Yeztugo (lenacapavir) / Gilead - LARVOL DELTA

Lenacapavir will not end the HIV epidemic in the current US political climate. (PubMed, Lancet HIV) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

WHO Recommends Lenacapavir for HIV Prevention in New Guidelines. (PubMed, JAMA) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Long-acting cabotegravir/rilpivirine, lenacapavir, and ibalizumab use among persons with HIV-1 viremia at a Ryan White-funded clinic in the urban U.S. South. (PubMed, Clin Infect Dis) - "In the largest Southern US cohort of PWH with viremia initiating LA-ART, 92% achieved VS despite significant barriers to care and disease burden, underscoring LA-ART as a tool to help achieve Ending the HIV Epidemic goals."

Journal • Human Immunodeficiency Virus • Infectious Disease • CD4

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."

USPI YEZTUGO (NMA 2025) - "Sponsored by: Gilead Health Sciences – HIV Objectives Indications and Usage Dosage and Administration Contraindications Warnings and Precautions Adverse Reactions Drug Interactions Use in Specific Populations Clinical Studies"

Human Immunodeficiency Virus • Infectious Disease

Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention (Businesswire) - "Gilead Sciences, Inc...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company’s injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo...The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead."

CHMP • Human Immunodeficiency Virus • Infectious Disease

Phase 2 once-weekly dose optimization for ulonivirine in combination with Islatravir 2 mg (IAS-HIV 2025) - P3 | "ULO data from Phase 1 and the previous Phase 2 studies were used to predict a safe and efficacious Phase 2 ULO dose to be combined with ISL 2 mg QW, which is the lower ISL dose used in ongoing clinical trials in combination with oral lenacapavir [NCT06630286; NCT06630299] and is expected to be safe and efficacious. Reduction in viral load (measured as log10 plasma HIV-1 RNA copies/mL]) and ULO pharmacokinetics (PK) from a Phase 1b study where treatment-naïve participants living with HIV-1 received single oral doses of ULO (40, 80, or 600 mg) were used to establish a wild-type (WT) efficacy PK threshold. Dose selection factors weighed PK coverage and virological efficacy. Weekly 200 mg ULO in combination with ISL 2 mg was selected for Phase 2 for continued clinical development."

Combination therapy • P2 data • 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 | Trial primary completion date: Jun 2027 ➔ Apr 2026

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Outcomes From People With HIV-1 Receiving Once-Weekly Oral Islatravir in Combination With Lenacapavir: Phase 2 Week 48 Results (EACS 2025) - No abstract available

Clinical • Combination therapy • P2 data • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Lenacapavir dosing in special situations: Tuberculosis and beyond (IAS-HIV 2025) - No abstract available

Infectious Disease • Respiratory Diseases • Tuberculosis

PrEP policy in a long acting era: a policy barrier study of 179 countries (IAS-HIV 2025) - "While oral PrEP is effective, policy gaps have hindered its full potential. However, Lenacapavir offers a unique opportunity to address these gaps in HIV prevention, particularly for high-risk groups who face issues with adherence or require a more frequent dosing schedule. Expanding PrEP eligibility policies by creating demand for Lencapavir can help accelerate the availability of generics while failing to use this opportunity may lead to governments rationing access to PrEP among vulnerable groups undermining efforts to end AIDS."

Human Immunodeficiency Virus • Infectious Disease

The impact of long-acting lenacapavir on adolescent girls and young women in Kenya: a mathematical modeling study (IAS-HIV 2025) - "These results emphasize the importance of not only transitioning to long-acting PrEP but also expanding coverage to achieve meaningful reductions in HIV incidence among AGYW. Lenacapavir has the potential to significantly reduce the burden of HIV among adolescent girls and young women if coverage can be effectively scaled up."

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

SY19 Pregnancy and long-acting ARVs for prevention and treatment (IAS-HIV 2025) - "This symposium will present new data on lenacapavir and cabotegravir in pregnancy and breastfeeding, outline plans for inclusive research, and discuss priority actions to advance research, development, introduction and use of new long-acting ARVs for HIV prevention and treatment during pregnancy and breastfeeding. It is aimed at research networks, communities, country programme managers, companies, funders, technical partners and regulators."

Human Immunodeficiency Virus • Infectious Disease

Long-acting ART (LEN/CAB and CAB/RPV) among viremic persons living with HIV (IAS-HIV 2025) - "In cases of drug resistance, combination, fully active injectable therapy—i.e. lenacapavir (LEN) with CAB +/- RPV—is also of interest, but has not been formally studied. We identified 27 viremic patients (VL >200copies/mL) interested in LAI-ART... We saw high rates of viral suppression with CAB/RPV and LEN/CAB +/- RPV among viremic patients and showed they can be effective options, including in cases of resistance."

Human Immunodeficiency Virus • Infectious Disease • CD4

Person-centred care considerations for rollout of lenacapavir (LEN), a future 6-monthly injectable PrEP option (IAS-HIV 2025) - "Organized by IAS – the International AIDS Society"

Human Immunodeficiency Virus • Infectious Disease

Introducing long-acting cabotegravir in Zambia: lessons learned from early implementation (IAS-HIV 2025) - "Based on early success with CAB-LA, Zambia will continue to scale injectable PrEP to address unmet need and curb HIV transmission. This early success positions Zambia to lead the way in choice-drive prevention programming and will inform the introduction of next-generation products, like lenacapavir."

