Corresponding Author: Michael S. Saag, MD, School of Medicine, University of Alabama at Birmingham, 845 19th St S, BBRB 256, Birmingham, AL 35294 (msaag@uabmc.edu).
Accepted for Publication: June 12, 2018.
Author Contributions: Dr Saag had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Saag, Benson, Gandhi, Hoy, Mugavero, Sax, Smith, Thompson, Buchbinder, del Rio, Eron, Fätkenheuer, Günthard, Jacobsen, Volberding.
Acquisition, analysis, or interpretation of data: Saag, Benson, Gandhi, Hoy, Landovitz, Mugavero, Sax, Smith, Thompson, Buchbinder, Eron, Fätkenheuer, Günthard, Molina, Volberding.
Drafting of the manuscript: Saag, Benson, Gandhi, Hoy, Landovitz, Mugavero, Sax, Smith, Thompson, Buchbinder, del Rio, Fätkenheuer, Molina, Jacobsen, Volberding.
Critical revision of the manuscript for important intellectual content: Saag, Benson, Gandhi, Hoy, Landovitz, Mugavero, Sax, Smith, Thompson, Buchbinder, del Rio, Eron, Fätkenheuer, Günthard, Molina.
Obtained funding: Jacobsen.
Administrative, technical, or material support: Saag, Landovitz, Mugavero, Sax, Smith, Günthard, Jacobsen, Volberding.
Supervision: Saag, Benson, Landovitz, Smith, Eron, Günthard.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Saag reported receiving consulting fees from Gilead, ViiV, and Merck and receiving grants paid to his institutions from Gilead, ViiV, Merck, and Proteus. Dr Benson reported receiving a grant paid to her institution from Gilead; receiving personal fees from ViiV-GlaxoSmithKline; and that her spouse receives consulting fees from Pfizer and Cytodyne. Dr Gandhi reported receiving educational grants to his institution from Gilead, ViiV, and Merck and receiving consulting fees from Gilead, Merck, and Theratechnologies. Dr Hoy reported receiving advisory board fees paid to her institution from Gilead, ViiV, and Merck Sharp & Dohme. Dr Landovitz reported receiving travel fees from Gilead and Merck. Dr Mugavero reported receiving personal fees from Gilead. Dr Sax reported receiving nonfinancial support from Bristol-Myers Squibb; receiving research grants paid to his institution from Gilead and ViiV-GlaxoSmithKline; and receiving consulting fees from Gilead, Janssen, Merck, and ViiV-GlaxoSmithKline. Dr Smith reported receiving a grant paid to his institution from ViiV and receiving consulting fees from Merck, Gilead, and the AIDS Healthcare Foundation. Dr Thompson reported receiving research funding paid to the AIDS Research Consortium of Atlanta from Bristol-Myers Squibb, CytoDyn, GlaxoSmithKline, Gilead, Merck Sharp & Dohme, Roche Laboratories, Taimed, and ViiV. Dr Buchbinder reported receiving nonfinancial support from Gilead. Dr del Rio reported receiving grants from the Emory Center for AIDS Research and the Emory–Centers for Disease Control and Prevention HIV Clinical Trials Unit and receiving consulting fees from ViiV. Dr Eron reported receiving personal fees from Merck, Janssen, Gilead, ViiV, and Bristol-Myers Squibb and receiving grants paid to the University of North Carolina from Janssen, ViiV, Gilead, and Bristol-Myers Squibb. Dr Fätkenheuer reported receiving grants from the Federal Ministry of Education and Research and the German Center for Infection Research. Dr Günthard reported receiving grant funding from the Swiss National Science Foundation, Systems.X (HIV.X), University of Zurich Clinical Research Priority Program, Swiss HIV Cohort Study, National Institutes of Health, Gilead, and the Yvonne Jacob Foundation and receiving consulting fees from Gilead, Sandoz, Teva, and Merck. Dr Molina reported receiving consulting fees from Merck, Gilead, ViiV, Bristol-Myers Squibb, Janssen, and Teva and receiving a grant paid to his institution from Gilead. Dr Volberding reported receiving personal fees from Merck. No other authors reported disclosures.
