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

The Effect of SARS-CoV-2 Vaccination on HIV Viral Load in Patients Under Bictegravir/Tenofovir Alafenamide/Emtricitabine Therapy: A Retrospective Observational Study. (PubMed, Healthcare (Basel)) - "The rebound rate was lower in the vaccinated group compared to non-vaccinated, with a statistically significant difference (respectively, 2.7% vs. 11.9%, p = 0.037). our data suggest that SARS-CoV-2 vaccination may stimulate an immune response that enhances CD4+ and CD8+ cell function, contributing to a reduction in the number of blips and maintaining good viro-immunological control in patients with HIV, supporting the importance of vaccination in this population."

Journal • Observational data • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

No DDI between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (EASL 2025) - "BEM/RZR and B/FTC/TAF, alone and co-administered, were well tolerated in healthy subjects with no clinically relevant PK DDI. These results support the enrollment of HCV/HIV-co- infected subjects receiving B/FTC/TAF in BEM/RZR clinical trials."

Human Immunodeficiency Virus • Infectious Disease

Exploring potential drug-drug interactions between masculinizing hormone therapy and oral pre-exposure prophylaxis (F/TDF and F/TAF) among transgender men (iMACT study): a randomized, open-label pharmacokinetic study in Thailand. (PubMed, J Int AIDS Soc) - P=N/A | "Our findings across multiple anatomical compartments suggest that oral PrEP should not affect the effectiveness of MHT and that F/TDF-based PrEP should be effective when taken with MHT. However, further research is needed to assess the effectiveness of TAF-based PrEP in transgender men."

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

Qualitative Assessment of Acceptability and Preferences for Injectable and Oral PrEP in PURPOSE 1 (CROI 2025) - "Background PURPOSE 1 demonstrated 100% efficacy of twice-yearly injectable lenacapavir (LEN) for HIV pre-exposure prophylaxis (PrEP) in cisgender adolescent girls and young women. Conclusions PURPOSE 1 participants valued sustained protection from HIV, often preferred the lifestyle fit of a twice-yearly injectable vs daily oral PrEP, and accepted pain and injection-site reactions. These data suggest acceptability and preference for twice-yearly injections and/or F/TAF, reinforcing the value of product choice."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • Pain

Weight Change on F/TAF vs Placebo: Using Common F/TDF Groups to Bridge Data Across Clinical Trials (CROI 2025) - P3 | "Reversible weight-suppressive effects of emtricitabine/tenofovir disoproxil fumarate (F/TDF) have been demonstrated, while effects of emtricitabine/tenofovir alafenamide (F/TAF) are debated. Greater weight gain among those who switched from F/TDF was consistent with a reversible weight-suppressive effect of F/TDF. Similar observed weight change with F/TAF and placebo in people without HIV suggests no clinically meaningful effect of F/TAF on weight gain."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Body Composition Changes in People With HIV Switching to DTG/3TC or BIC/TAF/FTC (CROI 2025) - P4 | "Background Background: Switching to DTG/3TC (DOV) or BIC/FTC/TAF (BIK) in the PASO-DOBLE trial (ClinicalTrials.gov NCT04884139) showed noninferior efficacy of DOV vs. BIK and weight gain in both groups, which was significantly greater for BIK at 48 weeks. Increases in TM and LFM were significantly greater with BIK than with DOV. Fat gain in any compartment was associated with insulin resistance."

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

Week 24 Outcomes of F/TAF Plus Cobicistat-Boosted Protease Inhibitors in Children ≥2 y and ≥14 kg (CROI 2025) - P2/3 | "An ongoing Phase 2/3 open-label trial is evaluating F/TAF in combination with cobicistat-boosted atazanavir (ATV/co) or darunavir (DRV/co) in children with HIV-1 (NCT02016924). Changes in height, weight, and body mass index Z-scores; spine and TBLH BMD; and eGFR were not clinically significant (Table). Conclusions In this interim analysis, F/TAF in combination with ATV/co or DRV/co in children aged 2-<12 y and weighing 14-<40 kg was efficacious, with an acceptable safety profile and no renal, bone, or weight concerns, supporting further evaluation in pediatric populations."

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

Re-Examining InSTI Effects on Weight Gain Among Treatment-Naive People With HIV in North America (CROI 2025) - "Results Among 32,962 included individuals, median baseline age and BMI were 41 years and 25.4 kg/m2, respectively; 84% were male, and 45% were Black; 10,406 started an INSTI, 13,500 an NNRTI, and 9,056 a PI; and 72% initiated on TDF/FTC, 12% ABC/3TC, and 11% TAF/FTC. These findings suggest that the previously reported differences in weight gain between ART regimens may not be entirely explained by EFV's weight-suppressive effects or its coformulation with TDF. Additionally, other agents, such as non-EFV NNRTIs and EVG/c, may also have weight-suppressive properties."

