Vocabria (cabotegravir oral) / ViiV Healthcare, Shionogi - LARVOL DELTA

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE (clinicaltrials.gov) - P3 | N=456 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

The hidden reservoir of INSTI resistance: large scale sequence analysis identifies prevalent Gag NC mutations compromising dolutegravir and cabotegravir efficacy. (PubMed, Sci China Life Sci) - No abstract available

Journal

Real-World Experience With Lenacapavir and/or Fostemsavir as Emerging Therapies for the Management of Multidrug-Resistant HIV-1 in Southeastern France. (PubMed, J Med Virol) - "In one of these 3 persistently viremic PWH, a dual-injectable rescue regimen combining lenacapavir and cabotegravir achieved viral suppression at 33 months with maintenance through the end of follow-up, bringing the success rate to 9 out of 11 (82%) among PWH who were viremic at baseline. A dual-injectable rescue regimen may represent a last-resort option in selected complex cases. Similar real-world studies should be expanded, and adherence support should be strengthened."

Journal • Real-world evidence • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • CD4

A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: ViiV Healthcare

New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Efficacy of dolutegravir or bictegravir-containing therapy in a real-life cohort of people with HIV-1 sub-subtype A6. (PubMed, AIDS) - "In PWH treated with DTG or BIC-containing first-line ART, LLV and virological failure with more than 1000 HIV RNA copies/ml were observed more frequently in PWH-1A6 than in PWH-1B. However, such events rarely resulted in INSTI resistance or discontinuation of INSTI-containing ART."

Journal • Human Immunodeficiency Virus • Infectious Disease

Comparing carbon emissions from oral tenofovir disoproxil fumarate/emtricitabine for preexposure prophylaxis and long-acting injectables for HIV prevention. (PubMed, AIDS) - "Estimated greenhouse gas emissions from active pharmaceutical ingredient (API) production were compared for oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and long-acting injectable preexposure prophylaxis (PrEP) agents, cabotegravir (CAB-LA) and lenacapavir (LEN). For 2 million person-years of PrEP, TDF/FTC generated approximately 108 million kg CO2e, compared with 4.1 million kg for CAB-LA and less than 0.1 million kg for LEN. These findings suggest substantially lower emissions with long-acting agents, supporting consideration of environmental sustainability in HIV prevention strategies."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Design of second-generation pirmitegravir analogues with enhanced resistance profiles | Poster Board #1367 (ACS-Fall 2026) - "Highly potent Integrase Strand Transfer Inhibitors (INSTIs), such as dolutegravir and cabotegravir, are FDA approved first-line therapies. These warrants continued efforts to develop PIR analogues with an enhanced barrier to resistance. This project focuses on the design, synthesis, and optimization of PIR-based analogues to support ALLINI development and HIV-1 therapeutic strategies."

Human Immunodeficiency Virus • Infectious Disease

Sex differences in long-acting cabotegravir trough concentrations in the SEARCH study in Kenya and Uganda. (PubMed, AIDS) - "In the first PK study of CAB-LA PrEP in East Africa, CAB concentrations were lower among men than women after the second and later injections. By weeks 24 and 48, fewer men than women had CAB troughs above published PK targets, though no participants acquired HIV. Findings highlight the importance of examining sex differences and real-world forgiveness in PK with long-acting PrEP scale-up."

Journal • Human Immunodeficiency Virus • Infectious Disease

Two-year efficacy and safety of long-acting cabotegravir and rilpivirine in the SCohoLART study. (PubMed, AIDS) - "CAB/RPV demonstrated high virological efficacy over 2 years in a real-world setting; ISRs represented the leading cause of discontinuation."

Journal • Human Immunodeficiency Virus • Infectious Disease

Provider Perspectives on the Delivery of Long-Acting PrEP for HIV Prevention to Men Who Have Sex with Men and Who Use Methamphetamine. (PubMed, AIDS Patient Care STDS) - "Long-acting pre-exposure prophylaxis (PrEP) formulations, such as bimonthly cabotegravir (CAB) and biannual lenacapavir (LEN) injections, may be particularly effective for HIV prevention in this population. Provider-level barriers were described, including overburdened clinics, limited hours, requisite staffing expertise, and billing restrictions. Strategies to increase long-acting PrEP provision among this population who could benefit from PrEP included reducing provider-side barriers and integrating long-acting PrEP with other appealing services (e.g., syringe services programs), extended hours, mobile delivery, and contingency management."