Funding/Support: The work is sponsored and funded by the International Antiviral Society–USA (IAS-USA). The IAS-USA is a mission-based, nonmembership, 501(c)(3) not-for-profit organization. No private sector or government funding was used to support the effort. Panel members are not compensated for participation in the effort.
Role of the Funder/Sponsor: The IAS-USA determined the need to update recommendations, selected the panel members, and provided administrative support and oversight. The panel designed and conducted the work; collected, managed, analyzed, and interpreted the data; prepared, reviewed, and approved the manuscript; and submitted the manuscript for publication.
Additional Contributions: We thank Michelle Valderama, BS (IAS-USA), for administrative support and Hacsi Horváth, MA (University of California San Francisco), for conducting the PubMed and EMBASE literature searches.
1.Günthard
HF, Saag
MS, Benson
CA,
et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2016 recommendations of the International Antiviral Society—USA panel.
JAMA. 2016;316(2):191-210. doi:
10.1001/jama.2016.8900PubMedGoogle ScholarCrossref 2.Canadian Task Force on the Periodic Health Examination. The periodic health examination.
Can Med Assoc J. 1979;121(9):1193-1254.
PubMedGoogle Scholar 7.Labhardt
ND, Ringera
I, Lejone
TI,
et al. Effect of offering same-day ART vs usual health facility referral during home-based HIV testing on linkage to care and viral suppression among adults with HIV in Lesotho: the CASCADE randomized clinical trial.
JAMA. 2018;319(11):1103-1112. doi:
10.1001/jama.2018.1818PubMedGoogle ScholarCrossref 11.Bacon
O, Chin
JC, Hsu
L,
et al. The Rapid ART Program Initiative for HIV Diagnoses (RAPID) in San Francisco. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
12.Pilcher
CD, Ospina-Norvell
C, Dasgupta
A,
et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a US public health setting.
J Acquir Immune Defic Syndr. 2017;74(1):44-51. doi:
10.1097/QAI.0000000000001134PubMedGoogle ScholarCrossref 13.Colasanti
J, Sumitani
J, Mehta
C,
et al. Implementation of a rapid entry program decreases time to viral suppression among vulnerable persons living with HIV in the Southern United States.
Open Forum Infect Dis. 2018;5(6):1-8.
Google Scholar 14.Perfect
JR, Dismukes
WE, Dromer
F,
et al. Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the Infectious Diseases Society of America.
Clin Infect Dis. 2010;50(3):291-322. doi:
10.1086/649858PubMedGoogle ScholarCrossref 15.Ingle
SM, Miro
JM, Furrer
H,
et al. Impact of ART on mortality in cryptococcal meningitis patients: high-income settings. Presented at: 22nd Conference on Retroviruses and Opportunistic Infections (CROI); February 23-26, 2015; Seattle, WA.
16.Buchacz
K, Lau
B, Jing
Y,
et al; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA. Incidence of AIDS-defining opportunistic infections in a multicohort analysis of HIV-infected persons in the United States and Canada, 2000-2010.
J Infect Dis. 2016;214(6):862-872. doi:
10.1093/infdis/jiw085PubMedGoogle ScholarCrossref 18.Yangco
BG, Buchacz
K, Baker
R, Palella
FJ, Armon
C, Brooks
JT; HIV Outpatient Study Investigators. Is primary
Mycobacterium avium complex prophylaxis necessary in patients with CD4 <50 cells/μL who are virologically suppressed on cART?
AIDS Patient Care STDS. 2014;28(6):280-283. doi:
10.1089/apc.2013.0270PubMedGoogle ScholarCrossref 19.Mocroft
A, Reiss
P, Kirk
O,
et al; Opportunistic Infections Project Team of the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE). Is it safe to discontinue primary
Pneumocystis jiroveci pneumonia prophylaxis in patients with virologically suppressed HIV infection and a CD4 cell count <200 cells/microL?
