- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare
Journal: Cabotegravir (Apretude) for HIV-1 pre-exposure prophylaxis. (Pubmed Central) - Feb 23, 2022 Not yet recruiting --> Enrolling by invitation No abstract available
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment open, Trial completion date, Trial primary completion date: GLACIER: Study Using CABENUVA (clinicaltrials.gov) - Feb 17, 2022 P4, N=120, Recruiting, No abstract available Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> Oct 2023 | Trial primary completion date: Feb 2023 --> Oct 2023
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion: Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants (clinicaltrials.gov) - Feb 15, 2022 P1, N=15, Completed, Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> Oct 2023 | Trial primary completion date: Feb 2023 --> Oct 2023 Active, not recruiting --> Completed
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
TRANSFORMATION OF DOLUTEGRAVIR INTO A YEAR-LONG PARENTERAL PRODRUG FORMULATION ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_622; The extended NM2DTG PK profile paralleled nanocrystal dissolution and pH-dependent prodrug activation. NM2DTG produced plasma DTG levels at or above the PA-IC90 for one year following a single intramuscular injection in rodents.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare
EFFECT OF L74I POLYMORPHISM ON FITNESS OF HIV-1 SUBTYPE A6 RESISTANT TO CABOTEGRAVIR ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_554; Presence of the L74I polymorphism conferred greater replication capacity to recombinant viruses expressing HIV-1 A6 IN when present together with INSTI resistance mutations at positions 118, 140, 148 and 263. This finding may explain, in part, the association of HIV-1 subtype A6 and virologic failure observed in clinical trials of CAB-LA in combination with RPV-LA.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Phase classification, Trial completion date, Trial primary completion date: Implementing Cabenuva in Arkansas HIV Programs (clinicaltrials.gov) - Feb 2, 2022 P=N/A, N=100, Not yet recruiting, This finding may explain, in part, the association of HIV-1 subtype A6 and virologic failure observed in clinical trials of CAB-LA in combination with RPV-LA. Phase classification: P1 --> P=N/A | Trial completion date: Nov 2022 --> Feb 2023 | Trial primary completion date: Nov 2022 --> Feb 2023
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Phase classification, Enrollment change, Trial initiation date: I-TRAINS: Improving Treatment and Retention Adherence in Nontraditional Settings (clinicaltrials.gov) - Jan 25, 2022 P=N/A, N=60, Not yet recruiting, Phase classification: P1 --> P=N/A | Trial completion date: Nov 2022 --> Feb 2023 | Trial primary completion date: Nov 2022 --> Feb 2023 Phase classification: P4 --> P=N/A | N=100 --> 60 | Initiation date: Dec 2022 --> Feb 2022
- |||||||||| Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Review, Journal: Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. (Pubmed Central) - Jan 7, 2022 Clinics will need to address barriers related to management of clinic workflow, procurement, reimbursement, and nonadherence. The aim of this review is to summarize the available safety, efficacy and pharmacokinetic/pharmacodynamic (PK/PD) data of this long-acting (LA) injectable regimen as well as discuss some potential considerations for prescribing and operationalization.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Long Acting Antiretroviral Therapy for the Treatment and Prevention of HIV Infection ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_4748; As novel antiretrovirals with unique delivery systems, the long-acting injections cabotegravir and rilpivirine will provide the first alternative option to daily oral medication for treating and preventing HIV...Recommend strategies for solving drug therapy related problems common to long-acting antiretroviral agents including missed doses, adverse drug reactions and drug–drug interactions. Target Audience: Pharmacist Level of Content:Advanced
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Phase classification: Implementing Cabenuva in Arkansas HIV Programs (clinicaltrials.gov) - Nov 17, 2021 P1, N=100, Not yet recruiting, Initiation date: Nov 2021 --> Dec 2022 Phase classification: P=N/A --> P1
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Trial initiation date, Trial primary completion date: Cabenuva Injection Tracking in CHORUS (clinicaltrials.gov) - Oct 29, 2021 P=N/A, N=43, Enrolling by invitation, Phase classification: P=N/A --> P1 Trial completion date: Mar 2022 --> Jul 2022 | Initiation date: Apr 2021 --> Oct 2021 | Trial primary completion date: Jan 2022 --> Jul 2022
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New P1 trial, New trial: Implementing Cabenuva in Arkansas HIV Programs (clinicaltrials.gov) - Oct 26, 2021 P=N/A, N=100, Not yet recruiting,
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Review, Journal: Design strategies for long-acting anti-HIV pharmaceuticals. (Pubmed Central) - Oct 13, 2021 The clinical phase III trials of FLAIR and ATLAS, showed two-drug injectable cabotegravir (CAB) and rilpivirine (RPV) formulation is potent, safe, and tolerable in HIV-infected patients...Broadly neutralizing antibodies (bNAbs) with excellent breath and efficiency against HIV have been investigated as LA antiviral weapons. Several modern modalities capable of sustained drug release for long-term treatment and prevention of HIV infection are also in development, such as implants, vaginal rings, and nanotherapies.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
