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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  MEDICINE AND THE LAW. (Pubmed Central) -  Dec 7, 2022   
    It has recently replaced efavirenz as the preferred third drug for people initiating antiretroviral therapy in South Africa (SA)...Despite the several advantages DTG offers, additional data informing risks over benefits have emerged that warrant clinical attention before DTG is prescribed. This article aims to give the primary care provider an overview of the benefits and risks associated with the roll-out of DTG in SA.
  • ||||||||||  Journal:  Drug resistance in children and adolescents with HIV in Panama. (Pubmed Central) -  Dec 2, 2022   
    Our findings open new perspectives to study the role of HERVs in the biological mechanisms underlying Autism. The high DRM prevalence to NRTIs and NNRTIs observed among treated HIV-infected children/adolescents in Panama justifies the need for routine resistance monitoring for optimal rescue therapy selection in this vulnerable population.
  • ||||||||||  Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Higher prevalence of QTc interval prolongation among virologically suppressed older people living with HIV. (Pubmed Central) -  Nov 19, 2022   
    In multivariable analysis, older age (OR 1.07, 95% CI 1.02-1.12, p = 0.005), female sex (OR 1.69, 95%CI 1.01-2.82, p = 0.046) and increasing BMI (OR 1.08, 95%CI 1.01-1.15, p = 0.03) were associated with QTc interval prolongation. With every 1-year increase in age, the odds of QTc interval prolongation increased by 7%.
  • ||||||||||  Turalio (pexidartinib) / Daiichi Sankyo
    Journal:  Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects. (Pubmed Central) -  Nov 16, 2022   
    P1
    The physiologically based pharmacokinetic model predicted that a moderate CYP3A4 inhibitor and a moderate CYP3A inducer would produce modest increases and decreases, respectively, in pexidartinib exposure. These results provide a basis for pexidartinib dosing recommendations when administered concomitantly with drugs with drug-drug interaction potential, including dose adjustments when concomitant administration cannot be avoided.
  • ||||||||||  efavirenz / Generic mfg., nevirapine / Generic mfg.
    Journal:  Prevalence of Pretreatment HIV-1 Drug Resistance in Armenia in 2017-2018 and 2020-2021 following a WHO Survey. (Pubmed Central) -  Nov 15, 2022   
    The prevalence of PDR to nucleoside reverse-transcriptase inhibitors decreased from 5.0% in phase I to 0.8% in phase II. In addition, we identified risk factors associated with the emergence of DR-male, MSM, subtype B, and residence in or around the capital of Armenia-and showed the active spread of HIV-1 among MSM in transmission clusters, i.e., harboring DR, which requires the immediate attention of public health policymakers for the prevention of HIV-1 DR spread in the country.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Low-frequency pre-treatment HIV drug resistance: effects on 2-year outcome of first-line efavirenz-based antiretroviral therapy. (Pubmed Central) -  Nov 4, 2022   
    We observed that pre-treatment HIV drug resistance detected at low frequencies increased the risk of virologic failure over 24 months of efavirenz-based ART, but that most failures, regardless of drug-resistant variants' frequencies, were detected within a year of ART initiation. These observations suggest that when efavirenz-based ART is prescribed, screening for pre-treatment drug resistance by an assay capable of detecting low-frequency variants, including OLA, may guide clinicians to prescribe more effective ART.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Urine tenofovir-monitoring predicts HIV viremia in patients treated with high genetic-barrier regimens. (Pubmed Central) -  Nov 4, 2022   
    Urine tenofovir-testing had a high negative-predictive value for viral failure in patients treated with DTG or ritonavir-boosted protease inhibitor regimens, where viral failure was largely explained by poor drug adherence. Frequent monitoring with inexpensive lateral flow urine TFV testing should be investigated prospectively in between viral load visits to improve viral load suppression on DTG-based first-line therapy in resource-limited settings.
