dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Viatris - LARVOL DELTA

Treatment Persistence and Switch Among Medicare-Insured People with HIV and Gaps in Care. (PubMed, Infect Dis Ther) - "Among Medicare-insured PWH with low adherence or significant gaps in care, those receiving B/F/TAF had a lower risk of switch compared with other ART regimens. Optimizing ART selection to improve persistence and reduce treatment switching remains an important consideration."

Journal • Medicare • Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

Distribution and efficacy of dolutegravir-based regimens in the main HIV outpatient care in Caracas, Venezuela. (PubMed, AIDS Res Ther) - "A high viral suppression rate of over 90% was documented for all DTG-based regimens, with no significant difference found between the main regimen (DTG/3TC/TDF) and its alternatives: DTG/emtricitabine/tenofovir alafenamide (TAF), abacavir/3TC + DTG and, DTG/3TC. Overall, almost all switches (97.1%) were made toward DTG/FTC/TAF. Osteoporosis was the main reason for switching treatments (80.1%)."

Journal • Human Immunodeficiency Virus • Infectious Disease • Osteoporosis • Rheumatology

Disseminated cryptococcosis and pneumocystosis as a rare and unusual presentation of primary HIV infection: case report and literature insights (EACS 2025) - "Antiretroviral therapy (ART) (tenofovir/emtricitabine/dolutegravir) was initiated...Liposomal amphotericin B and flucytosine were administered for disseminated cryptococcosis, and cotrimoxazole for Pneumocystis pneumonia...After four weeks of antifungal induction therapy, symptoms resolved; ART was resumed with fluconazole consolidation and prophylaxis...In the most recent retrospective cohort study involving 290 individuals with PHI, OIs were observed in 7% of subjects, but none involved cryptococcosis (Braun DL et al., 2015). Conclusion : This rare case of PHI complicated by two OIs highlights the importance of suspecting such conditions, even in acute HIV infection."

Case report • Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Prophylaxis failure or IRIS reality? A case of unmasking Mycobacterium avium complex (MAC)-associated IRIS (EACS 2025) - "ART with TAF/FTC+DTG and opportunistic infection prophylaxis, including weekly azithromycin (1.2 g), were initiated...He was treated with azithromycin (500mg qd), ethambutol (1000mg qd) and rifampicin (600mg qd), according to susceptibility results... Diagnosing unmasking MAC-associated IRIS is challenging yet remains a critical consideration in late presenters starting ART. This case confirms the futility of MAC-prophylaxis, highlights the need for heightened clinical awareness, and reinforces the importance of timely diagnosis and targeted treatment to improve outcomes."

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

The first case of lung abscess and bacteremia caused by Rhodococcus hoagii in a patient with advanced HIV infection in Croatia – a therapeutic challenge (EACS 2025) - "As the European Committee on Antimicrobial Susceptibility Testing (EUCAST) defines no breakpoints for Rhodococcus spp., due to similar growth, based on Corynebacterium spp., vancomycin, linezolid, and rifampicin are cautiously recommended by MIC, while penicillin, clindamycin, and moxifloxacin are not. The empirical combination of clarithromycin and rifampicin was changed to linezolid and rifampicin. ART (dolutegravir/emtricitabine/tenofovir) started on day four...Rifampicin and azithromycin continue until radiological resolution, with suppressive monotherapy until immune reconstitution...It presented a therapeutic challenge due to the absence of EUCAST susceptibility breakpoints. This highlights the importance of timely diagnosis, appropriate treatment, and early ART in achieving favourable outcomes, without IRIS or toxicity."

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

Impact of switching from a bictegravir- or dolutegravir-based regimen with emtricitabine/tenofovir alafenamide to dolutegravir/lamivudine on weight and metabolic profiles: a randomized, open-label, multicenter, parallel-group trial (EACS 2025) - "Conclusions : Switching from DTG/FTC/TAF, but not from BIC/FTC/TAF, to DTG/3TC was associated with weight loss at week 48. A significant weight difference between the switch and continuation groups was observed in the DTG arm."

