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General Reports
     

 

 

 

 

FULL-TEXT ARTICLE
Model Linking Plasma and Intracellular Tenofovir/Emtricitabine with Deoxynucleoside Triphosphates.
Chen X, Seifert SM, Castillo-Mancilla JR
PLoS One. 2016 Nov 10;11(11):e0165505
Paper
.

Daily Oral Tenofovir and Emtricitabine-Tenofovir Preexposure Prophylaxis Reduces Herpes Simplex Virus Type 2 Acquisition Among Heterosexual HIV-1-Uninfected Men and Women: A Subgroup Analysis of a Randomized Trial.
Celum C, Morrow RA, Donnell D,  et al
Ann Intern Med. 2014 Jul 1;161(1):11-19.

Abstract


HIV Indications
     

 
Tenofovir disoproxil fumarate/emtricitabine fits for all as appropriate HIV-1 preexposure prophylaxis?
Taramasso L, Riccardi N, Del Puente F, et al

AIDS Res Hum Retroviruse
s
. 2017 Nov 22
Abstract

Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men.
Carballo-Diéguez A, Giguere R, .et al 

AIDS Behav
. 2017 Nov 8.
Abstract

The role of menopause in tenofovir diphosphate and emtricitabine triphosphate concentrations in cervical tissue.
Nicol MR, Brewers LM, Kashuba AD, Sykes C.
AIDS. 2017 Nov 2.
Abstract

Plasma Tenofovir-levels to Support Adherence to TDF/FTC Pre-exposure Prophylaxis for HIV Prevention in MSM in Los Angeles, California
Landovitz RJ, Beymer M, Kofron R, et al
J Acquir Immune Defic Syndr. 2017 Sep 7
Abstract

Urine tenofovir and emtricitabine concentrations provide biomarker for exposure to HIV preexposure prophylaxis.
Haaland RE, Martin A, Holder A, et al
AIDS. 2017 Jul 17;31(11):1647-1650.
Abstract

InterPrEP: internet-based pre-exposure prophylaxis with generic tenofovir disoproxil fumarate/emtrictabine in London - analysis of pharmacokinetics, safety and outcomes.
Wang X, Nwokolo N, Korologou-Linden R, et al
HIV Med. 2017 Jun 28.

Abstract

HIV preexposure prophylaxis for adolescents and young adults.
Allen E, Gordon A, Krakower D, Hsu K.
Curr Opin Pediatr. 2017 Jun 8
Abstract

Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis.
Koenig HC, Mounzer K, Daughtridge GW, et al 

HIV Med
. 2017 Apr 26.
Abstract

Bone density, microarchitecture and tissue quality following long-term treatment with tenofovir/emtricitabine or abacavir/lamivudine.
Güerri-Fernández R, Molina-Morant D, et al 

J Acquir Immune Defic Syndr
. 2017 Apr 7.
Abstract

FULL-TEXT ARTICLE
p16<INK4a , a Senescence Marker, Influences Tenofovir/Emtricitabine Metabolite Disposition in HIV-Infected Subjects.
Dumond JB, Collins JW, Cottrell ML,
CPT Pharmacometrics Syst Pharmacol
. 2016 Dec 26.

Paper

Pre-existent NRTI and NNRTI resistance impacts on maintenance of virological suppression in HIV-1-infected patients who switch to a tenofovir/emtricitabine/rilpivirine single-tablet regimen.
Armenia D, Di Carlo D, Calcagno A, et al
J Antimicrob Chemother
. 2016 Dec 20
Abstract

Drug interactions between voriconazole, darunavir/ritonavir and tenofovir/emtricitabine in an HIV-infected patient treated for Aspergillus candidus lung abscess.
Becker A, Sifaoui F, Gagneux M, et al
Int J STD AI
DS. 2014 Sep 1.
Abstract

Fixed dose combination emtricitabine/tenofovir/efavirenz initiated during Acute HIV Infection; 96-week efficacy and durability.
Gay CL, Willis SJ, Cope AB, et al

AIDS
. 2016 Sep 20
Abstract

Intracellular Tenofovir and Emtricitabine anabolites in Genital, Rectal, and Blood Compartments from first dose to steady-state.
Seifert S, Chen X, Meditz A, et al
AIDS Res Hum Retroviruses
. 2016 Aug 15
Abstract

Exploratory Analysis for the Evaluation of Estimated Glomerular Filtration Rate, Cholesterol and Triglycerides after Switching from Tenofovir/Emtricitabine plus Atazanavir/Ritonavir (ATV/r) to Abacavir/Lamivudine plus ATV/r in Patients with Preserved Renal Function.
Postorino MC, Quiros-Roldan E, Maggiolo F, et al

Open AIDS J
. 2016 Jul 15;10:136-43.

Abstract

Drug safety evaluation of oral tenofovir disoproxil fumarate-emtricitabine for pre-exposure prophylaxis for human immunodeficiency virus infection.
Trang TP, Dong BJ, Kojima N, Klausner JD.