Clin Infect Dis. 2010;51(5):611-619. doi:
10.1086/655761PubMedGoogle ScholarCrossref 20.Gallant
J, Lazzarin
A, Mills
A,
et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
Lancet. 2017;390(10107):2063-2072. doi:
10.1016/S0140-6736(17)32299-7PubMedGoogle ScholarCrossref 21.Sax
PE, Pozniak
A, Montes
ML,
et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
Lancet. 2017;390(10107):2073-2082. doi:
10.1016/S0140-6736(17)32340-1PubMedGoogle ScholarCrossref 22.Squires
KE, Molina
J-M, Sax
PE,
et al. Fixed dose combination of doravirine/lamivudine/TDF is non-inferior to efavirenz/emtricitabine/TDF in treatment-naïve adults with HIV-1 infection: week 48 results of the phase 3 DRIVE-AHEAD study. Presented at: 9th International AIDS Society Conference on HIV Science; July 23-26, 2017; Paris, France.
23.Molina
JM, Squires
K, Sax
PE,
et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial.
Lancet HIV. 2018;5(5):e211-e220. doi: 10.1016/S2352-3018(18)30021-3.
PubMedGoogle ScholarCrossref 24.Eron
J, Orkin
C, Gallant
J,
et al; AMBER Study Group. Week 48 results of AMBER: a phase 3, randomised, double-blind trial in antiretroviral treatment-naïve HIV-1-infected adults to evaluate the efficacy and safety of the once-daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) versus darunavir/cobicistat plus emtricitabine/tenofovir disoproxil fumarate. Presented at: 16th European AIDS Conference (EACS); October 25-27, 2017; Milan, Italy.
25.Arribas
JR, Thompson
M, Sax
PE,
et al. Brief report: randomized, double-blind comparison of tenofovir alafenamide (TAF) vs tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir, cobicistat, and emtricitabine (E/C/F) for initial HIV-1 treatment: week 144 results.
J Acquir Immune Defic Syndr. 2017;75(2):211-218. doi:
10.1097/QAI.0000000000001350PubMedGoogle ScholarCrossref 26.Hill
A, Hughes
SL, Gotham
D, Pozniak
AL. Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety?
J Virus Erad. 2018;4(2):72-79.
PubMedGoogle Scholar 27.Girouard
MP, Sax
PE, Parker
RA,
et al. The cost-effectiveness and budget impact of 2-drug dolutegravir-lamivudine regimens for the treatment of HIV infection in the United States.
Clin Infect Dis. 2016;62(6):784-791. doi:
10.1093/cid/civ981PubMedGoogle ScholarCrossref 28.Lambert-Niclot
S, George
EC, Pozniak
A,
et al; NEAT 001/ANRS 143 Study Group. Antiretroviral resistance at virological failure in the NEAT 001/ANRS 143 trial: raltegravir plus darunavir/ritonavir or tenofovir/emtricitabine plus darunavir/ritonavir as first-line ART.
J Antimicrob Chemother. 2016;71(4):1056-1062. doi:
10.1093/jac/dkv427PubMedGoogle ScholarCrossref 29.Taiwo
BO, Zheng
L, Stefanescu
A,
et al. ACTG A5353: a pilot study of dolutegravir plus lamivudine for initial treatment of human immunodeficiency virus-1 (HIV-1)-infected participants with HIV-1 RNA <500 000 copies/mL.
Clin Infect Dis. 2017;66(11):1689-1697. doi:
10.1093/cid/cix1083PubMedGoogle ScholarCrossref 30.Figueroa
MI, Sued
OG, Gun
AM,
et al. DRV/r/3TC FDC for HIV-1 treatment naive patients: week 48 results of the ANDES study. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
31.Llibre
JM, Hung
CC, Brinson
C,
et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies.
Lancet. 2018;391(10123):839-849. doi:
10.1016/S0140-6736(17)33095-7PubMedGoogle ScholarCrossref 33.Best
B, Capparelli
E, Stek
A,
et al. Elvitegravir/cobicistat pharmacokinetics in pregnancy and postpartum. Presented at: 24th Conference on Retroviruses and Opportunistic Infections (CROI); February 16, 2017; Seattle, WA.
34.Gallant
JE, Daar
ES, Raffi
F,
et al. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial.
Lancet HIV. 2016;3(4):e158-e165. doi:
10.1016/S2352-3018(16)00024-2PubMedGoogle ScholarCrossref 35.Chan
HL, Fung
S, Seto
WK,
et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
Lancet Gastroenterol Hepatol. 2016;1(3):185–195. doi:
10.1016/S2468-1253(16)30024-3PubMedGoogle ScholarCrossref 36.Buti
M, Gane
E, Seto
WK,
et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
Lancet Gastroenterol Hepatol. 2016;1(3):196–206. doi:
10.1016/S2468-1253(16)30107-8PubMedGoogle ScholarCrossref 37.Borges
AH, Hoy
J, Florence
E,
et al. Antiretrovirals, fractures, and osteonecrosis in a large European HIV cohort [abstract 46]. Presented at: 23rd Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.