Clinical • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

Treatment switch among US Medicare beneficiaries with HIV (EACS 2025) - "The index date was the earliest initiation date of the following regimens: B/F/TAF, DTG/3TC, DTG/ABC/3TC, or DTG+FTC/TAF or DTG+FTC/TDF (multi-tablet regimens [MTRs]). In adjusted analyses, the HR of switch was 1.28 (CI: 1.13, 1.44) for DTG/3TC, 2.33 (2.15, 2.52) for DTG/ABC/3TC, and 4.75 (4.08, 5.55) for MTRs compared to B/F/TAF overall, with similar results in the mental health/substance use disorders subgroup (all P <0.05, Table 2 ). Conclusions : Among Medicare PWH, those taking B/F/TAF had lower likelihood of switch and longer time to switch than PWH taking other ART regimens, complementing persistence data from other countries."

Medicare • Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

Comparable Inflammatory and Metabolic Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Continuing Dolutegravir/Lamivudine in Virologically Suppressed Adults with HIV (INSTINCT/GESIDA10918 Study). (PubMed, Clin Infect Dis) - "In virologically suppressed individuals, maintaining DTG/3TC or switching to BIC/FTC/TAF demonstrated equivalent profiles with respect to systemic inflammation, metabolic outcomes, and immunologic markers over 96 weeks."

Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD8 • CRP • IL6

UNIVERSAL1: UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: PENTA Foundation | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

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

Growth-promoting hormonal alterations in pregnant women living with HIV receiving dolutegravir-based antiretroviral treatment are associated with lower infant 1-year weight z-scores. (PubMed, Front Pediatr) - "Pregnant women with HIV receiving dolutegravir/tenofovir/emtricitabine and HIV-seronegative women and their infants prospectively enrolled in the Botswana-based Tshilo Dikotla study were included in this analysis. Estradiol, sex-hormone binding globulin (SHBG), progesterone, cortisol, pituitary growth hormone-1 (GH1), insulin-like growth factor-1 (IGF-1), and insulin-like growth factor binding protein-1 (IGFBP-1) concentrations were measured in maternal plasma collected between 24 and 29 weeks' gestation...Associations between maternal growth-promoting hormones and infant weight at 1 year of life differ significantly by maternal HIV status, reflecting potential perturbations in the maternal-fetal-infant growth axis among pregnant women with HIV. Additional research is needed to identify mechanisms and possible interventions."

Journal • Human Immunodeficiency Virus • Infectious Disease • GH1 • IGF1 • IGFBP1

Opti-DOR: A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Professor Francois Venter | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Tenofovir alafenamide promotes weight gain and impairs fatty acid metabolism-related signaling pathways in visceral fat tissue compared to tenofovir disoproxil fumarate. (PubMed, Antiviral Res) - "We utilized a humanized mouse model of HIV-infection and administered two clinically relevant ART combinations TAF/dolutegravir (DTG)/emtricitabine (FTC) and TDF/DTG/FTC. Specifically, KEGG pathway analysis indicated that TAF/DTG/FTC treated mice showed suppression of multiple fatty acid metabolism related pathways, while TDF/DTG/FTC treated mice showed evidence for increased thermogenesis. The results suggest that weight gain associated with TAF-based ART may be due to impaired adipocyte mediated lipid handling, while suppressed weight gain with TDF-based ART may be secondary to increased browning of visceral adipocytes, although independent validation is necessary."

Journal • Human Immunodeficiency Virus • Infectious Disease • LEP

Bone mineral content, growth, and renal health of infants with perinatal exposure to maternal dolutegravir vs efavirenz and tenofovir disoproxil fumarate vs tenofovir alafenamide: the randomized IMPAACT 2010 (VESTED) trial. (PubMed, J Acquir Immune Defic Syndr) - "It is reassuring that maternal DTG-based ART during pregnancy and breastfeeding was associated with higher infant spine bone mineral content, better growth, and less stunting than EFV/FTC/TDF."

