- |||||||||| Journal: Challenges for novel antiretroviral development in an era of widespread TLD availability. (Pubmed Central) - Jul 11, 2024
We illustrate when generic TLD will become available worldwide and compare this with trial programmes and approval timelines for two case-study novel ART combinations: islatravir/doravirine and cabotegravir/rilpivirine. We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD.
- |||||||||| Edurant (rilpivirine) / J&J
Journal: COVID-19 in the Setting of HIV and Severe Hemophilia A: A Case Report. (Pubmed Central) - Jul 10, 2024
In this case, it is important to monitor for the risk and presence of superimposed bacterial or opportunistic infections. Treating a patient with these comorbidities who is infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) highlights the importance of balancing the risks and benefits.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Edurant (rilpivirine) / J&J
Review, Journal: Long-acting injection therapies: New opportunities and challenges (Pubmed Central) - Jul 9, 2024
LAI have the potential to relieve PLWH of some of the heavy psychological burdens associated with the continued stigmatization. However, as a new therapy, new challenges need to be considered the use of LAI.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
Journal: Long-acting prescriptions and therapy for HIV-1 from market launch to the present in Germany (May 2021 to December 2023). (Pubmed Central) - Jun 14, 2024
In Europe, the combination of cabotegravir (CAB) with rilpivirine (RPV) has been approved as a dual injection long-acting (LA) therapy for the treatment of human immunodeficiency virus type 1 (HIV-1) infections in adults since December 2020...Based on pharmacy prescription data derived from Insight Health, the monthly number of prescriptions for oral CAB, CAB-LA, and RPV-LA over the entire period of availability in Germany was analyzed and evaluated (May 2021 to December 2023)...Hence, the need for this mode of therapy in Germany appears to be limited. Follow-up studies at regular intervals on the further course would be useful and are recommended, as well as investigations into the possible reasons for the slow uptake to inform public health experts and possibly broaden treatment options.
- |||||||||| Edurant (rilpivirine) / J&J
Journal: Injectable antiretroviral therapy: best practice guide for nurses providing care to people living with HIV. (Pubmed Central) - Jun 8, 2024
HIV nurse specialists are leading the way in delivering this innovative new treatment, and the article concludes by discussing which patients may benefit from injectables in the future. This guide is aimed at nurses who work within the HIV field or are supporting this treatment in other settings, for example in outpatient parenteral antimicrobial therapy (OPAT) services.
- |||||||||| Edurant (rilpivirine) / J&J, Vemlidy (tenofovir alafenamide) / Gilead
Journal: Choice of antiretroviral therapy has low impact on weight gain. (Pubmed Central) - Jun 4, 2024
The choice of initial ART had little impact on weight gain. INSTIs or TAF were not independently associated with weight change after ART initiation, but EFV and TDF were.
- |||||||||| Edurant (rilpivirine) / J&J, Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Retrospective data, Journal: Negative impact of a health insurer-mandated de-simplification from a single-tablet regimen to a two-tablet regimen. (Pubmed Central) - May 30, 2024
A mandatory switch from an STR to a TTR in people with HIV proved unsuccessful, marked by low acceptance, and increased costs after 1 year. This underscores the necessity of incorporating patient and prescriber involvement in changing medication policies.
- |||||||||| Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment closed: More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (clinicaltrials.gov) - May 13, 2024
P1/2, N=168, Active, not recruiting,
Of significance, this analog showed augmented selectivity index (SI Recruiting --> Active, not recruiting
- |||||||||| Edurant (rilpivirine) / J&J, Pifeltro (doravirine) / Merck (MSD)
PK/PD data, Journal: In Silico Pharmacokinetics Evaluation of Forgiveness for Doravirine and Rilpivirine. (Pubmed Central) - May 9, 2024
These findings suggest that treatment with DOR may offer a more forgiving therapeutic profile than RLP, given the larger proportion of patients achieving effective drug exposure with DOR. However, it is important to acknowledge a significant limitation of this study, namely, the assumption that drug concentration is a perfect surrogate for drug effectiveness.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New trial, Real-world evidence, Real-world: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures (clinicaltrials.gov) - May 7, 2024
P=N/A, N=600, Recruiting,
- |||||||||| Monitoring the landscape of newer HIV medicines: multiple patenting and access challenges (Poster board: 647) - May 2, 2024 - Abstract #AIDS2024AIDS_3236;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Reasons for discontinuation of dolutegravir-based two- and three-drug regimens (Poster board: 118) - May 2, 2024 - Abstract #AIDS2024AIDS_1413;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
5 years of DoDo: experience with doravirine and dolutegravir as an alternative antiretroviral 2-drug regimen (Poster board: 095) - May 2, 2024 - Abstract #AIDS2024AIDS_1378;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| tenofovir disoproxil fumarate / Generic mfg.
Cystatin C as a marker of tubular and renal function in people living with HIV: the role of tenofovir disoproxil fumarate (Poster board: 089) - May 2, 2024 - Abstract #AIDS2024AIDS_1311;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J
Investigating lipid trends in DOR/RPV/DTG/BIC-including regimens using generalized additive mixed models (Poster board: 088) - May 2, 2024 - Abstract #AIDS2024AIDS_1284;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Transmitted drug resistance to reverse transcriptase and protease inhibitors in Argentina: an updated analysis (Poster board: 133) - May 2, 2024 - Abstract #AIDS2024AIDS_1133;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Prezista (darunavir) / J&J, Edurant (rilpivirine) / J&J, Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo
Review, Journal: Pathophysiology and Clinical Management of Dyslipidemia in People Living with HIV: Sailing through Rough Seas. (Pubmed Central) - Apr 27, 2024
For those intolerant or not meeting therapeutic goals, the addition of ezetimibe, PCSK9, bempedoic acid, fibrates, or fish oils should also be considered. This review summarizes the current literature on the multifactorial etiology and intricate pathophysiology of hyperlipidemia in PLHIV, with an emphasis on the role of different HAART agents, while also providing valuable insights into potential switching strategies and therapeutic options.
