- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Lung Transplant in HIV-Infected Patients. Single Centre Experience () - Apr 26, 2020 - Abstract #ISHLT2020ISHLT_240; At the end of the study the other four patients have been discharged and are improving the pulmonary function tests (Table 2). Conclusion The experience of the first five VIH LT patients in Spain shows that LT is feasible without increasing the risk of infectious or immunological complications.
- |||||||||| Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Trial primary completion date: More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (clinicaltrials.gov) - Apr 24, 2020 P1/2, N=155, Recruiting, This simplification strategy reduced pill burden and preserved viral suppression in treatment-experienced patients with no major mutations to rilpivirine at historical genotyping. Trial completion date: Aug 2023 --> Apr 2026 | Trial primary completion date: Apr 2021 --> May 2022
- |||||||||| Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: POPARV: Population Pharmacokinetics of Antiretroviral in Children (clinicaltrials.gov) - Apr 21, 2020 P=N/A, N=700, Recruiting, Trial completion date: Aug 2023 --> Apr 2026 | Trial primary completion date: Apr 2021 --> May 2022 Trial completion date: Jun 2019 --> Jun 2022 | Trial primary completion date: Jun 2019 --> Jun 2022
- |||||||||| Edurant (rilpivirine) / J&J
Journal: Dolutegravir-Rilpivirine, Dual Antiretroviral Therapy for the Treatment of HIV-1 Infection. (Pubmed Central) - Apr 16, 2020 TFV overencapsulated in digital pills are bioequivalentce to TFV in commercial formulations. This dual therapy combination of DTG-RPV provides maintenance of virological suppression as a switch strategy with few drug interactions and positive effects on lipids and renal and bone health.
- |||||||||| Edurant (rilpivirine) / J&J
Enrollment change: DRV/r + RPV QD: Efficacy and Toxicity Reduction (clinicaltrials.gov) - Apr 2, 2020 P3, N=37, Completed, Therefore, these analogs of the synthesized compounds can serve as excellent bases for the development of new anti-HIV-1 agents in the near future. N=132 --> 37
- |||||||||| cabotegravir (GSK1265744) / ViiV Healthcare
Clinical, Clinical Trial,Phase III, Journal: Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. (Pubmed Central) - Mar 26, 2020 P3 Injection-related adverse events were common but only infrequently led to medication withdrawal. (Funded by ViiV Healthcare and Janssen; ATLAS ClinicalTrials.gov number, NCT02951052.).
- |||||||||| Clinical, Journal: Lipid profile changings after switching from rilpivirine/tenofovir disoproxil fumarate/emtricitabine to rilpivirine/tenofovir alafenamide/emtricitabine: Different effects in patients with or without baseline hypercholesterolemia. (Pubmed Central) - Mar 12, 2020
In patients with baseline diagnosis of hypercholesterolemia (TC>200 mg/dl, N = 87), there was no significant change in TC (224 ±2.2 to 228 ±3.4 mg/dl, p = 0.286) or LDL (150±2.5 to 151±3.2 mg/dl, p = 0.751), while HDL increased from 51 ±1.6 to 55 ±1.7 mg/dl (p<0.0001) and both LDL/HDL and TC/HDL ratio decreased significantly, from 3.2±0.1 to 3.0 ±0.1 (p = 0.025) and from 4.7±0.1 to 4.4 ±0.1 (p = 0.004). In this real life study, a slight increase in lipids was found after switching from RPV/FTC/TDF to RPV/FTC/TAF, but these results were not confirmed in people with hypercholesterolemia, in which lipids did not change and LDL/HDL and TC/HDL ratio decreased.
- |||||||||| Clinical, Journal: Choice of the initial antiretroviral treatment for HIV-positive individuals in the era of integrase inhibitors. (Pubmed Central) - Mar 8, 2020
This work supports the notion that select NNRTIs might help promote the elimination of HIV-1 producing cells as an adjuvant during shock and kill therapy. The choice of initial ART regimens is consistent with Spanish guidelines' recommendations, but is also clearly influenced by physician's perception based on patient's clinical and sociodemographic variables and by the prescribing hospital location.
- |||||||||| cabotegravir (GSK1265744) / ViiV Healthcare
[VIRTUAL] HIV A1 OR B DO NOT DIFFERENTIALLY IMPACT CABOTEGRAVIR IN VITRO POTENCY OR DURABILITY ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_1232; A total of 3/283 (1%) participants (PTS) who received CAB+RPV LA had confirmed virologic failure (CVF)...However, our evaluations cannot determine if HIV subtype A1 with L74I has greater likelihood of selection of additional INSTI mutations under selection pressure. Other factors may contribute to the risk of CVF and require further investigation.
- |||||||||| Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare, abacavir / Generic mfg.
