Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero - LARVOL DELTA

Primary malignant solitary fibrous tumor of the neck in an HIV-positive patient: a case report. (PubMed, Front Oncol) - "The patient, who was on long-term antiretroviral therapy (EFV + 3TC+TDF), presented with a 5-month history of a progressively enlarging mass in the posterior neck (approx...Following a multidisciplinary team (MDT) consultation and according to the 2024 CSCO guidelines for bone and soft tissue tumors, the patient received two cycles of neoadjuvant chemotherapy (Epirubicin 30mg D1-D3 and Ifosfamide 2g D1-D5). Subsequent surgical resection was performed, and definitive histopathological and immunohistochemical analysis of the postoperative specimen confirmed MSFT (STAT6+, CD34+, P53 mutant type ~85%, and Ki-67 ~60%). This case emphasizes the diagnostic challenge of differentiating rare spindle cell sarcomas in HIV-infected patients; high-grade MSFT can mimic other aggressive sarcomas, and comprehensive postoperative pathological evaluation, especially STAT6 staining, is essential for definitive diagnosis and tailoring oncological management."

Journal • Cervical Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Osteosarcoma • Pain • Sarcoma • Solid Tumor • Spindle Cell Sarcoma • BCOR • CD34 • STAT6 • TP53

Profile of People Living with HIV Switching Prior Antiretroviral Treatment to a Doravirine-Based Regimen in the Real-World Clinical Setting in Greece: The Retrospective DORAVITO Study. (PubMed, Biomedicines) - "Most PLWH (98.2%) were prescribed DOR plus two nucleoside reverse transcriptase inhibitors; 87.3% were prescribed DOR/Lamivudine/Tenofovir Disoproxil Fumarate fixed-dose combination. This study highlights the patterns of DOR use in real-life clinical practice in Greece among treatment-experienced PLWH. Physicians switch HIV-1-infected individuals from prior ART to DOR-based regimens to offer a simplified regimen or to avoid or prevent toxicity."

Journal • Real-world evidence • Retrospective data • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Prevalence and Correlates of Dyslipidemia in HIV-Positive Patients at Selected Public Hospitals in Addis Ababa, Ethiopia, 2025. (PubMed, AIDS Res Treat) - "Predominant regimens included TDF+3TC+ DTG (72.8%)...Dyslipidemia was prevalent among approximately two in three HIV-positive patients receiving long-term ART at two tertiary hospitals in Addis Ababa, Ethiopia. These findings highlight the need for routine lipid monitoring and integrated cardiovascular risk management within HIV care settings in similar urban, tertiary-care contexts."

Journal • Cardiovascular • Dyslipidemia • Genetic Disorders • Human Immunodeficiency Virus • Hypertension • Hypertriglyceridemia • Infectious Disease • Metabolic Disorders • Obesity

Interim analysis of adverse pregnancy outcomes with injectable CAB-LA versus oral PrEP: findings from the PrIMO safety cohort (AIDS 2026) - "Oral PrEP (FTC/TDF, 3TC/TDF) is safe during pregnancy and breastfeeding, but safety data on long-acting injectable cabotegravir (CAB-LA) are limited. Although CAB-LA was associated with a higher relative risk of adverse pregnancy outcomes compared to oral PrEP, this difference was not statistically significant at interim analysis. As long-acting HIV prevention expands globally, generating robust pregnancy safety data is imperative. Dedicated safety cohorts such as PrIMO are essential to ensure that pregnant women are not left behind in biomedical innovation."

Adverse events • Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

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 (AIDS 2026) - "BACKGROUND: Previous 96-week results from the SPRINT extension study demonstrated that switching to the next-generation NNRTI ainuovirine coformulated with lamivudine and tenofovir DF (ANV/3TC/TDF) maintained viral suppression (VS) and improved cardiometabolic parameters in people with HIV-1 (PWH) switching from both classical NNRTI-based regimens and E/C/F/TAF. Switch to ANV/3TC/TDF maintained VS among PWH switching-off both classical NNRTIs-, and boosted INSTI-based regimens. 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 • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • CD4