Journal • Human Immunodeficiency Virus • Infectious Disease

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana (clinicaltrials.gov) - P4 | N=500 | Active, not recruiting | Sponsor: Beth Israel Deaconess Medical Center | Trial completion date: Nov 2027 ➔ Aug 2027

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

SAT50 From evidence to access: Implementation science to inform Lenacapavir scale-up (AIDS 2026) - "Substantial investments have been made with HIV prevention implementation studies of oral PrEP, dapivirine vaginal ring, cabotegravir, and lenacapavir. Describe promising differentiated service delivery models for integrating injectable lenacapavir alongside other PrEP options. ? Identify remaining evidence gaps and priority implementation research questions related to PrEP choice and lenacapavir rollout, and offer evidence-informed insights"

Human Immunodeficiency Virus • Infectious Disease

National cross-sectional survey on acquired HIV drug resistance in Haiti in 2023: warnings resistance to dolutegravir (AIDS 2026) - "3.77% of HIVs were resistant to dolutegravir and bictegravir, 4.4% to cabotegravir, 4.72% to raltegravir, and 5.03% to elvitegravir. Additionally, 15.19% of the viral strains were resistant to abacavir, 13.92% to lamivudine and emtricitabine, 6.65% to zidovudine, 8.23% to stavudine and didanosine, and 4.13% to tenofovir...Furthermore, some HIVs strains developed resistance against efavirenz (49.37%), nevirapine (50%), Rilpivirine (20.25%), Etravirine (12.66%), and doravirine (3.61%). Finally, HIV genome resistance was 0.63% against atazanavir/ritonavir and indinavir/ritonavir, 0.95% against lopinavir/ritonavir and 0.32% against darunavir/ritonavir. HIV acquired pharmacoresistance is moderate in Haiti and requires innovating adapted strategy for preventing its development, its transmission, and for protecting PLHIV health, while emphasizing on children and male individuals."

Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases

Expected hair concentrations of long-acting cabotegravir and rilpivirine with on-time injections: real-world studies allow for pharmacokinetic interpretations in the clinic (AIDS 2026) - "This study defined the average hair concentrations of CAB and RPV among clients receiving LAI therapy via on-time injections in routine care. In this cohort with confirmed adherence, RPV hair concentrations were consistently higher than those of CAB, highlighting matrix-specific differences in drug incorporation despite RPV's typically lower systemic exposure. Hair concentrations may be more useful in clinical practice to guide CAB/RPV dosing than plasma levels, given high interindividual variability."

Clinical • PK/PD data • Real-world • Real-world evidence • Human Immunodeficiency Virus • Infectious Disease

Building resilient PrEP systems amid funding disruptions: lessons from multi-country adaptation and lenacapavir readiness in Nigeria, Mozambique, Uganda and Zambia (AIDS 2026) - "Nigeria successfully transitioned PrEP delivery operations to 433 government-owned facilities, issued rapid policy guidance to expedite service scale-up, and reactivated cabotegravir (CAB-LA) pilot programs under direct government oversight and coordination...Mozambique sustained delivery of the dapivirine vaginal ring and CAB-LA through government facilities and decentralized models, while finalizing evaluation protocols to generate operational evidence and prevent commodity wastage... CIFF and GF’s catalytic support through the PrEP Matching Fund strengthened national HIV prevention systems to mitigate program disruptions while preparing for LEN introduction. Despite country adaptations, PrEP programs remain severely underfunded. Weakened PrEP infrastructure threatens to delay rollout of innovative products like LEN."

Human Immunodeficiency Virus • Infectious Disease

Efficacy and safety of long-acting cabotegravir and rilpivirine in adults with adherence or engagement challenges in sub-Saharan Africa: the IMPALA trial 96-week results (AIDS 2026) - P3 | "BACKGROUND: In sub-Saharan Africa, 1.3 million people taking oral ART are not virally-suppressed. CAB+RPV-LA remained safe and non-inferior to dolutegravir-based ART at 96-weeks, demonstrating good durability. CVF was uncommon overall, but more frequent with CAB+RPV-LA. Fewer episodes of viraemia (>1000copies/ml) were recorded on CAB+RPV-LA."

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

Beyond Efficacy: The Access, Delivery Systems, Acceptability, Persistence, and Transition Management "ADAPT" Framework for Long-Acting Injectable PrEP in Sub-Saharan Africa. (PubMed, HIV AIDS (Auckl)) - "ADAPT was developed through structured narrative synthesis of peer-reviewed and grey literature on oral PrEP scale-up, cabotegravir long-acting (CAB-LA) and lenacapavir (LEN) efficacy, HIV service delivery, task shifting and implementation frameworks, combined with non-research program experience from facility-facing implementation support in Uganda and Sierra Leone. For sub-Saharan Africa, safer and more equitable LA-PrEP rollout requires deliberate design across financing, service delivery, community governance, persistence systems and transition protocols. ADAPT offers a testable organizing model for this work."

Journal • Human Immunodeficiency Virus • Infectious Disease

Participants report positive experiences switching from subcutaneous to intravenous lotivibart (LVB, N6LS, VH3810109) and cabotegravir long-acting injections for HIV-1 treatment in EMBRACE study (AIDS 2026) - "Participants who switched from SC to IV treatment with lotivibart reported positive experiences with both SC and IV infusions and most indicated wanting to continue IV treatment."