38.Molina
JM, Ward
D, Brar
I,
et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial [published online June 18, 2018].
Lancet HIV. doi:
10.1016/S2352-3018(18)30092-4Google Scholar 39.Eron
JJ, Lelievre
JD, Kalayjian
R,
et al. Safety and efficacy of E/C/F/TAF in HIV-infected adults on chronic hemodialysis. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
40.Elion
RA, Althoff
KN, Zhang
J,
et al; North American AIDS Cohort Collaboration on Research and Design of IeDEA. Recent abacavir use increases risk of type 1 and type 2 myocardial infarctions among adults with HIV.
J Acquir Immune Defic Syndr. 2018;78(1):62-72. doi:
10.1097/QAI.0000000000001642PubMedGoogle ScholarCrossref 41.Dooley
K, Kaplan
R, Mwelase
N,
et al. Safety and efficacy of dolutegravir-based ART in TB/HIV coinfected adults at week 24. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
42.Custodio
JM, West
SK, Collins
S,
et al. Pharmacokinetics of bictegravir administered twice daily in combination with rafampin. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
43.Cerrone
M, Alfarisi
O, Neary
M,
et al. Rifampin effect on tenofovir alafenamide (TAF) plasma/intracellular pharmacokinetics. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
44.Swindells
S, Ramchandani
R, Gupta
A,
et al. One month of rifapentine/isoniazid to prevent TB in people with HIV: Brief TB/A5279 [abstract 37LB]. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
45.Brooks
KM, George
JM, Pau
AK,
et al. Cytokine-mediated systemic adverse drug reactions in a drug-drug interaction study of dolutegravir with once-weekly isoniazid and rifapentine [published online February 23, 2018].
Clin Infect Dis. 2018. doi:
10.1093/cid/ciy082PubMedGoogle Scholar 46.Trottier
B, Lake
JE, Logue
K,
et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, phase IIIb study.
Antivir Ther. 2017;22(4):295-305. doi:
10.3851/IMP3166PubMedGoogle ScholarCrossref 47.Post
FA, Yazdanpanah
Y, Schembri
G,
et al. Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial.
HIV Clin Trials. 2017;18(3):135-140. doi:
10.1080/15284336.2017.1291867PubMedGoogle ScholarCrossref 48.Marzolini
C, Gibbons
S, Khoo
S, Back
D. Cobicistat versus ritonavir boosting and differences in the drug-drug interaction profiles with co-medications.
J Antimicrob Chemother. 2016;71(7):1755-1758. doi:
10.1093/jac/dkw032PubMedGoogle ScholarCrossref 49.Negredo
E, Estrada
V, Domingo
P,
et al. Switching from a ritonavir-boosted PI to dolutegravir as an alternative strategy in virologically suppressed HIV-infected individuals.
J Antimicrob Chemother. 2017;72(3):844-849.
PubMedGoogle Scholar 50.Orkin
C, DeJesus
E, Ramgopal
M,
et al. 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;4(5):e195-e204. doi:
10.1016/S2352-3018(17)30031-0PubMedGoogle ScholarCrossref 51.Orkin
C, Molina
JM, Negredo
E,
et al; EMERALD Study Group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial.
Lancet HIV. 2018;5(1):e23-e34. doi:
10.1016/S2352-3018(17)30179-0PubMedGoogle ScholarCrossref 52.Daar
ES, DeJesus
E, Ruane
P,
et al. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial [published online June 15, 2018].
Lancet HIV. doi:
10.1016/S2352-3018(18)30091-2Google Scholar 53.Gallant
J, Brunetta
J, Crofoot
G,
et al; GS-US-292-1249 Study Investigators. Brief report: efficacy and safety of switching to a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in HIV-1/hepatitis B-coinfected adults.