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

UNIVERSAL1: UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: PENTA Foundation | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

UNIVERSAL1: UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: PENTA Foundation | Trial completion date: Dec 2025 ➔ Aug 2025

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Outcomes following prenatal exposure to DTG‐containing antiretroviral therapy regimens: data from the DOLOMITE‐EPPICC study (HIV-Glasgow 2024) - "Our analysis focussed on five DTG-containing regimens: DTG+lamivudine (3TC) +abacavir (ABC), DTG+tenofovir disoproxil fumarate (TDF) +emtricitabine (FTC), DTG+tenofovir alafenamide (TAF) +FTC, DTG+3TC and DTG+rilpivirine (RPV)...The earliest DTG-containing regimen was DTG+3TC+ABC in 468 (56.2%), DTG+TDF+FTC in 132 (15.9%), DTG+TAF+FTC in 23 (2.8%), DTG+3TC/RPV in seven (0.8%) pregnancies. Of the remaining 203 (24.4%) pregnancies with other first DTG-containing regimens, most (78.8% [160/203]) were on regimens containing a drug from an additional anchor class (e.g. darunavir/ritonavir+TDF+FTC+DTG, atazanavir/ritonavir+TDF+FTC+DTG)...aDTG+3TC (n = 3) or DTG+RPV (n = 4)... The birth defect prevalence reported here is consistent with rates reported for DTG-exposed pregnancies in the Antiretroviral Pregnancy Registry (3.96%). Monitoring of use and safety of DTG-containing regimens in pregnancy is ongoing in EPPICC, as sample size for some groups is too small to exclude..."

Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

Effectiveness of a dual therapy based on DTG/3TC on reduction of the viral reservoir, immune recovery and immune activation compared with a triple antiretroviral therapy based on DTG/TAF/FTC in patients with HIV infection without prior treatment (HIV-Glasgow 2024) - P4 | "After this comprehensive assessment, we did not find differences between 2DR and 3DR in viral reservoir dynamics, CD4+ and CD8+ phenotypic changes, inflammatory profile and immune recovery. Abbreviations: 2DR, two-drug regimen; 3DR, three-drug regimen; HLA-DR, human leukocyte antigen-DR; hsCRP, high sensitivity C reactive protein; IFN-γ, interferon-γ; IL-1β, interleukin-1β; IL-6, interleukin-6; IL-8, interleukin-8; IP-10, interferon gamma-induced protein 10; IPDA, intact provirus DNA assay; IVRA, intact viral RNA assay; LAG-3, lymphocyte-activation gene 3; PD-1, programmed death-1; sCD14, soluble cluster of differentiation 14; sCD16, soluble cluster of differentiation 16; TIGIT, T-cell immunoreceptor with Ig and ITIM domains; TIM-3, T-cell immunoglobulin and mucin containing protein-3; TNF-α, tumour necrosis factor-α."

Clinical • IO biomarker • Human Immunodeficiency Virus • Infectious Disease • Oncology • ANXA5 • B2M • B3GAT1 • CD14 • CD38 • CD8 • CRP • CXCL8 • HAVCR2 • IL1B • IL6 • LAG3 • PD-1 • TIGIT • TNFA

