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

Antiretroviral therapy regimens initiated during pregnancy and risks of adverse perinatal outcomes. (PubMed, AIDS) - "Our observational study findings for the composite outcome were comparable to the IMPAACT 2010/VESTED trial in a real-world programmatic setting and enabled evaluation of additional regimen and broader set of outcomes. In settings where randomized trial data are limited, well designed observational emulations of trials using nonrandomized data can provide informative evidence. As Botswana expands use of TAF in pregnancy, these results provide reassuring evidence supporting its safety."

Adverse events • Journal • Human Immunodeficiency Virus • Infectious Disease • Small for Gestational Age

Expediting a UNIVERSAL first-line regimen of a dolutegravir-emtricitabine-tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity trial. (PubMed, Lancet HIV) - P2 | "These data support proposed dosing of the dispersible fixed-dose combination (dolutegravir [5 mg]-emtricitabine [15 mg]-tenofovir alafenamide [1·88 mg]) for children weighing between 3 kg and less than 20 kg and extension of the licensed film-coated tablet (dolutegravir [50 mg]-emtricitabine [200 mg]-tenofovir alafenamide [25 mg]) for children weighing 20 kg or over."

Journal • P1/2 data • PK/PD data • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Malaria • Pediatrics

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

Simulation-Based Predictions to Support the Development of a Pediatric Fixed-Dose Combination of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate. (PubMed, Clin Pharmacokinet) - "This paper presents a modeling approach to determine an optimal FDC ratio for pediatric DTG/FTC/TAF. The strategy predicted effective drug exposure and safety across age and weight bands, supporting the development of a child-friendly FDC that could accelerate access to human immunodeficiency virus treatment in low- and middle-income countries. This dosing regimen is being further evaluated in the UNIVERSAL-1 clinical trial."

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

Access to quality affordable WHO-recommended non-TLD first-line HIV treatment – TAF-based, dual oral, and long-acting – regimens in LMICs: mapping the landscape of MPP-licensed products (AIDS 2026) - " Generic TAF-based products (TAF/FTC/DTG 25/200/50 mg and TAF/3TC/DTG 25/300/50 mg tablets), dual DTG-based regimen DTG/3TC (50/300 mg), and CAB-LA (200 mg/mL) + RPV-LA (300 mg/mL) are all potentially accessible in a large number of LMICs (Figure 1-A,B,C). This data shows that, despite limited progress to date, TAF-based and dual oral regimens could be implemented in many more LMICs – covering most of Africa and many countries in Asia, Eastern Europe, Latin America, and the Caribbean – at generic-induced affordable prices, which should further reduce as demand increases. Once developed, CAB-LA+RPV-LA could also be widely accessible."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Opti-DOR: 48 week data on DOR/3TC/TDF as an alternative first-line antiretroviral therapy (ART) regimen to integrase inhibitors for people with HIV and BMI>25kg/m2 in a randomised phase 3b non-inferiority study (AIDS 2026) - "DOR/3TC/TDF was non-inferior to DTG/TAF/FTC for Week 48 virologic efficacy, both regimens were well tolerated, with DOR/3TC/TDF associated with less weight gain. Individual agent contribution to weight gain cannot be isolated as this was a regimen-level comparison."

Clinical • Head-to-Head • Late-breaking abstract • P3 data • Human Immunodeficiency Virus • Infectious Disease

Internal migration of people living with HIV during armed aggression against Ukraine: challenges to HIV care retention and lessons from a country experience (AIDS 2026) - "Key interventions: • rapid scale-up of MMD; • accelerated transition to TLD as the preferred first-line regimen; • prioritization of fixed-dose combinations (TLD, TAF/FTC/DTG, ABC/3TC/DTG, TLE) • regulatory authorization to dispense up to three months of ARVs at the moment of HCF or regional change, regardless of prior registration; • establishment of a central buffer stock of ARVs to mitigate sudden regional shortages; • continuous operation of a nationwide unified electronic medical information system (IS MSSD), enabling all HIV physicians to access `ART history` and clinical data in real time... Ukraine’s experience shows that resilient HIV care during armed conflict is achievable through flexible regulation, differentiated ART delivery, supply chain buffering and interoperable information systems. These lessons are applicable to other humanitarian settings with high population mobility. Future efforts should focus on strengthen long-term retention among internally..."

Human Immunodeficiency Virus • Infectious Disease

Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Nave Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (clinicaltrials.gov) - P1/2 | N=660 | Recruiting | Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.

New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

UNIVERSAL1: UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (clinicaltrials.gov) - P2 | N=53 | Completed | Sponsor: PENTA Foundation | Trial primary completion date: Sep 2025 ➔ Jun 2025 | Active, not recruiting ➔ Completed

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

Pharmacokinetics of Dolutegravir, nucleoside analogues, and intracellular metabolites using plasma separation cards: A comparative analysis with traditional sampling methods in healthy volunteers. (PubMed, PLoS One) - P1 | "This study provides important insights into the elimination kinetics of NRTI, their intracellular metabolites and DTG. Plasma separation cards are a promising alternative for adherence monitoring, enabling simultaneous quantification of parent and intracellular moieties from a single sample. Differences in TFV-DP levels between TDF and TAF regimens, and DBS sampling method, underscore the need for matrix and regimen-specific interpretation to validate adherence benchmarks."

Clinical • Journal • PK/PD data

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