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

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

Real-world experience with therapies for SARS-CoV-2: Lessons from the Italian COVID-19 studies. (PubMed, Infez Med) - "However, with the exception of tocilizumab, baricitinib and perhaps anakinra, most studies with anti-cytokine biological agents in patients with severe COVID-19 did not show any significant clinical improvement or decrease in mortality at day 28. The same is true of several repurposed drugs including ivermectin, lactoferrin, interferon ß-1a, lopinavir/ritonavir alone or combined with hydroxychloroquine, and darunavir/ cobicistat, which did not show any benefits in clinical status or mortality...Three antiviral drugs against SARS-CoV-2 were studied extensively and initially available in Italy: remdesivir, molnupiravir, and nirmaltrelvir/ritonavir, but at present the latter is the only oral antiviral for SARS-CoV-2 available in Italy. Several real-world studies for the use of nirmatrelvir/ ritonavir in the Italian population have been published. Among the current unmet needs, a clear and universal definition for long COVID along with treatments and prevention are..."

Journal • Real-world evidence • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Integrase Inhibitor- Versus Protease Inhibitor-Based Therapy for People With Advanced HIV Disease (CROI 2025) - "Methods In this open-label, randomised, multicentre, non-inferiority trial, therapy-naive people with HIV aged ≥18 years, a viral load >1000 copies/mL, and either AIDS at any CD4 cell count, severe bacterial infection (BI) with a CD4 cell count <200/µL, a CD4 cell count <100/µL, or currently being treated for opportunistic infections (OI), were randomised 1:1 to receive bictegravir or darunavir/cobicistat, each co-formulated with tenofovir alafenamide/emtricitabine for 48 weeks. The incidence of grade 3-4 drug-related AEs (p=0.99), AE leading to study drugs interruption (p=0.92), and serious AEs (p=0.82) did not differ between groups. Conclusions In PWAH the bictegravir containing regimen was non-inferior to the darunavir containing regimen in terms of the composite outcome but had a better virologic response at week 48 and fewer overall AE."

Late-breaking abstract • Metastases • Human Immunodeficiency Virus • Infectious 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

New P4 trial • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks. (PubMed, J Antimicrob Chemother) - "Among treatment-naive people with HIV from this large multicentre cohort, DTG/3TC had similar effectiveness and better persistence and tolerability than those of the most frequently prescribed first-line regimens at 96 weeks."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Kidney transplantation in liver‐transplanted HIV‐positive recipients with end‐stage renal disease: two case reports (HIV-Glasgow 2024) - "A 62-year-old male, HIV-positive since 1984, with a history of liver cirrhosis (LC) due to HCV infection and alcohol abuse, underwent LT in 2011 and immunosuppressed treatment (IST) with mycophenolate sodium, prednisone, and cyclosporine. In 2014, he had HCV reinfection, receiving treatment with sofosbuvir + daclatasvir with sustained virological response...Three years later clinical progress is good on antiretroviral dual therapy with lamivudine/dolutegravir (since 2017), as is virological control with no interactions or complications after the second transplant (Table 1)...A 62-year-old male with HIV/HCV co-infection for over 30 years, HCV eradication in 2011 after direct-acting antivirals with ribavirin, and developed LC and CKD (type II hepatorenal syndrome), leading to LT in 2019...Currently, at 6 months post-KT, he is virologically suppressed on ART with dolutegravir/darunavir/cobicistat (previous resistance), with increasing CD4 counts...However, acute graft..."

Case report • Clinical • Chronic Kidney Disease • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Nephrology • Renal Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation • CD4

Two-Drug Combination Antiretroviral Therapy for HIV-1: Case Series and Literature Review. (PubMed, Hosp Pharm) - "Background: Doravirine (DOR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for use in combination antiretroviral therapy (cART) for treatment of human immunodeficiency virus (HIV) in treatment-naive patients... Patient 1 was transitioned to once daily DOR and darunavir with cobicistat (DRV/c)...Patient 2 was transitioned to once daily DOR and dolutegravir (DTG)... Two-drug cART including DOR appears to be an acceptable option for patients who may be limited to alternative ART regimens due to drug-drug interactions, resistance mutations, or toxicities. Additional evidence from case reports or clinical trials are needed to further evaluate the long-term efficacy and safety of DOR as part of a two-drug cART regimen."

