- |||||||||| 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) - Apr 12, 2025
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
Observational data, Journal, Real-world evidence: Real World Data from an Italian Outpatient Clinical Setting and from Home Care Assistance of Treatment-Experienced PWH Switching to CAB?+?RPV Regimen: A Prospective Observational Study. (Pubmed Central) - Apr 10, 2025
In the subgroup, we found no significant changes in the HIV-DNA levels over time (p?=?0.332). Our results confirm the efficacy of CAB?+?RPV as a switch strategy in virologically suppressed PWH and even in more complex individuals, encouraging its use in PWH in need, coupled with HCA home administration support.
- |||||||||| Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Retrospective data, Journal, Real-world evidence: Real-world efficacy and tolerability of CAB+RPV LA in women: addressing the gender gap in HIV treatment research. (Pubmed Central) - Apr 2, 2025
CAB?+?RPV LA is effective and well-tolerated in women with complex ART histories, providing a viable long-acting alternative for populations traditionally underrepresented in clinical trials. These findings underscore the importance of including women in studies of novel ART regimens to ensure equitable access and outcomes.
- |||||||||| Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Transient Viremia Among People with HIV Receiving Injectable Cabotegravir Plus Rilpivirine. (Pubmed Central) - Apr 1, 2025
No other characteristics were significantly associated with time to VB, and no participants experienced virologic failure. Considerations for baseline CD4 may be important when initiating a patient on LAI CAB/RPV, and future studies will help evaluate the VB occurrence and associated factors among PWH.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Comparison of At-Home Versus In-Clinic Receipt of Long-Acting Injectable Cabotegravir/Rilpivirine. (Pubmed Central) - Mar 17, 2025
Providers should consider LAI therapy among PWH with adherence difficulties. At-home administration of LA CAB/RPV by a healthcare provider was comparably safe, effective, and associated with high participant satisfaction relative to in-clinic administration.
- |||||||||| Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Clinical, Journal: Early Experience and Effectiveness of Long-Acting Injectable Cabotegravir and Rilpivirine in a South Side Chicago HIV Clinic. (Pubmed Central) - Mar 12, 2025
In a pharmacy-led model, 118 (18%) people with HIV were referred and 78 (12%) initiated long-acting injectable cabotegravir/rilpivirine from 1 January 2021 to 31 May 2023. Implementation, especially for people with HIV who were not virally suppressed, requires further support for patients, providers, and clinic systems.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi, Vemlidy (tenofovir alafenamide) / Gilead
Journal, Real-world evidence: The Real-World Impact of Long-Acting Injectable Cabotegravir-Rilpivirine on Weight and Renal Function. (Pubmed Central) - Mar 5, 2025
In this small set of patients, LAI CAB/RPV led to less weight gain compared to oral integrase inhibitor-based regimens. However, there was no significant change in the estimated glomerular filtration rate (eGFR) between patients who were started on LAI CAB/RPV and those who continued to receive oral regimens with or without tenofovir alafenamide (TAF).
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Characteristics of People With HIV Prescribed Long-Acting Cabotegravir/Rilpivirine in a US Cohort (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_1547;
Conclusions While each academic HIV clinic has been prescribing LA-CAB/RPV to underserved populations, including people with VNS and people who inject drugs, the rollout across clinics is uneven. Future scale-up efforts need to address access issues at the state/health system level to ensure that the diverse PWH populations that each clinic serves can benefit from LA-CAB/RPV.
- |||||||||| Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
A5359: Decreasing Oral Induction Duration in Support of LAI ART Use With Hardly Reached Populations (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_1288;
Of the 411 eligible for transition at the interim analysis, 61%, 77%, and 89% transitioned successfully to Step 2 with progressively shorter duration of viral suppression in Step 1(Table). Conclusions A5359 successfully enrolled a population not generally included in studies of investigational ART strategies and demonstrated that in-stream shortening of the required duration of virologic suppression significantly increased enrollment for the randomized strategy comparison.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Inter- and Intraindividual Variability of LA CAB/RPV Pharmacokinetics After 1 Year of Continuous Use (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_1281;
Conclusions After achieving proposed steady state concentrations, inter- and intraindividual variability persists for CAB and RPV. Despite this variability, there was no association between CAB/RPV concentrations and viremia.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Safety and Pharmacokinetics of Long-Acting Cabotegravir and Rilpivirine in Children 20 to 40 kg (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_1029;
Conclusions Administration of PO CAB+RPV followed by Q4W IM CAB-LA+RPV-LA in children 20-<40 kg achieved exposure concentrations comparable to adolescents and adults receiving this regimen. No new or unanticipated safety concerns were identified.
