Clinical trial NCT01815736: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Official title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
HIV Infections
Keywords: HIV
HIV 1 Infected
Virologically-Suppressed
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 1443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.


Eligibility criteria: Key Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study
* Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105
* Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA \< 50 copies/mL at the screening visit
* Normal echocardiograph (ECG)
* Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
* Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤ 5 × upper limit of the normal range (ULN)
* Direct bilirubin ≤ 1.5 x ULN
* Adequate hematologic function
* Serum amylase ≤ 5 × ULN
* Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens.
* Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
* Female participants who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range

Key Exclusion Criteria:

* A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
* Hepatitis B surface antigen position
* Hepatitis C antibody positive
* Participants experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test
* Have an implanted defibrillator or pacemaker
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
* Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
timeFrame: Baseline; Week 48
measure: Percent Change From Baseline in Spine BMD at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Serum Creatinine at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
timeFrame: Baseline; Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
timeFrame: Week 96
measure: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
timeFrame: Week 96
measure: Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in CD4 Cell Count at Weeks 96
timeFrame: Baseline; Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Southwest Center for HIV/AIDS
state: Arizona
city: Phoenix
country: United States
facility: Spectrum Medical Group
state: Arizona
city: Little Rock
country: United States
facility: Health for Life Clinic PLLC
state: Arkansas
city: Beverly Hills
country: United States
facility: AHF Research Center
state: California
city: Costa Mesa
country: United States
facility: Michael Keith Wensley, MD, Inc., A Medical Corporation
state: California
city: Long Beach
country: United States
facility: Living Hope Clinical Foundation
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Jeffrey Goodman Special Care Clinic
state: California
city: Los Angeles
country: United States
facility: Peter J Ruane, MD, Inc
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD Inc
state: California
city: Newport Beach
country: United States
facility: Orange Coast Medical Group
state: California
city: Oakland
country: United States
facility: Alameda County Medical Center
state: California
city: Oakland
country: United States
facility: East Bay AIDS Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: La Playa Medical Group and Clinical Research
state: California
city: San Francisco
country: United States
facility: Metropolis Medical Group
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center, Clinical Trials Unit
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente Hospital
state: California
city: Denver
country: United States
facility: Apex Research LLC
state: Colorado
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University HIV Clinical Trials Program
state: Connecticut
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Washington
country: United States
facility: Whitman Walker Clinic
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates, PC
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health/Comprehensive Care Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond,M.D.,P.A.
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Miami Beach
country: United States
facility: Wohlfeiler, Piperato and Associates, LLC
state: Florida
city: Miami
country: United States
facility: The Kinder Medical Group
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: IDOCF/ Value Health MD, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc.
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Comprehensive Research Institute
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Atlanta ID Group, PC
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Macon
country: United States
facility: Mercer University School of Medicine
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii - Hawaii Center for AIDS
state: Hawaii
city: Chicago
country: United States
facility: Ruth M. Rothstein CORE Center
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Chicago
country: United States
facility: NorthStar Medical Center
state: Illinois
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Infectious Diseases Clinical Research
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Central West Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Southampton Healthcare
state: Missouri
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Newark
country: United States
facility: Saint Michaels Medical Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Santa Fe
country: United States
facility: SouthWest CARE Center
state: New Mexico
city: Albany
country: United States
facility: Upstate ID Association
state: New York
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - AIDS Center
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital, Divison of Infectious Diseases
state: New York
city: Mount Vernon
country: United States
facility: Greiger Clinic
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center- Division of Infectious Diseases
state: New York
city: New York
country: United States
facility: Chelsea Village Medical, PC
state: New York
city: New York
country: United States
facility: Ricky K. Hsu, MD
state: New York
city: Chapel Hill
country: United States
facility: University of NC AIDS Clinical Trials Unit
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center-Myers Park
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Huntersville
country: United States
facility: Rosedale Infectious Diseases
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Dallas
country: United States
facility: AIDS Arms, Inc./ Peabody Health Center
state: Texas
city: Dallas
country: United States
facility: Southwest Infectious Disease Clinical Research, Inc.
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County Infectious Disease Associates
state: Texas
city: Harlingen
country: United States
facility: Garcia's Family Health Group
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, P.A.
state: Texas
city: Houston
country: United States
facility: Gordon E. Crofoot MD PA
state: Texas
city: Houston
country: United States
facility: Research Access Network
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Annandale
country: United States
facility: Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)
state: Virginia
city: Seattle
country: United States
facility: Peter Shalit, M.D.
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital, Sydney
state: New South Wales
city: Darlinghurst
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Surry Hills
country: Australia
facility: Albion Street Centre
state: New South Wales
city: Carlton
country: Australia
facility: Melbourne Sexual Health Clinic
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Northside Clinic
state: Victoria
city: South Yarra
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Vienna
country: Austria
facility: SMZ Baumgartner Hoehe - Otto-Wagner-Spital
city: Brussels
country: Belgium
facility: CHU Saint-Pierre University Hospital
city: Ghent
country: Belgium
facility: Hôpital Universitaire Erasme - ULB
city: Rio de Janeiro
country: Brazil
facility: Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
city: Sao Paulo
country: Brazil
facility: São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas
city: Sao Paulo
country: Brazil
facility: São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS
city: Vancouver
country: Canada
facility: Ubc Downtown I.D. Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
state: Manitoba
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Clinique medicale l'Actuel
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique OPUS
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC) - Montral Chest Institute
state: Quebec
city: Copenhagen
country: Denmark
facility: Epidemiklinikken 5112, Rigshospitalet
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virologicos - IDEV
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: Archet 1 CHU de Nice - 6ème Niveau
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Bichat Hospital
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Berlin
country: Germany
facility: EPIMED GmbH
city: Bonn
country: Germany
facility: University of Bonn
city: Duesseldorf
country: Germany
facility: Center for HIV and Hepatogastroenterology
city: Frankfurt am Main
country: Germany
facility: Infektio Research GmbH / Infektiologikum Frankfurt
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: ICH Study Center Hamburg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit
city: Köln
country: Germany
facility: University of Cologne, Department of Internal Medicine
city: München
country: Germany
facility: MUC Research GmbH
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
city: Milan
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Rome
country: Italy
facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
city: Torino
country: Italy
facility: Comprensorio Amedeo Di Savoia Birago Di Vische
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Servico De Doencas Infecciosas - Hospital De Sao Joao
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
city: Barcelona
country: Spain
facility: Hospital Universitari De Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Bern
country: Switzerland
facility: Universitätsklinik für Infektiologie, Universitätsspital Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
city: Bangkok
country: Thailand
facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital Foundation Trust
city: London
country: United Kingdom
facility: Courtyard Clinic, St. Georges Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2.
citation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.
citation: Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.
citation: Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.
citation: Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.
citation: Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.
citation: Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.
citation: Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.
citation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.
citation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.
citation: Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.
citation: Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.
citation: Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.
citation: Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.
citation: Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.
citation: Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.
citation: Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.
citation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.
citation: Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.
citation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.
citation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.
citation: Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019.
citation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.
citation: Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.
citation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.
citation: Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.
citation: Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.
citation: Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jun;20(3):73-81. doi: 10.1080/15284336.2019.1589232. Epub 2019 Jul 8.
citation: Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.
citation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.
citation: Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.
citation: Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.
citation: DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20.
citation: Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.
citation: Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.
citation: Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.
citation: Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.
citation: Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.
citation: Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087.
citation: Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.