Yeztugo (lenacapavir) / Gilead - LARVOL DELTA

Clinical Trials in the Post-Lenacapavir Era (CROI 2026) - No abstract available

Clinical • Infectious Disease

Lenacapavir and Capsid Structures (CROI 2026) - No abstract available

Infectious Disease

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined the proposal submitted by Hetero Labs Limited, Hetero Corporate for Lenacapavir Tablets 300 mg. (Medical Dialogues) - "Hetero Labs presented its proposal along with justification for waiving local Phase-III clinical trials and BE requirements. The committee was informed that the company had already received approval from the BA/BE division of CDSCO to conduct a BE study for export purposes, and this study is currently ongoing. The firm also submitted published global clinical trial data on Lenacapavir to support its request."

Regulatory • Human Immunodeficiency Virus

The Human T-cell Leukemia Virus capsid protein is a potential drug target. (PubMed, Nat Commun) - "Importantly, the first in-class anti-capsid drug approved, lenacapavir, can provide long-acting pre-exposure prophylaxis...Here we describe high-resolution crystal structures of the HTLV-1 capsid protein, define essential lattice interfaces, and identify a distinct ligand-binding pocket. We show that this pocket is essential for virus infectivity, providing a potential target for future anti-capsid drug development."

Journal • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Oncology

Malawi on Thursday approved the usage of the injectable HIV drug, lenacapavir, becoming the fourth African nation to authorize the medicine... (Anadolu Agency) - "The country’s Pharmacy and Medicines Regulatory Authority (PMRA) approved the drug following a 46-day expedited review, placing the country among the world’s earliest pioneers of the drug."

Approval • Human Immunodeficiency Virus

An Immunocompetent Host With Severe Disseminated Herpes Simplex Virus Type 2 Infection With Hepatorenal Involvement. (PubMed, Cureus) - "The patient was treated with intravenous acyclovir followed by oral valacyclovir, resulting in complete resolution of symptoms and normalization of liver and renal function. Given ongoing high-risk sexual behavior, he was also counseled on long-acting injectable HIV pre-exposure prophylaxis with lenacapavir...Early recognition and prompt antiviral therapy are critical to improving clinical outcomes. Physicians should consider a high index of suspicion for HSV hepatitis in candidates presenting with unexplained transaminitis and systemic symptoms, even in the absence of classic mucocutaneous findings or immunosuppression."

Journal • Acute Kidney Injury • Hepatology • Herpes Simplex • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Failure • Nephrology • Oncology • Renal Disease

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Gilead Sciences | Trial completion date: Dec 2026 ➔ Apr 2027 | Trial primary completion date: Jun 2026 ➔ Oct 2026

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

To err is human, to persist is diabolical: Are we repeating the same cost and insurance coverage mistakes again with injectable PrEP? (PubMed, J Acquir Immune Defic Syndr) - "Emerging data suggests high interest in injectable PrEP but low uptake, with some participants reporting challenges obtaining insurance coverage, alongside other clinic-level barriers. It is our hope that assessments of current and persisting barriers to cabotegravir can offer preliminary but critical insights for the rollout of lenacapavir."

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

Lenacapavir-induced capsid damage uncovers HIV-1 genomes emanating from nuclear speckles. (PubMed, EMBO J) - "This may ensure that genome uncoating occurs at optimal sites for integration into transcriptionally active chromatin. The results also shed further light on the mechanism of action of Lenacapavir."

Journal • Human Immunodeficiency Virus • Infectious Disease

HIV Therapy: The Latest Developments in Antiviral Drugs-A Scoping Review. (PubMed, Biomedicines) - "Content: The evidence base underscores capsid inhibition (lenacapavir) for multidrug-resistant HIV and its expansion into prevention, long-acting intramuscular maintenance with cabotegravir/rilpivirine, maturation inhibitors (zabofiravir), and attachment inhibition with fostemsavir. Summary: The pipeline is diversifying toward less frequent dosing, new targets, and combination strategies. Successful and ethical implementation will require resistance-informed selection, equitable access, and reimagined healthcare delivery models that accommodate long-acting technologies."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Lenacapavir-time to change the game for everyone. (PubMed, Lancet Infect Dis) - No abstract available

