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1. Efavirenz/Emtricitabine/Tenofovir disoproxil - HIV

Efavirenz/Emtricitabine/Tenofovir disoproxil - HIV 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 14 December 2017 EMA/846772/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Efavirenz/Emtricitabine/Tenofovir disoproxil Krka International non-proprietary name: efavirenz / emtricitabine / tenofovir (...) Diffraction Assessment report EMA/846772/2017 Page 5/38 1. Background information on the procedure 1.1. Submission of the dossier The applicant KRKA, d.d., Novo mesto submitted on 26 April 2017 an application for marketing authorisation to the European Medicines Agency (EMA) for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004– ‘Generic of a Centrally authorised product’. The eligibility to the centralised procedure

2018 European Medicines Agency - EPARs

2. CPIC Guideline for Efavirenz based on CYP2B6 genotype

CPIC Guideline for Efavirenz based on CYP2B6 genotype CPIC GUIDELINE CLINICAL PHARMACOLOGY & THERAPEUTICS | VOLUME 106 NUMBER 4 | OCTOBER 2019 726 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2B6 and Efavirenz- Containing Antiretroviral Therapy Zeruesenay Desta 1 , Roseann S. Gammal 2,3 , Li Gong 4 , Michelle Whirl-Carrillo 4 , Aditya H. Gaur 5 , Chonlaphat Sukasem 6,7 , Jennifer Hockings 8 , Alan Myers 9 , Marelize Swart 1 , Rachel F. Tyndale 10 , Collen (...) Masimirembwa 11 , Otito F. Iwuchukwu 12 , Sanika Chirwa 13 , Jeffrey Lennox 14 , Andrea Gaedigk 15 , T eri E. Klein 4 and David W . Haas 13,16,* The HIV type- 1 nonnucleoside reverse transcriptase inhibitor, efavirenz, is widely used to treat HIV type-1 infection. Efavirenz is predominantly metabolized into inactive metabolites by cytochrome P450 (CYP)2B6, and patients with certain CYP2B6 genetic variants may be at increased risk for adverse effects, particularly central nervous system toxicity

2019 Clinical Pharmacogenetics Implementation Consortium

3. Variability of efavirenz plasma concentrations among pediatric HIV patients treated with efavirenz based combination antiretroviral therapy in Dar es Salaam, Tanzania Full Text available with Trip Pro

Variability of efavirenz plasma concentrations among pediatric HIV patients treated with efavirenz based combination antiretroviral therapy in Dar es Salaam, Tanzania Children are subject to varying drug pharmacokinetics which influence plasma drug levels, and hence treatment outcomes especially for drugs like efavirenz whose plasma concentrations are directly related to treatment outcomes. This study is aimed at determining plasma efavirenz concentrations among Tanzanian pediatric HIV-1 (...) patients on efavirenz-based combination antiretroviral therapy (cART) and relating it to clinical, immunological and virologic treatment responses.A cross sectional study involving pediatric HIV patients aged 5-15 years on efavirenz-based cART for ≥ 6 months were recruited in Dar es Salaam. Data on demographics, cART regimens, efavirenz dose and time of the last dose were collected using structured questionnaires and checklists. Venous blood samples were drawn at 10-19 h post-dosing for efavirenz

2018 BMC pharmacology & toxicology

4. Application of Physiologically Based Pharmacokinetic (PBPK) Modeling Within a Bayesian Framework to Identify Poor Metabolizers of Efavirenz (PM), Using a Test Dose of Efavirenz Full Text available with Trip Pro

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling Within a Bayesian Framework to Identify Poor Metabolizers of Efavirenz (PM), Using a Test Dose of Efavirenz Poor metabolisers of CYP2B6 (PM) require a lower dose of efavirenz because of serious adverse reactions resulting from the higher plasma concentrations associated with a standard dose. Treatment discontinuation is a common consequence in patients experiencing these adverse reactions. Such patients benefit from (...) appropriate dose reduction, where efficacy can be achieved without the serious adverse reactions. PMs are usually identified by genotyping. However, in countries with limited resources genotyping is unaffordable. Alternative cost-effective methods of identifying a PM will be highly beneficial. This study was designed to determine whether a plasma concentration corresponding to a 600 mg test dose of efavirenz can be used to identify a PM. A physiologically based pharmacokinetic (PBPK) model was used

