Rekambys (rilpivirine LA) / J&J - LARVOL DELTA

Deltoid Administration of LAI-ART: Pharmacokinetic Implications When the Gluteal Site Is Not Feasible. (PubMed, Infez Med) - "Specifically, it focuses on intensive pharmacokinetic monitoring following deltoid administration of LAI rilpivirine and cabotegravir in a 29-year-old transgender woman with progressive multifocal leukoencephalopathy and swallowing difficulties...By day 10, the patient's clinical condition had deteriorated, leading to hospice care and subsequent death. Rilpivirine exposure after deltoid injection appeared lower than that typically reported after gluteal or thigh administration, although intracellular drug concentrations may differ from plasma levels, potentially mitigating clinical concerns."

Journal • PK/PD data • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Rare Diseases

Preclinical evaluation of long-acting cabotegravir and rilpivirine for HIV post-exposure prophylaxis in a macaque model. (PubMed, EBioMedicine) - "We document protection in macaques by one-time CAB LA/RPV LA PEP under highly stringent modeling conditions. Delayed breakthrough infections highlight potential diagnostic challenges associated with this PEP modality and underscore the need for prolonged follow-up."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

Genotyping not required for sustained effectiveness of long-acting cabotegravir plus rilpivirine: evidence from the RELATIVITY cohort. (PubMed, AIDS) - "In this large real-world cohort, the absence of genotypic data did not affect LAI CAB+RPV effectiveness in virologically suppressed PWH. Limitations, including ambispective design, short follow-up, and low non-B subtype prevalence, may limit generalizability."

Journal • Human Immunodeficiency Virus • Infectious Disease

Long-acting Cabotegravir/Rilpivirine for Treatment of HIV During Pregnancy: A Case Series. (PubMed, Open Forum Infect Dis) - "We present pharmacokinetic data on long-acting cabotegravir/rilpivirine (LA CAB/RPV) from two patients during their second and third trimesters. Monthly LA CAB/RPV dosing maintained concentrations above the proposed efficacy thresholds while bimonthly dosing resulted in subtherapeutic RPV concentrations. This highlights the potential of monthly LA CAB/RPV dosing in pregnancy."

Journal • 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

Hepatitis B Virus Reactivation in People Living with HIV Switching to Long Acting-Cabotegravir/Rilpivirine therapy: A Cohort Study Analysis (EACS 2025) - "Purpose : To evaluate the serological hepatitis B virus (HBV) profiles and risk of HBV reactivation or acquisition in people with HIV switching to long-acting cabotegravir/rilpivirine (LA-CAB/RPV), particularly in those with prior HBV exposure or unnoticed chronic infection. HBV reactivation is a rare but clinically significant risk in individuals with unnoticed chronic HBV switched to LA-CAB/RPV. Comprehensive HBV screening, vaccination, and ongoing liver monitoring are essential before and after switching to LA-CAB/RPV."

Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

Prospective evaluation of cardiovascular risk in PLWH receiving LA-cabotegravir/rilpivirine (EACS 2025) - "However, very few data are available on the CV risk in PLWH treated with Long Acting-cabotegravir/rilpivirine (LA-CAB/RPV), measured with currently available CV scores. Actually available CV risk scores, except D.A.D., showed that PLWH treated with LA-CAB/RPV maintained a low-moderate CV risk during treatment. Up to now, the fact that the mean CV scores did not change during follow-up, suggest that LA-CAB/RPV might not have an impact on CV risk."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Reasons for switching to long-acting injectable antiretroviral therapy with cabotegravir/rilpivirine among adult people living with HIV: the real-life PANTER study (EACS 2025) - "We evaluated reasons for switching to LA-ART with cabotegravir/rilpivirine (LA-CAB/RPV) among adult PLWH. All aspects of PLWH's quality of life should guide treatment switching decisions, especially in women. ​"

Clinical • Human Immunodeficiency Virus • Infectious Disease

Real-Life Effectiveness, Safety, and Patient-Reported Outcomes of Long-Acting Cabotegravir-Rilpivirine: Results from a large single center cohort (EACS 2025) - "Purpose : Long-acting intramuscular cabotegravir plus rilpivirine (LA-CAB/RPV) is available in Spain since January 2023. Items related to HIV medication and disclosure worries domains of the HIV/AIDS-targeted quality of life (HAT-QoL) Questionnaire also improved during follow up (Figures). Conclusions : LA-CAB/RPV shows high effectiveness, tolerability, and acceptance in a real-life setting, with improvements in treatment relationship and disclosure worries domains."

