- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Observational data, Journal: Determinants of Survival of HIV Patients Receiving Dolutegravir: A Prospective Cohort Study in Conflict-Affected Bunia, Democratic Republic of Congo. (Pubmed Central) - Sep 3, 2022 Improving baseline viral load monitoring, starting ART early in individuals with high baseline viral loads, the proper tailoring of ART regimens and optimizing long-term ART, and care to manage non-AIDS-related chronic complications are recommended actions to reduce mortality. Not least, fostering women's inclusion, justice, peace, and security in conflict zones is critical in preventing premature deaths in the general population as well as among PLHIV.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Changes in Body Mass Index after Initiation of Antiretroviral Treatment: Differences by Class of Core Drug. (Pubmed Central) - Sep 3, 2022 INSTIs are associated with faster weight gain. INSTIs' increased risk of treatment emergent obesity and, possibly, weight-related co-morbidities should be judged against their improved efficacy and tolerability but increased clinical attention is required.
- |||||||||| Mycobutin (rifabutin) / Pfizer, Lupin, Tivicay (dolutegravir) / ViiV Healthcare
Retrospective data, Journal: Effect of Rifabutin in Dolutegravir Dosing: A Case Series. (Pubmed Central) - Sep 3, 2022 Given the frequency of low DTG and RBN concentrations, therapeutic drug monitoring (TDM) for these drugs is advisable. Prospective clinical studies are needed to further determine the PK interactions between RBN and DTG, and virologic response to treatment.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals (clinicaltrials.gov) - Aug 31, 2022 P2, N=72, Suspended, Third-line regimens comprising of RAL, DRV/r and/or ETR were very well tolerated and had high rates of durable virologic suppression among PLWH in LMICs who were failing on second-line PI-based ART prior to the availability of dolutegravir. Trial completion date: Sep 2022 --> Oct 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
- |||||||||| Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Journal: Simultaneous Determination of Emtricitabine, Tenofovir Alafenamide Fumarate and Dolutegravir Sodium by Validated Stability-Indicating RP-HPLC-DAD Method. (Pubmed Central) - Aug 30, 2022 The in silico evaluation of three selected synthesized intermediates e.g. 7, 8 and 9 (structurally similar to dolutegravir) against SARS CoV-2 O-ribose methyltransferase (OMTase) (PDB: 3R24) indicated that compound 7 could be of interest as a possible inhibitor of this protein. The established approach was considered to be accurate, linear, precise, specific, robust and it can be utilized to analyse the drugs mentioned in its tablet.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial initiation date: A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 (clinicaltrials.gov) - Aug 29, 2022 P1, N=36, Not yet recruiting, The established approach was considered to be accurate, linear, precise, specific, robust and it can be utilized to analyse the drugs mentioned in its tablet. Initiation date: Jul 2022 --> Oct 2022
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Preclinical, Journal: In Vitro and In Silico Potential Inhibitory Effects of New Biflavonoids from Ochna rhizomatosa on HIV-1 Integrase and Plasmodium falciparum. (Pubmed Central) - Aug 27, 2022 Computational molecular docking revealed that compounds 1 and 2 had the highest binding score (-121.8 and -131.88 Kcal/mol, respectively) in comparison to chicoric acid and Dolutegravir (-116 and -100 Kcal/mol, respectively), towards integrase receptor (PDB:3LPT)...These results confirm the potential inhibitory effect of compounds 1 and 2 for HIV and malaria treatment. Therefore, our future investigation to find inhibitors of these receptors in vivo could be an effective strategy for developing new drugs.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
PK/PD data, Preclinical, Journal: In-vivo pharmacokinetic studies of Dolutegravir loaded spray dried Chitosan nanoparticles as milk admixture for paediatrics infected with HIV. (Pubmed Central) - Aug 22, 2022 This phenomenon was further reflected by the improved bioavailability of DTG (AUC: 678.3 ± 10.07 μg/h/mL) in the NPs administered to mice when compared to the AUC of animals administered with pure DTG (405.29 ± 7 μg/h/mL). Altogether, the research findings showed that Chitosan-based NPs were ideal carriers for oral administration of DTG along with milk and exhibited great potential to enhance the bioavailability of the drug and treatment adherence for paediatric HIV patients.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Mylan, Hetero, Macleods, Tivicay (dolutegravir) / ViiV Healthcare