2018 Frontiers in pharmacology

5. Combination of tenofovir and emtricitabine with efavirenz does not moderate inhibitory effect of efavirenz on mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line. Full Text available with Trip Pro

Combination of tenofovir and emtricitabine with efavirenz does not moderate inhibitory effect of efavirenz on mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line. Efavirenz (EFV), the most popular nonnucleoside reverse transcriptase inhibitor, has been associated with mitochondrial dysfunction in most in vitro studies. However, in real life the prevalence of EFV-induced mitochondrial toxicity is relatively low. We hypothesized that the agents given

2018 Antimicrobial Agents and Chemotherapy

6. Efavirenz (Sustiva) for the treatment of human immunodeficiency virus-1 (HIV-1) infected children 3 months of age to 3 years

Efavirenz (Sustiva) for the treatment of human immunodeficiency virus-1 (HIV-1) infected children 3 months of age to 3 years Final Appraisal Recommendation Advice No: 4015 – December 2015 Efavirenz (Sustiva ® ) 50mg, 100mg, 200mg hard capsules and 600mg film-coated tablets Limited submission by Bristol-Myers Squibb Pharmaceuticals Ltd Additional note(s): ? Please refer to the Summary of Product Characteristics for the full licensed indication. In reaching the above recommendation AWMSG has (...) for review every three years. Statement of use: No part of this recommendation may be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal Recommendation – 4015: Efavirenz (Sustiva ® ) 50mg, 100mg, 200mg hard capsules and 600mg film-coated tablets. Recommendation of AWMSG Efavirenz (Sustiva ® ) is recommended as an option for use within NHS Wales in antiviral combination treatment for the treatment of human immunodeficiency

2016 All Wales Medicines Strategy Group

7. Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. Full Text available with Trip Pro

Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. An efavirenz-based regimen (with a 600-mg dose of efavirenz, known as EFV600) was the World Health Organization preferred first-line treatment for human immunodeficiency virus type 1 (HIV-1) infection until June 2018. Given concerns about side effects, dolutegravir-based and low-dose efavirenz-based combinations have been considered as first-line treatments for HIV-1 in resource-limited settings.We conducted (...) an open-label, multicenter, randomized, phase 3 noninferiority trial in Cameroon. Adults with HIV-1 infection who had not received antiretroviral therapy and had an HIV-1 RNA level (viral load) of at least 1000 copies per milliliter were randomly assigned to receive either dolutegravir or the reference treatment of low-dose efavirenz (a 400-mg dose, known as EFV400), combined with tenofovir and lamivudine. The primary end point was the proportion of participants with a viral load of less than 50

2019 NEJM Controlled trial quality: predicted high

8. Risks and Benefits of Dolutegravir- and Efavirenz-Based Strategies for South African Women With HIV of Child-Bearing Potential: A Modeling Study. Full Text available with Trip Pro

Risks and Benefits of Dolutegravir- and Efavirenz-Based Strategies for South African Women With HIV of Child-Bearing Potential: A Modeling Study. Dolutegravir is superior to efavirenz for HIV antiretroviral therapy (ART) but may be associated with an increased risk for neural tube defects (NTDs) in newborns if used by women at conception.To project clinical outcomes of ART policies for women of child-bearing potential in South Africa.Model of 3 strategies: efavirenz for all women of child (...) -bearing potential (EFV), dolutegravir for all women of child-bearing potential (DTG), or World Health Organization (WHO)-recommended efavirenz without contraception or dolutegravir with contraception (WHO approach).Published data on NTD risks (efavirenz, 0.05%; dolutegravir, 0.67% [Tsepamo study]), 48-week ART efficacy with initiation (efavirenz, 60% to 91%; dolutegravir, 96%), and age-stratified fertility rates (2 to 139 per 1000 women).3.1 million South African women with HIV (aged 15 to 49 years

