMed, Lancet Infect Dis) - P3 | "In people with advanced HIV disease, bictegravir, emtricitabine, and tenofovir alafenamide was shown to be non-inferior to darunavir, cobicistat, emtricitabine, and tenofovir alafenamide and resulted in fewer adverse events, supporting its use as a preferred first-line antiretroviral regimen in this vulnerable population."

Head-to-Head • Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

High-level multi-class transmitted antiretroviral resistance in a man with newly acquired HIV. (PubMed, Int J STD AIDS) - "A 19 year old man was diagnosed newly acquired HIV and prescribed bictegravir/emtricitabine/tenofovir alafenamide at his initial visit for HIV care...Although he had an initial substantial decline in viremia in the first 4 weeks, it was felt that the risk of subsequent failure was too high, and his antiretroviral treatment (ART) regimen was therefore changed to daily dolutegravir and darunavir/cobicistat/emtricitabine/tenofovir alafenamide, plus injected lenacapavir. He had durable virologic suppression on this new regimen for 12 months as of his last follow-up. This case of high-level multi-class transmitted drug resistance, in the context of rapid emergence of resistance to dolutegravir where it has been used as part of a salvage regimen, suggests that assessing for RAM in the integrase gene should be added to the currently recommended resistance testing for all patients with newly acquired HIV prior to initiating ART."

Journal • Human Immunodeficiency Virus • Infectious Disease

Viral Sabotage: HBV Reactivation in the Shadow of HIV (ACG 2025) - "Introduction: This is a case report of a 57 year old gentleman who presented to a tertiary medical center in acute liver failure due to reactivation of hepatitis B virus (HBV) after not taking his Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) for four months. Treatment with Biktarvy and lactulose was initiated, and within 6 days, hepatic function recovered and mental status improved to baseline. HIV medication has antiviral effects on HBV, when HIV antiretroviral therapy is stopped HBV can become reactivated. This case is unique in it's presentation of seizures in the setting of acute reactivation of HBV, timely initiation of antiviral treatment in acute hepatitis with successful recovery despite poor prognosis, and management options for acute liver failure at a tertiary medical center.Figure: Prevalence of Chronic Hepatitis B Virus Among HIV Figure: Understanding Hepatitis B Serology"

CNS Disorders • Epilepsy • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Failure • CD4

When the Therapy Bites Back: Drug-Induced Necrotizing Pancreatitis in an HIV Positive Patient (ACG 2025) - "Two months prior to admission, the patient's antiretroviral therapy had been switched from dolutegravir/lamivudine to DRV/COBI/FTC/TAF due to weight gain. Drug-induced pancreatitis was determined to be the cause of severe necrotizing pancreatitis in our patient after other causes were ruled out. As novel antiretroviral therapies emerge, HIV positive patients should be closely monitored for rare complications following initiation or modification of therapy."

Clinical • CNS Disorders • Dyslipidemia • Gastroenterology • Hepatology • Human Immunodeficiency Virus • Hypertriglyceridemia • Infectious Disease • Pancreatitis • Septic Shock

TYPE B AORTIC DISSECTION COMPLICATED BY ESCHERICHIA COLI-INDUCED AORTITIS (CHEST 2025) - "CASE PRESENTATION: A 53-year-old woman with HIV on darunavir/cobicistat/emtricitabine/tenofovir alafenamide presented with chest pain radiating to her back and severe left flank pain...The patient was initially started on ceftriaxone for a suspected urinary tract infection (UTI) and transferred to our facility. Previously acquired blood and urine cultures grew E. coli, leading to escalation to cefepime. Despite initial treatment, including antibiotics and tight blood pressure control with IV clevidipine and esmolol, persistent fevers and leukocytosis prompted further investigation.Subsequent CT imaging revealed new inflammatory changes around the false lumen of the infrarenal aorta, raising concern for E. coli-associated aortitis...After stabilization, she was discharged a six-week oral course of cefdinir due to social barriers preventing home IV antibiotic therapy... This case highlights the importance of recognizing rare infectious complications of aortic dissections...."