[VIRTUAL] Implementation of Long-acting Injectable Cabotegravir/Rilpivirine for HIV-1 Treatment at a Ryan White-funded Clinic in the U.S. South () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1795; Our experience implementing LAI-ART at a Ryan White-funded HIV clinic in the Southern U.S. has been challenged by substantial human resource capital to attain drug, delayed therapy initiation due to insurance denials, and patient ineligibility primarily due to concern for potential RPV resistance. These barriers may perpetuate disparities in ART access and virologic suppression among PWH and need to be urgently addressed so that LAI-ART can be offered equitably.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Perspectives on the acceptability, appropriateness, feasibility, barriers, and facilitators from patients receiving cabotegravir + rilpivirine long-acting injectable treatment (CAB+RPV LA): interim results from the Cabotegravir and Rilpivirine Implementation Study in European Locations (CARISEL) (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_575; PSPs had high treatment satisfaction scores, the majority finding clinic wait time, recovery time, and treatment information appropriate and acceptable. At M1, 424 of 430 (98.6%) PSPs completed questionnaires; to date, 264 (61.4%) have completed M4 questionnaires.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Perspectives on the acceptability, appropriateness, feasibility, barriers, and facilitators from patients receiving cabotegravir + rilpivirine long-acting injectable treatment (CAB+RPV LA): interim results from the Cabotegravir and Rilpivirine Implementation Study in European Locations (CARISEL) (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_108; PSPs had high treatment satisfaction scores, the majority finding clinic wait time, recovery time, and treatment information appropriate and acceptable. At M1, 424 of 430 (98.6%) PSPs completed questionnaires; to date, 264 (61.4%) have completed M4 questionnaires.
- |||||||||| 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
Journal: Dual therapies as a treatment of human immunodeficiency virus : the end of a paradigm ? (Pubmed Central) - Sep 11, 2021 In the past, some dual therapies were associated with a higher risk of selecting resistance mutations. Nevertheless, current and future dual regimens based on powerful drugs with a high genetic barrier are non-inferior to triple therapies and could become the future gold standard for HIV treatment.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Cabenuva®: Differentiated service delivery and the community Pharmacists' roles in achieving UNAIDS 2030 target in Nigeria. (Pubmed Central) - Aug 20, 2021 It is therefore recommended that the Nigerian government embrace community pharmacy-led drug administration initiatives and embark on accredited training programmes for the profession in line with drug administration services. The government should also put in place necessary funding mechanisms for community pharmacists for the extra workload placed on them in administering injection drug formulation in their respective pharmacies.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New P4 trial: GLACIER: Study Using CABENUVA (clinicaltrials.gov) - Jul 28, 2021 P4, N=120, Not yet recruiting,
- |||||||||| Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Cabotegravir/rilpivirine (Cabenuva) for HIV-1 infection. (Pubmed Central) - Jul 14, 2021 Providing PLWH and healthcare providers with novel modes of ART administration, enhancing individualisation of treatment, may facilitate the achievement of UNAIDS 95-95-95 objectives. No abstract available
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: The potential role of long-acting injectable cabotegravir-rilpivirine in the treatment of HIV in sub-Saharan Africa: a modelling analysis. (Pubmed Central) - Jun 30, 2021 Our modelling suggests that injectable cabotegravir-rilpivirine offers potential benefits; however, to be a cost-effective option, its introduction might need to be carefully targeted to individuals with HIV who might otherwise have suboptimal adherence to ART. As data accumulate from trials and implementation studies, such findings can be incorporated into the model to better inform on the full consequences of policy alternatives.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Review, Journal: Recent advances in long-acting nanoformulations for delivery of antiretroviral drugs. (Pubmed Central) - Jun 22, 2021 Cabenuva™ is recently approved by Health Canada containing LA cabotegravir+LA rilpivirine nanocrystals (ViiV healthcare) for once monthly administration by intramuscular route...Moreover, it expatiates on application of profuse nanoformulations for long-acting effect with promising preclinical discoveries and two clinical leads. To add on, utilization of physiology- based and mechanism-based pharmacokinetic modelling and in vivo animal models which could lead to enhanced safety and efficacy of LA nanoformulations in humans have been included.
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