  • ||||||||||  ganaplacide (KAF156) / Novartis
    Enrollment open, Enrollment change, Trial completion date, Trial primary completion date:  Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz (clinicaltrials.gov) -  Nov 4, 2022   
    P1,  N=60, Recruiting, 
    Frequent monitoring with inexpensive lateral flow urine TFV testing should be investigated prospectively in between viral load visits to improve viral load suppression on DTG-based first-line therapy in resource-limited settings. Not yet recruiting --> Recruiting | N=20 --> 60 | Trial completion date: Jun 2022 --> Nov 2022 | Trial primary completion date: Jun 2022 --> Nov 2022
  • ||||||||||  efavirenz / Generic mfg., nevirapine / Generic mfg., lamivudine/zidovudine / Generic mfg.
    Retrospective data, Journal:  Rate of virological failure and HIV-1 drug resistance among HIV-infected adolescents in routine follow-up on health facilities in Cameroon. (Pubmed Central) -  Nov 2, 2022   
    The most common mutations were K103N (n = 21/42, 52.3%) resulting in high-level resistance to Efavirenz and Nevirapine, followed by M184V (n = 20/42, 47.6%) and thymidine analog mutations (n = 15/42, 35.7%) associated with high-level resistance to Lamivudine and Zidovudine respectively. The high rate of VF and HIVDR among ALHIV regularly followed in health facilities in Cameroon highlights the need to develop interventions adapted to an adolescent-centered approach to preserve future ART options.
  • ||||||||||  Pharmacogenomic Discovery in Villages of Neural Cells From a Cohort of Individuals With Severe Psychiatric Disorders (Grand Canyon 3-5) -  Oct 31, 2022 - Abstract #ACNP2022ACNP_677;    
    In astrocytes, however, simvastatin and atorvastatin significantly affected viability and upregulated genes involved in cytoskeletal matrix organization and cell migration and downregulated pathways mediating synaptic homeostasis and cell adhesion, possibly via regulating GTPases such as RHOA and RHOB, both upregulated in astrocytes. Conclusions Our findings suggest Clozapine treatment increases the expression of cholesterol synthesis genes in both neurons and astrocytes, suggesting a possible mechanism of action, while statin treatment alters GTPase signaling in astrocytes, impacting cell adhesion and synapse integrity and reducing overall viability.
  • ||||||||||  efavirenz / Generic mfg.
    LINE-1 reverse transcriptase activity in Hodgkin lymphoma cells (Great Hall) -  Oct 27, 2022 - Abstract #ISHL2022ISHL_40;    
    HL cells express LINE-1 reverse transcriptase sequences that might be responsible for the observed reverse transcriptase activity of these cells. LINE-1 reverse transcriptase might be interesting targets for future therapeutic developments.Our work is supported by Mitteldeutsche Kinderkrebsforschung.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Newly identified tree shrew cytochrome P450 2B6 (CYP2B6) and pig CYP2B6b are functional drug-metabolizing enzymes. (Pubmed Central) -  Oct 27, 2022   
    These patients might switch to dolutegravir-based regimen with compromised NRTIs, which could impair the long-term efficacy of ART. Tree shrews have high phylogenetic affinity to humans and are used in various fields of biomedical research, especially hepatitis virus infection; however, cytochromes P450 (P450s or CYPs) have not been investigated in this species.In this study, tree shrew CYP2B6 and pig CYP2B6b were newly identified and contained amino acid sequences highly identical (80% and 78%, respectively) to human CYP2B6 and included sequence motifs characteristic of P450s.Phylogenetic analysis revealed that novel tree shrew CYP2B6 was more closely related to known human CYP2B6 than dog, pig, or rat CYP2Bs are.Among the tissue types analysed, tree shrew CYP2B6 mRNA was preferentially expressed in liver and lung, whereas pig CYP2B6b mRNA was preferentially expressed in jejunum and lung.Tree shrew CYP2B6 and pig CYP2B6b proteins heterologously expressed in Escherichia coli metabolized human CYP2B6 substrates efavirenz, ethoxycoumarin, propofol, and testosterone, suggesting that these novel CYP2Bs are functional drug-metabolizing enzymes in liver and/or lung.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare
    PK/PD data, Journal:  Maraviroc Population Pharmacokinetics Within the First 6 Weeks of Life. (Pubmed Central) -  Oct 15, 2022   
    While maraviroc apparent clearance is decreased in the first few days of life, the current FDA-approved maraviroc weight band dosing provides maraviroc exposures for neonates in the first 6 weeks of life, which were consistent with adult maraviroc exposure range. Maraviroc provides another antiretroviral treatment option for very young infants.