Expert Opin Drug Saf
. 2016 Jul 8.
Abstract

FULL-TEXT ARTICLE
Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project PRELUDE
Vaccher S, Grulich A, McAllister J, et al
BMJ Open. 2016 Jun 20;6(6):e012179.
Paper

The Safety of Tenofovir-Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B
[No authors listed]
 
J Acquir Immune Defic Syndr
. 2016 Jul 1;72(3):e82
Abstract

FULL-TEXT ARTICLE
An Indirect Comparison of Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate and Abacavir/Lamivudine + Dolutegravir in Initial Therapy.
M Llibre J, Raffi F, Moyle G, et al
PLoS One. 2016 May 19;11(5):e0155406.
Paper

Risks and benefits of HIV pre exposure prophylaxis with tenofovir/emtricitabine in an older man with co-morbidities.
Girometti N, Jones R, Levy J, et al   
AIDS
. 2016 May 21
Abstract

Comparative risk of failure of ABC/3TC or TDF/FTC based first-line regimens in patients with a high viral load.
Flandre P, Pugliese P, Allavena C,  et al
HIV Med. 2016 May;17(5):380-4.
Abstract

Low risk of Proximal Tubular Dysfunction Associated with Emtricitabine-Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis in Men and Women.
Mugwanya K, Baeten J, Celum C,  et al
J Infect Di
2016 Mar 29
Abstract

Reversibility of Glomerular Renal Function Decline in HIV-Uninfected Men and Women Discontinuing Emtricitabine-Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis.
Mugwanya KK, Wyatt C, Celum C, et al
J Acquir Immune Defic Syndr. 2016 Apr 1;71(4):374-380.
Abstract

Preexposure tenofovir-emtricitabine reduced HIV infection in men who have unprotected anal sex with men.
Sacks HS.
Ann Intern Med
. 2016 Jan 19;164(2):JC3.
Abstract

Tenofovir/emtricitabine metabolites and endogenous nucleotide exposures are associated with p16INK4a expression in subjects on combination therapy.
Dumond JB, Francis O, Cottrell M, et al
Antivir Ther
. 2016 Jan 5.
A
bstract

Switching from a two-tablet regimen of tenofovir/emtricitabine and efavirenz to a one-tablet regimen may affect patients' perceptions and drug management.
Rotzinger A, Locatelli I, Bugnon O, et al
HIV Med
. 2015 Dec 21.
Abstract

Cost-effectiveness analysis of tenofovir/emtricitabine and abacavir/lamivudine in combination with efavirenz or atazanavir/ritonavir for treatment-naïve adults with HIV-1 infection in the UK, based on the AIDS Clinical Trials Group 5202 clinical trial.
Wilkins E, Fisher M, Brogan AJ, et al
HIV Med. 2015 Dec 9.
Abstract

The Incidence and Clinical Characteristics of Acute Serum Creatinine Elevation more than 1.5 mg/dL among the Patients Treated with Tenofovir/Emtricitabine-containing HAART Regimens.
Jin S, Kim MH, Park JH,  et al
Infect Chemother. 2015 Dec;47(4):239-46
Abstract

Changes in Serum Markers of Inflammation and Endothelial Activation in HIV-Infected Antiretroviral Naive Patients Starting A Treatment with Abacavir-Lamivudine or Tenofovir-Emtricitabine Plus Efavirenz.
Calza L, Magistrelli E, Danese I, et al  
Curr HIV Res
. 2016;14(1):61-70.
Abstract

Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine after Directly Observed Dosing in Healthy Volunteers to establish Adherence Benchmarks (HPTN 066).
Hendrix CW, Andrade A, Bumpus NN, et al
AIDS Res Hum Retroviruses
. 2015 Sep 28.
Abstract

How Stigma Surrounding the Use of HIV Preexposure Prophylaxis Undermines Prevention and Pleasure: A Call to Destigmatize "Truvada Whores".
Calabrese SK, Underhill K.
Am J Public Health
. 2015 Aug 13:
Abstract

Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir.
Brown TT, Moser C, Currier JS,  et al
J Infect Dis
. 2015 May 5
Abstract

Immune Reconstitution but Persistent Activation After 48 Weeks of Antiretroviral Therapy in Youth With Pre-Therapy CD4 >350 in ATN 061.
Rudy BJ, Kapogiannis BG, Worrell C,  et al

J Acquir Immune Defic Syndr
. 2015 May 1;69(1):52-60.
Abstract

Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial: DXA Results from iPrEx.
Mulligan K, Glidden DV, Anderson PL, et al
Clin Infect Dis
. 2015 Apr 23.
Abstract

The lipid-lowering effect of tenofovir/emtricitabine: a randomized, cross-over, double-blind, placebo-controlled trial.
Santos JR, Saumoy M, Curran A, et al

Clin Infect Dis
. 2015 Apr 13.
Abstract

The Science of Being a Study Participant: FEM-PrEP Participants' Explanations for Overreporting Adherence to the Study Pills and for the Whereabouts of Unused Pills.
Corneli AL, McKenna K, Perry B, et al.

J Acquir Immune Defic Syndr
. 2015 Apr 15;68(5):578-584.
Abstract

Renal safety of coformulated tenofovir/emtricitabine vs other nucleoside analogues in combination therapy in antiretroviral-naive patients aged 50 years or older in Spain: The TRIP study.
Pedrol E, Caro-Murillo AM, et al
HIV Clin Trials. 2015 Jan-Feb;16(1):43-8. 

