- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New P3 trial, Patient reported outcomes: Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study (clinicaltrials.gov) - Jun 9, 2023 P3, N=93, Active, not recruiting,
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion, Head-to-Head: SOLAR: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (clinicaltrials.gov) - May 10, 2023 P3, N=688, Completed, Implementation complexities must be addressed as LAI ART is introduced and expanded in Africa to best support viral suppression and address HIV care continuum gaps. Active, not recruiting --> Completed
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Cabotegravir + rilpivirine long-acting outcomes by sex at birth, age, race, and body mass index: a subgroup analysis of the Phase 3b SOLAR study () - May 5, 2023 - Abstract #IASHIV2023IAS_HIV_1497; Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST).
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
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 (Poster Exhibition area) - May 5, 2023 - Abstract #IASHIV2023IAS_HIV_465; Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST).
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Similar inflammatory markers after switching to cabotegravir + rilpivirine long-acting vs. continuing bictegravir/emtricitabine/tenofovir alafenamide: data from the Phase 3b SOLAR study (Poster Exhibition area) - May 5, 2023 - Abstract #IASHIV2023IAS_HIV_464; Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST).
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Cabenuva: A breakthrough in HIV/AIDS treatment. (Pubmed Central) - Mar 24, 2023 Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). No abstract available
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Single center experience evaluating and initiating people with HIV on long-acting cabotegravir/rilpivirine. (Pubmed Central) - Feb 27, 2023 Despite novel challenges over half of our cohort initiated LAI CAB/RPV. Evaluating for potential non-nucleoside reverse transcriptase inhibitor resistance is an important part of the workup for LAI CAB/RPV and proviral DNA resistance testing can be an additional tool to identify potential resistance.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment open: CAPRI: A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA (clinicaltrials.gov) - Feb 17, 2023 P3, N=12, Recruiting, Evaluating for potential non-nucleoside reverse transcriptase inhibitor resistance is an important part of the workup for LAI CAB/RPV and proviral DNA resistance testing can be an additional tool to identify potential resistance. Not yet recruiting --> Recruiting
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion: Cabenuva Injection Tracking in CHORUS (clinicaltrials.gov) - Feb 15, 2023 P=N/A, N=37, Completed, Not yet recruiting --> Recruiting Enrolling by invitation --> Completed
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Adherence: I-TRAINS: Improving Treatment and Retention Adherence in Nontraditional Settings (clinicaltrials.gov) - Dec 28, 2022 P=N/A, N=25, Active, not recruiting, A major factor associated with SWI was provider comfort with safety data, reinforcing the role of continued training regarding an SWI approach. Enrolling by invitation --> Active, not recruiting | N=60 --> 25 | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New P3 trial: CAPRI: A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA (clinicaltrials.gov) - Nov 1, 2022 P3, N=12, Not yet recruiting,
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Head-to-Head: SOLAR: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (clinicaltrials.gov) - Oct 26, 2022 P3, N=688, Active, not recruiting, Enrolling by invitation --> Active, not recruiting | N=60 --> 25 | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023 Trial completion date: Jul 2023 --> Mar 2023
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Trial primary completion date: Implementing Cabenuva in Arkansas HIV Programs (clinicaltrials.gov) - Oct 24, 2022 P=N/A, N=100, Recruiting, Trial completion date: Jul 2023 --> Mar 2023 Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Contribution of cabotegravir + rilpivirine long-acting for the treatment of HIV-1 infection. (Pubmed Central) - Oct 9, 2022 Cabotegravir + rilpivirine long-acting provides added value contribution to human immunodeficiency virus-1 management in Spain compared to daily oral single-tablet regimens. Patient Reported Outcomes and therapeutic benefit of cabotegravir + rilpivirine long-acting were highly valued by experts, as the expected benefit in adherence and stigma-related issues would improve overall quality of life for people living with human immunodeficiency virus-1.
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Six-month outcomes of every 2-months long-acting cabotegravir and rilpivirine in a real-world setting: effectiveness, adherence to injections and patient-reported outcomes from PLWHIV in the German CARLOS cohort () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_127; CAB+RPV LA shows high rates of maintenance of viral suppression, with low rates of treatment failure in the first 6 months following switch. Despite already high scores on oral ART, the treatment satisfaction score increased statistically significantly on long-acting ART in patients mostly self-selecting CAB+RPV LA.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Journal: Early Experience Implementing Long-Acting Injectable Cabotegravir/Rilpivirine for Human Immunodeficiency Virus-1 Treatment at a Ryan White-Funded Clinic in the US South. (Pubmed Central) - Sep 24, 2022 Implementing LAI-ART at a Southern US Ryan White-funded clinic has been challenged by the following: substantial human resource capital to attain drug, administer injections, and support enrolled patients; delayed therapy initiation due to insurance denials; patient ineligibility primarily due to possible RPV resistance; and inability to provide drug regardless of payor source. These barriers may perpetuate disparities in ART access and outcomes among PWH and should 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
Trial completion date: GLACIER: Study Using CABENUVA (clinicaltrials.gov) - Sep 22, 2022 P4, N=120, Recruiting, These barriers may perpetuate disparities in ART access and outcomes among PWH and should be urgently addressed so that LAI-ART can be offered equitably. Trial completion date: Jul 2023 --> Jan 2024
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Edurant (rilpivirine) / J&J
Journal: Frequency of genotypic factors possibly associated with cabotegravir/rilpivirine failure in antiretroviral treatment-naïve and -experienced HIV-1- infected population. (Pubmed Central) - Sep 4, 2022 As subtype A1/A6 becomes more common across real-life cohorts continued subtyping and RAM screening will remain of key importance for LAI treatment implementation. Sequence data from this article have been deposited in GenBank under accession numbers: GU906860, GU906864, GU906871-GU906874, JQ305750-JQ305791, KC409134-KC409222, KM057341-KM057362, KM283892-KM284490, KT340108-KT340205, MZ468643-MZ468894, MZ671788-MZ671823, OP298017-OP302727.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2-Months Is Cost Effective for the Treatment of HIV-1 in Spain (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1701; Sequence data from this article have been deposited in GenBank under accession numbers: GU906860, GU906864, GU906871-GU906874, JQ305750-JQ305791, KC409134-KC409222, KM057341-KM057362, KM283892-KM284490, KT340108-KT340205, MZ468643-MZ468894, MZ671788-MZ671823, OP298017-OP302727. From the Spanish NHS perspective, CAB+RPV LA Q2M is a cost-effective alternative versus STR daily oral ART, associated with small QALY gains but also with small incremental costs increase.
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