J Acquir Immune Defic Syndr. 2016;73(3):294-298. doi:
10.1097/QAI.0000000000001069PubMedGoogle ScholarCrossref 54.Sax
PE, DeJesus
E, Crofoot
G,
et al. A randomized trial of bictegravir or dolutegravir with entricitabine and tenofovir alafenamide (F/TAF) followed by open label switch to bictegravir/F/TAF fixed dose combination. Presented at: IDWeek; October 4-8, 2017; San Diego, CA.
55.Di Giambenedetto
S, Fabbiani
M, Quiros Roldan
E,
et al; Atlas-M Study Group. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M).
J Antimicrob Chemother. 2017;72(4):1163-1171.
PubMedGoogle Scholar 56.Perez-Molina
JA, Rubio
R, Rivero
A,
et al; GeSIDA 7011 Study Group. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study).
J Antimicrob Chemother. 2017;72(1):246-253. doi:
10.1093/jac/dkw379PubMedGoogle ScholarCrossref 57.Pulido
F, Ribera
E, Lagarde
M,
et al; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual therapy with darunavir and ritonavir plus lamivudine vs triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of human immunodeficiency virus type 1 viral suppression: randomized, open-label, noninferiority DUAL-GESIDA 8014-RIS-EST45 trial.
Clin Infect Dis. 2017;65(12):2112-2118. doi:
10.1093/cid/cix734PubMedGoogle ScholarCrossref 58.Joly
V, Burdet
C, Landman
R,
et al. Promising results of dolutegravir + lamivudine maintenance in ANRS 167 LAMIDOL trial [abstract 458]. Presented at: 24th Conference on Retroviruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, WA
59.Taiwo
BO, Marconi
VC, Berzins
B,
et al. Dolutegravir plus lamivudine maintains human immunodeficiency virus-1 suppression through week 48 in a pilot randomized trial.
Clin Infect Dis. 2018;66(11):1794-1797. doi:
10.1093/cid/cix1131PubMedGoogle ScholarCrossref 60.Armenia
D, Di Carlo
D, Calcagno
A,
et al. 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.
J Antimicrob Chemother. 2017;72(3):855-865.
PubMedGoogle Scholar 61.Huhn
GD, Tebas
P, Gallant
J,
et al. A randomized, open-label trial to evaluate switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide plus darunavir in treatment-experienced HIV-1-infected adults.
J Acquir Immune Defic Syndr. 2017;74(2):193-200. doi:
10.1097/QAI.0000000000001193PubMedGoogle ScholarCrossref 62.Brenner
BG, Thomas
R, Blanco
JL,
et al. Development of a G118R mutation in HIV-1 integrase following a switch to dolutegravir monotherapy leading to cross-resistance to integrase inhibitors.
J Antimicrob Chemother. 2016;71(7):1948-1953. doi:
10.1093/jac/dkw071PubMedGoogle ScholarCrossref 64.Galli
L, Spagnuolo
V, Bigoloni
A,
et al; MODAt Study Group. Atazanavir/ritonavir monotherapy: 96 week efficacy, safety and bone mineral density from the MODAt randomized trial.
J Antimicrob Chemother. 2016;71(6):1637-1642. doi:
10.1093/jac/dkw031PubMedGoogle ScholarCrossref 65.Girard
PM, Antinori
A, Arribas
JR,
et al. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial.
HIV Med. 2017;18(1):5-12. doi:
10.1111/hiv.12386PubMedGoogle ScholarCrossref 66.Aboud
M, Kaplan
R, Lombaard
J,
et al. Superior efficacy of dolutegravir (DTG) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) compared with lopinavir/ritonavir (LPV/RTV) plus 2 NRTIs in second-line treatment: interim data from the DAWNING study. Presented at: 9th International AIDS Society Conference on HIV Science; July 23-27, 2017; Paris, France.
67.Lewis
S, Fessel
J, Emu
B,
et al. Long-acting ibalizumab 17 in patients with multi-drug resistant HIV-1: a 24-week 18 study.
Top Antivir Med. 2017;25(suppl 1):185s.
Google Scholar 68.Emu
B, Fessel
WJ, Schrader
S,
et al. 48-Week safety and efficacy on-treatment analysis of ibalizumab in patients with multi-drug resistant HIV-1. Presented at: IDWeek; October 6, 2017; San Diego, CA.