Abstract

Changes in Glomerular Kidney Function Among HIV-1-Uninfected Men and Women Receiving Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis: A Randomized Clinical Trial.
Mugwanya KK, Wyatt C, Celum C,  at al
JAMA Intern Med. 2014 Dec 22
Abstract

Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention.
Clark MR, Peet MM, Davis S,
et al
Pharmaceutics
. 2014 Dec 8;6(4):616-631.
Abstract

Dose-response for Starting and Stopping HIV Pre-Exposure Prophylaxis (PrEP) for MSM.
Seifert SM, Glidden DV, Meditz AL,  et al

Clin Infect Dis
. 2014 Nov 18.
Abstract

Lower prevalence of drug resistance mutations at first-line virological failure to first-line therapy with atripla vs. tenofovir + emtricitabine/lamivudine + efavirenz administered on a multiple tablet therapy.
Blanco JL, Montaner JS, Marconi VC, et al
AIDS. 2014 Nov 13;28(17):2531-9.
Abstract

Single-agent tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis for HIV-1 acquisition: an update of data from a randomised, double-blind, phase 3 trial.
Baeten JM, Donnell D, Mugo NR, et al

Lancet Infect Dis
. 2014 Oct 8
Abstract 

Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine.
Wyatt CM, Kitch D, Gupta SK, et al
J Acquir Immune Defic Syndr
. 2014 Sep 1;67(1):36-44
Abstract 

The Combined Anti-HIV-1 Activity of Emtricitabine and Tenofovir with the Integrase Inhibitors Elvitegravir or Raltegravir Show High Levels of Synergy In Vitro.
Kulkarni R, Hluhanich R, McColl DM,  et al

Antimicrob Agents Chemother
. 2014 Aug 4.
Abstract 

Daily Oral Tenofovir and Emtricitabine-Tenofovir Preexposure Prophylaxis Reduces Herpes Simplex Virus Type 2 Acquisition Among Heterosexual HIV-1-Uninfected Men and Women: A Subgroup Analysis of a Randomized Trial.
Celum C, Morrow RA, Donnell D,  et al

Ann Intern Med
. 2014 Jul 1;161(1):11-19.
Abstract 

A 48-week study of fat molecular alterations in HIV naïve patients starting tenofovir/emtricitabine with lopinavir/ritonavir or efavirenz.
Domingo P, Gutierrez MD, Gallego-Escuredo JM,  et al
J Acquir Immune Defic Syndr. 2014 May 12
Abstract 

HIV-1 Drug Resistance in the iPrEx Pre-Exposure Prophylaxis Trial.
Liegler T, Abdel-Mohsen M, Bentley LG,  et al
J Infect Dis. 2014 Apr 16. 
Abstract 

Changes in biomarkers in HIV-1-infected treatment-naive patients treated with tenofovir DF/emtricitabine plus atazanavir/ritonavir or lopinavir/ritonavir for 96 weeks: The CASTLE biomarker substudy.
Moyle G, Hardy H, Uy J, et al
Antivir Ther. 2014 Apr 16.
Abstract
 

Delayed onset renal failure in a patient on tenofovir based antiretroviral regimen.
Krishna MM, Subbalaxmi MV, Uppin M, Radhika S.
Indian J Pharmacol
. 2014 Mar;46(2):230
Abstract 

-FULL-TEXT ARTICLE
Bone Mineral Density Changes among HIV-Uninfected Young Adults in a Randomised Trial of Pre-Exposure Prophylaxis with Tenofovir-Emtricitabine or Placebo in Botswana.
Kasonde M, Niska RW, Rose C,  et al
PLoS One
. 2014 Mar 13;9(3):e90111.
Paper

Tenofovir, Emtricitabine, and Darunavir/Ritonavir Pharmacokinetics in an HIV-Infected Patient After Roux-en-Y Gastric Bypass Surgery
Macbrayne CE, Blum JD, Kiser JJ.
Ann Pharmacother
.
2014 Mar 10.
Abstract 

Tenofovir/Emtricitabine/Efavirenz Plus Rosuvastatin Decrease Serum Levels of Inflammatory Markers More Than Antiretroviral Drugs Alone
in Antiretroviral Therapy-Naive HIV-Infected Patients.
Calza L, Vanino E, Salvadori C,  et al
HIV Clin Trials
. 2014 Jan-Feb;15(1):1-13.
Abstract 

Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis.
Solomon MM, Lama JR, Glidden DV,  et al
AIDS. 2014 Feb 4.
Abstract

FULL-TEXT ARTICLE
No Evidence of Sexual Risk Compensation in the iPrEx Trial of Daily Oral HIV Preexposure Prophylaxis.
Marcus JL, Glidden DV, Mayer KH,  et al

PLoS One
. 2013 Dec 18;8(12):e81997.
Paper

FULL TEXT ARTICLE
Neurological syndrome in an HIV-prevention trial participant randomized to daily tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) in Bondo, Kenya
Owino F, Mandala J, Ambia J, et al
Int Med Case Rep J
. 2013 Nov 29;6:91-
Paper

Safety, Efficacy, and Persistence of Emtricitabine/Tenofovir Versus Other Nucleoside Analogues in Naive Subjects Aged 50 Years or Older in Spain: The TRIP Study.
Blanco JR, Caro-Murillo AM, Castaño MA,  et al
HIV Clin Trials
. 2013 Sep-Oct;14(5):204-15.
Abstract

Efficacy and tolerability of antiretroviral therapy containing tenofovir disoproxil fumarate-emtricitabine-efavirenz in treatment-naive patients infected with HIV-1 in Bobo Dioulasso (Burkina Faso, 2009-2011).
Zoungrana J, Hema A, Bado G,  et al  
Bull Soc Pathol Exot
. 2013 Oct 16.
Abstract