Incidence of virological rebound among people living with HIV (PLHIV) receiving dolutegravir-based two-drug regimen (2DR) versus three-drug regimen (3DR): evidence from a real-world cohort in Brazil (AIDS 2026) - "Participants received either DTG + tenofovir disoproxil fumarate (TDF) + 3TC (3DR) or DTG + 3TC (2DR). Baseline was defined as the date of switch from DTG/TDF/3TC to DTG/3TC following virological suppression (VS) and the first HIV-1 RNA viral load (VL) =50 copies/mL after ART initiation, for 2DR and 3DR groups, respectively... This study provides real-world evidence that DTG-based 2DR is associated with longer time free of VR and greater long-term virological stability compared with 3DR. These findings extend evidence from randomized trials, suggesting that, in routine clinical practice, regimen simplicity may translate into improved virological durability, particularly in preventing clinically relevant VR."

Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Patterns of dolutegravir resistance in Malawi’s national HIV program 2021-2025 (AIDS 2026) - "In univariable LG analysis, the odds of intermediate/high-level dolutegravir resistance were higher with AZT/3TC and ABC/3TC backbones (vs. TDF/3TC), male sex and presence of NRTI resistance. While 95% of Malawians on dolutegravir-based regimens have suppressed VL, among those with confirmed virological failure, high-level dolutegravir resistance increased over time and was associated with dolutegravir exposure duration. Intermediate/high-level dolutegravir resistance was independently associated with NRTI resistance. These insights may inform future prioritization of HIVDR testing in an evolving global HIV funding landscape."

Human Immunodeficiency Virus • Infectious Disease

Metabolic and Immunological Trajectories and Virological Outcomes of Ainuovirine-Based Antiretroviral Therapy: A 48-Week Longitudinal Cohort Study in Treatment-Naïve Adults. (PubMed, J Med Virol) - "In this single-center longitudinal observational cohort study, 383 treatment-naïve adults with HIV-1 initiating ANV/lamivudine/tenofovir disoproxil fumarate (ANV/3TC/TDF) were followed for 48 weeks. In this 48-week real-world cohort, ANV/3TC/TDF was associated with sustained virological suppression, immune recovery, and generally favorable longitudinal trends in several metabolic and hepatic markers. However, because of the observational single-arm design and the inability to separate the contributions of ANV, the TDF-containing backbone, and recovery from baseline disease status, these findings should be interpreted cautiously and regarded as hypothesis-generating rather than confirmatory."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

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

Exposure-Response Modeling of QTc Interval and Creatine Kinase-MB in Healthy People and Treatment-Naïve Adults Living with HIV-1 Treated with Ainuovirine Monotherapy or Combined with Lamivudine and Tenofovir DF. (PubMed, Eur J Pharm Sci) - "ANV exhibits no statistically significant or clinically meaningful effect on QTc interval prolongation in healthy adults and treatment-naïve PLWH, even at supratherapeutic doses. CK-MB elevations were associated with tenofovir disoproxil fumarate exposure rather than ANV or lamivudine. These findings support the favorable cardiac safety profile of ANV-based regimens."

Journal • Monotherapy • Cardiovascular • Human Immunodeficiency Virus • Infectious Disease

Virologic, immunologic, and metabolic outcomes and mortality in people with HIV on bictegravir/emtricitabine/tenofovir alafenamide fumarate versus dolutegravir-based antiretroviral therapies: a retrospective multicenter cohort study in China. (PubMed, Lancet Reg Health West Pac) - "Inclusion criteria: baseline age ≥18 years, ART naïve, and initiated one of the following regimens: B/F/TAF, DTG+ tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) (DTG+TDF+3TC), or DTG/3TC. Subsequent weight gain after ART initiation merits heightened attention among individuals with higher baseline body weight. National Key Technologies R&D Program of China."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Optimizing Salvage ART: Real-World Outcomes of Doravirine Plus DTG or BIC in Heavily Treatment-Experienced Persons Living with HIV. (PubMed, Microorganisms) - "We conducted an observational, real-world-data study on HTE-PWH in active care at the "Victor Babeș" Hospital, Bucharest, receiving doravirine (DOR)-based salvage regimens combined with dolutegravir (DTG) or bictegravir (BIC)...Salvage regimens included BIC/FTC/TAF + DOR (50.0%), 3TC/TDF/DOR + DTG (35.2%), and 3TC/DTG + DOR (14.7%)...Individuals with PM infection were younger and had longer ART exposure than those with heterosexual acquisition. DOR-based salvage regimens combined with DTG or BIC were effective in adherent HTE-PWH, particularly those with extensive ART histories."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease • CD4

