- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Frequency of virologic factors possibly associated with CAB/RPV LAI failure () - May 12, 2022 - Abstract #AIDS2022AIDS_850; Despite common presence of factors associated with CAB/RPV failure they rarely occurred in combination. Defining subtype and screening for INSTI and NNRTI mutations should be performed prior to LAI treatment implementation.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare
'Give it a Shot': best practices from HCPs for administering long-acting cabotegravir+rilpivirine () - May 12, 2022 - Abstract #AIDS2022AIDS_779; In the Phase 3/3b studies, CAB+RPV LA injections were well tolerated, associated with low rates of treatment discontinuation due to injection site reactions, and preferred by patients over daily oral therapy. These data support that simple techniques, routinely used by injectors, help optimize the administration of CAB+RPV LA.
- |||||||||| Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare, lenacapavir (GS CA2) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Implementation of long-acting antiretroviral therapy in low-income and middle-income countries. (Pubmed Central) - Apr 26, 2022 However, there are multiple implementation considerations in LMICs including the need for exclusion of hepatitis B, cold chain, oral bridging in case of missed dosing and switching during tuberculosis therapy. Efficacy and safety data are also awaited for settings without routine access to baseline resistance testing or regular viral load monitoring and for special populations, such as pregnancy, children and the elderly.
- |||||||||| Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare, lenacapavir (GS CA2) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Implementation of long-acting antiretroviral therapy in low-income and middle-income countries. (Pubmed Central) - Apr 20, 2022 However, there are multiple implementation considerations in LMICs including the need for exclusion of hepatitis B, cold chain, oral bridging in case of missed dosing and switching during tuberculosis therapy. Efficacy and safety data are also awaited for settings without routine access to baseline resistance testing or regular viral load monitoring and for special populations, such as pregnancy, children and the elderly.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Will I gain weight on cabenuva 😟 (Twitter) - Apr 10, 2022
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment open: Implementing Cabenuva in Arkansas HIV Programs (clinicaltrials.gov) - Mar 22, 2022 P=N/A, N=100, Recruiting, Most participants preferred CAB+RPV long-acting to their prior oral CAB+RPV regimen at M12. Not yet recruiting --> Recruiting
- |||||||||| 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, Adherence: I-TRAINS: Improving Treatment and Retention Adherence in Nontraditional Settings (clinicaltrials.gov) - Jan 26, 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 18, 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 27, 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.
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