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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815736
• Other study ID #: GS-US-292-0109
• Secondary ID: 2012-005114-20
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2013
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2021
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1443
• Est. completion date: April 1, 2020
• Est. primary completion date: March 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
• E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
• EFV/FTC/TDF
600/200/300 mg FDC tablet administered orally once daily
• RTV
100 mg tablet administered orally once daily
• ATV
300 mg capsule administered orally once daily
• FTC/TDF
200/300 mg tablet administered orally once daily
• COBI
150 mg tablet administered orally once daily

Locations

Country	Name	City	State
Australia	Melbourne Sexual Health Clinic	Carlton	Victoria
Australia	East Sydney Doctors	Darlinghurst	New South Wales
Australia	Holdsworth House Medical practice	Darlinghurst	New South Wales
Australia	St Vincent's Hospital, Sydney	Darlinghurst	New South Wales
Australia	Taylor Square Private Clinic	Darlinghurst	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Northside Clinic	Melbourne	Victoria
Australia	Prahran Market Clinic	South Yarra	Victoria
Australia	Albion Street Centre	Surry Hills	New South Wales
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universitat Wien	Vienna
Austria	SMZ Baumgartner Hoehe - Otto-Wagner-Spital	Vienna
Belgium	CHU Saint-Pierre University Hospital	Brussels
Belgium	Hôpital Universitaire Erasme - ULB	Ghent
Brazil	Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz	Rio de Janeiro
Brazil	Faculdade de Medicina do ABC	Santo Andre
Brazil	São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS	Sao Paulo
Brazil	São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas	Sao Paulo
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique medicale l'Actuel	Montreal	Quebec
Canada	Clinique OPUS	Montreal	Quebec
Canada	McGill University Health Centre (MUHC) - Montral Chest Institute	Montréal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Maple Leaf Research	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
Canada	Ubc Downtown I.D. Clinic	Vancouver	British Columbia
Canada	Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg	Winnipeg	Manitoba
Denmark	Epidemiklinikken 5112, Rigshospitalet	Copenhagen
Dominican Republic	Instituto Dominicano de Estudios Virologicos - IDEV	Santo Domingo
France	Hôpital de La Croix Rousse	Lyon
France	CHU Hotel Dieu	Nantes
France	Archet 1 CHU de Nice - 6ème Niveau	Nice
France	Bichat Hospital	Paris
France	Hopital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier de Tourcoing	Tourcoing
Germany	EPIMED GmbH	Berlin
Germany	University of Bonn	Bonn
Germany	Center for HIV and Hepatogastroenterology	Duesseldorf
Germany	Infektio Research GmbH / Infektiologikum Frankfurt	Frankfurt am Main
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	ICH Study Center Hamburg	Hamburg
Germany	University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit	Hamburg
Germany	University of Cologne, Department of Internal Medicine	Köln
Germany	MUC Research GmbH	München
Italy	Fondazione Centro San Raffaele del Monte Tabor	Milan
Italy	Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive	Milano
Italy	Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS	Rome
Italy	Comprensorio Amedeo Di Savoia Birago Di Vische	Torino
Mexico	Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara
Netherlands	Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten	Amsterdam
Netherlands	Erasmus MC	Rotterdam
Portugal	Hospital de Santa Maria	Lisbon
Portugal	Servico De Doencas Infecciosas - Hospital De Sao Joao	Porto
Puerto Rico	Clinical Research Puerto Rico	San Juan
Puerto Rico	HOPE Clinical Research	San Juan
Puerto Rico	VA Caribbean Healthcare System	San Juan
Spain	Hospital Universitari De Bellvitge	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Virgen del Rocio	Sevilla
Sweden	Södersjukhuset	Stockholm
Switzerland	Universitätsklinik für Infektiologie, Universitätsspital Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	University Hospital of Zurich	Zürich
Thailand	HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University	Bangkok
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok
Thailand	Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine	Bangkok
Thailand	Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine	Chiang Mai
Thailand	Khon Kaen University	Khon Kaen
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton
United Kingdom	Barts and the London NHS Trust	London
United Kingdom	Chelsea and Westminster Hospital Foundation Trust	London
United Kingdom	Courtyard Clinic, St. Georges Hospital	London
United Kingdom	North Manchester General Hospital	Manchester
United States	Summa Health System	Akron	Ohio
United States	Albany Medical College	Albany	New York
United States	Upstate ID Association	Albany	New York
United States	Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Atlanta ID Group, PC	Atlanta	Georgia
United States	Be Well Medical Center	Berkley	Michigan
United States	AHF Research Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Community Research Initiative of New England	Boston	Massachusetts
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore Medical Center - AIDS Center	Bronx	New York
United States	University of NC AIDS Clinical Trials Unit	Chapel Hill	North Carolina
United States	Carolinas Medical Center-Myers Park	Charlotte	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	NorthStar Medical Center	Chicago	Illinois
United States	Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	Palmetto Health Richland	Columbia	South Carolina
United States	Michael Keith Wensley, MD, Inc., A Medical Corporation	Costa Mesa	California
United States	AIDS Arms, Inc./ Peabody Health Center	Dallas	Texas
United States	Southwest Infectious Disease Clinical Research, Inc.	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Apex Research LLC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	New York Hospital Queens	Flushing	New York
United States	Broward Health/Comprehensive Care Center	Fort Lauderdale	Florida
United States	Gary J. Richmond,M.D.,P.A.	Fort Lauderdale	Florida
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Tarrant County Infectious Disease Associates	Fort Worth	Texas
United States	East Carolina University	Greenville	North Carolina
United States	Greenwich Hospital	Greenwich	Connecticut
United States	Garcia's Family Health Group	Harlingen	Texas
United States	ID Care	Hillsborough	New Jersey
United States	University of Hawaii - Hawaii Center for AIDS	Honolulu	Hawaii
United States	Gordon E. Crofoot MD PA	Houston	Texas