  • ||||||||||  efavirenz / Generic mfg., nevirapine / Generic mfg.
    Journal:  Association of human leukocyte antigen alleles and hypersensitivity of Efavirenz/Nevirapine in HIV-infected Chinese patients. (Pubmed Central) -  Oct 14, 2022   
    In addition, the HLA-DRB1*04:05:01 antigen was expressed more frequently in the NVP hypersensitive group (23.8%, 5/21) compared to the control group (10.8%, 4/37) [OR = 7; 95% CI = 1.265 - 38.793, P = 0.026]. Our data not only revealed a significant association between HLA-C*01:02:01 and EFV-induced cutaneous adverse reactions but may also shed light on defining the treatment for Chinese HIV patients.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  Metabolic syndrome in people with HIV from Guatemala: analysis of components and risk factors. (Pubmed Central) -  Oct 13, 2022   
    Prevalence of metabolic syndrome in this study was high and driven mainly by social and cardiovascular risk factors such as age, urban dwelling, obesity, hyperuricemia and low physical activity. Efavirenz use and CD4 count were the only HIV-related factors associated with metabolic syndrome.
  • ||||||||||  artemether/lumefantrine / Generic mfg.
    Association of lumefatrine pharmacokinetics and resistance selection following artemether-lumefantrine treatment in children with and without HIV in Uganda (Convention Center - Hall 4A (4th Floor); In-Person-Only) -  Oct 9, 2022 - Abstract #ASTMH2022ASTMH_2419;    
    Using a time to event PK/PD model, more resistant (pfcrt K76) parasites were able to tolerate concentrations 3.5-fold higher than more sensitive parasites (pfcrt K76T mixed + mutant). This is the first population PK model of lumefantrine in HIV-infected children and provides evidence that wild-type K76 parasites are able withstand higher lumefantrine concentrations, which may help explain how selection is occurring in high transmission settings over repeated ACT treatments, a concern as we try to combat the recent emergence and spread of artemisinin resistance in Africa.
  • ||||||||||  efavirenz / Generic mfg.
    Journal:  A Concise Analytical Profile of Efavirenz: Analytical Methodologies. (Pubmed Central) -  Oct 7, 2022   
    This review plan to review the stereochemistry, mechanism of action, resistance, pharmacokinetics, pharmacodynamics, safety and adverse reaction, and various analytical approaches assessed for the same. The hyphenated and chromatographic techniques are frequently used for analysis of cited drug.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Osteoporosis among older persons living with HIV in Kenya: baseline results from the BFTAF elderly switch study () -  Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_305;    
    DXA is not readily available in Kenya, and risk calculation without BMD did not identify the majority of participants who qualify for treatment of osteoporosis. Additional data for this population are required on clinical implications of undiagnosed osteoporosis, ARV regimen selection to reduce osteoporosis risk, particularly in populations with widespread use of TDF, and on the impact of investment in osteoporosis screening and treatment, including population-specific risk calculators.
  • ||||||||||  efavirenz / Generic mfg.
    HIV resistance patterns in a cohort of adults living with HIV failing first-line efavirenz-based antiretroviral therapy in South Africa () -  Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_245;    
    Despite a small sample size, these insights offer valuable information into the resistance patterns of PLWHIV in South Africa, failing NNRTI-based first-line ART regimens. Cross-resistance within NNRTIs may be more prevalent with doravirine than recorded in previous clinical trials, this potentially compromising their role as an option for patients failing EFV-based regimens, particularly with the introduction of dolutegravir into first-line ART programmes in South Africa.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Interim doravirine safety results from a pilot switch study for women of childbearing potential in South Africa () -  Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_170;    
    A pilot open-label, single-arm, single-centre, phase III, switch study, recruited 100 HIV-positive ART-experienced women in South Africa, to evaluate viral suppression, tolerability, overall safety, and efficacy of DOR/3TC/TDF... Doravirine-based regimes are an effective, tolerable alternative first-line treatment in WCBP, with improved lipid profile, although potential long-term weight gain needs to be further investigated.