- |||||||||| Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J, Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Hepatitis B Reactivation in PWH With Isolated Anti-Core Pattern on Therapies Excluding Tenofovir (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_919;
Conclusions Our findings suggest that the risk of HBV reactivation in PLHIV with isolated anti-core patterns who are treated with TXF-free dual ART regimens is extremely low after more than 3 years of follow-up. This holds true even for regimens that do not have direct anti-HBV activity, such as DTG+RPV and CAB+RPV-LA.
- |||||||||| Edurant (rilpivirine) / J&J
Rilpivirine Drug-Resistant Mutations in Experienced Patients in Mexico: Impact on Long-Acting ART (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_912;
Conclusions This retrospective analysis indicates that rilpivirine DRMs are common in a setting wherein NNRTI-based treatment was widely implemented, and has implications for operational implementation of CAB/RPV LA. Screening for existing DRMs is logistically and technically challenging in Mexico and could be a barrier to use of CAB/RPV LA.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Distance to Care Measures Predict Injection Visit No-Shows Among Cabotegravir/Rilpivirine Recipients (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_896;
Conclusions Several DTC measures with CART-derived breakpoints were independently associated with IVNS among recipients of LAI CAB/RPV. Future studies should consider incorporating CART into the DTC measure used to predict injection visit adherence.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Implementation of LA-CAB/RPV in US Clinic Settings: A Survey of Front-Line Clinicians (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_895;
Conclusions While most clinicians surveyed have incorporated LA-CAB/RPV into their practices, key challenges remain, particularly among adolescents, cis-gender female patients, those with resolved Hepatitis B, and those with higher BMIs. Addressing barriers related to insurance and approval processes, along with continued education, is crucial to expanding access and optimizing the use of LA-CAB/RPV.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Outcomes in Those Who Discontinued Injectable Cabotegravir/Rilpivirine and Resumed Oral ART (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_894;
The percentage of those with HIV VL <50cpm and <200cpm up to 24 weeks was 91.4% and 94.8%, up to 48 weeks was 90.6% and 96.2%, and using the most recent documented VL was 91.9% and 95.9%, respectively. Conclusions In those who discontinued LAI CAB/RPV, returned to oral ART, and remained engaged in care, a high rate of ongoing viral suppression was observed.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Why Do People With HIV Stop Long-Acting Injectable Cabotegravir/Rilpivirine and What Happens? (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_892;
Conclusions Overall, discontinuation was low, and injection site pain was the most common reason. For PWH initiating LA-CAB/RPV with viremia, VF and missed/late injections accounted for over half of discontinuations, although most ultimately attained VS.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Outcomes of LAI ART for People With Detectable HIV Viremia in the NYC Public Healthcare System (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_891;
Background Long-acting injectable cabotegravir/rilpivirine (LAI CAB/RPV) has changed the landscape of antiretroviral therapy (ART) by creating an alternative to daily oral ART...One limitation of our study is that the period of observation for follow up VLS varied for each patient, (e.g. our assessment included most recent viral load). Addressing barriers to LAI access, including expanding current FDA labeling to include certain patients with baseline viremia, is crucial to achieve VLS and improved health outcomes in this population.
- |||||||||| Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Low-Level Viremia and Risk Factors for Failure on Long-Acting Cabotegravir/Rilpivirine (LA CAB/RPV) (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_890;
This study is the first to report that low-level viremia was not associated with virologic failure in clinical practice. Further research is needed to identify those at risk of virologic failure and to develop optimal prevention strategies.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Impact of Oral Lead-In on PK and Virologic Outcomes in People With HIV Transitioning to CAB+RPV LA (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_889;
Secondary analyses of participants with baseline VL<20 cp/mL (N=147) showed similar trends. Conclusions In conclusion, the use of an oral lead-in did not result in significant differences in pharmacokinetics or virological outcomes for PWH transitioning to CAB+RPV LA over 9 months.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Long-Acting Cabotegravir/Rilpivirine in Real Life: Sex-Based Characteristics, PROs, and Effectiveness (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_887;
Conclusions In conclusion, the use of an oral lead-in did not result in significant differences in pharmacokinetics or virological outcomes for PWH transitioning to CAB+RPV LA over 9 months. Background This study aimed to focus on sex-based characteristics, patient reported outcomes (PROs) and effectiveness in people with HIV switching to long-acting cabotegravir-rilpivirine (LA-CAB/RPV) administered Q2M in Hospital Cl
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Long-Acting Cabotegravir and Rilpivirine in Older People With HIV in the GEPPO Cohort (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_886;
