Descovy (emtricitabine/tenofovir alafenamide) / Gilead - LARVOL DELTA

Insurance Denials And Cost Sharing For PrEP Among Sexual And Gender Minority People. (PubMed, Health Aff (Millwood)) - "Of 11,410 participants reporting current or former PrEP use, 23.7 percent had ever experienced a denial for their PrEP, ranging from 8.5 percent for generic tenofovir disoproxil fumarate and emtricitabine to 48.2 percent for Descovy. The majority (58.3 percent) of cost-sharing instances were for laboratory bloodwork, and most (61.5 percent) were among privately insured people. Continued insurance denials and cost sharing associated with PrEP necessitate further policy intervention to address gaps in coverage, billing errors, and challenges resulting from formulary tiering."

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

Efficacy and safety of emtricitabine/tenofovir alafenamide (F/TAF) plus cobicistat-boosted protease inhibitors in children with HIV-1 aged 2-<12 years and weighing 14-<40 kg: Week 48 outcomes (IAS-HIV 2025) - P2/3 | "BACKGROUND: TAF is a nucleoside reverse transcriptase inhibitor with improved renal and bone safety compared with tenofovir disoproxil fumarate. F/TAF is approved in Europe and the US for use with boosted protease inhibitors in adults and older children, and is being evaluated with cobicistat-boosted atazanavir (ATV/co) or darunavir (DRV/co) in younger children in an ongoing open-label Phase 2/3 trial (NCT02016924)... Over 48 weeks of treatment, F/TAF + ATV/co or DRV/co in children aged 2-<12 years and weighing 14-<40 kg maintained high rates of virologic suppression, with an acceptable safety profile. There were no renal, bone, or weight gain/loss concerns, supporting further evaluation of these drug combinations in pediatric populations."

Clinical • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

A5391: a randomized multicenter 3-arm controlled trial for people with obesity on integrase inhibitors and tenofovir alafenamide switching to doravirine, with or without tenofovir disoproxil fumarate (The DO-IT Trial) (IAS-HIV 2025) - "ACTG A5391 evaluated whether switching to doravirine (DOR; a non-nucleoside reverse transcriptase inhibitor) with or without a switch to tenofovir disoproxil fumarate (TDF) would alter weight in people with HIV and obesity on INSTI+TAF regimens. A phase IV, 48-week, 3-arm, open-label, multicenter randomized trial to assess whether switch from an INSTI (bictegravir, dolutegravir, or raltegravir) with TAF/emtricitabine (TAF/FTC) to either DOR+TAF/FTC or DOR+TDF/FTC results in a >5% point between-group difference in body weight change (a clinically relevant effect), compared to continuing current INSTI+TAF/FTC. In people with HIV and obesity, switching from an INSTI+TAF/FTC regimen to doravirine/FTC with either TAF or TDF did not result in substantial weight change at one year, including among women and Blacks."

Clinical • Late-breaking abstract • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Making PrEP smart: persistence, use, and acceptability of a PrEP adherence and HIV-self testing app among women in the South Bronx, New York City (IAS-HIV 2025) - "Participants received PrEP (TDF/FTC or TAF/FTC), free HIV self-testing (HIVST) kits, and downloaded the "SmartPrEP" app which sent personalized daily adherence queries. The study found low HIV risk perception and heterogenous PrEP adherence over 12 months of observation among these women at elevated risk of HIV, despite high app acceptability. As long-acting PrEP formulations become available, addressing gaps in risk perception among women remains critical."

Adherence • Clinical • Human Immunodeficiency Virus • Infectious Disease

Prescription of HIV Pre-Exposure Prophylaxis and HIV incidence in a cohort of women with Severe Mental Illnesses in the U.S. (IAS-HIV 2025) - "PrEP was defined as prescription for TDF/FTC or TAF/FTC without concurrent prescription for a third antiretroviral. PrEP use relative to HIV incidence among commercially-insured women with SMI is lower than national trends suggesting rates of prescription are not meeting the public health need. Concerted, specific effort is needed to increase PrEP use among women, especially those living with SMI given disproportionate HIV incidence among this group."

Clinical • Bipolar Disorder • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry • Schizophrenia

Acceptability and adherence to daily oral PrEP among adolescent girls and young women in sub-Saharan Africa: a randomized clinical trial comparing F/TAF and F/TDF (IAS-HIV 2025) - "BACKGROUND: Adolescent girls and young women (AGYW) in sub-Saharan Africa face disproportionately high HIV infection rates and show low adherence to approved HIV prevention methods like F/TDF (Truvada®). While both oral PrEP products were acceptable, F/TAF characteristics appeared to support better adherence. However, with only a quarter of participants taking the products consistently, additional strategies to support adherence remain crucial for effective HIV prevention in AGYW."