Economic Evaluation of the Co-Formulated Antiretroviral Efavirenz 400mg/Lamivudine/Tenofovir Disoproxil Fumarate for the Treatment of HIV-1 Infection in Adult Patients From the Perspective of the Mexican Public Health System (ISPOR-EU 2024) - "The comparators included bictegravir+emtricitabine(FTC)+tenofovir alafenamide (TAF), dolutegravir(DTG)+abacavir+3TC, DTG+FTC+TAF, DTG+((FTC+TAF) or (FTC or 3TC [XTC]+tenofovir disoproxil [TDx]])), DTG+3TC, doravirine+TDx+3TC, efavirenz(EFV)+TDx, darunavir+cobicistat+ ((TAF+FTC) or (TDx+FTC or 3TC)), doravirine+((TAF+FTC) or (TDx+FTC or 3TC)), EFV+((TAF+FTC) or (TDx+XTC)), raltegravir+((TAF+FTC) o (TDx+FTC or 3TC)), darunavir+cobicistat+ 3TC. EFV400/3TC/TDF shows no statistically significant differences in viral suppression and safety. It is a cost-saving option with savings of up to 75.1% compared to some of its competitors, making it a valuable option for the National Health System in Mexico for treating HIV-1 infection in adult patients."

Clinical • HEOR • Human Immunodeficiency Virus • Infectious Disease

Impact of Dolutegravir plus Lamivudine as First-Line Antiretroviral Treatment on HIV-1 Reservoir and Inflammatory Markers in Peripheral Blood. (PubMed, J Infect Dis) - "First-line ART with DTG+3TC resulted in a similar reduction of HIV-1 persistence parameters in peripheral blood, and comparable changes in immune-associated soluble and T-cell markers compared with DTG+FTC/TAF. These findings support recommendation of DTG/3TC among preferred options for first-line ART in PWH."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD8 • IL6

Effects of switching to Dolutegravir/Lamivudine from Tenofovir Alafenamide Fumarate/Emtricitabine/Dolutegravir or Abacavir/Lamivudine/Dolutegravir on body weight and lipid profile in Japanese people living with HIV. (PubMed, J Infect Chemother) - "Switching from ABC/3TC/DTG to DTG/3TC lowered lipids significantly, but not with TAF/FTC/DTG. Neither switch affected body weight or other markers."

Journal • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study. (PubMed, Open Forum Infect Dis) - "Switching to DTG/3TC was noninferior to continuing B/F/TAF among adults with virologic suppression at week 48. Drug-related AEs and withdrawals were higher in the DTG/3TC arm, which is likely consistent with the open-label nature of this switch study."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Lipid and glucose profiles in pregnant women with HIV on tenofovir-based antiretroviral therapy. (PubMed, Clin Infect Dis) - "Pregnant women randomized to start TAF/FTC+DTG had higher lipids than those randomized to TDF/FTC+DTG within eight weeks of ART initiation. However, lipid levels were within normal reference ranges."

Journal • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease

Characterizing HIV drug resistance in cases of vertical transmission in the VESTED randomized antiretroviral treatment trial. (PubMed, J Acquir Immune Defic Syndr) - P3 | "VESTED (NCT03048422) compared the safety and efficacy of three antiretroviral treatment (ART) regimens in pregnant and postpartum women: dolutegravir+emtricitabine/tenofovir alafenamide fumarate; dolutegravir+emtricitabine/tenofovir disoproxil fumarate (TDF); efavirenz/emtricitabine/TDF...Their infants received postnatal nevirapine+/-zidovudine prophylaxis and were breastfed...VT was rare. New-onset NNRTI HIVDR in Case mothers was likely from efavirenz-ART prescribed prior to study dolutegravir-ART, and in one case appeared transmitted to the infant despite nevirapine prophylaxis."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

Health care resource utilization and costs for treatment-experienced people with HIV switching or restarting antiretroviral regimens since 2018. (PubMed, J Manag Care Spec Pharm) - "We examined all-cause HCRU and costs and HIV-related HCRU and combined costs to the health plan and direct patient costs by site of service and compared between INSTI-based regimens: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (single tablet) vs dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) (single tablet), dolutegravir + emtricitabine/tenofovir alafenamide (DTG+FTC/TAF) (multitablet), and dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+FTC/TDF) (multitablet). HIV-related medical costs during the LOT were lowest for PWH treated with INSTI-based single-tablet regimens. Simplifying treatment regimens may help PWH maintain lower health care costs."

HEOR • Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease