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

Use of long-acting cabotegravir and rilpivirine in people living with HIV: A prospective observational cohort study. (PubMed, HIV Med) - "CAB+RPV LA appears to be an effective, safe and durable option for a switch strategy."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Hepatitis B reactivation in people living with HIV and isolated anti-HBc receiving tenofovir-sparing dual antiretroviral therapy. (PubMed, HIV Med) - "In this cross-sectional assessment, no evidence of HBV reactivation was detected in people living with HIV with isolated anti-HBc receiving TFV-sparing dual ART, including regimens without direct anti-HBV activity."

Journal • Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation

FLAIR: Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (clinicaltrials.gov) - P3 | N=631 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Dec 2029

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Efficacy of Long-Acting Injectable Cabotegravir and Rilpivirine Compared With Daily Oral Antiretroviral Therapy in Patients With HIV: A Systematic Review. (PubMed, Cureus) - "Patient-reported outcomes consistently favored the injectable regimen, with higher treatment satisfaction scores and excellent adherence within the dosing window, while adverse events were mainly mild-to-moderate injection-site reactions (ISRs), resulting in treatment discontinuation in fewer than 1% of participants. Overall, the certainty of evidence was high for virological efficacy and moderate for safety and satisfaction outcomes, supporting long-acting CAB/RPV-LA as an effective and well-tolerated alternative that improves adherence, convenience, and quality of life in long-term HIV management."

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

Determinants of long-acting cabotegravir plus rilpivirine discontinuation in real-world HIV care: insights from the RELATIVITY cohort. (PubMed, AIDS) - "In this large national cohort, LAI-CAB+RPV demonstrated strong persistence, excellent tolerability, and very low rates of VF. Discontinuations were mainly structural, highlighting the need to reinforce continuity-of-care pathways and system-level support for optimal LAI-CAB+RPV scale-up."

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

221611: PH 3b, CAB + RPV in people with suboptimal response to oral ART (CROWN) (clinicaltrialsregister.eu) - P2/3 | N=98 | Active, not recruiting | Sponsor: Viiv Healthcare UK Limited

Head-to-Head • New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

Clinical management of detectable viraemia during CAB/RPV long-acting therapy: Are really PIs the only exit strategies? (PubMed, HIV Med) - No abstract available

Journal

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 primary completion date: Dec 2026 ➔ Aug 2026

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

IMAdART: Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units". (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Trial completion date: Jul 2025 ➔ Feb 2026 | Active, not recruiting ➔ Completed

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

“MOCHA” More Options for Children and Adolescents (clinicaltrialsregister.eu) - P1/2 | N=155 | Sponsor: National Institute of Allergy and Infectious Diseases, Division of AIDS

New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

Bimonthly Administered Long-Acting Cabotegravir and Rilpivirine Are Highly Effective and Well-Tolerated in People With Human Immunodeficiency Virus Above 65 Years. (PubMed, Open Forum Infect Dis) - "Older people with HIV (PWH) may benefit from long-acting cabotegravir/rilpivirine (LA-CAB/RPV), a population underrepresented in trials and observational cohorts. After 17.4 months, virological suppression (HIV-RNA <50 copies/mL) was maintained in all, while 15 participants discontinued them (11.1%, 10% in the first 12 months): 1 participant with isolated HbCAb at baseline showed a late HBV reactivation (19.4 months after starting). These findings support LA-CAB/RPV's efficacy and tolerability in older PWH."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Y181C-associated virologic failure during long-acting injectable cabotegravir/Rilpivirine in a patient engaged in intensive intravenous Chemsex. (PubMed, HIV Med) - "This case highlights that unexpected resistance can emerge during adequately administered LA-CAB/RPV therapy. Careful clinical evaluation is warranted when virologic failure occurs, particularly in the presence of extreme behavioural or physiological stressors."

Journal • Human Immunodeficiency Virus • Infectious Disease

Impact of Switching from Oral to Long-Acting Injectable Cabotegravir and Rilpivirine on the Lipid Profile of HIV-Positive Patients. (PubMed, Microorganisms) - "Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) have been incorporated into the treatment of people living with HIV (PLWH), but evidence on their metabolic impact in real-world settings remains limited. These findings suggest that switching to long-acting injectable cabotegravir and rilpivirine maintains virological and immunological control without adversely affecting the total cholesterol, LDL cholesterol, or triglycerides, and is associated with an improvement in HDL cholesterol. LA-CAB/RPV therefore appears to be a metabolically safe therapeutic option for PLWH, with a potentially favorable effect on cardiovascular risk factors."

Journal • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • CD4

Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. (PubMed, Lancet HIV) - P1/2 | "Week 48 data from the first virologically suppressed adolescents with HIV-1 who switched from daily oral to intramuscular cabotegravir and intramuscular rilpivirine every 8 weeks showed favourable safety, pharmacokinetics, and virological suppression informing both real-world use, where approved, and ongoing regulatory submissions, where approval is pending."

Journal • P1/2 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pain • Pediatrics

Hepatitis B Outcomes After Switching to Long-Acting Cabotegravir/Rilpivirine in People With HIV: Reactivation, Incident Infection, and Liver Safety Across Diverse Serological Profiles. (PubMed, Clin Infect Dis) - "LA-CAB/RPV appears safe in individuals with prior HBV exposure, including those with isolated anti-HBc. Comprehensive HBV screening, vaccination, and liver monitoring are essential."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Evaluating long-acting injectable HIV treatment: an update on cabotegravir and rilpivirine. (PubMed, Expert Rev Anti Infect Ther) - "Long-acting cabotegravir (CAB) and rilpivirine (RPV) provide the first complete regimen administered by intramuscular injections every 4 or 8 weeks, enabling virologic maintenance without daily pills...Phase II (LATTE, LATTE-2) and phase III (FLAIR, ATLAS, ATLAS-2 M, SOLAR) trials demonstrated that CAB+RPV long-acting is non-inferior to oral therapy, showing durable viral suppression...Its successful implementation requires careful patient selection, robust systems to support timely injections, and strategies to mitigate pharmacokinetic challenges. Future directions include expanding eligibility to broader populations, optimizing ultra-long-acting formulations, and integrating injectables into differentiated care models to ensure equity of access."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

ATLAS: Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (clinicaltrials.gov) - P3 | N=618 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Dec 2025 ➔ Dec 2029

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

Durability of Long-Acting Cabotegravir + Rilpivirine in Virologically Suppressed Adults Living With HIV: A Multicenter Observational Cohort in Tuscany (LAHIV). (PubMed, J Med Virol) - "Discontinuation rates were slightly higher than clinical trials but consistent with real-world data. The VF incidence was slightly higher than reported in prior reports, highlighting the need for real-life clinical monitoring."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

VOLITION: A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (clinicaltrials.gov) - P3 | N=171 | Active, not recruiting | Sponsor: ViiV Healthcare | Trial completion date: Sep 2026 ➔ Apr 2026

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Injection-Site Pain after Long-Acting Rilpivirine: No Association with Tempering Time in a Prospective Observational Study. (PubMed, Int J Infect Dis) - "In this real-world cohort, tempering time of RPV-LA was not independently associated with injection-site pain. Age was the only consistent predictor of pain intensity. These findings suggest that strict adherence to tempering recommendations may not substantially influence patient comfort. Further randomized studies are warranted to confirm these observations and explore additional strategies to minimize injection-site discomfort."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease • Pain

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