[VIRTUAL] CLINICAL FEATURES AND OUTCOMES OF PATIENTS STOPPING DTG FOR NEUROPSYCHIATRIC SYMPTOMS ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_1212; In several, but not all, cohorts a high rate of discontinuation for neuropsychological side effects (NPS) has been reported: age, female gender, older age and abacavir co-administration have been suggested as potential risk factors while pharmacological and genetic features are still under study...Patients were switched to raltegravir (30.3%), elvitegravir/cobicistat (28.8%), darunavir/cobicistat (25.8%) or rilpivirine (12.1%)-containing regimens...In our cohort study 11.7% of participants stopped DTG due to NPS: they were mostly sleep disorders and headache and a full regression of both was observed after switching to other drugs. In most cases a complete resolution of symptoms was observed; the incomplete resolution in almost one third of participants suggests alternative reasons.
- |||||||||| [VIRTUAL] TOXICITY OF INTEGRASE INHIBITORS IN A HUMAN EMBRYONIC STEM-CELL MODEL ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_988;
The Tsepamo study reported a signal for risk of neural tube defects in infants exposed to the InSTI dolutegravir (DTG) from conception...CA1S hESCs were cultured (n=5 independent experiments) in the presence of 0.1% DMSO or 1X Cmax of the following regimens: DTG, raltegravir (RAL), bictegravir (BIC), cobicistat-boosted elvitegravir (EVG/COBI), or efavirenz (EFV) on a TDF/FTC backbone; DTG, RAL, BIC, EVG/COBI, or rilpivirine (RPV) on a TAF/FTC backbone; DTG, RAL, or ritonavir-boosted darunavir (DRVr) on an ABC/3TC backbone; cabotegravir (CAB)/RPV...Our results further suggest that exposure to the InSTIs DTG and CAB can induce hESC differentiation. Given the increasing use of DTG and other InSTIs, it is imperative to investigate their long-term safety in the context of pregnancy and embryonic development.
- |||||||||| [VIRTUAL] RACE IMPACT ON DOLUTEGRAVIR-ASSOCIATED WEIGHT GAIN AMONG PREVIOUSLY ART-NAIVE PLWH ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_951;
ART regimens included efavirenz, rilpivirine, atazanavir, darunavir, and DTG-based ≥3 drug regimens...We conducted sensitivity analyses including baseline HIV disease severity as measured by lowest CD4 count (cells/mm3) and limiting regimens to tenofovir (TDF) with emtricitabine/lamivudine backbones...Black PLWH had an increased risk of substantial weight gain compared to white PLWH in their first year after DTG initiation. Additional studies are needed to clarify reasons for racial disparities.
- |||||||||| Edurant (rilpivirine) / J&J
[VIRTUAL] BENEFITS OF RILPIVIRINE FOR LIVER FIBROSIS IN HIV/HCV COINFECTED SUBJECTS ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_535; This difference in the case group was found only in subjects who had CHC, mean difference of -2.9Kpa ([CI95% -4.6 - -1.3]; p <0.01). In patients co-infected with HIV / HCV receiving an ART based on RPV, a significant reduction in liver stiffness measured by TE was observed.
- |||||||||| Edurant (rilpivirine) / J&J
[VIRTUAL] TRENDS IN TRANSMITTED DRUG RESISTANCE IN SPAIN THROUGH THE PERIOD 2007-2018 ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_513; Clinically Relevant resistance to recommended first line regimens showed a slow decline from 2007-2012, and peaked in 2013-2014 due to the inclusion of Rilpivirine for 1st line in the Spanish recommendations...Resistance to INsTIs remains at very low levels. These findings, together with the very low prevalence of resistance to recommended first line NRTIs in 2015-2018 reinforce GESIDA recommendations on baseline resistance testing and test and treat strategies when starting PIs or INsTIs based regimens.
- |||||||||| Edurant (rilpivirine) / J&J, rilpivirine LA (TMC278 LA) / J&J
Journal: The Use of Droplet Digital PCR to Quantify HIV-1 Viral Replication in the Colorectal Explant Model. (Pubmed Central) - Feb 29, 2020 ddPCR also required less sample and based on p24 vs ddPCR correlation, could potentially reduce the explant culture time from 14 to 10 days (r2=0.78, p<0.001) due to the increased sensitivity of ddPCR. We demonstrate that ddPCR is a suitable alternative to HIV-1 p24 ELISA to quantify HIV-1 infection in the explant model and has the potential to decrease explant culture time.
- |||||||||| Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Enrollment change, Trial termination, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Feb 27, 2020 P=N/A, N=1, Terminated, We demonstrate that ddPCR is a suitable alternative to HIV-1 p24 ELISA to quantify HIV-1 infection in the explant model and has the potential to decrease explant culture time. N=400 --> 1 | Suspended --> Terminated; Unfavourable opinion of ethical comittee for Amendment Nr 3
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