70.Hoornenborg
E, Achterbergh
RCA, Schim van der Loeff
MF,
et al; Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam Initiative, MOSAIC Study Group. MSM starting preexposure prophylaxis are at risk of hepatitis C virus infection.
AIDS. 2017;31(11):1603-1610. doi:
10.1097/QAD.0000000000001522PubMedGoogle ScholarCrossref 71.Girometti
N, Gutierrez
A, Nwokolo
N, McOwan
A, Whitlock
G. High HIV incidence in men who have sex with men following an early syphilis diagnosis: is there room for pre-exposure prophylaxis as a prevention strategy?
Sex Transm Infect. 2017;93(5):320-322. doi:
10.1136/sextrans-2016-052865PubMedGoogle ScholarCrossref 75.Crowell
TA, Colby
DJ, Pinyakorn
S,
et al; RV254/SEARCH010 Study Group. Acute retroviral syndrome is associated with high viral burden, CD4 depletion, and immune activation in systemic and tissue compartments.
Clin Infect Dis. 2018;66(10):1540-1549. doi:
10.1093/cid/cix1063PubMedGoogle ScholarCrossref 77.Koullias
Y, Sax
PE, Fields
NF, Walensky
RP, Hyle
EP. Should we be testing for baseline integrase resistance in patients newly diagnosed with human immunodeficiency virus?
Clin Infect Dis. 2017;65(8):1274-1281. doi:
10.1093/cid/cix542PubMedGoogle ScholarCrossref 78.Stekler
JD, McKernan
J, Milne
R,
et al. Lack of resistance to integrase inhibitors among antiretroviral-naive subjects with primary HIV-1 infection, 2007-2013.
Antivir Ther. 2015;20(1):77-80. doi:
10.3851/IMP2780PubMedGoogle ScholarCrossref 79.Ambrosioni
J, Nicolás
D, Manzardo
C,
et al. Integrase strand-transfer inhibitor polymorphic and accessory resistance substitutions in patients with acute/recent HIV infection.
J Antimicrob Chemother. 2017;72(1):205-209. doi:
10.1093/jac/dkw376PubMedGoogle ScholarCrossref 82.Sax
PE, DeJesus
E, Mills
A,
et al; GS-US-236-0102 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks.
Lancet. 2012;379(9835):2439-2448. doi:
10.1016/S0140-6736(12)60917-9PubMedGoogle ScholarCrossref 86.Zaccarelli
M, Santoro
MM, Armenia
D,
et al. Genotypic resistance test in proviral DNA can identify resistance mutations never detected in historical genotypic test in patients with low level or undetectable HIV-RNA.
J Clin Virol. 2016;82:94-100. doi:
10.1016/j.jcv.2016.07.007PubMedGoogle ScholarCrossref 87.Doyle
T, Dunn
DT, Ceccherini-Silberstein
F,
et al; CORONET Study Group. Integrase inhibitor (INI) genotypic resistance in treatment-naive and raltegravir-experienced patients infected with diverse HIV-1 clades.
J Antimicrob Chemother. 2015;70(11):3080-3086. doi:
10.1093/jac/dkv243PubMedGoogle ScholarCrossref 89.Gunthard
HF, Calvez
V, Paredes
R,
et al. HIV drug resistance: 2018 review and recommendations of the International Antiviral Society–USA 1440 Panel [published online July 20, 2018].
Clin Infect Dis. doi:
10.1093/cid/ciy463Google Scholar 90.Gandhi
RT, Zheng
L, Bosch
RJ,
et al; AIDS Clinical Trials Group A5244 Team. The effect of raltegravir intensification on low-level residual viremia in HIV-infected patients on antiretroviral therapy: a randomized controlled trial.
PLoS Med. 2010;7(8):e1000321. doi:
10.1371/journal.pmed.1000321PubMedGoogle ScholarCrossref 92.Rodger
AJ, Cambiano
V, Bruun
T,
et al; PARTNER Study Group. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy.
JAMA. 2016;316(2):171-181. doi:
10.1001/jama.2016.5148PubMedGoogle ScholarCrossref 95.Mugavero
MJ, Westfall
AO, Cole
SR,
et al; Centers for AIDS Research Network of Integrated Clinical Systems (CNICS). Beyond core indicators of retention in HIV care: missed clinic visits are independently associated with all-cause mortality.
