Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings
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{"title"=>"Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings", "type"=>"journal", "authors"=>[{"first_name"=>"Thomas B.", "last_name"=>"Campbell", "scopus_author_id"=>"8255687100"}, {"first_name"=>"Laura M.", "last_name"=>"Smeaton", "scopus_author_id"=>"6602400448"}, {"first_name"=>"N.", "last_name"=>"Kumarasamy", "scopus_author_id"=>"7003549856"}, {"first_name"=>"Timothy", "last_name"=>"Flanigan", "scopus_author_id"=>"18834782100"}, {"first_name"=>"Karin L.", "last_name"=>"Klingman", "scopus_author_id"=>"34571514300"}, {"first_name"=>"Cynthia", "last_name"=>"Firnhaber", "scopus_author_id"=>"24491418700"}, {"first_name"=>"Beatriz", "last_name"=>"Grinsztejn", "scopus_author_id"=>"6603296078"}, {"first_name"=>"Mina C.", "last_name"=>"Hosseinipour", "scopus_author_id"=>"6508221424"}, {"first_name"=>"Johnstone", "last_name"=>"Kumwenda", "scopus_author_id"=>"8614133200"}, {"first_name"=>"Umesh", 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Jan", "last_name"=>"Geiseler", "scopus_author_id"=>"6602981582"}, {"first_name"=>"Bartolo", "last_name"=>"Santos", "scopus_author_id"=>"24451140200"}, {"first_name"=>"Eric S.", "last_name"=>"Daar", "scopus_author_id"=>"7006098438"}, {"first_name"=>"Ruben", "last_name"=>"Lopez", "scopus_author_id"=>"57198529414"}, {"first_name"=>"Laurie", "last_name"=>"Frarey", "scopus_author_id"=>"6507076291"}, {"first_name"=>"David", "last_name"=>"Currin", "scopus_author_id"=>"22034408600"}, {"first_name"=>"David H.", "last_name"=>"Haas", "scopus_author_id"=>"56762688800"}, {"first_name"=>"Vicki L.", "last_name"=>"Bailey", "scopus_author_id"=>"8043563700"}, {"first_name"=>"Pablo", "last_name"=>"Tebas", "scopus_author_id"=>"7003860683"}, {"first_name"=>"Larisa", "last_name"=>"Zifchak", "scopus_author_id"=>"36159205700"}, {"first_name"=>"Jolene", "last_name"=>"Noel-Connor", "scopus_author_id"=>"55347205300"}, {"first_name"=>"Madeline", "last_name"=>"Torres", "scopus_author_id"=>"24473734800"}, {"first_name"=>"Beverly E.", "last_name"=>"Sha", "scopus_author_id"=>"7005779955"}, {"first_name"=>"Janice M.", "last_name"=>"Fritsche", "scopus_author_id"=>"57197266300"}, {"first_name"=>"Michelle", "last_name"=>"Cespedes", "scopus_author_id"=>"8703234300"}, {"first_name"=>"Janet", "last_name"=>"Forcht", "scopus_author_id"=>"6504426237"}, {"first_name"=>"William A.", "last_name"=>"O'Brien", "scopus_author_id"=>"16195284700"}, {"first_name"=>"Cheryl", "last_name"=>"Mogridge", "scopus_author_id"=>"6507268061"}, {"first_name"=>"Christine", "last_name"=>"Hurley", "scopus_author_id"=>"7101900354"}, {"first_name"=>"Roberto", "last_name"=>"Corales", "scopus_author_id"=>"6505923209"}, {"first_name"=>"Maria", "last_name"=>"Palmer", "scopus_author_id"=>"56257773300"}, {"first_name"=>"Mary", "last_name"=>"Adams", "scopus_author_id"=>"56419201800"}, {"first_name"=>"Amneris", "last_name"=>"Luque", "scopus_author_id"=>"55166825700"}, {"first_name"=>"Luis", "last_name"=>"Lopez-Detres", "scopus_author_id"=>"55346980700"}, {"first_name"=>"Todd", "last_name"=>"Stroberg", "scopus_author_id"=>"16305610600"}], "year"=>2012, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491277", "scopus"=>"2-s2.0-84865566725", "sgr"=>"84865566725", "pui"=>"365532678", "pmid"=>"22936892", "doi"=>"10.1371/journal.pmed.1001290"}, "id"=>"63c48285-427b-39b2-a300-4652c8fd6c44", "abstract"=>"BACKGROUND: Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world. METHODS AND FINDINGS: 1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was </=1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; p<0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39-0.64 for women; HR 0.79, CI 0.62-1.00 for men; p = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12-2.04; p = 0.007). CONCLUSION: EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen. TRIAL REGISTRATION: www.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/efficacy-safety-three-antiretroviral-regimens-initial-treatment-hiv1-randomized-clinical-trial-diver-1", "reader_count"=>64, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>4, "Librarian"=>2, "Researcher"=>9, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>9, "Student > Postgraduate"=>4, "Student > Master"=>13, "Other"=>7, "Student > Bachelor"=>6, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>4, "Librarian"=>2, "Researcher"=>9, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>9, "Student > Postgraduate"=>4, "Student > Master"=>13, "Other"=>7, "Student > Bachelor"=>6, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Agricultural and Biological Sciences"=>9, "Arts and