emtricitabine/tenofovir disoproxil fumarate / Generic mfg. - LARVOL DELTA

Integrating long-acting injectable cabotegravir for HIV prevention into the Brazilian public health system (ImPrEP CAB Brasil): a hybrid type-2 implementation-effectiveness cohort study. (PubMed, Lancet HIV) - P3 | "Same-day CAB-LA delivery effectively reduced HIV incidence and increased PrEP coverage, supporting the implementation of long-acting options within SUS in Brazil."

Journal • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (clinicaltrials.gov) - P3 | N=4390 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Effect of Same-Day, Direct HIV PrEP Dispensation on PrEP Initiation and Early Retention in a Sexual Health Clinic. (PubMed, Sex Transm Dis) - "In this urban SHC, early PrEP retention remained stable at approximately 70%. Same-day, in-clinic dispensing was not associated with improved early retention but may reduce barriers and delays, representing a feasible low-barrier delivery model in resourced SHCs."

Journal • Human Immunodeficiency Virus • Infectious Disease

Evaluating the Optimal Frequency of Renal Monitoring with Daily Oral TDF/FTC PrEP: A Retrospective Chart Review (IDWeek 2026) - No abstract available

Retrospective data • Review • Human Immunodeficiency Virus • Infectious Disease

Effect of Pregnancy on Intracellular Tenofovir Diphosphate Exposure and Thresholds following Oral Emtricitabine-Tenofovir Disoproxil fumarate Pre-Exposure Prophylaxis: A Directly Observed Dosing Study. (PubMed, J Infect Dis) - "Steady-state TFV-DP concentrations in PBMCs were reassuringly not meaningfully different between pregnant and non-pregnant women."

Journal • Human Immunodeficiency Virus • Infectious Disease

Exploring Preferences for Long-Acting Injectable PrEP Among Postpartum Women in South Africa Using the Consolidated Framework for Implementation Research: The Siphila Sonke Study. (PubMed, AIDS Behav) - "While oral TDF/FTC pre-exposure prophylaxis (PrEP) is safe, effective, and recommended for pregnant and postpartum women, adherence to a daily pill is challenging, particularly during the postpartum period...At the outer setting, cultural beliefs/practices during postpartum were important determinants. Our findings indicate interest and willingness to consider LAI PrEP among postpartum women and highlight implementation opportunities to reduce HIV acquisition and perinatal transmission."

Journal • Human Immunodeficiency Virus • Infectious Disease

Predicting Oral HIV Pre-Exposure Prophylaxis Efficacy in Cisgender Women Across Pregnancy and Postpartum. (PubMed, J Clin Pharmacol) - "Oral pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate (F/TDF) is recommended in pregnancy despite limited published pharmacokinetic (PK) and efficacy data during pregnancy. At high adherence levels of five or more pills per week, predicted effectiveness remained high across pregnancy and postpartum and effectiveness exceeded 97% for both regimens, with maximum decreases in the second trimester of only 0.9 percent point for F/TDF and 0.3 percent point for F/TAF. These findings suggest that adherence is the primary determinant of PrEP effectiveness during pregnancy and postpartum, while pregnancy-related PK changes have a limited impact on efficacy."

Journal • Human Immunodeficiency Virus • Infectious Disease

SimpPrEP: Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. (clinicaltrials.gov) - P3 | N=524 | Recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Trial completion date: May 2027 ➔ May 2028 | Trial primary completion date: Oct 2026 ➔ Dec 2027

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

Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Brigham and Women's Hospital

New P1 trial • Alzheimer's Disease • CNS Disorders

Daily HIV pre-exposure prophylaxis enhances monocyte activation and reprogrammes immune cell metabolism. (PubMed, Front Immunol) - "Reduced glucose dependency was observed in monocytes, CD56dim NK cells and CD4+ T cells 6-9 months after PrEP initiation. Daily TDF/FTC promotes monocyte activation, enhances pro-inflammatory responses, and appears to reprogramme immune cell metabolism, highlighting ART's potential to modulate immune-mediated inflammatory pathways in HIV-negative individuals."

IO biomarker • Journal • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD14 • CD40 • CSF2 • GZMB • IFNG • IL1B

Determinants of PrEP Delivery Platform Choice in Adolescents and Young People: The Fast-PrEP Project in Cape Town, South Africa. (PubMed, Int J Environ Res Public Health) - "Our results indicate that offering community-based PrEP alongside public sector facilities increases the reach of a diverse group of AYP who may benefit from PrEP."

Journal • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Psychiatry

Estimated benefits of providing on-demand pre-exposure prophylaxis options for cisgender women in South Africa: A modeling study. (PubMed, PLoS One) - "Our model suggests that on-demand PrEP could benefit women with low daily PrEP adherence by decreasing the number of days when pills need to be taken and modestly increasing effectiveness compared to a daily regimen. This would be a valuable and easy-to-implement additional option in places where daily oral PrEP is already available."

