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26 Diseases |  |
58 Trials |
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58 Trials |  |
4692 News |  |
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- | Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Efficacy, Safety and Pharmacokinetics of DTG with RIF (clinicaltrials.gov) - Mar 23, 2022
P2, N=200, Recruiting, Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
- || Tivicay (dolutegravir) / ViiV Healthcare
Trial initiation date: BMS02: Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana (clinicaltrials.gov) - Mar 23, 2022
P=N/A, N=200, Not yet recruiting, Sponsor: Duke University
Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022 Initiation date: Feb 2022 --> Sep 2022
- | Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion, Trial completion date: Effect on HIV Medications on EPC Cells (clinicaltrials.gov) - Mar 22, 2022
P=N/A, N=22, Completed, Sponsor: Sabyasachi Sen
Initiation date: Feb 2022 --> Sep 2022 Recruiting --> Completed | Trial completion date: Dec 2020 --> Dec 2021
- |||| New P4 trial: META-D: The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients (clinicaltrials.gov) - Mar 21, 2022
P4, N=60, Not yet recruiting, Sponsor: Chelsea and Westminster NHS Foundation Trust
- | Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Assessment of Herb-Drug Interaction Potential of Five Common Species of Licorice and Their Phytochemical Constituents. (Pubmed Central) - Mar 19, 2022
The metabolism of dolutegravir was also increased by G. glabra (2.8-fold) but not by its marker compound, glabridin. These results suggest that licorice and its phytochemicals could affect the metabolism and clearance of certain drugs that are substrates of CYP3A4 and CYP1A2.Supplemental data for this article is available online at https://doi.org/10.1080/19390211.2022.2050875 .
- | Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: High-content analysis and Kinetic Image Cytometry identify toxicity and epigenetic effects of HIV antiretrovirals on human iPSC-neurons and primary neural precursor cells. (Pubmed Central) - Mar 18, 2022
These results suggest that licorice and its phytochemicals could affect the metabolism and clearance of certain drugs that are substrates of CYP3A4 and CYP1A2.Supplemental data for this article is available online at https://doi.org/10.1080/19390211.2022.2050875 . This study establishes human preclinical assays that can screen potential ARVs for CNS toxicity to develop safer cART regimens and HAND therapeutics.
- || ganaplacide (KAF156) / Novartis
Enrollment open: Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir (clinicaltrials.gov) - Mar 17, 2022
P1, N=48, Recruiting, Sponsor: Novartis Pharmaceuticals
This study establishes human preclinical assays that can screen potential ARVs for CNS toxicity to develop safer cART regimens and HAND therapeutics. Not yet recruiting --> Recruiting
- | Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients (clinicaltrials.gov) - Mar 16, 2022
P2/3, N=186, Completed, Sponsor: Funda
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: CYP2B6 Genotype and Weight Gain Differences Between Dolutegravir and Efavirenz. (Pubmed Central) - Mar 15, 2022
CYP2B6 metaboliser genotype was associated with weight gain in PLWH starting efavirenz-based ART. Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies.
- || emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: Bone mineral density, kidney function, weight gain and insulin resistance in women who switch from TDF/FTC/NNRTI to ABC/3TC/DTG. (Pubmed Central) - Mar 15, 2022
Although weight gain was common in women who switched from TDF/FTC/NNRTI to ABC/3TC/DTG, we did not detect adverse effects on glucose homeostasis. Larger studies need to confirm these findings.
- || Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Virological response and resistance profile in highly treatment-experienced HIV-1-infected patients switching to dolutegravir plus boosted darunavir in clinical practice. (Pubmed Central) - Mar 15, 2022
In highly treatment-experienced patients, the use of dual therapy based on DTG + bDRV appears to be a very good regimen for switch therapy, with a high rate of virological control in both viraemic and virologically suppressed patients. Among non-responding patients, the selection of further resistance is a rare event.