Adherence • Clinical • Human Immunodeficiency Virus • Infectious Disease

Differential HIV incidence and PrEP-to-need ratio among a large, diverse cohort of people with Mental Illnesses in the U.S. (IAS-HIV 2025) - "We determined the number of new HIV diagnoses (defined as a two outpatient claims on different dates or one inpatient claim with an HIV-associated diagnosis code) and prescriptions for PrEP (defined as at least 28 days of TDF/FTC or TAF/FTC without prescription of another antiretroviral). In this large, national analysis, commercially-insured people with schizophrenia experienced the highest HIV incidence and lowest PrEP use. While the PnR for all groups increased during the period of analysis, HIV incidence remained relatively constant or increased for all groups despite national decrease. Targeted efforts are needed to accurately identify people with MI who may benefit from PrEP and to include in the PrEP care continuum."

Bipolar Disorder • CNS Disorders • Depression • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Psychiatry • Schizophrenia

"It seemed like something I couldn't ask for:" a qualitative analysis of cis- and transgender women's experiences along the PrEP cascade in the South Bronx, New York City (IAS-HIV 2025) - "Participants received daily oral PrEP (TDF/FTC or TAF/FTC) and downloaded a study-specific adherence support smartphone app. This rigorous analysis from a small but diverse cohort of C/TGW enriches understanding of the PrEP cascade in C/TGW, particularly awareness and adherence stages. Both cis- and transgender women identified addressing stigma, increasing awareness, and fostering provider willingness to prescribe PrEP as strategies to strengthen the PrEP cascade for C/TGW."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Effect of SARS-CoV-2 vaccination on HIV viral load in patients under BIC/TAF/FTC therapy: a retrospective observational study (EACS 2025) - No abstract available

Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease

Efficacy and tolerability of BIC/TAF/FTC in people with HIV and solid and hematological neoplasms: a multicenter observational study (BIKONCO Study) (EACS 2025) - No abstract available

Clinical • Observational data • Human Immunodeficiency Virus • Infectious Disease

Switch to BIC/TAF/FTC or DTG + TDF/FTC in virologically suppressed PWH: outcomes in real-world setting and impact of tenofovir resistance (EACS 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease

LONG-TERM BIC/TAF/FTC DURABILITY AND IMPACT OF DTG/3TC OR LONG-ACTING CABO/RPV (EACS 2025) - No abstract available

Infectious Disease

Impact of bictegravir/emtricitabin/tenofovir alafenamid (BIC/TAF/FTC) and Dolutegravir/Lamivudine on Depression Symptoms in People Living with HIV: A Retrospective Analysis of Beck Depression Inventory Scores (EACS 2025) - No abstract available

Retrospective data • Human Immunodeficiency Virus • Infectious Disease

Exclusionary data, inclusionary appeals: Gender and equity in an HIV-prevention clinical trial. (PubMed, Soc Stud Sci) - "Extending prior work in science and technology studies on how epistemological frameworks in clinical trials matter for concerns about the production of knowledge and social justice, we show how different conceptualizations of inclusion and equity (specifically, equity in data versus equity in access) come into tension in deliberations over pharmaceutical drug approvals. We argue that the discursive conflict over gender and inclusionary/exclusionary research practices that emerged in the case of Descovy points to an underappreciated feature of equity-temporality-that should be attended to when examining knowledge production in 21st-century clinical and regulatory landscapes."

Journal • Human Immunodeficiency Virus • Infectious Disease

Use of cognitive interviews to develop PrEP education for men in New York and Alabama. (PubMed, Patient Educ Couns) - "The training series has the potential to promote shared decision making in a healthcare setting. Feedback collected during cognitive interviews demonstrates the need for clear and comprehensive PrEP educational tools made specifically for patients as well as the need for involvement of the priority intervention audience in the creation of the training materials prior to their release to the public."

Interview • Journal • Human Immunodeficiency Virus • Infectious Disease

PURPOSE 1: Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (clinicaltrials.gov) - P3 | N=5368 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Jul 2027 ➔ Jan 2028

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic data of atazanavir/ritonavir in second-line treatment of children living with HIV. (PubMed, J Acquir Immune Defic Syndr) - "This nested pharmacokinetic sub-study shows that children weighing 14-24.9 kg and >25 kg taking ATV/r 200/75 mg and 300/100 mg respectively, achieve concentrations comparable to those that are safe and effective in adults."