Pre-exposure prophylaxis for the prevention of sexual HIV transmission; new preventative strategy using tenofovir/emtricitabine.
Boot J, Rump BO, Boucher CA, et al

Ned Tijdschr Geneeskd
. 2013;157(27):A6063
Abstract

Neutrophil gelatinase-associated lipocalin, a marker of tubular dysfunction, is not increased in long-term virologically controlled patients receiving a tenofovir/emtricitabine + nevirapine regimen.
Allavena C, Bach-Ngohou K, Billaud E,  et al
J Antimicrob Chemother. 2013 Jun 30
Abstract

Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts.
Ouattara E, Danel C, Moh R, Gabillard D,  et al
J Int AIDS Soc
. 2013 Apr 30;16:
Abstract

Once-daily darunavir/ritonavir and abacavir/lamivudine versus tenofovir/emtricitabine for treatment-naïve patients with a baseline viral load of more than 100 000 copies/ml.
Nishijima T, Komatsu H, Teruya K,  et al
AIDS
. 2013 Mar 13;27(5):839-42
Abstract

Emtricitabine/Tenofovir Disoproxil Fumarate: A Review of its Use in HIV-1 Pre-Exposure Prophylaxis.
Plosker GL.
Drugs. 2013 Feb 27
Abstract

Pharmacokinetics of two common antiretroviral regimens in older HIV-infected patients: a pilot study.
Dumond J, Adams J, Prince H,  et al
HIV Med
. 2013 Feb 24
Abstract

SWIFT: Prospective 48 Week Study to Evaluate Efficacy and Safety of Switching to Emtricitibine/Tenofovir from Lamivudine/Abacavir in Virologically Suppressed HIV-1 Infected Patients on a Boosted Protease Inhibitor Containing Antiretroviral Regimen.
Campo R, Dejesus E, Bredeek UF,  et al 
Clin Infect Dis. 2013 Jan 29.
Abstract

Tenofovir, emtricitabine intracellular and plasma, and efavirenz plasma concentration decay following drug intake cessation: implications for HIV treatment and prevention.
Jackson A, Moyle G, Watson V,  et al
J Acquir Immune Defic Syndr
. 2012 Dec 28
Abstract

FULL TEXT ARTICLE

Prevention of Vaginal SHIV Transmission in Macaques by a Coitally-Dependent Truvada Regimen.
Radzio J, Aung W, Holder A, et al
PLoS One. 2012;7(12):e50632.
Paper

Indirect treatment comparison of efficacy, safety and resistance of EVG/COBI/FTC/TDF (Quad) vs. RAL+FTC/TDF in treatment-naïve HIV patients.
Dejesus E, Felix J, Vandewalle B, et al
J Int AIDS Soc. 2012 Nov 11;15(6):18239.
Abstract

Impact of emtricitabine/tenofovir (FTC/TDF) on renal function in antiretroviral-naïve patients≥50 years - TRIP study.
Blanco J, Castaño M, Olalla J,  et al
J Int AIDS Soc. 2012 Nov 11;15(6):18312.

Abstract

STRike - characteristics of HIV-1-infected patients treated with a single-tablet regimen in daily clinical practice.
Esser S, Heiken H, Gallo L,  et al
J Int AIDS Soc. 2012 Nov 11;15(6):18356
Abstract

Effectiveness and safety of a single-tablet regimen of emtricitabine/efavirenz/tenofovir in HIV-1-infected patients in infectious diseases department.
Xerinda S, Neves N, Santos S,
J Int AIDS Soc. 2012 Nov 11;15(6):18383.
Abstract

A randomized pilot study of tenofovir/emtricitabine (TDF/FTC) + boosted atazanavir (ATV/r) vs. raltegravir (RAL BID) + ATV/r
vs. RAL BID + ATV BID.
Cohen C, Green J, Olivet H, et al
J
 Int AIDS Soc
. 2012 Nov 11;15(6):18279.
Abstract

Changes in Fat Mitochondrial DNA and Function in Subjects Randomized to Abacavir/Lamivudine or Tenofovir DF/Emtricitabine with Atazanavir/Ritonavir or Efavirenz: AIDS Clinical Trials Group Study A5224s, substudy of A5202.
McComsey GA, Daar ES, O'Riordan , et al
J Infect Dis. 2012 Nov 29.
Abstract

Tenofovir Diphosphate and Emtricitabine Triphosphate Concentrations in Blood Cells Compared with Isolated
Peripheral Blood Mononuclear Cells: A New Measure of Antiretroviral Adherence?
Adams JL, Sykes C, Menezes P, et al
J Acquir Immune Defic Syndr
. 2012 Oct 29.
Abstract

Incidence of renal toxicity in HIV-infected, antiretroviral-naïve patients starting tenofovir/emtricitabine associated
with efavirenz, atazanavir/ritonavir, or lopinavir/ritonavir.
Calza L, Trapani F, Salvadori C, et al
Scand J Infect Dis
. 2012 Sep 19.
Abstract

Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men.
Anderson PL, Glidden DV, Liu A et al.
Sci Transl Med. 2012 Sep 12;4(151):
Abstract

Oral antiretroviral chemoprophylaxis: current status.
Baeten J, Celum C.
Curr Opin HIV AIDS. 2012 Sep 7
Abstract

Emtricitabine/tenofovir in the treatment of HIV infection: current PK/PD evaluation.
Uglietti A, Zanaboni D, Gnarini M, Maserati R.
Expert Opin Drug Metab Toxicol. 2012 Sep
Abstract

Tenofovir, emtricitabine, and tenofovir-diphosphate in dried blood spots for determining recent and cumulative drug exposure.
Castillo-Mancilla J, Zheng JH, Rower JE,  et al
AIDS Res Hum Retroviruses
. 2012 Aug 31.
Abstract

Duration of first-line antiretroviral therapy with tenofovir and emtricitabine combined with atazanavir/ritonavir, efavirenz
or lopinavir/ritonavir in the Italian ARCA cohort.