- || Tivicay (dolutegravir) / ViiV Healthcare
Retrospective data, Review, Journal, HEOR, Real-world evidence: Effectiveness and safety of dolutegravir two-drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta-analysis of real-world evidence. (Pubmed Central) - Mar 15, 2022
Among non-responding patients, the selection of further resistance is a rare event. Treatment with DTG + 3TC or DTG + RPV in clinical practice provides a low rate of VF and a high rate of VS when initiated in virologically suppressed PLHIV with diverse backgrounds.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Gestational diabetes in women living with HIV in Botswana: lower rates with dolutegravir- than with efavirenz-based antiretroviral therapy. (Pubmed Central) - Mar 15, 2022
Among WLHIV, the risk of GDM was lower with DTG- than with EFV-based ART. Further studies with larger cohorts are warranted to confirm these findings.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Coverage of maternal viral load monitoring during pregnancy in South Africa: Results from the 2019 national Antenatal HIV Sentinel Survey. (Pubmed Central) - Mar 15, 2022
The low viral suppression among women who initiated ART during pregnancy despite receiving ART for three months highlights the importance of enhanced adherence counselling during pregnancy. Our finding supports the WHO recommendation that a Dolutegravir-containing regimen be the preferred regimen for women who are newly initiating ART during pregnancy for more rapid viral suppression.
- | Tivicay (dolutegravir) / ViiV Healthcare
Preclinical, Journal: In vitro assessment of the potential for dolutegravir to affect hepatic clearance of levonorgestrel. (Pubmed Central) - Mar 15, 2022
In summary, this in vitro study suggests that dolutegravir has the potential to increase hepatic clearance of levonorgestrel by inducing both CYP3A and non-CYP3A enzymes. The observed in vitro dolutegravir-levonorgestrel drug-drug interaction should be further examined in clinical studies.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Dolutegravir in the long term in children and adolescents: frequent virological failure but rare acquired genotypic resistance. (Pubmed Central) - Mar 15, 2022
Whereas VF is relatively common on dolutegravir in the paediatric population, regimens associating dolutegravir with more than one fully active drug were associated with a low rate of emergent drug resistance. This result strengthens the recommendation of dolutegravir as part of preferred combinations in children/adolescents.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor- to dolutegravir-based antiretroviral therapy: A prospective cohort study in Lesotho (DO-REAL study). (Pubmed Central) - Mar 15, 2022
This result strengthens the recommendation of dolutegravir as part of preferred combinations in children/adolescents. The high levels of viral suppression observed are encouraging regarding virological outcomes upon programmatic transitioning from NNRTI- to DTG-based ART.
- || Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD)
Clinical, Journal: No overall impact on rate of weight gain with integrase inhibitor-containing regimens in antiretroviral-naïve adults. (Pubmed Central) - Mar 15, 2022
Weight increased in the cohort both pre- and post-ART. We found no evidence of a higher rate of weight gain following ART initiation with an INSTI compared with other regimens.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Dolutegravir drug-resistance monitoring in Africa. (Pubmed Central) - Mar 15, 2022
We found no evidence of a higher rate of weight gain following ART initiation with an INSTI compared with other regimens. No abstract available
- || Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Bone mineral density, kidney function and participant-reported outcome measures in women who switch from tenofovir disoproxil emtricitabine and a nonnucleoside reverse transcriptase inhibitor to abacavir, lamivudine and dolutegravir. (Pubmed Central) - Mar 15, 2022
Switching from TDF/FTC/NNRTI to ABC/3TC/DTG improved the BMD of the lumbar spine and kidney function. These benefits need to be balanced against modest weight gain and the need for antiretroviral therapy substitutions in a proportion of participants.
- || bictegravir (GS-9883) / Gilead
Review, Journal: Use of integrase inhibitors in HIV-associated tuberculosis in high-burden settings: implementation challenges and research gaps. (Pubmed Central) - Mar 15, 2022
Ongoing and planned studies will address some critical questions on the use of INSTIs in settings with a high tuberculosis burden, including dosing of dolutegravir, bictegravir, and cabotegravir when used with the rifamycins for both tuberculosis treatment and prevention. Failure, in the past, to include people with tuberculosis in HIV clinical treatment trials has been responsible for some of the research gaps still evident for informing optimisation of HIV and tuberculosis co-treatment.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: South African healthcare workers' knowledge of dolutegravir's drug-drug interactions in the first year of its rollout: a cross-sectional online survey. (Pubmed Central) - Mar 15, 2022
Failure, in the past, to include people with tuberculosis in HIV clinical treatment trials has been responsible for some of the research gaps still evident for informing optimisation of HIV and tuberculosis co-treatment. There are gaps in the awareness and knowledge of dolutegravir interactions and how to adjust dosing among South African healthcare workers.
