Sunlenca (lenacapavir) / Gilead - LARVOL DELTA

An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens. (PubMed, Curr HIV/AIDS Rep) - "While long-acting antiretroviral therapies (LA-ART) like cabotegravir/rilpivirine and lenacapavir exist, data on their safety and efficacy in pregnant individuals are limited...For active drug-resistant TB, the new 6-month BPaLM regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) is not recommended in pregnancy due to limited safety data on pretomanid...While standard ART remains the recommended approach for HIV/TB co-infection in pregnancy, further research is crucial to establish the safety and efficacy of newer LA-ART and bedaquiline-based TB regimens in this high-risk population. Concerns around the safety of TPT in pregnancy remain unanswered and further prospective research is urgently needed."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Machine learning-driven docking of diverse DDAs as promising cysteine protease inhibitors targeting Mpox virus. (PubMed, In Silico Pharmacol) - "Our docking simulations identified four DAAs-Paritaprevir (DB09297), Ledipasvir (DB09027), Lenacapavir (DB15673), and Bictegravir (DB11799)-as having particularly strong binding affinities for mpox protease. This research provides a foundational basis for exploring DAAs as potential new treatments for mpox, with future investigations required to fully determine their therapeutic value. The online version contains supplementary material available at 10.1007/s40203-025-00374-w."

Journal • Human Immunodeficiency Virus • Infectious Disease

Long-acting lenacapavir is a breakthrough for preventing HIV infection, but HIV vaccine research must continue. (PubMed, Front Med) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

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

ISLEND-1: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - P3 | N=609 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

The road to lenacapavir, a breakthrough HIV treatment. (PubMed, Science) - "Three individuals have been awarded the AAAS Mani L. Bhaumik Breakthrough of the Year Award for their work on the drug."

Journal • Human Immunodeficiency Virus • Infectious Disease

Investigation of Natural Resistance to Fostemsavir and Lenacapavir in Naïve Primary Infections by Ultra-Deep Sequencing of near Full-Length HIV-1 Genomes. (PubMed, Viruses) - "In the gp120 encoding region, the M426R variant was found with a frequency of 100% in two HIV subtypes B: one of these also showed the A204T variant at 100%. In the more conserved capsid coding region no mutations possibly related to LEN natural resistance were observed."

Journal • Human Immunodeficiency Virus • Infectious Disease

Genetic Diversity in the Capsid Protein-Coding Region of HIV-1 Circulating in Benguela, Angola: Implications for Primary Resistance to the Novel Capsid Inhibitor Lenacapavir. (PubMed, Viruses) - "Regarding resistance mutations, none were detected, apart from four polymorphic mutations. These findings reinforce Angola's position as a transitional HIV-1 hotspot between the genetically highly diverse Central Africa and the subtype C-dominated Southern Africa, while also supporting the potential effectiveness of LEN-based regimens for treatment and prevention of HIV-1 infections in the future."

Journal • Human Immunodeficiency Virus • Infectious Disease

More Than Sexual Side Effect Management: Integrating Biomedical Prevention for HIV and Stis for Sexual Health Promotion in Psychiatric Practice (APA 2025) - "Recent trials also demonstrated success of lenacapavir, a novel drug administered as a subcutaneous LAI at 6-month intervals as PrEP...Doxycycline administered as post-exposure prophylaxis (DoxyPEP) 24-72 hours after sexual activity is up to 80% effective in preventing syphilis and chlamydia, and up to 50% effective preventing gonorrhea...Objective Three: Discuss ways of integrating prescription of these preventive interventions into psychiatric practice. Objective Four: Objective Five:; Objective One: Understand the current literature related to sexual risk of psychiatric patients.; Objective Two: Present the evidence-based options for preventing HIV and STIs.; Objective Three: Discuss ways of integrating prescription of these preventive interventions into psychiatric practice.; Objective Four:; Objective Five:"

Adverse events • Human Immunodeficiency Virus • Infectious Disease • Psychiatry

LENAddON: Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

ISLEND-2: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: ViiV Healthcare

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Perceptions of long-acting Lenacapavir as an alternative to HIV vaccine among cisgender female sex workers in Abuja, Nigeria (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Evaluating the potential of Lenacapavir and Doxy-PEP as a game-changer in HIV and Sexually Transmitted Infections prevention for female sex workers in Abuja, Nigeria (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Lenacapavir Plus Cabotegravir Real-world Use Cases from the National Clinician Consultation Center (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Real-world • Real-world evidence

Intention to use and cost-benefit analysis of long-acting lenacapavir for HIV pre-exposure prophylaxis among cisgender women experiencing incarceration in northcentral Nigeria: a cross-sectional pharmacoeconomic assessment of community perspective (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • HEOR • Human Immunodeficiency Virus • Infectious Disease

Can it protect my baby and me from HIV? A mixed-methods evaluation of intention to discuss, accept and use lenacapavir by pregnant women in polygamous relationships in a Nigerian community (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Capsid Inhibition with Lenacapavir in HIV-1 Infection: Real-life Results from the French Compassionate Use Program (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Lessons learnt from the introduction of long-acting PrEP in South Africa – leveraging to prepare for lenacapavir (IAS-HIV 2025) - "Organized by Wits RHI and Unitaid"

SY12 Let's get real: Implementing PrEP choice in practice (IAS-HIV 2025) - "Proven PrEP regimens include oral PrEP, two-monthly long-acting injectable cabotegravir, six-monthly long-acting injectable lenacapavir and the dapivirine vaginal ring. While access to these non-oral PrEP options is currently limited, settings all over the world will need to come to grips with practical methods to implement PrEP within a choice framework. This session will focus on practical examples from the real world and large-scale studies on what PrEP choice really means, how to deliver PrEP to the community in the context of multiple options, and tools used in clinical and community settings to implement PrEP choice."

OAC05 Purposeful PrEP: New insights on lenacapavir for prevention (IAS-HIV 2025) - No abstract available

Predictors of HIV pre-exposure prophylaxis preferences using the Health Belief Model: twice-yearly subcutaneous lenacapavir versus daily pills in the PURPOSE 1 trial (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Human Immunodeficiency Virus • Infectious Disease

Efficacy, safety, and pharmacokinetics of twice-yearly subcutaneous lenacapavir for PrEP among adolescents and young people in the phase 3 trials PURPOSE 1 and PURPOSE 2 (IAS-HIV 2025) - "The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Monday, 14 July 2025, at 15:30 Central African Time (CAT). If an abstract is part of an official IAS 2025 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference."

Clinical • P3 data • PK/PD data

Lessons learnt from the introduction of long-acting PrEP in Brazil – leveraging to prepare for lenacapavir (IAS-HIV 2025) - "Organized by Wits RHI and Unitaid"

Conditions for lenacapavir access and success (IAS-HIV 2025) - "Organized by Wits RHI and Unitaid"