Di Biagio A, Prinapori R, Giannarelli D,  et al
J Antimicrob Chemother
. 2012 Aug 21
Abstract

Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles.
Behrens G, Maserati R, Rieger A
Antivir Ther
. 2012 Aug 15
Abstract

Double Oral Administration of Emtricitabine/Tenofovir Prior to Virus Exposure Protects against Highly Pathogenic
Simian/Human Immunodeficiency Virus Infection in Macaques.
Nakasone T, Murakami T, Yamamoto N.
Jpn J Infect Dis
. 2012 Jul;65(4):345-9.
Abstract

A randomized comparison of second-line lopinavir/ritonavir monotherapy vs. tenofovir/lamivudine/lopinavir/ritonavir i
n patients failing NNRTI-regimens: the HIV STAR study.
Bunupuradah T, Chetchotisakd P, Ananworanich J, et al
Antivir Ther. 2012 Jul 2.
Abstract

FULL-TEXT DOCUMENT
FDA Approves Truvada for reducing the risk of sexually acquired HIV infection

USFDA
July 16,2012
Internet Document

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women.
Baeten JM, Donnell D, Ndase P, Mugo NR,  et al
N Engl J Med
. 2012 Jul 11. .
Abstract

FULL-TEXT ARTICLE
Changes in Bone Turnover and Bone Loss in HIV-Infected Patients Changing Treatment to Tenofovir-Emtricitabine or
Abacavir-Lamivudine.

Haskelberg H, Hoy JF, Amin J, et al
PLoS One
. 2012;7(6):e38377
Paper

WITHDRAWN: Effectiveness and safety of first-line tenofovir + emtricitabine + efavirenz for patients with HIV.
Omeje I, Okwundu CI.
Cochrane Database Syst Rev
. 2012 May 16;5:CD007276.
Abstract

The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes
in a prospective observational study.
The HIV-CAUSAL Collaboration.
AIDS
. 2012 Apr 26.
Abstract

Changes in body composition and mitochondrial DNA in HIV-1-infected patients switching
to fixed-dose abacavir/lamivudine or tenofovir/emtricitabine: a substudy of the BICOMBO Trial.
Curran A, Martinez E, Podzamczer D, et al
Antivir Ther
. 2012 Feb 28. 
Abstract

FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection
Gilead Sciences Press Release
Feb. 13, 2012

News Release

Effectiveness and safety of first-line tenofovir + emtricitabine + efavirenz for patients with HIV.
Omeje I, Okwundu CI.
Cochrane Database Syst Rev
. 2012 Feb 15;2:CD007276.
Abstract
 
FULL TEXT PDF ARTICLE
Prospective evaluation of bone markers, parathormone and 1,25-(OH)2 vitamin D in HIV-positive patients
after the initiation of tenofovir/emtricitabine with atazanavir/ritonavir or efavirenz.

Foca E, Motta D, Borderi M, et al
BMC Infect Dis
.
2012 Feb 14;12(1):38
Paper

Penetration of Tenofovir and Emtricitabine in Mucosal Tissues: Implications for Prevention of HIV-1 Transmission.
Patterson KB, Prince HA, Kraft E, et al
Sci Transl Med. 2011 Dec 7;3(112):112re4
Abstract

FULL-TEXT ARTICLE
Predictors of Limb Fat Gain in HIV Positive Patients Following a Change to Tenofovir-Emtricitabine or
Abacavir-Lamivudine.
Martin A, Amin J, Emery S,  et al
PLoS One. 2011;6(10):e26885
Paper

A randomized, pilot trial to evaluate glomerular filtration rate by creatinine or cystatin C in naïve
HIV-infected patients after tenofovir/emtricitabine in combination with atazanavir/ritonavir or efavirenz.
Albini L, Cesana BM, Motta D, et al
J Acquir Immune Defic Syndr
. 2011 Oct 11
Abstract

Once-daily antiretroviral therapy among treatment-experienced Muslim patients fasting for the month of Ramadan.
Yakasai AM, Muhammad H, Babashani M, et al
Trop Doct
. 2011 Sep 13
Abstract

Abacavir/Lamivudine Versus Tenofovir DF/Emtricitabine as Part of Combination Regimens for Initial Treatment of HIV:
Final Results.

Sax PE, Tierney C, Collier AC,  et al
J Infect Dis
. 2011 Oct;204(8):1191-1201.

Abstract

Comparison of Abacavir/Lamivudine and Tenofovir/Emtricitabine Among Treatment-Naive
HIV-Infected Patients Initiating Therapy.

