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

Viral kinetics, pharmacokinetics, and exposure-response analysis of monotherapy of multiple ascending dose asuptegravir, a new-generation integrase strand transfer inhibitor, followed by combination with emtricitabine and tenofovir alafenamide in treatment-naïve people living with HIV-1: a two-period, randomised, placebo-controlled phase I/II study (ESCMID Global 2026) - No abstract available

Clinical • Late-breaking abstract • Monotherapy • P1/2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

A 48-week, Randomized Controlled Trial of Doravirine for Individuals with HIV and Obesity on Integrase Inhibitors and Tenofovir Alafenamide: The Do IT Study (ACTG A5391). (PubMed, Clin Infect Dis) - P4 | "In people with HIV and obesity, switching from an INSTI+TAF/FTC regimen to DOR/FTC with either TAF or TDF did not produce clinically meaningful differences in weight change or metabolic health after 48 weeks."

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

ADHERENCE AND PERSISTENCE IN US REAL-WORLD NEW PREP USERS: CABOTEGRAVIR VS EMTRICITABINE/TENOFOVIR ALAFENAMIDE (ISPOR 2026) - "New PrEP initiators using CAB-LA exhibit improved adherence/persistence relative to those using FTC/TAF."

Adherence • Clinical • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Safety and Tolerability of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Men and Transgender Women Who Have an Elevated Likelihood of HIV-1 Exposure: Results From the IMPOWER-24 Randomized Phase 3 Study. (PubMed, Clin Infect Dis) - P3 | "Islatravir qm was generally well-tolerated; decreases in total lymphocytes were observed with islatravir. Original primary efficacy objectives were not assessed due to early study stoppage."

Journal • P3 data • Gastroenterology • Gastroesophageal Reflux Disease • Human Immunodeficiency Virus • Infectious Disease

PROPEL: Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention (clinicaltrials.gov) - P=N/A | N=3000 | Not yet recruiting | Sponsor: Gilead Sciences

New trial • Human Immunodeficiency Virus • Infectious Disease

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: ViiV Healthcare | N=550 ➔ 150 | Trial primary completion date: May 2027 ➔ Sep 2027 | Not yet recruiting ➔ Recruiting

Enrollment change • Enrollment open • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Longitudinal changes in bone mineral density among children living with HIV over 96 weeks following switch to second-line antiretroviral therapy in Uganda. (PubMed, PLOS Glob Public Health) - "CLWH aged 3-15 years switched to second-line ART including tenofovir alafenamide fumarate-emtricitabine (TAF/FTC) or standard-of-care (SOC) (abacavir (ABC) or zidovudine (ZDV) with dolutegravir (DTG), atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r)...-0.30,95% CI: -0.46, -0.15], p < 0.001) and first-line nevirapine (NVP) exposure (-0.25,95% CI: -0.43, -0.06, p = 0.009)...Smaller declines in TBLH BMD were associated with higher baseline fat mass, higher LS HA BMD, and use of DRV/r, DTG, or ATV/r compared with LPV/r. These findings emphasize the importance of ART selection and body composition in supporting bone health among CLWH."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Feasibility and acceptability of daily oral emtricitabine/tenofovir alafenamide fumarate (FTC/TAF) for HIV pre-exposure prophylaxis among people who inject drugs with opioid use disorder. (PubMed, Sex Transm Infect) - P=N/A | "FTC/TAF PrEP was acceptable among PWID with OUD. However, feasibility challenges were due to low uptake and continuation, with only two participants completing PrEP pick-up at all follow-up visits, despite higher self-reported adherence among those retained at 6 months."

Journal • Addiction (Opioid and Alcohol) • Fatigue • Human Immunodeficiency Virus • Infectious Disease • Substance Abuse

A comparison of F/TAF and F/TDF as HIV pre-exposure prophylaxis in a predominantly cisgender women population in East and South Africa: a randomised, factorial, non-inferiority trial. (PubMed, J Acquir Immune Defic Syndr) - "Despite similar HIV incidence rates, the non-inferiority of F/TAF was not demonstrated, probably due to low statistical power primarily driven by low adherence. However, there is compelling evidence from multiple studies supporting the efficacy of F/TAF as PrEP regardless of sex."

Head-to-Head • Journal • Human Immunodeficiency Virus • Infectious Disease

CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD) (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Heather Henderson

New trial • Real-world evidence

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: University of Texas Southwestern Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Aug 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2025 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

DD-PrEP:: Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Johns Hopkins University

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Longitudinal analysis of metabolic changes in people with HIV on integrase inhibitor-based versus efavirenz-based therapy: a prospective real-world cohort study in China. (PubMed, BMC Infect Dis) - "INSTI-based ART was associated with sustained weight gain but did not worsen long-term dyslipidemia compared to an EFV-based regimen in a real-world setting. Hepatic steatosis correlated with metabolic parameters rather than INSTI exposure."