- | Tivicay (dolutegravir) / ViiV Healthcare
Enrollment open: CODA: Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV (clinicaltrials.gov) - Mar 15, 2022
P4, N=140, Recruiting, Sponsor: Botswana Harvard AIDS Institute Partnership
There are gaps in the awareness and knowledge of dolutegravir interactions and how to adjust dosing among South African healthcare workers. Not yet recruiting --> Recruiting
- || Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Effectiveness, Durability, and Safety of Dolutegravir and Lamivudine Versus Dolutegravir, Lamivudine, and Abacavir in a Real-Life Cohort of HIV-Infected Adults. (Pubmed Central) - Mar 11, 2022
Nevertheless, all effectiveness measures support the use of 2-DR in a real-life cohort of TN and TE. Additionally, durability and safety of 2-DR were confirmed to be similar to that of 3-DR.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Dolutegravir-Based Dual Therapies in HIV Pretreated Patients: A Real-Life Study in Madrid. (Pubmed Central) - Mar 11, 2022
The use of DTG-based dual therapies has increased in real life, showing a favorable effectiveness and safety profile. Treatment costs increased, except for the switch to DTG plus 3TC.
- || Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, Journal: Clinical Safety Considerations of Integrase Strand Transfer Inhibitors in the Older Population Living with HIV. (Pubmed Central) - Mar 11, 2022
Elvitegravir is also well tolerated with limited adverse effects, but has many drug-drug interactions that may pose problems for older patients with polypharmacy. Dolutegravir has been associated with more frequent adverse events, such as neuropsychiatric disorders.
- | ritonavir / Generic mfg.
Journal: Lentiviral Infections Persist in Brain despite Effective Antiretroviral Therapy and Neuroimmune Activation. (Pubmed Central) - Mar 11, 2022
The present studies show that in different experimental platforms, contemporary ART did not suppress viral burden in the brain, regardless of ART component regimen, the duration of therapy, and its interruption. Thus, new strategies for effective HIV-1 suppression in the brain are imperative to achieve sustained HIV suppression.
- ||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, P3 data, Journal: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants with Pre-existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials. (Pubmed Central) - Mar 9, 2022
This small cohort with primary INSTI-R achieved and/or maintained virologic suppression through 48 weeks of B/F/TAF treatment. Consistent with the potent in vitro activity of bictegravir against most INSTI-R patterns, B/F/TAF may be a potential treatment option for patients with select pre-existing INSTI-R, if confirmed by further studies.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, PK/PD data, Journal: Optimizing Dolutegravir Initiation in Neonates using Population Pharmacokinetic Modeling and Simulation. (Pubmed Central) - Mar 8, 2022
Newborn DTG dosing requirements during the first days of life depend upon maternal DTG dosing history prior to delivery. These results may inform the design of future clinical studies of DTG in the neonatal population.
- || Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Comparison of efficacy, safety and durability of a switch to co-formulated RPV/TDF-TAF/FTC or DTG/ABC/3TC in virologically suppressed HIV-1-infected patients in a single Italian center: a cohort data analysis. (Pubmed Central) - Mar 8, 2022
This study evaluated the efficacy, safety and durability of a switch to co-formulated RPV/TDF-TAF/FTC (RPV-STR) or DTG/ABC/3TC (DTG-STR) in virologically-suppressed HIV-positive patients in a single Italian centre...No difference in VF rate was observed between the two groups [RR 0.47 95%CI 0.10- 2.14; p=0.335] : Undetectable patients switched to DTG-STR or RPV-STR maintained virologic suppression with a low risk of VF. A higher discontinuation rate was observed with DTG-STR compared to RPV-STR in particular within 3 months from the switch.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children. (Pubmed Central) - Mar 8, 2022
A higher discontinuation rate was observed with DTG-STR compared to RPV-STR in particular within 3 months from the switch. These studies demonstrate the successful development of pediatric dolutegravir-containing formulations as SE and FDC that permit pediatric dosing in line with WHO recommendations.