2019 Annals of Internal Medicine

9. Prediction of plasma efavirenz concentrations among HIV-positive patients taking efavirenz-containing combination antiretroviral therapy Full Text available with Trip Pro

Prediction of plasma efavirenz concentrations among HIV-positive patients taking efavirenz-containing combination antiretroviral therapy We investigated the predictors of plasma mid-dose concentrations (C12) of efavirenz by enrolling 456 HIV-positive patients who had received 2 nucleos(t)ide reverse-transcriptase inhibitors plus efavirenz (600 mg daily) for 2 weeks or longer and had their CYP2B6 516G>T polymorphism and efavirenz C12 determined. The median efavirenz C12 was 2.41 mg/L (IQR, 1.93 (...) -3.14). In analysis of covariance models, patients with CYP2B6 516GT and TT genotypes compared to those with GG genotype had higher efavirenz C12 (for GT genotype, an increase by 0.976 mg/L [95%CI, 0.765-1.188], and TT genotype, 4.871 mg/L [95%CI, 4.126-5.616]), while per 10-kg increment in weight decreased C12 by 0.199 mg/L (95%CI, 0.111-0.287). Models incorporating CYP2B6 516G>T polymorphism and weight had moderate predictive values in predicting efavirenz C12 ≥ 2 mg/L (ROC area under curve

2017 Scientific reports

10. Population pharmacokinetic model linking plasma and peripheral blood mononuclear cells (PBMCs) concentrations of efavirenz and its metabolite, 8-hydroxy-efavirenz in HIV patients. Full Text available with Trip Pro

Population pharmacokinetic model linking plasma and peripheral blood mononuclear cells (PBMCs) concentrations of efavirenz and its metabolite, 8-hydroxy-efavirenz in HIV patients. The objectives of this study were to characterize the population pharmacokinetics (PK) of efavirenz (EFV) and 8-hydroxy-efavirenz (8OHEFV) in plasma and peripheral blood mononuclear cells (PBMCs) and to explore covariates affecting the PK parameters. Fifty-one patients had steady-state 0-to-24-h concentrations of EFV

2017 Antimicrobial Agents and Chemotherapy

11. Role of efavirenz plasma concentrations on long-term HIV suppression and immune restoration in HIV-infected children. Full Text available with Trip Pro

Role of efavirenz plasma concentrations on long-term HIV suppression and immune restoration in HIV-infected children. To access the long term relationship between efavirenz plasma concentrations and evolution of HIV RNA loads and CD4 cell counts in children.Retrospective analysis of data from HIV-infected children on first line efavirenz-containing regimen. A population pharmacokinetic-pharmacodynamic (PK-PD) model was developed to describe the evolution of HIV RNA load and CD4 cell count (...) (efficacy outcomes) in relation to efavirenz plasma concentration. Individual CYP2B6 516 G>T genotype data were not available for this analysis. A score (ISEFV) quantifying the effect of efavirenz concentrations on the long-term HIV replication was calculated from efavirenz concentrations and PD parameters and, a value of ISEFV below which HIV replication is likely not suppressed was determined. Cox proportional hazards regression models were used to assess the association of the risk of viral

2019 PLoS ONE

12. Depression and Suicidal Ideation Among HIV-Infected Adults Receiving Efavirenz Versus Nevirapine in Uganda: A Prospective Cohort Study. Full Text available with Trip Pro