Journal • Real-world evidence • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

Switch to BIC/TAF/FTC or DTG + TDF/FTC in virologically suppressed PWH: outcomes in real-world setting with and without tenofovir resistance. (PubMed, Clin Infect Dis) - P | "in a real-world setting, switching to BIC/TAF/FTC or DTG + TDF/FTC in PWH with virological success was associated with a non-significant risk of VF, but M184V or M184I mutations and tenofovir resistance had no effect on VF. Most VF were blips or related to unmeasured adherence issues."

Journal • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

PURPOSE 2: Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (clinicaltrials.gov) - P3 | N=3292 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: May 2028 ➔ Aug 2028

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (clinicaltrials.gov) - P2 | N=550 | Not yet recruiting | Sponsor: ViiV Healthcare | Trial completion date: Mar 2029 ➔ Nov 2028

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Viral Tug-of-War: Incomplete Hepatitis B Suppression Despite Tenofovir Alafenamide-Emtricitabine Therapy in Human Immunodeficiency Virus and Hepatitis B Co-Infection (ASHP 2025) - No abstract available

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Pilot outcomes of a telehealth model for youth PrEP (TelePrEP) among youth at risk for HIV in Colorado. (PubMed, HIV Res Clin Pract) - "Youths 14-24 years of age eligible for PrEP using oral tenofovir alafenamide and emtricitabine (F/TAF) were enrolled in a prospective type 1 hybrid effectiveness implementation study...PrEP uptake and retention remain challenging for youth at risk for HIV. Further tailoring of PrEP models of care is needed to achieve risk reduction goals for youth."

Journal • Human Immunodeficiency Virus • Infectious Disease

Bictegravir's effect on persistent low-level viremia and immunological response. BELAIR study: A pilot prospective observational study. (PubMed, Int J STD AIDS) - "A significant gradual elevation of CD4/CD8 ratio was also observed (0.51 ± 0.30 before switch vs 0.69 ± 0.35 at 12 months, p < 0.001).ConclusionThe results of the present study indicate that BIC/TAF/FTC may improve the immunological response and reduce the proportion of PWHIV experiencing persistent LLV. Further studies in larger patient series are needed to determine the full beneficial role of bictegravir."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Preexposure Prophylaxis Prescription Dispensation Status and HIV-1 Acquisition. (PubMed, JAMA Netw Open) - "Retrospective observational cohort study from January 2021 to December 2023 using US pharmacy claims data from HIV-1-negative adults who received daily oral brand emtricitabine and tenofovir disoproxil fumarate (F/TDF), generic F/TDF (gF/TDF), or emtricitabine and tenofovir alafenamide fumarate (F/TAF), or intramuscular injection of cabotegravir every 2 months, for PrEP (after a 180-day washout period for previous PrEP use). In this cohort study, HIV-1 incidence was higher in individuals with abandoned or rejected PrEP claims compared with those with dispensed claims. These findings highlight the importance of targeted strategies to improve PrEP claim dispensation and remove payer barriers to reduce HIV-1 transmission."

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

Authors' Reply to Letter to the Editor Regarding 'Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study'. (PubMed, HIV Med) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Clinical Efficacy and Safety of BIC/TAF/FTC in Elderly HIV-Infected Individuals in Southwest China: A Retrospective Observation Study. (PubMed, Immun Inflamm Dis) - "For elderly HIV/AIDS patients, B/F/TAF is a safe option to achieve and maintain virological suppression and immune recovery. In terms of lipid metabolism, the metabolic effects of BIC/FTC/TAF in the treated patients are not significant, and the effects in untreated patients require longer follow-up."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4 • CD8

Diagnosis of HIV infection during pregnancy: Trends from a national cohort in Spain. (PubMed, HIV Med) - "Among women diagnosed with HIV during pregnancy, half were late presenters, and one-third were diagnosed after the first trimester, with higher percentages among African and Latin American women. There was a high proportion of caesarean deliveries. Most women initiated ART promptly after cohort enrolment and achieved undetectable VL at the end of pregnancy."

Journal • Human Immunodeficiency Virus • Infectious Disease

Tenofovir alafenamide fumarate use for HIV pre-exposure prophylaxis and weight gain. (PubMed, Sci Rep) - "Daily oral pre-exposure prophylaxis (PrEP), including emtricitabine/tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir alafenamide fumarate (TAF), is a key strategy for HIV prevention. TAF-only (β = 2.532, 95%CI 0.708-4.356) and TDF-TAF (β = 2.756, 95%CI 0.890-4.621) were associated with significantly increased weight gain compared to TDF-only use. Closer monitoring of weight gain is recommended for individuals using TAF to prevent HIV."

Journal • Human Immunodeficiency Virus • Infectious Disease

EXPRESS-PrEP: Evaluating PrEP Rapid Engagement and Same-Day Start for HIV Prevention in gbMSM. (PubMed, Int J Infect Dis) - "Same-day PrEP initiation is safe, feasible, and improves uptake and persistence. Adoption of this model may reduce barriers and accelerate HIV prevention."

Journal • Human Immunodeficiency Virus • Infectious Disease