Clinical • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Health and Virological Outcomes Among People with HIV Switching to Long-Acting Injectable Cabotegravir and Rilpivirine (LANTERN) (EACS 2025) - "Antiretroviral therpy regimens before switching included BIC/FTC/TAF (n=37, 27.1%), DTG/3TC (n=65, 47.4%), DTG/RPV (n=6, 4.4%), TAF/FTC/RPV (n=28, 20.4%) and DTG/3TC/ABC (n=1, 0.7%). Conclusions : Switching to CAB plus RPV LA was associated with improved treatment satisfaction and high acceptance, alongside high rates of virological suppression, with no individuals experiencing virological failure during the observation period. In conclusion, this study suggests that CAB plus RPV LA may be a beneficial treatment option in Taiwan."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-Acting Cabotegravir-Rilpivirine in Vulnerable Population: Chemsex Practices-based Analysis (EACS 2025) - "Purpose : Limited data exists on long-acting Cabotegravir-Rilpivirine (LA-CAB/RPV) therapy in people engaged in chemsex. Adverse effects and discontinuations related to the medication appeared in 10% and 2% of patients respectively without differences between groups. FIGURE 1: Percentage of reported drugs in Chemsex Users (n=68) FIGURE 2: Effectiveness of LA-CAB/RPV at 52 weeks of follow-up (CSU: chemsex users vs non-CSU): Conclusions : In people engaged in chemsex with the described consumption patterns, treatment with LA-CAB/RPV showed high effectiveness and good adherence with minor significant differences compared to the general cohort."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Long-Acting Cabotegravir-Rilpivirine in Real-Life: Sex-based Characteristics and Effectiveness (EACS 2025) - "Purpose : This study aimed to focus on sex-based characteristics, effectiveness, tolerability and acceptance, in people with HIV switching to long-acting cabotegravir-rilpivirine (LA-CAB/RPV) administered Q2M in Hospital Clínic of Barcelona, Spain. Men: 4 (11%) virological failure, 13 (36%) potential TRAEs, 6 (17%) participant preference, 5 (14%) medical decision, and 8 (22%) changed location. Conclusions : Although proportionally less women than men switched to LA-CAB/RPV, there were no differences in effectiveness and adherence."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV (EACS 2025) - "Purpose : Intramuscular cabotegravir/rilpivirine is the first long-acting antiretroviral therapy (LA-CAB/RPV) approved for people with HIV (PWH), with excellent results in virologically suppressed individuals. Conclusions : In this cohort, LA-CAB/RPV demonstrated rapid virologic control (60% suppression by Week 12) and excellent adherence, despite baseline viremia and socioeconomic challenges. These real-world data suggest LA-CAB/RPV may be beneficial in carefully selected PWH presenting viremia, though further studies are needed to confirm the durability of suppression."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Durability and reasons for treatment discontinuation of BIC/FTC/TAF in real life: data from 927 Persons With HIV in charge to “D. Cotugno” hospital, Naples, Southern Italy (EACS 2025) - "Most common post-TD treatments were LA-Cabotegravir+LA-Rilpivirine and Dolutegravir/Lamivudine...Post-TD regimens varied significantly by discontinuation reason: DTG/3TC, LA RPV+LA CAB, DRV/c/FTC/TAF, FTC/TDF+RAL 1200mg, and DRV/c/FTC/TAF again were the regimens most used in case of switch for Simplification/proactive switch, Patients’ choice, Toxicity, Pregnancy, and Virologic failure, respectively. Conclusions : B/F/T shows excellent real-life durability, with a low TD rate. When discontinuation occurs, it is mostly due to physician-driven proactive strategies or PWH-driven decisions rather than efficacy or tolerability issues."

Clinical • Human Immunodeficiency Virus • Infectious Disease

Experience of treatment with long-acting injectable cabotegravir/rilpivirine (LA iCAB/RPV) in viremic young patients with perinatally acquired HIV with adherence challenges: a five-case series. (PubMed, Int J Infect Dis) - "LA iCAB/RPV appears to be a promising treatment strategy for youth with perinatally acquired HIV facing persistent adherence barriers and previous treatment failures. Further studies with larger cohorts and extended follow-up are needed to confirm these results and inform care strategies."

