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

“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

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