- |||||||||| Prezista (darunavir) / J&J, Edurant (rilpivirine) / J&J, Intelence (etravirine) / J&J
Journal: Exploring Darunavir, Rilpivirine and Etravirine as Potential Therapies for Bladder Cancer: Efficacy and Synergistic Effects. (Pubmed Central) - Mar 28, 2024
In summary, this pre-clinical investigation underscores the promising therapeutic potential of ETV and RPV, both as standalone treatments and in combination, hinting at repurposing opportunities in bladder cancer therapy, which could give a new treatment method for this disease that is faster and without as severe side effects as anticancer drugs. These findings represent a substantial stride in advancing personalized medicine within cancer research and will be further scrutinized in forthcoming studies.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare
Model-Based Comparison of Cabotegravir Pharmacokinetics Following Thigh and Gluteal Injections (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_951;
PPK modeling and simulation support chronic thigh administration of CAB LA QM and intermittent thigh injections for both QM and Q2M regimens. However, simulated chronic Q2M thigh administration did not maintain PK target established in pivotal trials and therefore is not recommended.
- |||||||||| First Trimester Exposure to Newer Antiretroviral Agents and Congenital Anomalies in a US Cohort (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_769;
The odds of congenital anomalies among infants with first trimester exposure to newer ARVs did not differ substantially from that among infants unexposed to these specific ARVs. However, modest effects cannot be ruled out, highlighting the need for continued evaluation of these associations in larger populations.
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare
Cabotegravir PopPK Analysis of Adults & Adolescents Living With/At Risk for HIV Receiving PrEP (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_756;
P1/2, P2,
The addition of adolescent data to the adult PopPK dataset allowed expansion of the prior PopPK model down to 35 kg and optimization of predictions in adolescents. Given the similarity of CAB PK across adolescents and adults, same dosing regimens apply for adults and adolescents.
- |||||||||| Estimated Costs of Eliminating Medicaid Prior Authorizations for Antiretrovirals in Washington State (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_544;
PrEP models assumed a 10% annual increase in the number of PrEP users and evaluated the impact of annual declines in the relative percentage of PrEP users on TDF/FTC with compensatory increases in TAF/FTC use; some models assumed the percentage of PrEP users on cabotegravir (CAB) would increase 1% annually...Our No PA Model assumed: 1) 18% annual relative increase in the percentage of PLWH on bictegravir/TAF/FTC; 2) the percentage of people on tenofovir/FTC taking TAF/FTC (vs. TDF/FTC) increases 9% annually; 3) CAB/rilpivirine increases 1% annually; 4) no change in darunavir/cobisistat; and 5) use of other ART drugs decline in proportion to their 2022 use...Elimination of Medicaid PAs will likely result in substantial new costs. Changes in drug formulary policy should consider opportunity costs.
- |||||||||| Antiretroviral Regimens Are Associated With Cognitive Function in People With HIV (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_515;
Tenofovir (including TAF or TDF) and FTC were common in such regimens in combination with either DRV+COBI, RPV, or EFV. Our findings suggest complex associations between ART regimens and cognition, such that specific ART combinations rather than individual agents are associated with cognition.
- |||||||||| Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Viatris
Antiretroviral Concentrations in Post-Mortem Tissues: Preliminary Results From the Last Gift Program (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_500;
This is the first study to report different ARV concentrations in different anatomical sites in humans. Previous studies on non-human primates showed similar results about the poor, but rather uniform, concentrations of DTG in all the districts of the CNS, and higher concentrations in kidney and intestine.
- |||||||||| efavirenz / Generic mfg.
TDF and Efavirenz but Not InSTI or TAF Use Are Associated With Weight Gain During cART (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_404;
Background: Combination antiretroviral therapy (cART) containing integrase strand transfer inhibitors (INSTIs) and/or tenofovir alafenamide (TAF) has been associated with greater weight gain (WG) than cART without these drugs...From 2008-2022 we studied all patients who initiated cART with either dolutegravir (DTG), bictegravir, elvitegravir, raltegravir, atazanavir, darunavir (DRV), rilpivirine (RIL), or efavirenz (EFV) as exclusive anchor drug if used in combination with either TAF, tenofovir disoproxil fumarate (TDF), or abacavir (ABC) as backbone...Over a 15-year period, our demographically diverse patient population experienced substantial WG in the first 3 years after cART initiation. Among 11 examined ARVs, only EFV and TDF were independently associated with (decreased) WG.
- |||||||||| Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare
Phase I Study of Cabotegravir Long-Acting Injectable Formulations Supports ?4-Monthly Dose Interval () - Mar 5, 2024 - Abstract #CROI2024CROI_213;
P1
Safety and PK results from part A indicate low potential to achieve less frequent dosing with CAB200 and rHuPH20. The new CAB400 formulation (SC and IM) exhibits favorable safety and PK commensurate with dose intervals of ?4 months and is in ongoing clinical development.
- |||||||||| 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.
- |||||||||| efavirenz / Generic mfg.
Journal, Adverse events: Influence of efavirenz and 8-hydroxy-efavirenz plasma levels on cognition and central nervous system side effects. (Pubmed Central) - Dec 18, 2023
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. Higher levels of 8-OH-EFV were associated with CNS side effects, while EFV levels were only marginally associated with cognitive performance, thus suggesting that EFV and its metabolite may act differently in determining detrimental neurological effects.
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