Human Immunodeficiency Virus • Infectious Disease

The first six months of national injectable lenacapavir PrEP prescribing and equity, United States, June-December 2025 (AIDS 2026) - " Using a national medical and pharmacy claims database that captures a substantial majority of US PrEP claims, we assessed use of the two oral tenofovir-based PrEP regimens and injectable lenacapavir (LEN) and cabotegravir (CAB) regimens by sociodemographics, insurance, and copay amount. In the first six months of US availability, LEN accounted for about 1% of all PrEP use. In this short period, disparities emerged that align with longstanding PrEP disparities across all regimens –race/ethnicity, sex, and age. Higher LEN use by Medicaid users and higher rates of copay >$100 likely indicate that insurance-related barriers hinder LEN use among commercially insured persons."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Uptake, persistence and preference for long-acting injectable versus oral PrEP among Mobile Men in Uganda and South Africa: primary user effectiveness and implementation outcomes in the Mobile Men trial (AIDS 2026) - " Mobile Men is a phase 3b, open-label, trial comparing cabotegravir (CAB-LA) with oral tenofovir/emtricitabine (TDF/FTC; daily/event-driven) among men who travel for work. Same-day PrEP delivery is feasible this population. Although persistence was low, it was higher with injectable PrEP, which was also the preferred modality, particularly among prior users. Long-acting PrEP is a promising HIV prevention option for mobile populations; ongoing qualitative analyses will inform strategies to improve persistence and cost-effectiveness will be assessed."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Lessons learned on early launch of lenacapavir: uptake and switching patterns, among clients attending STI specialized clinic in Eswatini (AIDS 2026) - "More switching was from Cabotegravir (44.8%, n = 217), driven by the shorter duration of CAB-LA, with 16.7% ( n = 81) switching from oral PrEP. Rollout of Lenacapavir in STI specialized clinic in Eswatini shows high uptake. STI clinics represent a strategic platform for scaling up Lenacapavir. These findings provide important programmatic insights to guide national scale-up of long-acting HIV prevention interventions."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Presence, severity, interference with usual and daily life activities and bothersomeness of injection site reactions with cabotegravir vs lenacapavir: insights from participant reported outcomes in the CLARITY study (AIDS 2026) - P1 | "CAB demonstrated consistently lower presence, severity, and interference with daily activities of common visible ISRs compared with LEN, both in the short-term and up to 6 months post-last injection. LEN was associated with longer-lasting and more bothersome ISRs than CAB. These findings complement clinical assessments and highlight the importance of patient–provider discussions when selecting an LA treatment aligned with individual preferences."

Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

The impact of removing insurance pre-approval on access to HIV pre-exposure prophylaxis in California, U.S. (AIDS 2026) - "PA rejections for generic Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) spiked after approval, primarily due to Medicaid FFS formulary delays, so analyses were performed without Medicaid FFS g/TDF claims...However, newer medications introduced post-SB159 had higher rejection rates: Emtricitabine/Tenofovir Alafenamide (F/TAF)=6.8%, Cabotegravir=5.0%... SB159 was associated with an immediate, short-term reduction in prior authorization rejections of PrEP claims, but substantial barriers persist. Increased HIV diagnosis following claims rejections highlight ongoing structural gaps in PrEP access that may undermine prevention efforts despite policy reform. Continued support for regulatory efforts is critical to improving PrEP uptake."

Reimbursement • US reimbursement • Human Immunodeficiency Virus • Infectious Disease

PrEP awareness and modality choice under shifting HIV financing among key populations in Nigeria (AIDS 2026) - "The headline finding was a mismatch between awareness of newer modalities and preference as only 24% of respondents aware of PrEP had heard of cabotegravir (CAB-LA), yet 51% preferred injectable or long-acting PrEP... Under current transitions, PrEP outcomes in Nigeria are driven less by awareness than by delivery quality, privacy, and trust. Despite high self-rated understanding and willingness, misconceptions about injectable PrEP were common, suggesting demand shaped by misunderstanding rather than informed choice. Low trust and widespread facility discrimination expose service reintegration as a prevention leak, where referral breakdowns, confidentiality concerns, provider judgement, and stock-outs undermine continuity."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders

Between disclosure and silence: motivations, meanings, and relational care implications of PrEP use disclosure (AIDS 2026) - "The most frequent concealment strategies included hiding pill bottles, lying about trips to PrEP services, and managing care through less visible modalities, such as cabotegravir... The findings indicate that PrEP is not a biomedical technology but also a relational artifact, whose disclosure or concealment expresses processes of autonomy, security production, and stigma management across social relationships. Rather than being determined solely by PrEP modalities, disclosure practices are shaped by family dynamics, friendship networks, and affective-sexual partnerships, underscore the importance of PrEP strategies that consider youth social networks and address barriers within the family context, contributing to the strengthening of combination prevention among adolescents."

Human Immunodeficiency Virus • Infectious Disease