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

Antiretroviral therapy in pregnancy in England in 2019‐2022: common regimens and treatment modifications (HIV-Glasgow 2024) - "Among pregnancies conceived on ART, most common (reported in >5%) first regimens were efavirenz (EFV) + tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) (13.5% [267/1974]), rilpivirine (RPV) +TDF+FTC (11.6% [228/1974]), darunavir/ritonavir (DRV/r) +TDF+FTC (8.0% [158/1974]), dolutegravir (DTG) + lamivudine (3TC) + abacavir (ABC) (7.7% [152/1974]), and raltegravir (RAL) +TDF+FTC (6.4% [127/1974]). Where ART was initiated during pregnancy (55.7% [234/420] diagnosed antenatally), median gestational age at start was 15 weeks (IQR 12–19); most common first regimens were RAL+TDF+FTC (17.7% [75/423]), DRV/r+TDF+FTC (15.4% [65/423]), atazanavir/ritonavir (ATV/r) +TDF+FTC (12.5% [53/423]), DTG+3TC+ABC (9.2% [39/423]) and DTG+TDF+FTC (8.3% [35/423])...3TC, lamivudine; ABC, abacavir; ATV/c, atazanavir/cobicistat; ATV/r, atazanavir/ritonavir; BIC, bictegravir; DRV/c, darunavir/cobicistat; DRV/r, darunavir/ritonavir; DTG, dolutegravir; EFV, efavirenz; EVG/c,..."

Human Immunodeficiency Virus • Infectious Disease

Patient‐reported outcomes in switching to long‐acting cabotegravir/rilpivirine: a real‐life experience (HIV-Glasgow 2024) - " Thirty-six patients have joined it, via own mobile phone; 11 assigned female at birth (30.5%), with a median age of 47 years (range 29–68), 11% with a AIDS history; pre-switch treatment were: DTG/3TC (27.8%), RPV/TAF/FTC (25%), BIC/TAF/FTC (22.2%), DTG/RPV (11%), DRV/cobi/TAF/FTC (5.6%), TDF/FTC + RAL (2.8%), TDF/FTC/ABC (2.8%), DRV+RTV+3TC+ETV (2.8%). For patients who agree to the therapeutic switch, CAB/RPV LA is a well-tolerated therapy that improves quality of life and own relationship with the infection."

Clinical • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Pain • Psychiatry • RBL1

Long‐term efficacy and safety of dolutegravir/lamivudine in virologically suppressed persons with HIV and history of resistance to lamivudine: week 96 results of VOLVER clinical trial ‐ GESIDA 11820 (HIV-Glasgow 2024) - P2 | "Week 96 efficacy data (FDA Snapshot intention to treat-exposed) All (n = 121) HIV-1 RNA <50 copies/ml 105 (86.8%) HIV-1 RNA ≥50 copies/ml 4 (3.3%) HIV-1 RNA ≥50 copies/ml in week 96 window 0 (0%) Discontinuation due to lack of efficacya 2 (1.7%) Discontinuation for other reasons and last available HIV-1 RNA ≥50 copies/mlb 2 (1.7%) No virological data at week 96 12 (9.9%) Discontinuation due to an adverse event 3 (2.5%) Discontinuation for other reasons and last available HIV-1 RNA <50 copies/mlc 9 (7.4%) aOne precautionary virological withdrawal (re-suppressed with co-formulated darunavir/cobicistat/tenofovir alafenamide/emtricitabine); one confirmed virological withdrawal (re-suppressed while still on dolutegravir/lamivudine but met withdrawal criteria and was switched to dolutegravir plus darunavir/cobicistat). After excluding lamivudine mutations in proviral DNA by population sequencing, dolutegravir/lamivudine effectively maintained virological..."

Clinical • Chronic Obstructive Pulmonary Disease • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

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