- ||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment (clinicaltrials.gov) - Mar 8, 2022
P3b, N=627, Completed, Sponsor: ViiV Healthcare
These studies demonstrate the successful development of pediatric dolutegravir-containing formulations as SE and FDC that permit pediatric dosing in line with WHO recommendations. Active, not recruiting --> Completed
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Virological outcomes with dolutegravir plus either lamivudine or two NRTIs as switch strategies: a multi-cohort study. (Pubmed Central) - Mar 5, 2022
Active, not recruiting --> Completed Lamivudine/dolutegravir maintenance DT showed similar efficacy to dolutegravir-based TT; however, past M184V/I may favour VF.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Specific mutations in the HIV-1 G-tract of the 3'-polypurine tract cause resistance to integrase strand transfer inhibitors. (Pubmed Central) - Mar 5, 2022
Lamivudine/dolutegravir maintenance DT showed similar efficacy to dolutegravir-based TT; however, past M184V/I may favour VF. Mutations at the second and fifth positions in the G-tract of the 3'-PPT may result in complex resistance mechanism(s), rather than simply affecting INSTI binding at the IN active site.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Predictors of Viral Non-Suppression among Patients Living with HIV under Dolutegravir in Bunia, Democratic Republic of Congo: A Prospective Cohort Study. (Pubmed Central) - Mar 5, 2022
This study suggests that we should better evaluate adherence, especially among adolescents and economically vulnerable populations, such as the Sudanese ethnic group in the city of Bunia. This suggests that an awareness of the potential effects of DTG and tenofovir is important for providers who take care of HIV-positive patients using antiretroviral therapy (ART), especially those with abnormal serum creatinine levels before starting treatment.
- | Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Journal: HIV-1-RNA and total HIV-1-DNA loads in the genital compartment in men receiving dolutegravir- versus darunavir-based combined ART (cART) regimens during primary HIV infection. (Pubmed Central) - Mar 5, 2022
For the first time, to the best of our knowledge, we showed that a dolutegravir-based regimen initiated as soon as PHI reduces HIV-RNA and HIV-DNA with no difference compared with a control group receiving a darunavir-based regimen. Although the viral purge in semen seems longer after treatment in PHI than CHI, due to high viral loads, early dolutegravir-based treatment initiation permits a major decay of both viral particles and infected cells in semen, efficiently reducing the high risk of transmission during PHI.
- || Tivicay (dolutegravir) / ViiV Healthcare
PK/PD data, Journal: Pharmacokinetics and placental transfer of dolutegravir in pregnancy. (Pubmed Central) - Mar 4, 2022
The animal studies available demonstrate that in utero dolutegravir exposure can be associated with neural tube defects. Taking into consideration that antiretroviral exposure may be associated with poor placental development or function and increased risk of adverse effects to the fetus, it is crucially important that these risks are evaluated, especially with the rapid scale up of dolutegravir-based ART into national treatment programmes.
- || Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Dolutegravir-based dual maintenance regimens combined with lamivudine/emtricitabine or rilpivirine: risk of virological failure in a real-life setting. (Pubmed Central) - Mar 4, 2022
In this large real-life cohort, dolutegravir/rilpivirine and dolutegravir/xTC sustained virological suppression and were associated with a low rate of VF and RAM emergence. Careful virological screening is essential before switching to dolutegravir/rilpivirine in virologically suppressed patients with a history of NNRTI therapy.
- | bictegravir (GS-9883) / Gilead
Preclinical, Journal: In vitro analysis of the replicative capacity and phenotypic susceptibility to integrase inhibitors of HIV-2 mutants with integrase insertions. (Pubmed Central) - Mar 4, 2022
These first data on the newly described resistance pathway 231ins, using site-directed mutagenesis, showed no measurable impact on viral fitness and confirmed the decreased susceptibility to a first-generation INSTI (raltegravir) and cabotegravir. Resistance to second-generation INSTIs (dolutegravir and bictegravir) occurred for mutants with a 5 amino acid 231ins.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Observational data, Retrospective data, Journal: COPEDOL: a two-year observational study in pretreated HIV-1-infected patients switching to a dolutegravir-based regimen. (Pubmed Central) - Mar 4, 2022
Resistance to second-generation INSTIs (dolutegravir and bictegravir) occurred for mutants with a 5 amino acid 231ins. A sustained treatment response can be obtained with a dolutegravir-based treatment regimen in PLWHIV experiencing treatment failure, even in vulnerable patients with a long history of previous ART failure, infected with multidrug-resistant HIV strains, and with multiple comorbidities.
