Prezcobix (darunavir/cobicistat) / Gilead, J&J - LARVOL DELTA

Switching from etravirine to doravirine in people with HIV harbouring NNRTI resistance-associated mutations: the DorSwitch pilot study. (PubMed, J Antimicrob Chemother) - "In this small, highly selected pilot cohort, switching from etravirine to doravirine as part of an otherwise suppressive regimen was associated with maintenance of virological suppression through Week 48 and a more favourable predicted NNRTI resistance profile in most participants. The favourable resistance profile, safety, metabolic effects and PK findings consistent with expected exposure-particularly in combination with darunavir/cobicistat- support further evaluation of doravirine as a switch option in carefully selected individuals with prior NNRTI failure."

Journal • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Rivaroxaban with Cobicistat or Darunavir/Cobicistat in Healthy Participants. (PubMed, J Acquir Immune Defic Syndr) - "Coadministration of cobicistat and cobicistat-boosted darunavir with rivaroxaban resulted in a clinically significant increase in rivaroxaban drug exposure. Further study can inform safety and efficacy of rivaroxaban dose reduction."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

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

Sustained HIV-1 remission following CCR5 delta32/delta32 allogeneic hematopoietic stem cell transplantation: the Kansas City patient (AIDS 2026) - "The gray shaded area indicates time on ART (raltegravir, emtricitabine/tenofovir, darunavir/cobicistat; then bictegravir, emtricitabine, tenofovir)...AlloHSCT, which occurred in October 2020 following myeloablative conditioning (busulfan/cyclophosphamide), led to full donor chimerism and remission... We report HIV-1 remission sustained for 14 months following ATI in our patient post alloHSCT from a CCR5 delta32/delta32 donor. Ongoing monitoring will further determine HIV reservoir eradication."

Clinical • Late-breaking abstract • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Leukemia • Transplantation • CCR5 • CD34

Efficacy and safety of switching to BIC/FTC/TAF plus DRV/cob versus DRV/r, RAL, TDF for maintaining virologic suppression in heavily-experienced people living with HIV-1 (AIDS 2026) - "Data on the combination of BIC/FTC/TAF + darunavir/cobicistat in this scenario are scarce. Switching to BIC/FTC/TAF plus DRV/cob was noninferior to continuing DRV/, RAL, TDF for maintaining virologic suppression at week 48 with no observed resistance, supporting the efficacy, good safety, and high barrier to resistance of BIC/FTC/TAF plus DRV/cob."

Clinical • Human Immunodeficiency Virus • Infectious Disease

TLALOC-2: Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up (clinicaltrials.gov) - P4 | N=78 | Recruiting | Sponsor: Instituto Mexicano del Seguro Social

New P4 trial • Human Immunodeficiency Virus • Infectious Disease

Delayed Onset of Diabetic Ketoacidosis After Bictegravir Antiretroviral Therapy With Complete Resolution Upon Discontinuation (ENDO 2026) - "Clinical Case: A 59-year-old female with virally suppressed HIV on lopinavir/ritonavir and tenofovir disoproxil fumarate/lamivudine was transitioned to bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) in June 2024 to simplify her ART regimen...Following BIC/TAF/FTC discontinuation and transition to a protease inhibitor-based ART regimen with darunavir/cobicistat/TAF/FTC, glycemia rapidly normalized (A1c 6.4%, random BG 101 mg/dL, estimated A1c by CGM 5.7%, time-in-range 100%) over approximately 7 weeks, allowing discontinuation of all antidiabetic medications... Compared to previous reports of BIC-induced hyperglycemia, this case is notable for its delayed onset, suggesting a broader timeline of risk. Consistent with prior reports, improvement in glycemia was observed following discontinuation of BIC. This case highlights the importance of ongoing metabolic monitoring with BIC-based ART, even beyond the early treatment period and suggests consideration of..."

First-in-human • Late-breaking abstract • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Disorders

Prescription of colchicine and NSAIDs for acute gout flares in severe chronic kidney disease and colchicine in major drug–drug interactions: evidence from an electronic health-record based gout register (EULAR 2026) - "Strong inhibitors included atazanavir, clarithromycin, cobicistat, darunavir, fluconazole, ketoconazole, lopinavir, ritonavir, nirmatrelvir–ritonavir, voriconazole, and ciclosporin. Moderate to weak inhibitors included erythromycin, verapamil, amiodarone, diltiazem, and dronedarone...Conclusions Colchicine was frequently prescribed for acute gout flares in patients with severe chronic kidney disease despite society guideline recommendations, although co-prescription with strong CYP3A4 or P-glycoprotein inhibitors was uncommon. These findings suggest partial adherence to recommendations and warrant further evaluation of colchicine safety in patients with severe chronic kidney disease."