Humanities"=>1, "Chemistry"=>1, "Computer Science"=>1, "Economics, Econometrics and Finance"=>3, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>35, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Psychology"=>1, "Social Sciences"=>4, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>35}, "Social Sciences"=>{"Social Sciences"=>4}, "Psychology"=>{"Psychology"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Chemistry"=>{"Chemistry"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>3}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>9}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}}, "reader_count_by_country"=>{"United States"=>2, "Tanzania"=>1, "Brazil"=>1, "South Africa"=>1, "Ethiopia"=>1}, "group_count"=>4}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/592800"], "description"=>"<p>Subgroup analyses were conducted for the baseline covariates self-reported sex and race/ethnicity and the countries in which the participating research sites were located. The relative risk and 95% CIs are provided for all participants (overall) and for each subgroup. <i>p</i>-Value represents interaction test between baseline covariate and randomized treatment group. Comparisons between ATV plus DDI and FTC and EFV plus 3TC-ZDV are in red. Comparisons between EFV plus FTC-TDF and EFV plus 3TC-ZDV are in green. (A) Treatment failure (efficacy) composite endpoint. (B) Safety events composite endpoint.</p>", "links"=>[], "tags"=>["efficacy", "endpoints", "randomly", "assigned", "antiretroviral"], "article_id"=>263256, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001290.g003", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Subgroup_analysis_for_primary_efficacy_and_safety_endpoints_by_randomly_assigned_antiretroviral_treatment_/263256", "title"=>"Subgroup analysis for primary efficacy and safety endpoints by randomly assigned antiretroviral treatment.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-08-14 00:54:16"}
  • {"files"=>["https://ndownloader.figshare.com/files/593041"], "description"=>"a<p>Also known as relative risk. Estimated from Cox regression model stratified by both country and RNA stratum and including randomized treatment group as sole covariate.</p>b<p><i>p</i>-Value calculated from stratified log-rank test between arms. Not applicable (NA) because no formal hypothesis testing was performed based on DSMB recommendations.</p>c<p>The five most common causes of death were infection (17 deaths) and unknown cause (five deaths) followed by suicide, trauma, and stroke (three deaths each).</p>d<p>Disease progression diagnoses are in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s012\" target=\"_blank\">Table S7</a>; grade 3 and 4 laboratory adverse events in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s013\" target=\"_blank\">Table S8</a>; and signs and symptoms in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s014\" target=\"_blank\">Table S9</a>.</p>e<p>All events meeting these criteria are reported; some participants met criteria for multiple endpoints.</p>f<p>Confirmed plasma HIV RNA≥1,000 copies/ml at study week 16 or later.</p>g<p>Change in any component of initial randomized antiretroviral regimen.</p>h<p>The following antiretroviral substitutions were prespecified and were not included in this endpoint: stavudine or TDF for ZDV, nevirapine for EFV, or didansoine for TDF.</p>i<p>CD4+ lymphocytes <100/µl at week 48 or later.</p>", "links"=>[], "tags"=>["time-to-event", "outcomes", "efavirenz", "emtricitabine-tenofovir-df", "lamivudine-zidovudine"], "article_id"=>263490, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001290.t002", "stats"=>{"downloads"=>3, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Primary_and_secondary_time_to_event_outcomes_for_comparison_of_efavirenz_plus_emtricitabine_tenofovir_DF_to_efavirenz_plus_lamivudine_zidovudine_using_data_collected_through_31_May_2010_/263490", "title"=>"Primary and secondary time-to-event outcomes for comparison of efavirenz plus emtricitabine-tenofovir-DF to efavirenz plus lamivudine-zidovudine using data collected through 31-May-2010.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-08-14 00:58:10"}
