Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi 
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  • ||||||||||  Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi, Vemlidy (tenofovir alafenamide) / Gilead
    Hepatitis B Reactivation in PLWH With Anti-Core Antibody After Switch to an Anti-HBV Sparing Regimen (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_875;    
    We decided to investigate HBV reactivation in antiHBc-PLWH (with isolated anti-HBc or with anti-HBc and anti-HBsAg) after the switch from ART including drugs active on both viruses (tenofovir disoproxil fumarate, TDF and tenofovir alafenamide, TAF) to an antiHBV sparing regimen (antiHBVsr) because in PLWH the loss of HBsAg with or without anti-HBsAg seroconversion is probably consequent to ART treatment including drugs active on both viruses (HIV/HBV) rather than past HBV infection. Additionally, HBV reactivation has been described in immunocompromised anti-HBsAg positive people.HBV reactivation in antiHBc-PLWH was assessed by an alteration of alanine aminotransferase (ALT) above the upper limit of the normal range after the switch to antiHBVsr dolutegravir/rilpivirine (DOL/RPV) or long acting therapy cabotegravir/rilpivirine (CAB/RPVLA)...The HBV reactivation is unlikely in antiHBc-PLWH with anti-HBsAg positivity after switch to anti-HBVsr, while close monitoring of ALT and possibly HBV-DNA in PLWH with antiHBc alone, after switch to anti-HBVsr is necessary.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Method for Analyzing Cabotegravir and Rilpivirine in Hair May Help Identify Risk Factors for Failure (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_634;    
    The UCSF HIV Clinic (Ward 86) has ~250 patients on long-acting CAB/RPV with demographics typically assessed in population PK models (age, sex, BMI, etc.) available in the medical record. A research study to analyze CAB and RPV levels in hair and plasma, construct population PK models, and define risk factors for low LA CAB/RPV exposure, portending virologic failure, will be launched at Ward 86 using the hair method described here.
  • ||||||||||  Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Injectable Cabotegravir/Rilpivirine Reach and Effectiveness in a South Side Chicago HIV Clinic (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_542;    
    However, challenges exist in starting PWH on LAI CAB/RPV, especially among those without VS. More work is needed to support providers, patients, and clinic systems to deliver LAI-CAB/RPV to this group.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Implementing Long-Acting ART in a Community Health Center: Insights and Early Outcomes (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_541;    
    These patients have maintained viral suppression at a high rate. We also provide further evidence suggesting efficacy of CAB-RPV LAI in non-suppressed PLWH who struggle with adherence to oral ART.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Access to Long-Acting Injectable ART Through State AIDS Drug Assistance Programs (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_533;    
    States should consider expanding access to Cabenuva, including working to reduce supply and payment chain barriers, to promote equitable access to LAI ART. Future work should examine access to Cabenuva using patient-level data.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Predictors of Injection Visit Adherence in Those Receiving Injectable Cabotegravir/Rilpivirine (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_494;    
    Background: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) provides a novel treatment option for people with HIV (PWH)... Evaluating attendance to office visits prior to switching to LAI CAB/RPV may help identify those more likely to miss injection visits, however it was not associated with late injections or having a detectable viral load or virologic failure.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    HIV-1 RNA Blips and Low-Level Viral Replication: SOLAR (CAB+RPV LA vs BIC/FTC/TAF) (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_491;    
    P3
    The proportions of study participants with HIV-1 RNA viral blips, TND, and HIV-1 RNA <40 c/mL were similar between CAB+RPV LA and BIC/FTC/TAF through Month 12. HIV-1 viral blips with CAB+RPV LA did not appear to be associated with CVF, consistent with prior CAB+RPV LA Phase 3 clinical study data.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Real-World Virologic Outcomes of Cabotegravir/Rilpivirine in Patients With Elevated Body Mass Index (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_490;    