Background The association of intramuscularly administered Long-acting cabotegravir and rilpivirine (LA CAB+RPV) has been proven to be effective and safe in the maintenance treatment of people with HIV (PWH)...The pre-switch regimen was mainly based on a three-drug combination in 53.5% of study participants (mostly bictegravir or rilpivirine-based) or two-drug combinations by 45.1% (mostly dolutegravir/rilpivirine and dolutegravir/lamivudine)...Conclusions Our results suggest that the LA CAB+RPV combination is effective and safe in OPWH despite a long history of ART and a high prevalence of multimorbidity and polypharmacy. Older age should not be a barrier to the LA regimen: this study paves the way to evaluate the risk of an ageism attitude when clinicians consider ART choices in older PWH.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Clinical Outcomes Among Virologically Suppressed Women Receiving CAB+RPV LA in the OPERA Cohort (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_885;
Conclusions A diverse population of women with HIV was able to receive CAB+RPV LA on-time and remain suppressed in this real-world study. Confirmed virologic failure was infrequent in these antiretroviral experienced women.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Long-Term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_883;
Suppressed PWH on CAB+RPV LA had favorable virologic outcomes as most maintained VLs <50 c/mL and CVF was infrequent. Further, virologic suppression was maintained regardless of BMI category at initiation.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Long-Acting Cabotegravir/Rilpivirine in Pregnancy (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_636;
Background Long-acting cabotegravir and rilpivirine (LA-CAB/RPV) is a novel injectable antiretroviral therapy approved for virologically suppressed individuals with HIV-1...Additionally, 81% (n=17) of the newborns received zidovudine only post-delivery...Given the small sample size, it was not possible to conduct a meaningful analysis of any associations between perinatal outcomes and the use of LA-CAB/RPV during pregnancy. Our findings support the consideration of LA-CAB/RPV as a viable treatment option during pregnancy, though further research with larger cohorts is needed to validate these findings and ensure long-term safety.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
LA-ART for Breastfeeding Women With HIV in Zimbabwe: Clinical Impact and Cost-Effectiveness (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_635;
We modeled 2 ART approaches immediately after delivery: standard of care (SOC: continuation of TLD) and LA-ART (switching from TLD to cabotegravir/rilpivirine [LA-CAB/RPV])...Conclusions LA-ART for breastfeeding women with adherence challenges to oral TLD could reduce infant infections. If efficacy is confirmed in postpartum women, LA-ART for women without viral suppression at delivery would improve outcomes and save money; for women with viral suppression, it would be cost-effective in Zimbabwe if costs were ?$7/month.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Drug Resistance Mutations (DRMs) for Long-Acting Injectable Cabotegravir and Rilpivirine (CAB/RPV LAI) in the HIV-1 Subtype A6 Epidemic in Poland. (Pubmed Central) - Feb 26, 2025
Compared to subtype B infections, subtype A6 infections were characterized by more frequent major transmitted drug-resistance mutations for non-nucleoside reverse transcriptase inhibitors (8.5% vs. 1.9%, p = 0.007) and rilpivirine (5.1% vs. 0.6%, p = 0.016). Due to the frequent occurrence of the L74I polymorphism and drug-resistance mutations in HIV A6 subtype infection, about 40% of people with HIV in Poland may be at risk of long-acting injectable treatment failure.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial primary completion date: CAPRI: A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA (clinicaltrials.gov) - Feb 12, 2025
P3, N=12, Active, not recruiting,
Due to the frequent occurrence of the L74I polymorphism and drug-resistance mutations in HIV A6 subtype infection, about 40% of people with HIV in Poland may be at risk of long-acting injectable treatment failure. Trial primary completion date: Dec 2024 --> Apr 2025
- |||||||||| Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare, Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Willingness to Switch to Long-Acting Injectable Cabotegravir and Rilpivirine Every 2 Months for People Living with HIV in Nanjing, China. (Pubmed Central) - Feb 10, 2025
Our survey demonstrated that the majority of PLWH were willing to switch to CAB+RPV therapy, mainly due to its improved convenience and reduced risk of disease exposure. However, their concerns regarding price, efficacy, and safety could be the key challenges for the clinical implementation of the CAB+RPV LA regimen in the future.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment open, Trial completion date: Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium (clinicaltrials.gov) - Feb 5, 2025
P=N/A, N=600, Recruiting,
Most expressed preference for LAI over daily oral ART and had minimal concerns over potential LAI-ART use impacting reproductive health. Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Jul 2025
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
P3 data, Journal, Patient reported outcomes: Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy With Cabotegravir?+?Rilpivirine Long-Acting Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in the Phase 3b SOLAR Study. (Pubmed Central) - Jan 17, 2025
P3
Most (90%, 382/425) questionnaire respondents preferred CAB?+?RPV LA vs. BIC/FTC/TAF (5%, 21/425). Switching to CAB?+?RPV LA was associated with significantly improved treatment satisfaction and relief from the fear of disclosure, anxiety surrounding adherence and reminder of HIV status.
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