Clin Infect Dis. 2014;59(10):1471-1479. doi:
10.1093/cid/ciu603PubMedGoogle ScholarCrossref 96.Pence
B, Mugavero
M, Boswell
S,
et al. Who will show? predicting missed visits in the CFAR Network of Integrated Systems (CNICS) cohort of patients in HIV care in the United States. Presented at: 11th International Conference on HIV Treatment and Prevention Adherence; May 9-11, 2016; Fort Lauderdale, FL.
97.Hart-Malloy
R, Brown
S, Bogucki
K, Tesoriero
J. Implementing data-to-care initiatives for HIV in New York state: assessing the value of community health centers identifying persons out of care for health department follow-up.
AIDS Care. 2018;30(3):391-396. doi:
10.1080/09540121.2017.1363851PubMedGoogle ScholarCrossref 99.Metsch
LR, Feaster
DJ, Gooden
L,
et al. Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial.
JAMA. 2016;316(2):156-170. doi:
10.1001/jama.2016.8914PubMedGoogle ScholarCrossref 104.Dombrowski
JC, Galagan
S, Ramchandani
M, Dhanireddy
S, Harrington
RD, Golden
MR. Improved outcomes with maximum assistance, low-threshold HIV care (the “MAX CLINIC”). Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
105.Thompson
MA, Mugavero
MJ, Amico
KR,
et al. Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel.
Ann Intern Med. 2012;156(11):817-833. doi:
10.7326/0003-4819-156-11-201206050-00419PubMedGoogle ScholarCrossref 107.Clemenzi-Allen
AA, Geng
E, Christopoulos
KA,
et al. Degree of housing instability shows independent “dose-response” with HIV suppression. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
108.Bowen
EA, Canfield
J, Moore
S, Hines
M, Hartke
B, Rademacher
C. Predictors of CD4 health and viral suppression outcomes for formerly homeless people living with HIV/AIDS in scattered site supportive housing.
AIDS Care. 2017;29(11):1458-1462. doi:
10.1080/09540121.2017.1307920PubMedGoogle ScholarCrossref 115.Pence
BW, Mills
JC, Bengtson
AM,
et al. Association of increased chronicity of depression with HIV appointment attendance, treatment failure, and mortality among HIV-infected adults in the United States [published online February 21, 2018].
JAMA Psychiatry. 2018. doi:
10.1001/jamapsychiatry.2017.4726PubMedGoogle Scholar 121.Sutton
SS, Magagnoli
J, Hardin
JW. Odds of viral suppression by single-tablet regimens, multiple-tablet regimens, and adherence level in HIV/AIDS patients receiving antiretroviral therapy.
Pharmacotherapy. 2017;37(2):204-213. doi:
10.1002/phar.1889PubMedGoogle ScholarCrossref 124.Crepaz
N, Tang
T, Marks
G, Mugavero
MJ, Espinoza
L, Hall
HI. Durable viral suppression and transmission risk potential among persons with diagnosed HIV infection: United States, 2012-2013.
Clin Infect Dis. 2016;63(7):976-983. doi:
10.1093/cid/ciw418PubMedGoogle ScholarCrossref 125.Kuhar
DT, Henderson
DK, Struble
KA,
et al; US Public Health Service Working Group. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis [published correction appears in
Infect Control Hosp Epidemiol. 2013;34(11):1238].
Infect Control Hosp Epidemiol. 2013;34(9):875-892. doi:
10.1086/672271PubMedGoogle ScholarCrossref 127.Lancki
N, Almirol
E, Alon
L, McNulty
M, Schneider
JA. Preexposure prophylaxis guidelines have low sensitivity for identifying seroconverters in a sample of young black MSM in Chicago.
AIDS. 2018;32(3):383-392.
PubMedGoogle Scholar 128.Gilead Sciences. TRUVADA (emtricitabine and tenofovir disoproxil fumarate) [package insert]. Foster City, CA: Gilead Sciences Inc; 2014.
130.Cottrell
ML, Yang
KH, Prince
HM,
et al. A translational pharmacology approach to predicting outcomes of HIV preexposure prophylaxis against HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine.