P4 data, Journal: A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1. (Pubmed Central) - Aug 22, 2022 At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells. This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Altered adipose tissue macrophage populations in people with HIV on integrase inhibitor-containing ART. (Pubmed Central) - Aug 22, 2022 We report the loss of metabolically beneficial ATM populations in PWH on ART, altered fatty acid metabolism of blood immune cells, and evidence that dolutegravir alters macrophage fatty acid metabolism. Future studies should examine direct or indirect effects and mechanisms of dolutegravir, and other integrase inhibitors and ART classes, on fatty acid beta-oxidation.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Unusual case of tuberculous chancre at the exact site of application of the Mantoux test () - Aug 16, 2022 - Abstract #ESDR2022ESDR_370; The patient was also diagnosed with pulmonary tuberculosis, confirmed by real time PCR assay in sputum, which identified rifampicin-sensitive bacilli. The treatment was performed with pyrazinamide, rifampicin, isoniazid and ethambutol, with good response.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Dolutegravir Inhibits Proliferation and Motility of BT-20 Tumor Cells Through Inhibition of Human Endogenous Retrovirus Type K. (Pubmed Central) - Aug 10, 2022 The antiproliferative effect of DTG correlated with enhanced expression of E-cadherin and reduction in cell motility and invasiveness. Surprisingly, DTG stimulated expression of the env gene of MMTV in vivo and promoted metastasis of 4T1 tumor cells to the lungs. Taken together, our data support the role of ERVs in tumor development and encourage the further search for antiretroviral agents to treat malignancies in which ERVs are active.
- |||||||||| Trial completion, Trial completion date: BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (clinicaltrials.gov) - Aug 10, 2022
P1/2, N=77, Completed, Surprisingly, DTG stimulated expression of the env gene of MMTV in vivo and promoted metastasis of 4T1 tumor cells to the lungs. Taken together, our data support the role of ERVs in tumor development and encourage the further search for antiretroviral agents to treat malignancies in which ERVs are active. Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> May 2022
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date: DolPHIN-2: Dolutegravir in Pregnant HIV Mothers and Their Neonates (clinicaltrials.gov) - Aug 9, 2022 P3, N=250, Active, not recruiting, Controlled studies are needed to verify acceptable pharmacokinetic and pharmacodynamic metrics for crushed B/FTC/TAF given via tube, with and without tube feeds, before use in this manner. Trial completion date: Mar 2021 --> Jan 2023
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Dolutegravir in late pregnancy: where to from here? (Pubmed Central) - Aug 6, 2022 Importantly, albumin concentrations, bedaquiline coadministration, and HIV co-infection (dolutegravir coadministration) did not have an effect on delamanid and DM-6705 PK. No abstract available
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Mutations in the 3'-PPT Lead to HIV-1 Replication without Integration. (Pubmed Central) - Jul 31, 2022 Here, we show that replication of a selected dolutegravir-resistant virus with mutations in the 3'-PPT (polypurine tract) was effective, although no integrated viral DNA was detected, due to the accumulation of unintegrated viral DNA present as 1-LTR circles...This mutation modifies the reverse transcription step leading to the accumulation of 1-LTR circles and not the linear DNA. This accumulation of 1-LTR circles leads to viral replication without integration of the viral genome.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Modern ART for South Africa () - Jul 29, 2022 - Abstract #AIDS2022AIDS_4577; Since 2016, HIV i-Base, UK, and the Treatment Action Campaign (TAC), SA, funded by Unitaid, have provided community engagement to support the ADVANCE study and the transition to dolutegravir-based first-line treatment in South Africa...TAC will hold some Q&A sessions on HIV treatment at dedicated times during the conference from the booth. The expected outcome is that the zone will demonstrate to stakeholders the value of engaging with communities and sharing HIV treatment information in a variety of ways for different literacy levels, settings and audiences.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: RADIANT-TB: Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis (clinicaltrials.gov) - Jul 23, 2022 P2, N=108, Completed, A combination of strengthened health literacy, economic empowerment, improved privacy and patient-provider relationships as well as community interventions that tackle inimical cultural practices on pregnancy and unfair gender norms may be required. Active, not recruiting --> Completed
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