Human Immunodeficiency Virus • Infectious Disease • CD4

Oral and Injectable PrEP Use Among US Adolescents and Young Adults, 2019-2023 (CROI 2025) - "We estimated the number of adolescents (aged 13–19 years) and young adults (aged 20–24 years) prescribed branded or generic FTC/TDF, branded FTC/TAF, or long-acting injectable cabotegravir (CAB-LA) during 2019–2023. Injectable PrEP use among adolescents and young adults was low compared with oral medication, though its use has increased slightly since it has become available. Increasing PrEP use among young people who would benefit from it remains important to address the HIV epidemic."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Suboptimal Laboratory Testing of PrEP Users: United States, 2022-2023 (CROI 2025) - "Testing users of tenofovir alafenamide and emtricitabine (TAF/FTC) for lipids is recommended at initiation and annually during use...PrEP users might have been tested for HIV using only a point-of-care (POC) test to facilitate rapid PrEP initiation despite a recommendation to confirm a negative POC test result with lab-based HIV testing. Implementation of clinical decision supports with automated lab order sets tailored to each type of PrEP medication could increase adherence to recommended PrEP lab testing."

Late-breaking abstract • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Point-of-Care Urine Tenofovir Feedback Counseling Improves PrEP Adherence for US MSM in Pilot RCT (CROI 2025) - "Conclusions In a diverse sample of YMSM using daily oral F/TDF or F/TAF PrEP, a pilot RCT of a telehealth MI-informed POC urine TFV testing intervention demonstrated preliminary efficacy for biologically verified increases in long-term adherence, assessed via hair TFV levels. Given the low-cost of the POC test, the remote nature of the intervention, and increasing use of telehealth to provide PrEP care, this approach could be scaled nationally and implemented outside of in-person clinic settings if more definitive RCTs provide evidence of efficacy."

Adherence • Human Immunodeficiency Virus • Infectious Disease

PURPOSE 1: Preference for Twice-Yearly Injection vs Daily Oral Pills for HIV PrEP in Cisgender Women (CROI 2025) - P3 | "In the Phase 3 PURPOSE 1 trial, twice-yearly subcutaneous (SC) lenacapavir (LEN) was safe and 100% efficacious in preventing HIV infection in cisgender women in South Africa and Uganda...Methods In PURPOSE 1 (NCT04994509), cisgender women aged 16-25 years were randomized 2:2:1 in a blinded fashion to receive SC LEN every 26 weeks, daily oral emtricitabine–tenofovir alafenamide (F/TAF), or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF)...Importantly, many also felt that they were more likely to be protected from HIV, and remain adherent, on Q6M injections vs daily pills. Participant preference and clinical data strongly suggest twice-yearly LEN could increase the uptake of, adherence to, and persistence on PrEP among cisgender women."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Integrase Inhibitor- Versus Protease Inhibitor-Based Therapy for People With Advanced HIV Disease (CROI 2025) - "Methods In this open-label, randomised, multicentre, non-inferiority trial, therapy-naive people with HIV aged ≥18 years, a viral load >1000 copies/mL, and either AIDS at any CD4 cell count, severe bacterial infection (BI) with a CD4 cell count <200/µL, a CD4 cell count <100/µL, or currently being treated for opportunistic infections (OI), were randomised 1:1 to receive bictegravir or darunavir/cobicistat, each co-formulated with tenofovir alafenamide/emtricitabine for 48 weeks. The incidence of grade 3-4 drug-related AEs (p=0.99), AE leading to study drugs interruption (p=0.92), and serious AEs (p=0.82) did not differ between groups. Conclusions In PWAH the bictegravir containing regimen was non-inferior to the darunavir containing regimen in terms of the composite outcome but had a better virologic response at week 48 and fewer overall AE."

Late-breaking abstract • Metastases • Human Immunodeficiency Virus • Infectious Disease • CD4

Adherence to F/TAF in Cisgender Women Prevents HIV With Low Risk of Resistance or Diagnostic Delay (CROI 2025) - P3 | "Background PURPOSE 1 (NCT04994509) is a Phase 3, double-blind, randomized, controlled trial assessing the efficacy of lenacapavir (LEN) and emtricitabine plus tenofovir alafenamide (F/TAF) for pre-exposure prophylaxis (PrEP) in adolescent girls and young women. Taken together, these results suggest that HIV infections in PURPOSE 1 occurred almost always in the context of nonadherence to F/TAF, with rare emergence of HIV resistance and low risk of HIV diagnosis delay. Thus, F/TAF could be important for women who prefer a daily oral HIV prevention option."