Tan DH, Chan K, Raboud J,  et al
J Acquir Immune Defic Syndr
. 2011 Sep 1;58(1):38-46.
Abstract

Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus
tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week
results from the ASSERT study.
Post FA, Moyle GJ, Stellbrink HJ, et al
J Acquir Immune Defic Syndr. 2010 Sep;55(1):49-57.
Abstract

Prevalence of low-level HIV-1 variants with reverse transcriptase mutation K65R and the effect of antiretroviral
drug exposure on variant levels.
Kozal MJ, Chiarella J, St John EP,  et al
Antivir Ther
. 2011;16(6):925-9.

Abstract

Comparison of abacavir/lamivudine and tenofovir/emtricitabine among treatment-naïve
HIV-infected patients initiating therapy.
Tan DH, Chan K, Raboud J, Cooper C, et al
J Acquir Immune Defic Syndr
. 2011 Jun 24.
Abstract

Peripheral and Central Fat Changes in Subjects Randomized to Abacavir-Lamivudine or Tenofovir-Emtricitabine
With Atazanavir-Ritonavir or Efavirenz: ACTG Study A5224s.
McComsey GA, Kitch D, Sax PE, et al
Clin Infect Dis
. 2011 Jul;53(2):185-96.
Abstract

Protection against Rectal Transmission of an Emtricitabine (FTC)-Resistant SHIV162p3M184V
Mutant by Intermittent Prophylaxis with Truvada.
Cong ME, Youngpairoj AS, Zheng Q,  et al
J Virol
. 2011 Jun 1.
Abstract

Bone Mineral Density and Fractures in Antiretroviral-Naive Persons Randomized to Receive
Abacavir-Lamivudine or Tenofovir Disoproxil Fumarate-Emtricitabine Along With Efavirenz or
Atazanavir-Ritonavir: AIDS Clinical Trials Group A5224s, a Substudy of ACTG A5202.
McComsey GA, Kitch D, Daar ES,  et al
J Infect Dis
. 2011 Jun;203(12):1791-801.
Abstract

Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised
study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz.
Cooper V, Moyle GJ, Fisher M,  et al
AIDS Care. 2011 Apr 5:1-9.
Abstract

Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection.
Anderson PL, Kiser JJ, Gardner EM, et al
J Antimicrob Chemother
. 2010 Nov 30.
Abstract

Concomitant Administration of BILR 355/r with Emtricitabine/Tenofovir Disoproxil Fumarate
Increases Exposure to Emtricitabine and Tenofovir: A Randomized, Open-Label, Prospective Study.
Huang F, Scholl P, Huang DB,  et al
Basic Clin Pharmacol Toxicol
. 2010 Oct 27.
Abstract

Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and
lopinavir/ritonavir tablet formulation.
Tosini W, Muller P, Prazuck T,  et al 
AIDS
. 2010 Aug 19
Abstract

Pharmacokinetics and Bioavailability of an Integrase and Novel Pharmacoenhancer-
Containing Single-Tablet Fixed-Dose Combination Regimen for the Treatment of HIV.
German P, Warren D, West S, Hui J, Kearney BP.
J Acquir Immune Defic Syndr
. 2010 Jul 30.
Abstract

Randomized Comparison of Renal Effects, Efficacy, and Safety With Once-Daily
Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz,
in Antiretroviral-Naive, HIV-1-Infected Adults: 48-Week Results From the ASSERT
Study.
Post FA, Moyle GJ, Stellbrink HJ,  et al  
J Acquir Immune Defic Syndr
. 2010 Apr 24
Abstract

Impact of Low Abundance HIV Variants on Response to Ritonavir-Boosted
Atazanavir or Fosamprenavir Given Once Daily with Tenofovir/Emtricitabine
in Antiretroviral-Naive HIV-Infected Patients.
Ross LL, Weinberg WG, Dejesus E, et al  
AIDS Res Hum Retroviruses
. 2010 Apr 9
Abstract

Does choice of combination antiretroviral therapy (cART) alter changes in
cerebral function testing after 48 weeks in treatment-naive, HIV-1-infected
individuals commencing cART? A randomized, controlled study.
Winston A, Duncombe C, Li PC,  et al
Clin Infect Dis
. 2010 Mar 15;50(6):920-9.
Abstract

Safety and efficacy of tenofovir/emtricitabine plus nevirapine in HIV-infected patients.
Labarga P, Medrano J, Seclen E, et al
AIDS
. 2010 Feb 15.
Abstract

Emerging mutations at virological failure of HAART combinations containing
tenofovir and lamivudine or emtricitabine.
Maserati R, De Silvestri A, Uglietti A,  et al

AIDS
. 2010 Jan 30.
Abstract

Switching the nucleoside reverse transcriptase inhibitor backbone to
reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate +
emtricitabine promptly improves triglycerides and low-density lipoprotein
cholesterol in dyslipidaemic patients.
Valantin MA, Bittar R, de Truchis P, et al
J Antimicrob Chemother
. 2010 Jan 6
Abstract
 

Simplification of Antiretroviral Therapy with Tenofovir-Emtricitabine or Abacavir-Lamivudine:
A Randomized, 96-Week Trial.
Martin A, Bloch M, Amin J, et al
 
Clin Infect Dis
. 2009 Nov 15;49(10):1591-1601
Abstract

Viral Load Decay in Antiretroviral-Naïve Patients Receiving Once-Daily Tenofovir and Emtricitabine
plus Twice-Daily Nevirapine.
Amoroso A, Gilliam BL, Talwani R,
et al
HIV Clin Trials
. 2009 Sep-Oct;10(5):320-3.
Abstract