Journal • Human Immunodeficiency Virus • Infectious Disease

Comparing carbon emissions from oral tenofovir disoproxil fumarate/emtricitabine for preexposure prophylaxis and long-acting injectables for HIV prevention. (PubMed, AIDS) - "Estimated greenhouse gas emissions from active pharmaceutical ingredient (API) production were compared for oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and long-acting injectable preexposure prophylaxis (PrEP) agents, cabotegravir (CAB-LA) and lenacapavir (LEN). For 2 million person-years of PrEP, TDF/FTC generated approximately 108 million kg CO2e, compared with 4.1 million kg for CAB-LA and less than 0.1 million kg for LEN. These findings suggest substantially lower emissions with long-acting agents, supporting consideration of environmental sustainability in HIV prevention strategies."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Oak Crest Institute of Science | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Perinatal antiretroviral-associated cytokine and gut microbiota outcomes in deer mouse dams and their behaviorally diverse adult offspring. (PubMed, Brain Behav Immun) - "Roll-out of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based pre-exposure prophylaxis (PrEP) for HIV prevention during pregnancy is increasing the number of infants perinatally exposed to antiretrovirals...These findings suggest involvement of gut-immune-brain mechanisms as important modulators of the long-term impact of perinatal ART exposure on offspring neurobehavioral outcomes. This work also confirms the deer mouse as a valuable model for investigating naturalistic neurodevelopmental consequences of perinatal ART exposure."

Journal • Preclinical • Alzheimer's Disease • Cognitive Disorders • Human Immunodeficiency Virus • Immune Modulation • Immunology • Infectious Disease • Inflammation

Cost-effectiveness of lenacapavir versus tenofovir disoproxil fumarate plus emtricitabine for pre-exposure prophylaxis to prevent HIV-1 transmission in gay, bisexual, and other men who have sex with men in Spain. (PubMed, Lancet Reg Health Eur) - "Substantial price reductions will likely be required to enable equitable access and realise its full public health potential. None."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

High Baseline Prevalence and Stable Incidence of Chlamydia and Gonorrhea During the First Year of HIV Pre-Exposure Prophylaxis: A Multicenter Italian Cohort Study. (PubMed, Sex Transm Dis) - "In this real-world PrEP cohort undergoing quarterly NAAT screening, CT/NG diagnoses were common at baseline and maintained high but stable incidence during the first year after PrEP initiation, with no clear upward trend over time."

Journal • Human Immunodeficiency Virus • Infectious Disease

Lenacapavir: A Review in HIV Pre-Exposure Prophylaxis. (PubMed, Drugs) - "HIV incidence with lenacapavir was significantly lower than the background HIV incidence and the HIV incidence with daily oral PrEP (emtricitabine/tenofovir disoproxil fumarate). Lenacapavir was generally well tolerated, with mostly mild or moderate injection‑site reactions (ISRs) that declined in frequency over time. With its convenient twice‑yearly dosing schedule and SC route of administration, lenacapavir represents a valuable addition to the current portfolio of HIV PrEP options."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

PURPOSE-4: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (clinicaltrials.gov) - P2 | N=181 | Active, not recruiting | Sponsor: Gilead Sciences | Trial primary completion date: Jan 2028 ➔ Jul 2026

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project (clinicaltrials.gov) - P4 | N=162 | Completed | Sponsor: Rutgers, The State University of New Jersey | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Antiretroviral Therapy in India (2025): Drugs, Indications, Contraindications, Mechanisms, and Prophylaxis (PEP/PrEP). (PubMed, J Assoc Physicians India) - "India's ART platform is strong and increasingly INSTI-based. Scaling PrEP, standardizing DTG-aligned PEP, fortifying viral load and resistance monitoring, and integrating long-acting prevention as it becomes available are the next priorities."

Journal • Review • 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

Preclinical Pharmacokinetics of a Triple-Combination Intravaginal Ring for HIV Prevention. (PubMed, Pharmaceutics) - " We formulated two different triple-combination antiretroviral IVRs, both delivering the acid salt tenofovir (TFV), disoproxil fumarate (TDF), and the free base emtricitabine (FTC), with one delivering elvitegravir (EVG) as the free acid and the other as the sodium salt. TFV and FTC concentrations in rectal tissue and fluid suggested potential for dual-compartment HIV-1 protection, although the vaginal-to-rectal drug transport mechanism appeared to differ across both species. The humanized mouse vaginal HIV-1 efficacy model was used to empirically compare combination effects when TDF, FTC, and EVG were co-administered, and TDF-EVG was identified as a promising combination to be developed further for IVR delivery in parallel with the triple combination."

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

Maternal and pregnancy outcomes in women offered daily oral preexposure prophylaxis during pregnancy and postpartum. (PubMed, AIDS) - "Daily oral FTC-TDF remains a well tolerated and essential component of HIV prevention in pregnancy."

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

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