    HIV-1 viral blips with CAB+RPV LA did not appear to be associated with CVF, consistent with prior CAB+RPV LA Phase 3 clinical study data. Background: Injectable cabotegravir (CAB) and rilpivirine (RPV) is the first complete long-acting antiretroviral (ARV) regimen approved in persons with HIV with sustained virologic suppression (HIV RNA 50 copies/mL and VF were similar between groups regardless of BMI category.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare, Sunlenca (lenacapavir) / Gilead
    Case Series Examining the Long-Acting Combination of Lenacapavir and Cabotegravir: Call for a Trial (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_489;    
    Background: Injectable cabotegravir (CAB) and rilpivirine (RPV) is the first complete long-acting antiretroviral (ARV) regimen approved in persons with HIV with sustained virologic suppression (HIV RNA 50 copies/mL and VF were similar between groups regardless of BMI category. The currently-approved LA-ART combination
  • ||||||||||  Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare, Sunlenca (lenacapavir) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Review, Journal:  Polymer Delivery Systems for Long-Acting Antiretroviral Drugs. (Pubmed Central) -  Feb 24, 2024   
    We posit that the physicochemical properties of the formulation chemical design can optimize drug release profiles. We posit that the strategic design of LA DDS polymers will further improve controlled drug release to simplify dosing schedules and improve regimen adherence.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    PK/PD data, Journal:  Physiologically-based pharmacokinetic modelling of long-acting injectable cabotegravir and rilpivirine in pregnancy. (Pubmed Central) -  Feb 10, 2024   
    Model predictions suggest that monthly long-acting cabotegravir could maintain antiviral efficacy throughout pregnancy, but that bimonthly administration may require careful clinical evaluation. Both monthly and bimonthly long-acting rilpivirine may not adequately maintain antiviral efficacy in pregnancy.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Journal:  People with HIV pioneers of injectable cabotegravir and rilpivirine long acting in Italy: who are they? (Pubmed Central) -  Feb 1, 2024   
    Injectable cabotegravir and rilpivirine long-acting therapy is a revolutionary new antiretroviral treatment (ART) option for HIV infection in virologically suppressed adults on a stable ART. The aim of this study from SCOLTA multicenter observational prospective database is to describe the first people living with HIV (PWH) who started this regimen in Italy, assessing adherence to eligibility criteria, describing clinical-epidemiological characteristics compared to registration trials-population and describe early treatment-discontinuations.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Journal:  Early adopters of long-acting injectable cabotegravir/rilpivirine: what lessons can we learn? (Pubmed Central) -  Feb 1, 2024   
    The aim of this study from SCOLTA multicenter observational prospective database is to describe the first people living with HIV (PWH) who started this regimen in Italy, assessing adherence to eligibility criteria, describing clinical-epidemiological characteristics compared to registration trials-population and describe early treatment-discontinuations. No abstract available
  • ||||||||||  Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    P3 data, PK/PD data, Journal:  Efficacy, safety, and pharmacokinetics by BMI category in Phase 3/3b cabotegravir?+?rilpivirine long-acting trials. (Pubmed Central) -  Dec 22, 2023   
    Not yet recruiting --> Recruiting CAB?+?RPV LA was efficacious and well tolerated, regardless of baseline BMI category.Main point summary: CAB?+?RPV LA is effective in the maintenance of HIV-1 virologic suppression in adults regardless of BMI category, with longer-length needles (?2 inches) recommend for those with BMI ?30?kg/m2 to accommodate individual body habitus and ensure appropriate administration.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare, Edurant (rilpivirine) / J&J
    Review, Journal:  Practical dosing guidance for the management of clinician-administered injections of long-acting cabotegravir and rilpivirine. (Pubmed Central) -  Dec 18, 2023   