Chronic Kidney Disease • Gout • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • CYP3A4

ITACO_2780_OPBG_2022: The Italian Cohort (ITACO) and the Analytical Antiretroviral Treatment Interruption Italian Cohort (ITACO-ATI) study guided by molecular HIV-1 reservoir profiling (clinicaltrialsregister.eu) - P2/3 | N=61 | Completed | Sponsor: Ospedale Pediatrico Bambino Gesu | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Treatment failure with bictegravir/emtricitabine/tenofovir alafenamide in a treatment-naïve person with HIV under perfect adherence. (PubMed, Intern Med) - "We describe a treatment-naïve 30-year-old man with an advanced HIV infection who experienced virologic failure on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) despite complete adherence. Switching to darunavir/cobicistat/TAF/FTC, followed by intensification with dolutegravir, achieved partial viral suppression. This case suggests a possible contribution of transmitted drug resistance or minority variants undetectable at baseline, with selective outgrowth under therapeutic pressure."

Journal • Human Immunodeficiency Virus • Infectious Disease

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

Beyond the Colon: Hepatobiliary CMV as a Rare End-Organ Manifestation of AIDS (ACG 2025) - "He had been out of HIV care for over a year after previously being on Biktarvy and Prezcobix...Initial stool studies were positive for cryptosporidium, and nitazoxanide was initiated...Ganciclovir was initiated and transitioned to valganciclovir 900 mg BID...Treatment included antiviral therapy. This case underscores the importance of a broad differential, timely biopsy, and multidisciplinary care in managing complex presentations of AIDS-related GI and hepatobiliary disease.Figure: MRI showing Dilated intrahepatic bile ducts with beaded appearance of ductal dilatation."

Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

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

Antiretroviral Switch and Weight Gain: Cardiometabolic Implications of Switching to Darunavir/Cobicistat + Lamivudine (EACS 2025) - "We included males aged >18 years with adquire HIV, virological suppression for ≥6 months, and on a regimen of darunavir/cobicistat (DRV/c) plus tenofovir/emtricitabine (TDF/FTC). No significant changes in cardiovascular risk were observed. Metabolic alterations should be considered when selecting an antiretroviral regimen."

Human Immunodeficiency Virus • Infectious Disease

Potential for replacing the boosted-PI with doravirine in ART-experienced subjects successfully treated with darunavir-cobicistat plus dolutegravir dual regimen (EACS 2025) - "In 31/219 (14%), DTG bid may be used if DRV/c removal is necessary. Conclusions : According to our results, most people in our cohort were eligible to be switched to DOR+DTG regimen, with potential benefits in lipid profile, cardiovascular risk, drug-drug interactions, and overall costs."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Unconventional DORAVIRINE antiretroviral regime: a single-center experience (EACS 2025) - "1,2 Available in a once-daily combination with tenofovir-disoproxil/lamivudine (TDF/3TC), DOR showed versatility in more unconventional combinations, especially in dual-therapy with dolutegravir (DTG) 1,3 or 3TC...Twenty-two were dual-therapy with DOR+darunavir/cobicistat (DRV/c) (9/30; 30%) and DOR+DTG (7/30; 23%) being the most common...DOR+ARV ensured good immunovirological control and neutral impact on cholesterol and BMI as already reported 1,3,4 with high tolerability, having only one person/30 discontinuing DOR. Conclusions : Unconventional DOR combinations in dual-therapy including those with DRV/c or raltegravir are effective and well-tolerated options among others for multi-treated PLWH experiencing aging and comorbidities."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Effect of Dolutegravir compared to Darunavir/Cobicistat, both with TDF/FTC, in neuropsychiatric effects at 12 weeks of treatment in PLH with baseline neuropsychiatric disorders and no antiretroviral therapy experience (IAS-HIV 2025) - P4 | "Preliminary data from this study, with 12 weeks of follow-up, suggests difference in HADS-A and PHQ-9 scores between the two groups. Patients in the DTG + TDF/FTC group reported a higher risk of suicidality."

CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder • Suicidal Ideation • CD4

A peculiar case of persistent CPK elevation in a person diagnosed with acute HIV: what is behind? (PubMed, HIV Res Clin Pract) - "A 24-year-old gentleman was diagnosed with an acute HIV in May 2023 (HIV-RNA > 10.000.000 copies/ml, CD4+ count 417 cell/L) and started same-day combinarion antiretroviral therapy, cART, with darunavir/cobicistat/tenofovir alafenamide/emtricitabine+dolutegravir), switching to dolutegravir/lamivudine once undetectable, 6 weeks after. This case highlights the diagnostic complexity of rare metabolic disorders, especially when coexisting with acute HIV, continuous medication use and drug exposure. It allows us to highlight the importance of considering rare metabolic disorders as differential diagnoses, as they can mimic systemic illnesses or drug-related effects."

Journal • Acute Kidney Injury • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Disorders • Muscular Atrophy • Musculoskeletal Pain • Myositis • Pain • Renal Disease • CD4

MORFEO: Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults. (clinicaltrials.gov) - P4 | N=140 | Not yet recruiting | Sponsor: Instituto Mexicano del Seguro Social | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Clinical Evaluation of Drug-Drug Interactions Between Bictegravir and Strong Inhibitors/Inducers of the CYP3A4, UGT1A1, or P-gp Pathways. (PubMed, J Clin Pharmacol) - "The pharmacokinetics (PK) and safety of bictegravir (administered alone or as bictegravir/emtricitabine/tenofovir alafenamide fumarate [TAF]) were assessed when co-administered with inducers (rifampin, rifabutin, and rifapentine) or inhibitors (atazanavir ± cobicistat, darunavir + cobicistat, and voriconazole) of cytochrome P450 3A4 (CYP3A4), uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), and/or P-glycoprotein (P-gp). Induction of CYP3A4 with/without UGT1A1 significantly influenced bictegravir PK, although Ctrough remained above the protein-adjusted 95% effective concentration. These findings should be considered when co-administering medications with bictegravir."

Journal • Human Immunodeficiency Virus • Infectious Disease • CYP3A4 • UGT1A1

Pediatric darunavir/cobicistat fixed-dose combination tablet for dispersion: Bioequivalence versus separate agents in healthy participants and acceptability in children living with human immunodeficiency virus-1. (PubMed, Antivir Ther) - "Acceptability questionnaires were completed by observers, participants and caregivers.ResultsThe bioequivalence study indicated that the geometric mean ratios for DRV maximum plasma concentration and area under the concentration-time curve of the dispersed DRV/COBI-600/90-mg FDC tablet versus the separate formulations fell within the 80-125% bioequivalence limits. In the acceptability study in children, per independent observers 83% (10/12) of the children were able to swallow the dispersion completely and rated the dispersed FDC tablet as "ok" to "very easy" to swallow.ConclusionThe DRV/COBI 600/90-mg FDC tablet dispersed in water was bioequivalent to coadministration of the separate formulations and was acceptable for long-term daily use in the intended pediatric population."

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

Rezolsta - opinion on variation to marketing authorisation (European Medicines Agency) - "On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Rezolsta. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV. Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 4025 kg)."

CHMP • Human Immunodeficiency Virus

Long-term durability of dolutegravir plus darunavir/cobicistat dual regimen in highly antiretroviral-experienced people with HIV (DoDaco study). (PubMed, J Antimicrob Chemother) - "Dolutegravir plus darunavir/cobicistat is a durable combination in heavily treatment-experienced PWH. Those who were viraemic at the time of switch were more likely to discontinue, although most reasons for TD were other than virological failure."

Journal • Human Immunodeficiency Virus • Infectious Disease

MANAGEMENT OF LEFT VENTRICULAR THROMBUS IN HIV-POSITIVE PATIENTS - Syifa R. Djunaedi (ACC 2025) - "Due to an interaction with cobicistat (ART), she transitioned to warfarin.Decision-making: According to the 2013 ACC/AHA STEMI Guidelines, initiating direct oral anticoagulants therapy alongside dual antiplatelet therapy for patient with ST-elevation myocardial infarction (STEMI) and LV thrombus is reasonable for at least three months. Our case emphasizes the importance of managing cardiovascular disease with other chronic medical conditions such as HIV. Patients taking protease inhibitors should exercise caution when starting DOAC therapy in the setting of post-MI complication of LV thrombus due to drug-drug interactions and increased bleeding risk."

Clinical • Atherosclerosis • Cardiovascular • CNS Disorders • Depression • Diabetes • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Pain • Psychiatry • Thrombosis • CYP3A4

TLALOC: Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico (clinicaltrials.gov) - P4 | N=138 | Recruiting | Sponsor: José Antonio Mata Marín

New P4 trial • Human Immunodeficiency Virus • Infectious Disease