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

Evaluating adherence in an active-controlled HIV pre-exposure prophylaxis trial (PrEPVacc) to inform the estimation of HIV incidence in a counterfactual placebo arm. (PubMed, HIV Res Clin Pract) - P2 | "From December 2020 to March 2023 participants were recruited into the trial which included a comparison of Emtricitabine/Tenofovir Alafenamide (TAF/FTC) to TDF/FTC as PrEP over 26 weeks of follow-up, in Uganda, Tanzania, and South Africa. TDF/FTC adherence in the PrEPVacc trial was low, with considerable levels of white coat dosing. Inferring the counterfactual placebo HIV incidence using the estimated effectiveness of TDF/FTC is a promising approach, however, the approach requires further elaboration and evaluation."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Incidence of Metabolic syndrome in people with HIV without experienCe to antiretroviral Therapy who start doLutegravir based-regimen compared with bictegrAvir based-regimeN after 48 weeks (MICTLAN trial). (PubMed, AIDS) - "Incidence of MetS among PWH receiving an INSTI-based regimen was high, with no difference between BIC/TAF/FTC and DTG/ABC/3TC groups. Age, overweight and elevated visceral fat at baseline were all associated with MetS."

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

CROI 2025: global epidemiology and prevention of HIV and other sexually transmitted diseases. (PubMed, Top Antivir Med) - "Although the use of long-acting injectable cabotegravir (CAB-LA) remains low in the US, several programs have demonstrated high persistence...PrEP with emtricitabine/tenofovir alafenamide was shown to reduce HIV infections in cisgender women adherent to PrEP. A single once-yearly injection with lenacapavir showed promising pharmacokinetic results and a phase III trial is planned. Interest in doxycycline postexposure prophylaxis is high, and real-world implementation has been associated with significant declines in bacterial sexually transmitted infections."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Epidural Gas Tracking in a Case of Streptococcus Dysgalactiae (ATS 2025) - "Case:53 year old female with past medical history of HIV–on Descovy and Tivicay (with viral load 91 and CD4 count of 18), cervical myelopathy status-post fusion on 4/1/2024, neurogenic bladder, DM, pressure injury of sacral region who was transferred for septic shock...Treated with vancomycin and meropenem for CNS penetration and TMX-SMX for prophylaxis...Prompt diagnosis is required since it can lead to severe neurological deficits and meningitis. Mainstay of diagnosis is MRI, and treatment is source control with surgical evacuation/source control."

Clinical • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Septic Shock • CD4

Cost-effectiveness of cabotegravir versus tenofovir alafenamide plus emtricitabine versus tenofovir disoproxil fumarate plus emtricitabine for pre-exposure prophylaxis to prevent HIV-1 transmission in gay, bisexual and other men that have sex with men. (PubMed, Enferm Infecc Microbiol Clin (Engl Ed)) - "The present Spanish policy of PrEP is a cost-saving strategy. TAF/FTC and CAB are not cost-effective at current market prices."

HEOR • Journal • Human Immunodeficiency Virus • Infectious Disease

A Stable Switch From Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) to Dolutegravir/Lamivudine (DTG/3TC) in the Absence of Historical Resistance Records: Results From the Switch to Dovato in Patients Suppressed on Biktarvy (SOUND) Cohort. (PubMed, Cureus) - " Results from SOUND support the efficacy and safety of switching to DTG/3TC for people living with HIV-1 who are virologically suppressed on B/FTC/TAF with unknown resistance history and may confer a weight advantage."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

No significant drug-drug interaction between oral TAF-based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT-3 study. (PubMed, J Int AIDS Soc) - P=N/A | "No bidirectional clinically significant DDI between FHT and F/TAF-based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF-based PrEP among transgender women."

Journal • Human Immunodeficiency Virus • Infectious Disease

Salvage therapy with an Albuvirtide-based antiretroviral regimen for multi-drug resistant HIV and drug-resistant HBV with renal impairment: a case report. (PubMed, Virol J) - "This case underscores the potential value of individualized treatment strategies for patients with multidrug-resistant HIV and HBV co-infection complicated by renal impairment. The observed virological control following the use of novel agents such as Albuvirtide (ABT), in combination with second-generation integrase strand transfer inhibitors (INSTIs) like DTG, alongside renal-sparing antivirals, highlights the importance of designing optimized regimens based on resistance profiles and renal function. This personalized and adaptive therapeutic approach may offer clinical benefits in similarly complex scenarios."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Nephrology • Renal Disease