 

Lower limb high arterial flow induced by tenofovir and emtricitabine treatment.
Periard D, Yerly P, Hayoz D, et al 
Antivir Ther. 2009;14(6):865-7.
Abstract

Tenofovir-Emtricitabine-Efavirenz in HIV-1-Infected Adults in Senegal: A 96-Week Pilot Trial in
Treatment-Naive Patients.
Landman R, Poupard M, Diallo M, et al
 
J Int Assoc Physicians AIDS Care
 
2009 Sep 15.
Abstract

Complete Protection from Repeated Vaginal SHIV Exposures in Macaques by a
Topical Gel Containing Tenofovir Alone or with Emtricitabine.
Parikh UM, Dobard C, Sharma S, et al 

J Virol
. 2009 Aug 5.
Abstract

Development of HIV-1 Drug Resistance Through 144 Weeks in Antiretroviral-
Naïve Subjects on Emtricitabine, Tenofovir Disoproxil Fumarate, and Efavirenz
Compared With Lamivudine/Zidovudine and Efavirenz in Study GS-01-934.
Margot NA, Enejosa J, Cheng AK, et al

J Acquir Immune Defic Syndr
. 2009 Jul 29
Abstract

A Randomized Comparative Trial of Continued Zidovudine/Lamivudine or Replacement
With Tenofovir Disoproxil Fumarate/Emtricitabine in Efavirenz-Treated HIV-1-Infected
Individuals.
Fisher M, Moyle GJ, Shahmanesh M, et al

J Acquir Immune Defic Syndr
. 2009 Jun 25
Abstract

Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or
tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment.
Smith KY, Patel P, Fine D, et al

AIDS
. 2009 Jun 17.
Abstract

Switch from a ZDV/3TC-based Regimen to a Completely Once Daily (QD) Regimen of
Emtricitabine/Tenofovir DF Fixed Dose Combination plus a Third QD Agent (sonett).
Arasteh K, Weitner L, Fenske S, et al
Eur J Med Res. 2009 May 14;14(5):195-9.
Abstract

Emtricitabine/Tenofovir Disoproxil Fumarate: In Combination with a Protease Inhibitor in HIV-1 Infection.
Perry CM.

Drugs
. 2009;69(7):843-57.
Abstract

A Simplification Trial Switching From Nucleoside Reverse Transcriptase Inhibitors to Once-Daily
Fixed-Dose Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1-Infected Patients With Virological
Suppression.
Martínez E, Arranz JA, Podzamczer D, et al

 J Acquir Immune Defic Syndr
. 2009 Apr 24.
Abstract

Combination of Tenofovir and Emtricitabine plus Efavirenz: In Vitro Modulation of ABC transporter and
Intracellular Drug Accumulation.
Bousquet L, Pruvost A, Guyot AC, et al

Antimicrob Agents Chemother
. 2008 Dec 15
Abstract

Pharmacokinetics of emtricitabine/tenofovir disoproxil fumarate and tacrolimus at steady state
when administered alone or in combination.
Chittick GE, Zong J, Begley JA,. et al 
 Int J Clin Pharmacol Ther. 2008 Dec;46(12):627-36
Abstract
 

Two novel fixed formulations of nucleoside analogues (tenofovir-emtricitabine, and
abacavir-lamivudine). Prospective, open study on clinical practice and therapeutic
perspectives, in patients naïve and in subjects pre-treated with antiretrovirals
Manfredi R, Calza L.
Recenti Prog Med. 2008 Oct;99(10):492-501
Abstract
 
Effectiveness and safety of simplification from tenofovir-lamivudine (TDF-3TC) to tenofovir-emtricitabine (TDF-FTC)
co-formulation (Truvada) in virologically suppressed HIV-infected patients on HAART.

Palacios R, Hidalgo C, Ríos MJ, et al

Eur J Clin Microbiol Infect Dis.
2008 Oct 8.
Abstract
 
Drug-Susceptible HIV-1 Infection Despite Intermittent Fixed-Dose Combination Tenofovir/Emtricitabine as Prophylaxis Is
Associated With Low-Level Viremia, Delayed Seroconversion, and an Attenuated Clinical Course.

Prada N, Davis B, Jean-Pierre P, Roche ML, et al
 
J Acquir Immune Defic Syndr.
2008 Sep 2.
Abstract
 
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination
of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study.
Gomes NA, Vaidya VV, Pudage A, et al
J Pharm Biomed Anal. 2008 Aug
Abstract
 
Impact of Switching Virologically Suppressed, HIV-1-Infected Patients from Twice-Daily Fixed-Dose
Zidovudine/Lamivudine to Once-Daily Fixed-Dose Tenofovir Disoproxil Fumarate/Emtricitabine.
Wright D, Rodriguez A, Godofsky E,et al

HIV Clin Trials
. 2008 Mar-Apr;9(2):103-14.
Abstract
 
Cost-effectiveness analysis of emtricitabine/tenofovir versus lamivudine/zidovudine, in
combination with efavirenz, in antiretroviral-naive, HIV-1-infected patients.

Sánchez-de la Rosa R, Herrera L, Moreno S.
Clin Ther. 2008 Feb;30(2):372-81.
Abstract
 
Recent Availability of Two Novel, Fixed Formulations of Antiretroviral Nucleoside Analogues:
A 12-Month Prospective, Open-Label Survey of Their Practical Use and Therapeutic Perspectives
in Antiretroviral-Naive and -Experienced Patients.
Manfredi R, Calza L.