- | Journal: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57). (Pubmed Central) - Mar 4, 2022
There were no differences in CD4 cell count or weight changes. We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated.
- || Mycobutin (rifabutin) / Pfizer, Lupin, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, PK/PD data, Journal: Pharmacokinetic features of dolutegravir with rifampicin and rifabutin among patients coinfected with human immunodeficiency virus and tuberculosis/mycobacterium avium complex. (Pubmed Central) - Mar 3, 2022
We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated. Due to the relatively low trough concentrations of DTG with RBT, DTG 50mg once daily together with RBT could only serve as an alternative option for HIV/TB (or MAC) co-infected patients.
- ||| Tivicay (dolutegravir) / ViiV Healthcare
Enrollment closed, Trial completion date, Trial primary completion date: D (clinicaltrials.gov) - Mar 3, 2022
P3b/4, N=813, Active, not recruiting, Sponsor: Kirby Institute
Due to the relatively low trough concentrations of DTG with RBT, DTG 50mg once daily together with RBT could only serve as an alternative option for HIV/TB (or MAC) co-infected patients. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- | Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion, Trial completion date, Adherence: APTAMER: Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs (clinicaltrials.gov) - Mar 3, 2022
P1, N=30, Completed, Sponsor: Rhonda Brand
Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Sep 2021
- | Tivicay (dolutegravir) / ViiV Healthcare
Enrollment closed: The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART (clinicaltrials.gov) - Mar 3, 2022
P=N/A, N=2820, Active, not recruiting, Sponsor: University of Bern
Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Sep 2021 Recruiting --> Active, not recruiting
- |||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical: Join us this Wednesday for the @CUNYSPH Epidemiology and Biostatistics monthly forum, with @DelivetteC speaking on HIV prevention in women and @mattromo28 speaking about his recent work with @iedeaglobal on disparities in dolutegravir uptake. Details here: https://t.co/QIIfWfWQ6y (Twitter) - Feb 28, 2022
- | Preclinical, Journal: Evaluation of the Potency of Anti-HIV and Anti-HCV Drugs to Inhibit P-Glycoprotein Mediated Efflux of Digoxin in Caco-2 Cell Line and Human Precision-Cut Intestinal Slices. (Pubmed Central) - Feb 27, 2022
However, abacavir, dolutegravir, maraviroc, sofosbuvir, tenofovir disoproxil fumarate, and zidovudine had no inhibitory effect...More inhibitors were identified when using digoxin as the ABCB1 probe substrate than when using rhodamine123. However, both approaches had limitations, indicating that inhibitory potency should be tested with at least these two ABCB1 probes.
- || Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
Clinical, P4 data, Journal: A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal function in HIV-1 antiretroviral naïve patients. (Pubmed Central) - Feb 26, 2022
INSTIs in combination with TDF/FTC impact differently on tubular microproteinuria, eGFR, metabolic markers and weight. Use of TDF/FTC with RAL had the least tubular effects and the most favorable metabolic profile.
- || Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD)
Clinical, Journal: Cerebral function parameters in people with HIV switching integrase inhibitors: a randomized controlled trial. (Pubmed Central) - Feb 26, 2022
CSF HIV RNA was <5 copies/mL at baseline and day 120 in all subjects. Geometric mean pre-dose CSF dolutegravir concentration was 7.6 ng/mL (95% CI: 5.2-11.1).Switching integrase inhibitor in virologically suppressed PWH without overt neuropsychiatric symptoms resulted in no significant changes in an extensive panel of CNS pharmacodynamics parameters.
- | Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Hypersensitivity reactions, hepatotoxicity, and other discontinuations in persons receiving integrase strand transfer inhibitors: results from the EuroSIDA study. (Pubmed Central) - Feb 26, 2022
There was one hepatotoxicity discontinuation on DTG with ABC (discontinuation rate 0.18, CI 0.00-0.99/1000 PYFU). During 5 years of observations in the EuroSIDA cohort independently reviewed discontinuations due to HSR or hepatotoxicity were very rare, indicating a low rate of SAEs.