Atherosclerosis • Cardiovascular • Chronic Obstructive Pulmonary Disease • Diabetes • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Respiratory Diseases

THE FIRE WITHIN: PARADOXICAL PULMONARY INFLAMMATION UNMASKED BY IMMUNE RECONSTITUTION (CHEST 2025) - "He was started on a fixed-dose combination therapy of cobicistat, darunavir, emtricitabine, and tenofovir alafenamide (Symtuza) alongside doxycycline for syphilis.Despite adherence to ART, the patient developed progressive fatigue, subjective fevers, dry cough, and worsening malaise, leading to hospital admission...Prednisone therapy was initiated, resulting in marked clinical improvement within 48 hours... Recognition, timely initiation of corticosteroid therapy, and coordinated multidisciplinary management crucial for improving outcomes in patients with IRIS. Early involving of infectious disease specialists and pulmonary consultation is essential to differentiate IRIS from progressive infections and to optimize management strategies. This case highlights the need for clinicians to remain vigilant for pulmonary IRIS in patients with advanced HIV starting ART, as early intervention can significantly improve prognosis."

Cough • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pneumonia • Tuberculosis • CD4

Interaction between GLP-1 receptor agonists and cART in PLWH and obesity: a case report (EACS 2025) - "Newer regimens, particularly those containing second-generation integrase strand transfer inhibitors (INSTIs) and tenofovir alafenamide (TAF), have been associated with significant weight gain, while tenofovir disoproxil fumarate (TDF) appears to have a weight-suppressive effect.We describe a 62-year-old man living with HIV on a stable ART regimen (TAF/FTC/DRV/c), with a history of hypertensive heart disease and class II obesity (BMI 35 kg/m2). This case highlights the potential of GLP-1 receptor agonists as an effective treatment option for obesity in PLWH, particularly when lifestyle modifications have failed. Further studies are warranted to explore their long-term safety and efficacy in this population, and to better characterize any pharmacological interactions with antiretroviral therapy."

Case report • Clinical • Human Immunodeficiency Virus • Infectious Disease

Virological failure with NNRTI resistance on CAB+RPV-LA in a man with subtherapeutic cabotegravir levels (EACS 2025) - "He achieved sustained virological suppression (HIV-RNA 10 years on oral ART (TDF/FTC/EFV, then TDF/3TC/DOR)...Oral TAF/FTC/DRV/c was briefly initiated but stopped once the subsequent HIV-RNA measurement was <50 c/mL and HIV-DNA sequencing showed no RAMs... This case suggests a potential influence of injection technique and illustrates how retrospective TDM can help elucidate pharmacological contributors to virological failure on long-acting injectables. TDM may assist clinical decision-making in selected cases and inform real-world optimisation strategies."

Human Immunodeficiency Virus • Infectious Disease • CD4

Possible CNS compartmentalization and lenacapavir resistance in multidrug-resistant HIV (EACS 2025) - "Due to resistance to four antiretroviral classes, a salvage regimen was initiated in August 2023 including darunavir/cobicistat/emtricitabine/tenofovir alafenamide, fostemsavir, and subcutaneous lenacapavir every six months, according to CAPELLA study criteria*. 2022;386(19):1793-1803. doi:10.1056/NEJMoa2115542."

Human Immunodeficiency Virus • Infectious Disease • CD4

Intersecting Pathologies: A Unique Case of Usual Interstitial Pneumonia and Organizing Pneumonia in an HIV Patient (ATS 2025) - "Clinical summary: A 65-year-old male with a past medical history of coronary artery disease and HIV on darunavir/ cobicistat/ emtricitabine /tenofovir alafenamide (CD4 - 667, viral load - 30) presented with fever, flu-like illness, and shortness of breath for 4 days, with no sick contacts and noncontributory social history...Intravenous Levofloxacin was commenced for possible bilateral atypical pneumonia; however, throat, sputum, and blood culture showed no growth... Non-infectious lung complications are rare but challenging to manage in HIV patients. The coexistence of usual interstitial pneumonia (UIP) and organizing pneumonia (OP) suggests a complex underlying process. This inflammatory and fibrotic response can worsen symptoms and lead to disease progression."

Clinical • Acute Lung Injury • Cardiovascular • Coronary Artery Disease • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease • Interstitial Lung Disease • Pneumonia • Pulmonary Arterial Hypertension • Respiratory Diseases • CD4

Cabotegravir/rilpivirine resistance in a patient living with HIV despite on-time administration: A case report. (PubMed, Am J Health Syst Pharm) - "This case demonstrates the potential for patients living with HIV to develop resistance to CAB/RPV despite on-time administration of the medication. Proper administration and timing of antiretroviral therapy for these patients is essential to ensure efficacy and safety in the management of HIV but does not completely prevent development of resistance."