AIDS Patient Care
STDS. 2008 Feb 21
Abstract
 
FULL TEXT ARTICLE
Review of tenofovir-emtricitabine.
Masho SW, Wang CL, Nixon DE.
Ther Clin Risk Manag. 2007 Dec;3(6):1097-104.
Paper
 
Tenofovir DF Plus Lamivudine or Emtricitabine for Nonoccupational Postexposure
Prophylaxis (NPEP) in a Boston Community Health Center.
Mayer KH, Mimiaga MJ, Cohen D,et al
J Acquir Immune Defic Syndr. 2007 Dec 20
Abstract
 
Tenofovir Disoproxil Fumarate, Emtricitabine, and Efavirenz Compared With Zidovudine/Lamivudine
and Efavirenz in Treatment-Naive Patients: 144-Week Analysis.

Arribas JR, Pozniak AL, Gallant JE
J Acquir Immune Defic Syn
dr. 2007 Oct 25;
Abstract
 
Characterization of a novel drug-resistance pattern associated with the mutations K70G and
M184V in HIV-1 reverse transcriptase.
Bradshaw D, Malik S, Booth C, et al

Antimicrob Agents Chemother
. 2007 Sep 17;
Abstract
 
Bone disease and pathologic fractures in a patient with tenofovir-induced Fanconi syndrome.
Brim NM, Cu-Uvin S, Hu SL, O'Bell JW.

AIDS Read.
2007 Jun;17(6):322-8, C3.
Abstract
 
Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone.
Munoz de Benito RM, Arribas Lopez JR.
Expert Rev Anti Infect Ther. 2006 Aug;4(4):523-535.
Abstract
 
In Vitro HIV-1 Resistance Selections with Combinations of Tenofovir and Emtricitabine or Abacavir
and Lamivudine.
Margot NA, Waters JM, Miller MD.  
Antimicrob Agents Chemother.
2006 Sep 18;
Abstract
 
Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients.
Gazzard BG.
Expert Opin Pharmacother. 2006 Apr;7(6):793-802
Abstract
 
Two-once-daily fixed-dose NRTI combinations for HIV.
[
No authors listed]  
Med Lett Drugs Ther
. 2005 Feb 28;47(1203):19-20
Abstract
 
Emtricitabine/tenofovir disoproxil fumarate.
Dando TM, Wagstaff AJ.
Drugs. 2004;64(18):2075-82;
Abstract

HBV Indications
     

 
Tenofovir is effective as monotherapy or in combination with emtricitabine in adefovir
treated patients with chronic hepatitis B infection.
Berg T, Marcellin P, Zoulim F, et al  
Gastroenterology
. 2010 Jun 20
Abstract

Effect of switching to tenofovir with emtricitabine in patients with chronic hepatitis B failing to
respond to an adefovir-containing regimen.
Santos SA, Uriel AJ, Park JS, et al
 
Eur J Gastroenterol Hepatol.
2006 Dec;18(12):1247-53.
Abstract

HIV/HBV Coinfection
     

 
Virologic Outcome of Using Tenofovir/Emtricitabine to Treat Hepatitis B in HIV-Coinfected Patients.
Engell CA, Pham VP, Holzman RS, Aberg JA.I
SRN Gastroenterol
. 2011;2011:405390.
Abstract

Managing hepatitis B/HIV co-infected: adding entecavir to truvada (tenofovir/emtricitabine)
experienced patients.
Ratcliffe L, Beadsworth MB, Pennell A,  et al
AIDS
. 2011 Feb 22.
Abstract

Efficacy of tenofovir disoproxil fumarate/emtricitabine compared with emtricitabine alone
in antiretroviral-naive HIV-HBV coinfection in Thailand.
Avihingsanon A, Lewin SR, Kerr S,  et al
Antivir Ther
. 2010;15(6):917-22.
Abstract

Interruptions of tenofovir/emtricitabine-based antiretroviral therapy in patients with
HIV/hepatitis B virus co-infection.

Nüesch R, Ananworanich J, Srasuebkul P, et al 
AIDS. 2008 Jan 2;22(1):152-4.

Abstract


Diagnostics/Monitoring
     

 
Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots.
Zheng JH, Rower C, McAllister K,  et al J
 Pharm Biomed Anal
. 2016 Jan 21;122:16-20
Abstract

Development and validation of a LC-MS/MS assay to quantify intracellular tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP).
Watson V, Else L, Tjia J, Khoo S, Back D.
J Int AIDS Soc
. 2012 Nov 11;15(6):18336
Abstract

Selective Determination of Antiretroviral Agents Tenofovir, Emtricitabine, and Lamivudine in Human Plasma
by a LC-MS-MS Method for a Bioequivalence Study in Healthy Indian Subjects.
Yadav M, Singhal P, Goswami S, Pande UC, Sanyal M, Shrivastav PS.
J Chromatogr Sci
. 2010;48(9):704-13.
Abstract

The simultaneous assay of tenofovir and emtricitabine in plasma using LC/MS/MS and isotopically
labeled internal standards.
Delahunty T, Bushman L, Robbins B, Fletcher CV .

J Chromatogr B Analyt Technol Biomed Life Sci
. 2009 May 21

Abstract

 


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