Journal • Human Immunodeficiency Virus • Infectious Disease

Efficacy and Safety of Long-acting Injectable Cabotegravir and Rilpivirine in Improving HIV-1 Control in sub-Saharan Africa: Protocol for a Phase 3b Open-Label Randomized Controlled Trial (IMPALA). (PubMed, Wellcome Open Res) - P3 | "IMPALA seeks to demonstrate the non-inferior antiviral effectiveness of switching to CAB LA + RPV LA Q2M, compared to the continuation of first-line daily oral ART containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus dolutegravir (DTG). Initial: TMC278LAHTX3005 Version Amendment 1, 30 September 2022 Superseded by: TMC278LAHTX3005 Version Amendment 2, 3 June 2024 This clinical trial was registered on Clinical Trials.gov on 19 September 2022 (NCT05546242), available from https://clinicaltrials.gov/ct2/show/NCT05546242. The study was also registered on Pan African Clinical Trials Registry on 23 January 2023 (PACT202301600757432TMC278LAHTX3005), available from https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24291."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease

Acceptability, Facilitators, and Barriers of Long-Acting Injectable Cabotegravir/Rilpivirine Among Youth With HIV in the United States. (PubMed, J Adolesc Health) - "LAI-CAB/RPV barriers among AYWH included side effects and more frequent visits. Removal of pill burden and fatigue and thinking less about their HIV diagnosis were the main facilitators. Further studies are needed for the implementation of LAI-CAB/RPV for AYWH in the United States."

Journal • Fatigue • Human Immunodeficiency Virus • Infectious Disease

Treatment experience of people living with HIV who transitioned from oral to long-acting injectable antiretrovirals in Puerto Rico: A qualitative study. (PubMed, PLoS One) - "This study explores the treatment experience of people living with HIV who transitioned from oral ART to long-acting injectable therapy Cabotegravir/Rilpivirine (LAI-CAB/RPV) in Puerto Rico. Study participants' positive experiences underscore the potential of LAI-CAB/RPV to revolutionize the standard of care, enhancing both the treatment experience and the overall well-being of people living with HIV. Continued research is crucial to refine and expand the benefits of this treatment approach."

Journal • Human Immunodeficiency Virus • Infectious Disease

No apparent effect of modafinil on long-acting rilpivirine and cabotegravir concentrations: a case report in a person with HIV. (PubMed, Eur J Clin Pharmacol) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (clinicaltrials.gov) - P1/2 | N=168 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

HOLA: Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine (clinicaltrials.gov) - P4 | N=103 | Completed | Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

CROWN: A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 (clinicaltrials.gov) - P3 | N=332 | Recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2027 ➔ May 2028 | Trial primary completion date: May 2026 ➔ Oct 2026

Head-to-Head • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Switching to Long-Acting Cabotegravir and Rilpivirine in Turkey: Perspectives from People Living with HIV in a Setting of Increasing HIV Incidence. (PubMed, Medicina (Kaunas)) - "Background and Objectives: Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) offers an alternative to daily oral antiretroviral therapy (ART) for people living with HIV (PLWH). Addressing these patient-centered factors and logistical barriers may support the successful integration of long-acting therapies into routine HIV care. Future longer-interval agents may improve patient-centered acceptability."

Journal • Human Immunodeficiency Virus • Infectious Disease

Safety, Tolerability, and Metabolic Effects of Long-Acting Cabotegravir and Rilpivirine in HIV Care: A Comprehensive Review. (PubMed, Viruses) - "The use of long-acting cabotegravir and rilpivirine (LA CAB/RPV) is a novel approach to manage human immunodeficiency virus (HIV). Although real-world data are still emerging, they suggest similar trends, including a possible improvement in lipid profiles. Overall, LA CAB/RPV appears to be a safe, well-tolerated and effective treatment option, although longer-term follow-up is needed."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

ATLAS-2M: Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults (clinicaltrials.gov) - P3 | N=1049 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Dec 2029

Head-to-Head • Trial completion date • Human Immunodeficiency Virus • Infectious Disease