Journal • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease

An Investigation of Granulomatous Liver Injury in Immunocompetent and Immunocompromised Patients at a Tertiary Care Center (USCAP 2025) - "Implicated drugs included ipiliumumab, etanercept, Symtuza, and others. In our large case series, the etiology of granulomatous liver injury was determined in a majority of patients, while 31% of cases were unknown. Immunosuppressed patients had a higher proportion of granulomas attributed to steatosis, infection, and rejection in comparison to immunocompetent patients. A retrospective investigation of the 77 idiopathic cases is ongoing to determine whether H+E re-review and further clinicopathologic correlation is revealing."

Clinical • Autoimmune Hepatitis • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Nontuberculous Mycobacterial Disease • Respiratory Diseases • Rheumatology • Sarcoidosis

Rapid start with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with HIV‐1 (PWH): a systematic literature review (SLR) of clinical and patient‐reported outcomes (PROs) (HIV-Glasgow 2024) - "Efficacy and safety outcomes at key timepoints reported by included rapid start (RS) studies Characteristic/Endpoints BIC-NOW (Spain) [5] BIFAST (Spain) [6] FAST (France) [7] Rainbow (Italy) [8] Test&Treat (Spain) [9] Benidir 2022 (USA) [10] Study design Single arm Single arm Single arm Single arm Single arm Non-RCT (RS vs non-RS) Phase IV IV IV IV III NR Treatment arms B/F/TAF RS (n=208) B/F/TAF RS (n=59) B/F/TAF RS (n=112) B/F/TAF RS (n=30) B/F/TAF RS (n=100) B/F/TAF RS (n=65) B/F/TAF non-RS (n=42) Efficacy Outcomes Virologic suppression (Viral load <50 copies/mL) W24 (n=160), 88.8% W24 (n=59), 84.4% W24 (n=112), 80.4% W24 (n=30), 80%, p < 0.001 W4 (n=100), 52% Visit 5 (timepoint NR) (n=65), 100%, p ≥ 0.05 Visit 5 (timepoint NR) (n=42), 100% Engagement in care (Attendance at visits) W48 (n=30), 100% W4 (n=100), 100% Visit 4 (median 192.0 [IQR 185.0,238.0] days) (n = 16), 56.3%, p = 0.003 Visit 4 (median 243.5 [IQR 180.2, 306.8] days) (n = 22), 9.1% Safety..."

Clinical • Patient reported outcomes • Review • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry

Comparison of treatment‐emergent resistance associated mutations among single tablet regimens and cabotegravir+rilpivirine for the treatment of virologically suppressed people with HIV: a systematic literature review and network meta‐analysis (HIV-Glasgow 2024) - "Pooled estimates for risk of TE-RAMs at 48 weeks (RR [95% CI]) B/F/TAF 0.45 (0.05−4.34) CAB+RPV Q4W 0.20 (0.02−1.83) 0.44 (0.16−1.22) CAB+RPV Q8W 0.34 (0.00−30.94) 0.76 (0.01−79.65) 1.74 (0.02−186.99) D/C/F/TAF 0.99 (0.02−49.69) 2.21 (0.02−205.13) 5.04 (0.06−458.15) 2.90 (0.01−1134.89) DTG+2NRTIs 0.35 (0.01−12.32) 0.78 (0.02−28.74) 1.78 (0.05−69.14) 1.03 (0.01−163.78) 0.35 (0.00−70.41) DTG/3TC 1.00 (0.02−50.04) 2.23 (0.02−206.57) 5.08 (0.06−461.38) 2.92 (0.01−1142.90) 1.01 (0.00−256.15) 2.85 (0.01−566.10) DTG/ABC/3TC 0.35 (0.00−31.65) 0.79 (0.01−81.51) 1.80 (0.02−191.35) 1.04 (0.00−261.33) 0.36 (0.00−138.70) 1.01 (0.01−159.53) 0.35 (0.00−137.72) DTG/RPV 0.26 (0.03−2.01) 0.58 (0.08−4.41) 1.31 (0.15−11.17) 0.75 (0.01−54.12) 0.26 (0.00−21.66) 0.73 (0.04−14.89) 0.26 (0.00−21.51) 0.73 (0.01−51.62) E/C/F/TXF 0.10 (0.01−1.81) 0.22 (0.01−4.52) 0.49 (0.02−10.90) 0.28 (0.00−26.61) 0.10 (0.00−12.98) 0.28 (0.01−5.57) 0.10 (0.00−12.89) 0.27 (0.00−25.40) 0.37 (0.04−3.95) EFV/FTC/TDF..."

Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) - P3 | N=447 | Completed | Sponsor: NEAT ID Foundation | Active, not recruiting ➔ Completed

Metastases • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT. (PubMed, HIV Res Clin Pract) - "Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. Both regimens demonstrated good tolerability with infrequent laboratory abnormalities and no grade 3 or 4 adverse events. In this first head-to-head study in the context of ART initiation, HIV RNA decline from baseline to week 12 was significantly more rapid for BIC/F/TAF compared with DRV/c/F/TAF."

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

DEFINE: A Prospective, Randomized, Phase 4 Trial to Assess a Protease Inhibitor-based Regimen Switch Strategy to Manage Integrase Inhibitor-related Weight Gain. (PubMed, Clin Infect Dis) - P4 | "While no significant change in body weight was observed at 24 weeks after switching from InSTI+TAF/FTC to D/C/F/TAF among adults with weight gain, a trend towards weight loss emerged with longer time post-ARV switch, supporting further investigation of antiretroviral selection/switch for weight management."

Journal • P4 data • Human Immunodeficiency Virus • Infectious Disease

First Case of HIV Seroconversion With Integrase Resistance Mutations on Long-Acting Cabotegravir for Prevention in Routine Care. (PubMed, Open Forum Infect Dis) - "Viral suppression was maintained for 6 months on darunavir/cobicistat/emtricitabine/tenofovir alafenamide, then switched to doravirine + emtricitabine/tenofovir alafenamide due to nausea. Accelerated pathways to minimize time between HIV testing and CAB-LA initiation are needed to optimize acute HIV detection and mitigate resistance risk. Sustained product access regardless of insurance is imperative to reduce HIV infections on CAB-LA."

Journal • Human Immunodeficiency Virus • Infectious Disease

Characteristics and outcomes of Virally Suppressed (VS) Treatment Experienced (VSTE) people with HIV (PWH) (AIDS 2024) - "Of PWH with results within 3 years, 78% had =1 major mutation (48% NRTIs, 44% NNRTIs, 26% PIs, 11% INSTIs); 44% =2 class resistance; most common mutations: M184VI (34%); A62V (33%); K103NS (22%).During follow-up (median 2.8 years), 5% had =1 VB and 6% had VF (more common on regimens >2 core classes, 9% vs 5% p2 Core ARV Classes1,082 (19%)243 (22%)74 (30%)93 (9%)VSTE: virologically suppressed treatment experienced; ARV: antiretroviral; HTE: heavily treatment experienced; STR: single tablet regimen; Core regimen classes: non-nucleoside reverse transcriptase inhibitors [NNRTIs], integrase inhibitors [INSTIs], nucleoside/nucleotide reverse transcriptase inhibitors [NRTIs], protease inhibitors [PIs].†Complex regimen: 2 out of 3 core classes (NNRTI, PI, INSTI), darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) or tenofovir disoproxil fumarate (TDF), multi-dosing per day, complex multi-pill regimen (excluding regimens reflecting available single-tablet..."

Human Immunodeficiency Virus • Infectious Disease

Additional time post–integrase inhibitor to protease inhibitor switch shows trend to weight loss: DEFINE 48-week results (AIDS 2024) - P4 | "The primary analysis of DEFINE found no significant difference in percent body weight change from baseline to Week 24 when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) vs continuing INI+TAF/emtricitabine (FTC)... The trajectory of weight change after INI to PI switch appeared different in the first 24 weeks post-switch (no weight loss observed) vs Weeks 24-48, where a trend to weight loss emerged. Secondary metabolic endpoints remained stable or paralleled weight loss. Longer time post–ARV switch suggests medication management may be an important component to address this issue."

Human Immunodeficiency Virus • Infectious Disease