Journal

Assessing Demand for Long-Acting Injectable PrEP and Emerging PrEP Options for HIV Prevention in Australia: Results from a Cross-Sectional Survey of Men Who have Sex with Men. (PubMed, AIDS Behav) - "Long-acting injectable Cabotegravir (CAB-LA) received regulatory approval in Australia but is not available for prevention...Interest in using CAB-LA was associated with younger age (aOR = 0.98, 95%CI = 0.97-0.99), having ever taken PrEP (aOR = 2.06, 95%CI = 1.48-2.88), having 11 or more sexual partners in the last 6 months (aOR = 1.65, 95%CI = 1.25-2.17), believing some friends or sex partners are taking PrEP (aOR = 1.58, 95%CI = 1.18-2.11), reporting wanting to try CAB-LA if it was more effective than oral PrEP (aOR = 2.05, 95%CI = 1.48-2.86), or believing CAB-LA is more effective than event-driven oral PrEP (aOR = 1.48, 95%CI = 1.10-1.99). This analysis demonstrated Australian GBMSM have a diverse range of preferences of PrEP options, and access to newer options is needed to increase HIV prevention coverage."

Journal • Human Immunodeficiency Virus • Infectious Disease

Twice-Yearly Injectable Pre-Exposure Prophylaxis With Lenacapavir: Redefining Adherence and Access in the Global Fight Against HIV. (PubMed, J Int Assoc Provid AIDS Care) - "WHO's endorsement marks a pivotal milestone, but real-world implementation must address cold-chain logistics, cost, provider training, and systemic inequities. Integrating lenacapavir through decentralized delivery models, differentiated care, and inclusive national guidelines will be key to equitable access, decreasing gaps and advancing epidemic control."

Journal • Review • Fatigue • Human Immunodeficiency Virus • Infectious Disease

Lenacapavir Plus Cabotegravir as Combination Treatment: Real-world Use Cases From the National Clinician Consultation Center. (PubMed, Open Forum Infect Dis) - "LEN+ CAB+/-RPV was effective and well-tolerated: among 10 cases with follow-up information, viral load decreased by a mean of 3.88log10 copies/mL within a median of 56 days (range = 29-166 days), and 5 experienced injection-site reactions rated as "not at all" to "slightly" problematic. These data support further investigations into LEN+ CAB+/-RPV use among PWH with oral ART challenges and/or drug resistance."

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

Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry. (PubMed, J Antimicrob Chemother) - No abstract available

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

High-level multi-class transmitted antiretroviral resistance in a man with newly acquired HIV. (PubMed, Int J STD AIDS) - "A 19 year old man was diagnosed newly acquired HIV and prescribed bictegravir/emtricitabine/tenofovir alafenamide at his initial visit for HIV care...Although he had an initial substantial decline in viremia in the first 4 weeks, it was felt that the risk of subsequent failure was too high, and his antiretroviral treatment (ART) regimen was therefore changed to daily dolutegravir and darunavir/cobicistat/emtricitabine/tenofovir alafenamide, plus injected lenacapavir. He had durable virologic suppression on this new regimen for 12 months as of his last follow-up. This case of high-level multi-class transmitted drug resistance, in the context of rapid emergence of resistance to dolutegravir where it has been used as part of a salvage regimen, suggests that assessing for RAM in the integrase gene should be added to the currently recommended resistance testing for all patients with newly acquired HIV prior to initiating ART."

Journal • Human Immunodeficiency Virus • Infectious Disease

Resistance Analysis of Low-Level Virologic Rebound During HIV-1 Treatment with Lenacapavir and Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab. (PubMed, J Infect Dis) - P1 | "Lenacapavir, teropavimab, and zinlirvimab maintained a high rate of virologic suppression through W26, with a low rate of emergent lenacapavir resistance and no bNAb resistance, supporting further evaluation of this combination in Phase 2."

Journal • Human Immunodeficiency Virus • Infectious Disease

Classification System Proposed to Guide the Design, Development, Regulatory Approval, and Scaling of Long Acting, Small and Macro-Molecule Parenteral Products (CS-BLAP). (PubMed, J Pharm Sci) - "In addition, injectable solution of lenacapavir that form solid at injection site may be viewed as a sustained release or depot product, but it could be regulated as an injectable pharmaceutical solution for product bioequivalency. The proposed CS-BLAP framework could serve as a foundation for scientists in design and development, for regulators in evaluation and approval, and for sponsors in planning post-approval scaling of long-acting products."