    Practical guidance on the clinical management of CAB+RPV LA dosing, including a detailed discussion using case-based scenarios that may be encountered in clinical practice, is provided. The clinician-administered CAB+RPV LA regimen has dosing management considerations that are flexible and considerate of the patient and has the potential to provide a highly desirable and efficacious alternative to daily oral antiretroviral therapy for many people with HIV-1.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Journal:  Predictors of post-switch viremia in people with HIV on injectable cabotegravir/rilpivirine. (Pubmed Central) -  Dec 7, 2023   
    Despite virologic suppression at the time of switch and the perceived adherence benefits, participants still experienced blips or pLLV after switch to LAI CAB/RPV. Having detectable HIV RNA on oral therapy before switch was associated with detectable HIV RNA after switching.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Enrollment closed, Enrollment change, Trial primary completion date:  GLACIER: Study Using CABENUVA (clinicaltrials.gov) -  Nov 18, 2023   
    P4,  N=44, Active, not recruiting, 
    Tolerability of cabotegravir + rilpivirine LA intramuscular lateral thigh injections was similar to gluteal administration. Recruiting --> Active, not recruiting | N=120 --> 44 | Trial primary completion date: Jul 2023 --> Feb 2024
  • ||||||||||  Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Journal, Real-world evidence, Real-world:  Cabotegravir (Pubmed Central) -  Nov 15, 2023   
    Recruiting --> Active, not recruiting | N=120 --> 44 | Trial primary completion date: Jul 2023 --> Feb 2024 In this large US cohort, most monthly CAB
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Off-label use of long-acting injectable cabotegravir/rilpivirine in viremic patient living with HIV (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1518;    
    Our case demonstrates the usefulness of CAB/RPV-LA in a patient not VS. The results add validity to the existing data on its use (1) and are optimistic so far with HIV-RNA <50 copies/mL However, our results are short-term, and follow-up studies are needed to clarify long-term outcomes.
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Off-label use of long-acting injectable cabotegravir/rilpivirine in viremic patient living with HIV (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1517;    
    Our case demonstrates the usefulness of CAB/RPV-LA in a patient not VS. The results add validity to the existing data on its use (1) and are optimistic so far with HIV-RNA <50 copies/mL However, our results are short-term, and follow-up studies are needed to clarify long-term outcomes.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    SOLAR 12-Month European Results: Randomized Switch Trial of CAB+RPV LA vs. Oral BIC/FTC/TAF (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_636;    
    P3
    *results are expressed as median (IQR25%-75%) Conclusions : Mean adjusted HIVTSQs scores improved significantly (p<0.001) from baseline to M12 for LA (+3.64) vs. BIC/FTC/TAF participants (
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    SOLAR 12-Month European Results: Randomized Switch Trial of CAB+RPV LA vs. Oral BIC/FTC/TAF (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_635;    
    P3
    Mean adjusted HIVTSQs scores improved significantly (p<0.001) from baseline to M12 for LA (+3.64) vs. BIC/FTC/TAF participants ( Mean adjusted HIVTSQs scores improved significantly (p<0.001) from baseline to M12 for LA (+3.64) vs. BIC/FTC/TAF participants (
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Safety of cabotegravir/rilpivirine long acting for individuals previously exposed to HBV infection (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_568;    
    Linear regression analysis failed to predict a significant FIB-4 evolution over time within the overall (b=-0.004, CI: -0.183-0.175, p=0.967), the HBV-exposed (b=-0.081, 95% CI: -0.440-0.279, p=0.659), and the unexposed population (b=-0.000, 95% CI: -0.180-0.180, p=0.997) (Figure 2). Conclusions :
  • ||||||||||  Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    Safety of cabotegravir/rilpivirine long acting for individuals previously exposed to HBV infection (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_567;    
    Linear regression analysis failed to predict a significant FIB-4 evolution over time within the overall (b=-0.004, CI: -0.183-0.175, p=0.967), the HBV-exposed (b=-0.081, 95% CI: -0.440-0.279, p=0.659), and the unexposed population (b=-0.000, 95% CI: -0.180-0.180, p=0.997) (Figure 2). Conclusions :