J Infect Dis. 2016;214(1):55-64. doi:
10.1093/infdis/jiw077PubMedGoogle ScholarCrossref 133.Antoni
G, Tremblay
C, Charreau
I,
et al. On-demand PrEP with TDF/FTC remains highly effective among MSM with infrequent sexual intercourse: a sub-study of ANRS iPERGAY trial. Presented at: IAS Conference on HIV Science; July 23-27, 2017; Paris, France.
135.Molina
JM, Pialoux
G, Ohayon
M,
et al. One-year experience with pre-exposure prophylaxis (PrEP) implementation in France with TDF/FTC. Presented at: 9th International AIDS Society Conference on HIV Science; July 23-27, 2017; Paris, France.
136.Balavoine
S, Noret
M, Loze
B,
et al. PrEP uptake, safety and efficacy in a hospital-based clinic in Paris. Presented at: 9th International AIDS Society Conference on HIV Science; July 23-26, 2017; Paris, France.
139.Tan
DHS, Hull
MW, Yoong
D,
et al; Biomedical HIV Prevention Working Group of the CIHR Canadian HIV Trials Network. Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis.
CMAJ. 2017;189(47):E1448-E1458. doi:
10.1503/cmaj.170494PubMedGoogle ScholarCrossref 140.Mugwanya
KK, Wyatt
C, Celum
C,
et al; Partners PrEP Study Team. Reversibility of glomerular renal function decline in HIV-uninfected men and women discontinuing emtricitabine-tenofovir disoproxil fumarate pre-exposure prophylaxis.
J Acquir Immune Defic Syndr. 2016;71(4):374-380. doi:
10.1097/QAI.0000000000000868PubMedGoogle ScholarCrossref 141.Delaugerre
C, Antoni
G, Mahjoub
N,
et al; IPERGAY Study Group. Assessment of HIV screening tests for use in preexposure prophylaxis programs.
J Infect Dis. 2017;216(3):382-386.
PubMedGoogle Scholar 142.Hoornenborg
E, Prins
M, Achterbergh
RCA,
et al; Amsterdam PrEP Project Team in the HIV Transmission Elimination AMsterdam Consortium (H-TEAM). Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report.
Lancet HIV. 2017;4(11):e522-e528. doi:
10.1016/S2352-3018(17)30132-7PubMedGoogle ScholarCrossref 146.Krakower
P, Maloney
KM, Levine
K. Unplanned discontinuation of HIV pre-exposure prophylaxis during clinical care. Presented at: 2nd HIV Research for Prevention Conference (HIVR4P); October 17-21, 2016; Chicago, IL.
147.Jain
S, Krakower
DS, Mayer
KH. The transition from postexposure prophylaxis to preexposure prophylaxis: an emerging opportunity for biobehavioral HIV prevention.
Clin Infect Dis. 2015;60(suppl 3):S200-S204. doi:
10.1093/cid/civ094PubMedGoogle ScholarCrossref 148.Margolis
DA, Gonzalez-Garcia
J, Stellbrink
HJ,
et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial.
Lancet. 2017;390(10101):1499-1510. doi:
10.1016/S0140-6736(17)31917-7PubMedGoogle ScholarCrossref 149.Markowitz
M, Frank
I, Grant
R,
et al. ÉCLAIR: phase 2A safety and PK study of cabotegravir LA in HIV-uninfected men [abstract 106]. Presented at: 23rd Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.
150.Baeten
J, Palanee-Phillips
T, Mgodi
N,
et al. High uptake and reduced HIV-1 incidence in an open-label trial of the dapivirine ring. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
151.Nel
A, van Niekerk
N, Van Baelen
B, Rosenberg
Z. HIV incidence and adherence in DREAM: an open-label trial of dapivirine vaginal ring. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.
156.Gaudinski
MR, Coates
EE, Houser
KV,
et al; VRC 606 Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: a phase 1 open-label clinical trial in healthy adults.
PLoS Med. 2018;15(1):e1002493. doi:
10.1371/journal.pmed.1002493PubMedGoogle ScholarCrossref 161.Borducchi
E, Abbink
P, Nkolola
J, Lewis
MG, Geleziunas
R, Barouch
D. PGT121 combined with GS-9620 delays viral rebound in SHIV-infected rhesus monkeys. Presented at: 25th Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2018; Boston, MA.