Journal

Beyond Viral Suppression: Navigating Structural Barriers, Aging and Frailty, Drug Resistance, Therapeutic Innovations, and Reproductive Health Challenges in the Global HIV/AIDS Epidemic. (PubMed, J AIDS HIV Treat) - "This narrative review synthesizes evidence from peer-reviewed studies, global guidelines, and major clinical trials published up until September 2025 to explore these converging issues. By highlighting gaps and opportunities across aging, structural barriers to care, social determinants of health, therapeutic innovation, and reproductive health, we underscore the need for inclusive, multidisciplinary, and evidence-based HIV care models for the next decade."

Journal • Human Immunodeficiency Virus • Infectious Disease

Distinct Target Site of Lenacapavir in Immature HIV-1 and Concurrent Binding with the Maturation Inhibitor Bevirimat. (PubMed, J Am Chem Soc) - "In addition, a more accurate model of BVM engaging the Gag lattice is revealed, one that is independent of LEN binding. These insights expand our understanding of the inhibitory mechanisms of LEN and BVM on HIV-1 and provide valuable clues for the design of future inhibitors."

Journal • Human Immunodeficiency Virus • Infectious Disease

Comparative Performance of iSeq 100 and MiSeq i100 for Pooled Sequencing of HIV, HCV, TB, and 16S rRNA (AMP 2025) - "Both sequenced HIV capsid and envelope, enabling detection of mutations related to new treatments (e.g., enfuvirtide, fostemsavir, lenacapavir). Both platforms are suitable for high-throughput sequencing of pooled HIV, HCV, TB, and 16S rRNA samples. MiSeq i100 offers superior sensitivity, depth, and speed, making it well suited for research and diagnostics. iSeq 100 remains a cost-effective tool for routine diagnostics."

Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Respiratory Diseases • Tuberculosis

Combined use of ibalizumab and lenacapavir for the treatment of multidrug-resistant HIV-1: A case series. (PubMed, Clin Infect Dis) - "In this small group of individuals with MDR HIV who were heavily treatment-experienced and/or faced adherence challenges, the use of IBA + LEN ± OBR was well tolerated and led to clinically significant reductions in VL and improvements in CD4+ counts."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Breaking barriers in HIV management: the rise of long-acting lenacapavir. (PubMed, Ann Med Surg (Lond)) - "Ongoing PURPOSE trials are evaluating its role in high-risk populations. Lenacapavir's favorable safety profile and public health potential support its integration into evolving HIV management and prevention strategies, potentially accelerating progress toward epidemic control."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline. (PubMed, Open Forum Infect Dis) - "ARTISTRY-1 is a phase 2/3 trial of bictegravir (BIC; 75 mg) plus lenacapavir (LEN; 25 mg or 50 mg) versus complex antiretroviral therapy regimens in 128 virologically suppressed people with HIV-1. At 48 weeks, BIC + LEN (at either LEN dose) was highly effective at maintaining virologic suppression and was well tolerated."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Innovations in the biomedical prevention, diagnosis, and service delivery of HIV and other sexually transmitted infections. (PubMed, Lancet) - "This Series paper explores the potential of pre-exposure prophylaxis (PrEP) for HIV in different forms (eg, daily oral PrEP, event-driven PrEP, and long-acting injectable PrEP), and highlights the challenges of adherence to daily regimens and the promise of longer-acting agents, such as cabotegravir and lenacapavir. The potential of doxycycline post-exposure prophylaxis for the prevention of bacterial STIs is also discussed, with concerns about antimicrobial resistance...This Series paper discusses the benefits, landscape, and pipeline of rapid diagnostic tests (eg, lateral flow tests and molecular assays) and the challenges of implementing these tests in low-resource settings, particularly the need for rapid results to inform clinical decisions, promote convenience, and reduce cost. This Series paper also addresses innovations in service delivery and advocates for integrated and person-centred approaches (eg, differentiated services) that combine HIV and STI services,..."

Journal • Review • Herpes Simplex • Human Immunodeficiency Virus • Infectious Disease • Oncology