Depression and Suicidal Ideation Among HIV-Infected Adults Receiving Efavirenz Versus Nevirapine in Uganda: A Prospective Cohort Study. Evidence regarding potential adverse neuropsychiatric effects of efavirenz is conflicting, and data from sub-Saharan Africa, where 70% of persons living with HIV (PLHIV) reside and efavirenz is used as first-line therapy, are limited.To estimate associations between efavirenz use and depression and suicidal ideation among PLHIV in Uganda.Prospective (...) observational cohort study. (ClinicalTrials.gov: NCT01596322).Mbarara, Uganda.Adult PLHIV enrolled at the start of antiretroviral therapy (ART) and observed every 3 to 4 months from 2005 to 2015.The exposure of interest was time-varying efavirenz use, defined as use during the 7 days and in 60 or more of the 90 days before a study visit, compared with nevirapine use. Self-reported outcomes were depression, defined as a mean score greater than 1.75 on the Hopkins Symptom Checklist depression subscale

2018 Annals of Internal Medicine

13. Prevalence and correlates of persistent intracellular HIV transcription in individuals on efavirenz versus atazanavir-based regimens: A prospective cohort study. Full Text available with Trip Pro

Prevalence and correlates of persistent intracellular HIV transcription in individuals on efavirenz versus atazanavir-based regimens: A prospective cohort study. Despite successful virological suppression, HIV transcription frequently persists intracellularly. In this study, we hypothesize that HIV persistent transcription(HIVpt) may affect to a different extent patients on stable efavirenz(EFV) versus atazanavir(ATV)-based regimens. The role of the expression of drug efflux transporters

2018 PLoS ONE

14. Treatment with a fixed dose combination antiretroviral therapy drug containing tenofovir, emtricitabine and efavirenz is associated with cardioprotection in high calorie diet-induced obese rats. Full Text available with Trip Pro

Treatment with a fixed dose combination antiretroviral therapy drug containing tenofovir, emtricitabine and efavirenz is associated with cardioprotection in high calorie diet-induced obese rats. HIV-infection, certain antiretroviral drug classes, especially protease inhibitors (PI), and obesity are associated with increased ischaemic heart disease (IHD) risk. However, the effect of PI-free fixed dose combination (FDC) antiretroviral therapy (ART) on hearts exposed to ischaemia-reperfusion (...) injury (I/R) is unknown, particularly in obesity. This is becoming relevant as World Health Organisation guidelines recommend a FDC ART containing (non-) nucleoside reverse transcriptase inhibitors (tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) as first-line HIV treatment. Additionally, obesity rates are rising in HIV-infected populations, not only in ART-experienced individuals, but also at the time of ART initiation, which may further increase the risk of IHD. Therefore, we investigated

2018 PLoS ONE

15. Efavirenz reduces renal excretion of lamivudine in rats by inhibiting organic cation transporters (OCT, Oct) and multidrug and toxin extrusion proteins (MATE, Mate). Full Text available with Trip Pro

Efavirenz reduces renal excretion of lamivudine in rats by inhibiting organic cation transporters (OCT, Oct) and multidrug and toxin extrusion proteins (MATE, Mate). Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor used in first-line combination antiretroviral therapy (cART). It is usually administered with nucleoside reverse transcriptase inhibitors (NRTI), many of which are substrates of OCT uptake solute carriers (SLC22A) and MATE (SLC47A), P-gp (MDR1, ABCB1), BCRP (ABCG2 (...) ), or MRP2 (ABCC2) efflux transporters. The aim of this study was to evaluate the inhibitory potential of efavirenz towards these transporters and investigate its effects on the pharmacokinetics and tissue distribution of a known Oct/Mate substrate, lamivudine, in rats. Accumulation and transport assays showed that efavirenz inhibits the uptake of metformin by OCT1-, OCT2- and MATE1-expressing MDCK cells and reduces transcellular transport of lamivudine across OCT1/OCT2- and MATE1-expressing MDCK

2018 PLoS ONE

16. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial. Full Text available with Trip Pro

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial. Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks. Planned follow-up was extended to 144 weeks, maintaining (...) original randomisation.BREATHER was an open-label, non-inferiority trial. Participants aged 8-24yrs with virological suppression on efavirenz-based first-line ART were randomised 1:1, stratified by age and African/non-African sites, to remain on CT or change to SCT. The Kaplan-Meier method was used to estimate the proportion of participants with viral rebound (confirmed VL≥50 copies/mL) under intent-to-treat at 48 weeks (primary outcome), and in extended follow-up at 96, 144, and 192 weeks. SCT