Human Immunodeficiency Virus • Infectious Disease

Compulsory vs. voluntary licensing: good for the people or to the market? (IAS-HIV 2025) - "This study examines access to ARVs in Brazil through CL and VL, focusing on efavirenz (EFZ) and dolutegravir (DTG).DESCRIPTION: Since 2006, the Brazilian government has attempted to negotiate EFZ pricing with Merck, the patent holder. Pharmaceutical monopolies make Brazil dependent on secret contracts, prioritizing private over public interests. For new treatments, like lenacapavir, CL could eliminate patent barriers, enabling access and local production. Transparency, justice, and public health must be prioritized."

Human Immunodeficiency Virus • Infectious Disease

Indirect treatment comparison of the efficacy of cabotegravir and lenacapavir for HIV pre-exposure prophylaxis (PrEP) versus no PrEP (IAS-HIV 2025) - "CAB and LEN both offer high and similar efficacy in reducing HIV acquisition risk compared with No PrEP and this was generally consistent when using oral PrEP as a common comparator with adjustment for differences in adherence (data not shown here). Additional factors associated with these regimens, including the potential for drug-drug interactions and adverse events (eg, injection site reactions), real-world usage, seroconversion resistance, and patient preference, will be important to comprehensively assess clinical value and assist with decision-making."

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

Unlocking access to long-acting HIV medications: a 194 country study of compulsory licensing (IAS-HIV 2025) - "Compulsory licensing provisions are widely adopted including in 84 of the 88 countries excluded from the Gilead lenacapavir agreement. However, there is a need for short- and medium-term reforms to enable the formal participation of civil society in compulsory licensing processes. Granting the ability to these organisations to formally trigger compulsory licensing proceedings would enhance their ability to enhance their ability to influence national policy agendas and advocate for the expanded access to lenacapavir."

Human Immunodeficiency Virus • Infectious Disease

Comparing carbon emissions from oral Truvada for PrEP and long-acting injectable CAB for HIV prevention in PEPFAR-supported countries (IAS-HIV 2025) - "Shifting from oral Truvada to CAB-LA offers dual benefits: superior clinical efficacy and significant GHG emission reductions. While this analysis focuses on CAB-LA, similar benefits may extend to Lenacapavir as data become available. These findings highlight the importance of integrating sustainability into global HIV prevention strategies, aligning health outcomes with global climate goals."

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) - "Lenacapavir, a long-acting HIV pre-exposure prophylaxis, and Doxycycline Post-Exposure Prophylaxis (Doxy-PEP) hold promise as transformative tools in reducing transmission in high risk populations. There is a huge gap in awareness of Lenacapavir and Doxy-PEP among high-risk populations, particularly female sex workers. Despite concerns over side effects, there is a clear preference for long-acting injectable methods emphasizing the need for more research to be conducted in this population and tailored educational and outreach programs to address misconceptions and increase knowledge of these innovative prevention options."

Human Immunodeficiency Virus • Infectious Disease

The role of PEPFAR's DREAMS (determined, resilient, empowered, AIDS-free, mentored, and safe) program in pre-exposure prophylaxis (PrEP) rollout and scale-up among adolescent girls and young women (IAS-HIV 2025) - "PEPFAR's DREAMS program provides an effective platform and approach for PrEP scale-up. With promising new biomedical prevention options such as Lenacapavir on the horizon, it's critical that HIV programs build off the lessons learned and utilize structures in place, such as those implemented via DREAMS, to increase uptake and continuation of PrEP and other HIV prevention options among AGYW."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Community priorities for PrEP research and delivery: insights from the People's Research Agenda (IAS-HIV 2025) - "Innovations like injectable options, including cabotegravir (CAB) and lenacapavir (LEN), have transformed HIV prevention by offering diverse delivery mechanisms, protection durations, and adding choice. Communities play an important role in shaping HIV prevention R&D and delivery. The PRA provides a clear roadmap for aligning innovations with community-defined needs and preferences. In 2025, the PRA will focus on developing a framework for advocacy, decision-making and accountability to address critical gaps in HIV prevention research and delivery."

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) - "OBR included mainly darunavir/r (n=13), dolutegravir (n=11), cabotegravir (n=10), fostemsavir (n=12), maraviroc (n=8), ibalizumab (n=7) and enfuvirtide (n=4). In this real-life cohort of highly treatment-experienced HIV-1 participants, lenacapavir in combination with an OBR resulted in a high level of virological suppression up to 26 weeks, even increasing throughout the end of follow-up."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Exploratory qualitative analysis of the acceptability of HIV prevention methods among pregnant and lactating women interviewed during the randomized blinded phase of PURPOSE 1 (IAS-HIV 2025) - P3 | "BACKGROUND: PURPOSE 1 (NCT04994509) was the first pre-exposure prophylaxis (PrEP) trial to support inclusion of pregnant and lactating people (PLP) and demonstrated safety and 100% efficacy of lenacapavir for PrEP among cisgender young women, including PLP... Among this subsample of 13 PLP, participants shared concerns about the use of investigational study drugs while pregnant or lactating; while also noting benefits for consistent HIV protection and appreciating the option for an alternative injection site in the thighs. These findings underscore the value of education and counseling about the efficacy, safety, tolerability, and pharmacokinetics for successful PrEP implementation among PLP."

Clinical • Interview • Human Immunodeficiency Virus • Infectious Disease • Pain