Adherence • Clinical • Human Immunodeficiency Virus • Infectious Disease

Genotypic Resistance in the African Paediatric CHAPAS-4 Trial of Second-Line Antiretroviral Therapy (CROI 2025) - "Background In the CHAPAS-4 trial of second-line antiretroviral therapy following NNRTI-based first-line, 96-week efficacy was superior for tenofovir alafenamide (TAF) vs standard-of-care (SOC: abacavir (ABC)/zidovudine (ZDV)), and for dolutegravir (DTG) vs ritonavir-boosted lopinavir (LPV/r)/atazanavir (ATV/r)...Methods Randomisation was simultaneously to TAF vs ABC/ZDV, and DTG vs darunavir (DRV/r) vs LPV/r vs ATV/r...Intermediate/high-level resistance to anchor was: 0/29 LPV/r, 4% (1/26) ATV/r (1 TAF/FTC), 0/18 DRV/r and 22% (2/9) DTG (2 ZDV/3TC)...Three children on ZDV/3TC (2 DTG,1 LPV/r) developed new high-level emtricitabine/lamivudine (FTC/3TC) resistance (M184V)...W96 intermediate/high-level anchor drug resistance was uncommon, and as in second-line adult and paediatric trials, resistance to DTG only occurred in children taking ZDV. These results will inform second-line treatment guidelines for children."

Clinical • Pediatrics

Safety, Tolerability, and Efficacy of a BIC/FTC/TAF Dose Reduction Strategy (CROI 2025) - P4 | "Conclusions In virally suppressed PWH on BETAF OD, the strategy of reducing the BETAF OD dose to 3W, 2W, or 1W for 48 weeks was safe, well tolerated, and effective as compared with continuing OD. Consistent with subtherapeutic drug levels, the risk of viral failure was higher with 1W than with 2W or 3W; there was no emergent resistance and viral control was regained upon switching to OD."

Clinical • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4 • CD8 • CRP • IL6

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | N=20 ➔ 30

Enrollment change • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Change in weight and BMI associated with switching to bictegravir/emtricitabine/tenofovir alafenamide versus a dolutegravir-based regimen among virologically suppressed adults living with HIV through 144 weeks. (PubMed, Medicine (Baltimore)) - "This observational study collected demographics, clinical characteristics, weight, and BMI from virologically suppressed adults switched to BIC/emtricitabine/tenofovir alafenamide (TAF), emtricitabine/TAF plus DTG, DTG/abacavir/lamivudine, DTG/rilpivirine (RPV), and DTG/lamivudine 2 years prior to switch through 144 weeks post-switch...DTG plus emtricitabine/TAF switches had the highest annualized weight gain (0.68 kg/year, 95% confidence interval: -0.32, 1.65) whereas, DTG/RPV switches had the lowest annualized weight gain (-2.22 kg/year, 95% confidence interval: -3.69, -0.62) post-switch...Baseline BMI < 18.5 kg/m2 was associated with the highest annualized weight gain post-switch, whereas switching from protease inhibitors and self-report of dieting were associated with the lowest annualized weight gain post-switch. At week 144, switching to a BIC versus DBR were both associated with lower annualized weight gain post-switch among a large and diverse cohort of..."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Updates on HIV Pre-exposure Prophylaxis in Latin America: Available Drugs and Implementation Status. (PubMed, Infez Med) - "Among the oral drugs, we have emtricitabine/tenofovir and emtricitabine/tenofovir alafenamide, while alternative options include the dapivirine vaginal ring, injectable drugs such as Cabotegravir, and the most recently studied Lenacapavir. Barriers such as lack of awareness, inadequate funding, political instability, and outdated policies contribute to disparities in access, leaving many populations at high risk of HIV infection without this preventative measure. Innovative strategies need to be implemented to address and monitor policies that ensure access for all at-risk populations."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Adherence and Forgiveness of Two Modern ART Regimens: Lamivudine/Dolutegravir and Emtricitabine/Tenofovir Alafenamide/Rilpivirine. (PubMed, J Acquir Immune Defic Syndr) - "In this study, we found a similar and high level of forgiveness with the INSTI-based 2-drug regimen 3TC/DTG and the NNRTI-based 3-drug regimen FTC/TAF/RPV."

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

Cellular pharmacology of tenofovir alafenamide and emtricitabine in neutrophils and platelets in people with and without HIV. (PubMed, J Antimicrob Chemother) - "Our findings highlight differential drug disposition across cell types that also vary by serostatus in DBS and platelets. The mechanisms and implications of these findings require additional research."

Journal • Human Immunodeficiency Virus • Infectious Disease

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (clinicaltrialsregister.eu) - P3 | N=5369 | Sponsor: Gilead Sciences, Inc.

New P3 trial • Human Immunodeficiency Virus • Infectious Disease

Budget Impact of Eliminating Medicaid Prior Authorizations for Antiretrovirals in Washington State. (PubMed, Sex Transm Dis) - "Elimination of Medicaid PAs will result in substantial new costs. Changes in drug formulary policy should consider opportunity costs."

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

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (clinicaltrials.gov) - P2/3 | N=133 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pediatrics

Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: The PrEPVacc trial. (PubMed, Clin Trials) - P2 | "In principle, the use of a registration cohort is one of the most straightforward and reliable methods for estimating the counterfactual placebo HIV incidence. However, the predictions in PrEPVacc are complicated by an implausibly large calendar time effect, with uncertainty as to whether this can be validly extrapolated over the period of trial follow-up. Other limitations are discussed, along with suggestions for mitigating these in future studies."

Journal • Human Immunodeficiency Virus • Infectious Disease