2018 PLoS ONE Controlled trial quality: predicted high

17. Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial. Full Text available with Trip Pro

Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial. A randomized controlled noninferiority trial was conducted in HIV-infected patients receiving tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) with virological suppression in a resource-limited setting. Switching to TDF/FTC/rilpivirine was noninferior to continuing TDF/FTC/EFV in terms of maintaining

2019 Open forum infectious diseases Controlled trial quality: uncertain

18. Efficacy and safety of artemether-lumefantrine as treatment for Plasmodium falciparum uncomplicated malaria in adult patients on efavirenz-based antiretroviral therapy in Zambia: an open label non-randomized interventional trial. Full Text available with Trip Pro

Efficacy and safety of artemether-lumefantrine as treatment for Plasmodium falciparum uncomplicated malaria in adult patients on efavirenz-based antiretroviral therapy in Zambia: an open label non-randomized interventional trial. HIV-infected individuals on antiretroviral therapy (ART) require treatment with artemisinin-based combination therapy (ACT) when infected with malaria. Artemether-lumefantrine (AL) is the most commonly used ACT for treatment of falciparum malaria in Africa (...) but there is limited evidence on the safety and efficacy of AL in HIV-infected individuals on ART, among whom drug-drug interactions are expected. Day-42 adequate clinical and parasitological response (ACPR) and incidence of adverse events was assessed in HIV-infected individuals on efavirenz-based ART with uncomplicated falciparum malaria treated with AL.A prospective, open label, non-randomized, interventional clinical trial was conducted at St Paul's Hospital in northern Zambia, involving 152 patients aged 15

2019 Malaria journal

19. Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya. (Abstract)

Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya. Our objective was to evaluate if increasing body mass index (BMI) or weight influences the association between efavirenz-based antiretroviral therapy (ART) and implant effectiveness.We conducted a secondary cohort analysis of HIV-positive women aged 15 to 45years enrolled in HIV care in western Kenya (...) ).In this analysis, 12,960 women contributed a total of 11,285 woman-years (w-y) of observation time while using an implant, with a median of 6.6months. The aIRRs comparing efavirenz- to nevirapine-based ART groups did not increase as BMI increased; the aIRRs were 2.0 (1.1-3.6) for underweight, 1.9 (1.5-2.5) for normal, 3.1 (1.6-6.0) for overweight, and 2.1 (0.6-6.9) for obese women. The aIRRs comparing efavirenz- to nevirapine-based ART groups did not increase as weight increased; the aIRRs were 2.0 (1.6-2.6

2019 Contraception

20. Population pharmacokinetics of efavirenz in HIV and TB/HIV coinfected children: the significance of genotype-guided dosing. Full Text available with Trip Pro

Population pharmacokinetics of efavirenz in HIV and TB/HIV coinfected children: the significance of genotype-guided dosing. The current WHO weight-based dosing recommendations for efavirenz result in a wide variability of drug exposure in children. Our objectives are to characterize the effects of rifampicin- and isoniazid-containing anti-TB therapy and CYP2B6 activity on efavirenz concentrations in children, using non-linear mixed-effects modelling.This is a pharmacokinetic (PK) substudy (...) of a prospective study that examined the interactions between anti-TB therapy and efavirenz in HIV-infected children with and without TB. PK samples were obtained 4 weeks after starting efavirenz (PK1) and repeated 4 weeks after completing TB therapy (PK2) in TB/HIV coinfected patients. Drug concentrations were measured using LC-MS/MS. Composite CYP2B6 516/983/15582 genotype was determined. Population PK modelling was performed in Monolix. Simulations were performed to obtain the predicted mid-dose

2019 Journal of Antimicrobial Chemotherapy

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