United States	Research Access Network	Houston	Texas
United States	Therapeutic Concepts, P.A.	Houston	Texas
United States	Rosedale Infectious Diseases	Huntersville	North Carolina
United States	Health for Life Clinic PLLC	Little Rock	Arkansas
United States	Living Hope Clinical Foundation	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Anthony Mills MD Inc	Los Angeles	California
United States	Jeffrey Goodman Special Care Clinic	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	Peter J Ruane, MD, Inc	Los Angeles	California
United States	Mercer University School of Medicine	Macon	Georgia
United States	North Shore University Hospital, Divison of Infectious Diseases	Manhasset	New York
United States	The Kinder Medical Group	Miami	Florida
United States	Wohlfeiler, Piperato and Associates, LLC	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Greiger Clinic	Mount Vernon	New York
United States	Yale University HIV Clinical Trials Program	New Haven	Connecticut
United States	Beth Israel Medical Center- Division of Infectious Diseases	New York	New York
United States	Chelsea Village Medical, PC	New York	New York
United States	Ricky K. Hsu, MD	New York	New York
United States	Saint Michaels Medical Center	Newark	New Jersey
United States	Orange Coast Medical Group	Newport Beach	California
United States	Alameda County Medical Center	Oakland	California
United States	East Bay AIDS Center	Oakland	California
United States	IDOCF/ Value Health MD, LLC	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Southwest Center for HIV/AIDS	Phoenix	Arizona
United States	Spectrum Medical Group	Phoenix	Arizona
United States	Kaiser Permanente Medical Group	Sacramento	California
United States	University of California, Davis Medical Center	Sacramento	California
United States	Central West Clinical Research	Saint Louis	Missouri
United States	Saint Louis University	Saint Louis	Missouri
United States	Southampton Healthcare	Saint Louis	Missouri
United States	La Playa Medical Group and Clinical Research	San Diego	California
United States	Kaiser Permanente Medical Center, Clinical Trials Unit	San Francisco	California
United States	Metropolis Medical Group	San Francisco	California
United States	Kaiser Permanente Hospital	San Leandro	California
United States	SouthWest CARE Center	Santa Fe	New Mexico
United States	Peter Shalit, M.D.	Seattle	Washington
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Premier Clinical Research	Spokane	Washington
United States	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts
United States	The Research Institute	Springfield	Massachusetts
United States	Infectious Disease Research Institute Inc.	Tampa	Florida
United States	St. Joseph's Comprehensive Research Institute	Tampa	Florida
United States	University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department	Tampa	Florida
United States	Capital Medical Associates, PC	Washington	District of Columbia
United States	Dupont Circle Physicians Group	Washington	District of Columbia
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Whitman Walker Clinic	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  Dominican Republic,  France,  Germany,  Italy,  Mexico,  Netherlands,  Portugal,  Puerto Rico,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

References & Publications (40)

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: abst

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.

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

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 #72

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 Clinica

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 anal

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 treatmen

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 Thr — View 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 Socie

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. — View 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: abstra

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 alafen — View 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 Soc

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/e — View 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)

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 Con

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 Dis

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 Ann

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- — View 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. 2

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 disopro — View 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 He

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 Agent

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: ab

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 Dru

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 o

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 d

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 Chemot

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) - V

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 -

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 S

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: abst

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.

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.

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 Co

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 Congres

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.

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 presenta

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)

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.

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48	Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.	Baseline; Week 48
Secondary	Percent Change From Baseline in Spine BMD at Week 48	Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.	Baseline; Week 48
Secondary	Change From Baseline in Serum Creatinine at Week 48		Baseline; Week 48
Secondary	Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48	The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement.; EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.	Baseline; Week 48
Secondary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96
Secondary	Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Secondary	Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96
Secondary	Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48	The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.	Baseline; Week 48
Secondary	Change From Baseline in CD4 Cell Count at Weeks 96	The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.	Baseline; Week 96