Acquired immune deficiency syndrome-related intravascular large B-cell lymphoma primarily arising from lymph nodes: a case report. (PubMed, Front Oncol) - "She had been on long-term antiviral therapy with Lamivudine, Tenofovir, and Efavirenz (3TC/TDF/EFV)...Following effective antiretroviral therapy and six cycles of CHOP/R-CHOP chemotherapy, the patient achieved complete remission...This case illustrates four critical teaching points: (1) intravascular large B-cell lymphoma (IVLBCL) is a rare subtype of DLBCL; (2) isolated lymph node involvement is exceptionally uncommon in reported cases; (3) the absence of typical cutaneous or central nervous system involvement further complicates the diagnosis; and (4) its occurrence in an HIV-positive patient represents a particularly unusual clinical scenario. Early recognition of these atypical features, together with prompt combined antiretroviral and chemotherapy, achieved complete remission despite profound immunosuppression, highlighting the need for vigilant and individualized management in such rare and diagnostically challenging presentations."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology

Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients. (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: Shanxi Kangbao Biological Product Co., Ltd. | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Effects of the ANV/3TC/TDF on Lipid Metabolism in Virologically Suppressed People Living with HIV with LDL-C>= 3 mmol/L: A Multicenter Prospective Observational Cohort Study (ChiCTR) - P=N/A | N=500 | Recruiting | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New trial • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

The impact of long-term potent antiviral therapy on the natural course of disease in patients with hepatitis B virus-related cirrhosis. (PubMed, Hepatol Forum) - "Potent antiviral treatment effectively maintained VR in the long-term follow-up of patients with HBV-related cirrhosis. HCC may still develop, albeit at a lower rate in these patients."

Journal • Fibrosis • Hepatitis B • Hepatocellular Cancer • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Antiviral efficacy of doravirine-based regimens in patients with NNRTI resistance in Europe: a retrospective observational study (EACS 2025) - "Most received DOR with TDF/3TC (91.4%); 8.6% received DOR with TAF/FTC. One experienced patient (1.8%) with multiple baseline NRTI and NNRTI RAMs that collectively may impact sensitivity to DOR experienced virological failure. Conclusions : In this well-characterised multicentre European cohort of PLWH with NNRTI RAMs and preserved genotypic DOR susceptibility, DOR-based regimens achieved high virological success and excellent treatment retention at 48 weeks."

Late-breaking abstract • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

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

Severe disseminated cryptococcosis, with asymptomatic central nervous system involvement, in a very late presenter (EACS 2025) - "Due to a lack of Amphotericin B and 5-Flucytosine, he initially received high-dose intravenous Fluconazole (1600 mg/day) for 30 days, which was replaced by Voriconazole because of continued blood culture positivity; they turned negative after five weeks. A single dose of liposomal Amphotericin B (10 mg/kg) was administered at week 7th.ART (DOR-TDF-3TC) was also initiated at this moment... Our case highlights the diagnostic and therapeutic challenges of a severe disseminated cryptococcosis, particularly in the absence of neurological symptoms despite extensive CNS involvement, with the importance of maintaining a high index of suspicion for cryptococcal meningitis in all patients with a CD4 count of less than 100 cells/mm³, regardless of their clinical presentation. Additionally, the importance of carefully timing ART initiation to avoid IRIS. Figure:"

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

Switch to DOR/TDF/3TC in People With Controlled HIV and history of RNA genotype M184V/I mutation: Interim Results of the DRIVE OFF-ROAD Multicenter Single-Arm Phase II trial (EACS 2025) - P2 | "Purpose : Doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) fixed-dose combination is approved for people with HIV-1 (PWH) with no prior or current resistance to the NNRTI class, TDF, or 3TC. Enrollment is currently paused, pending the Week 24 follow-up of the #13 participant, expected in July 2025. Conclusions : These interim findings suggest efficacy of DOR/TDF/3TC in individuals with historical M184V/I lamivudine resistance, supporting to move the DRIVE OFF-ROAD trial forward."

Clinical • P2 data • 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