  • {"files"=>["https://ndownloader.figshare.com/files/592446"], "description"=>"<p>The outcomes of all participants randomized to the three arms are provided. The most common prior antiretroviral exposure was for prevention of mother-to-child transmission of HIV-1 with either ZDV monotherapy (19 women; median duration 32 d; intraquartile range 30–60 d) or a single dose of nevirapine in the peripartum period (16 women). Continuous variable values are the median for the treatment arm. Creatinine clearance was calculated by Crockoft-Gault equation. Follow-up visits were conducted for 1,571 participants. ATV plus FTC and DDI follow-up was terminated on 22 May 2008 in response to the DSMB recommendation and comparison of ATV plus FTC and DDI to EFV plus 3TC-ZDV used data available up to the time of the ATV arm closure (red box); median follow-up 81 wk. Comparison of EFV plus FTC-TDF to EFV plus 3TC-ZDV used all follow-up data for participants in these arms through 31 May 2010 (green box); median follow-up 184 wk.</p>", "links"=>[], "tags"=>["diagram"], "article_id"=>262915, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001290.g001", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_diagram_for_participant_outcomes_/262915", "title"=>"Flow diagram for participant outcomes.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-08-14 00:48:35"}
  • {"files"=>["https://ndownloader.figshare.com/files/593120"], "description"=>"a<p>Also known as relative risk. Estimated from Cox regression model stratified by both country and RNA stratum and including randomized treatment group as sole covariate.</p>b<p><i>p</i>-Value calculated from stratified log-rank test between arms.</p>c<p>The five most common causes of death were infection (six deaths), liver disease (three deaths), malignancy (two deaths), suicide (two deaths), and unknown cause (two deaths).</p>d<p>Disease progression diagnoses are in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s007\" target=\"_blank\">Table S2</a>; grade 3 and 4 laboratory events in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s008\" target=\"_blank\">Table S3</a>; and signs and symptoms in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s009\" target=\"_blank\">Table S4</a>.</p>e<p>All events meeting these criteria are reported; some participants met criteria for multiple endpoints.</p>f<p>Confirmed plasma HIV RNA≥1,000 copies/ml at study week 16 or later.</p>g<p>Elevated bilirubin concentration not included.</p>h<p>Change in any component of initial randomized antiretroviral regimen.</p>i<p>The following antiretroviral substitutions were prespecified and were not included in this endpoint: TDF for DDI, stavudine or TDF for ZDV, or nevirapine for EFV.</p>j<p>CD4+ lymphocytes <100/µl at week 48 or later.</p>", "links"=>[], "tags"=>["time-to-event", "outcomes", "atazanavir", "didanosine-ec", "emtricitabine", "efavirenz", "lamivudine-zidovudine", "22"], "article_id"=>263573, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001290.t001", "stats"=>{"downloads"=>9, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Primary_and_secondary_time_to_event_outcomes_for_the_comparison_of_atazanavir_plus_didanosine_EC_and_emtricitabine_to_efavirenz_plus_lamivudine_zidovudine_using_data_collected_through_22_May_2008_/263573", "title"=>"Primary and secondary time-to-event outcomes for the comparison of atazanavir plus didanosine-EC and emtricitabine to efavirenz plus lamivudine-zidovudine using data collected through 22 May 2008.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-08-14 00:59:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/310161", "https://ndownloader.figshare.com/files/310249", "https://ndownloader.figshare.com/files/310343", "https://ndownloader.figshare.com/files/310434", "https://ndownloader.figshare.com/files/310506", "https://ndownloader.figshare.com/files/310584", "https://ndownloader.figshare.com/files/310669", "https://ndownloader.figshare.com/files/310725", "https://ndownloader.figshare.com/files/310788", "https://ndownloader.figshare.com/files/310874", "https://ndownloader.figshare.com/files/310954", "https://ndownloader.figshare.com/files/311023", "https://ndownloader.figshare.com/files/311085", "https://ndownloader.figshare.com/files/311170", "https://ndownloader.figshare.com/files/311250", "https://ndownloader.figshare.com/files/311330", "https://ndownloader.figshare.com/files/311382", "https://ndownloader.figshare.com/files/311623", "https://ndownloader.figshare.com/files/311740"], "description"=>"<div><h3>Background</h3><p>Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.</p> <h3>Methods and Findings</h3><p>1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure.</p> <p>An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72–1.27; <em>p</em> = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54–0.76; <em>p</em><0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39–0.64 for women; HR 0.79, CI 0.62–1.00 for men; <em>p</em> = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12–2.04; <em>p</em> = 0.007).</p> <h3>Conclusion</h3><p>EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.</p> <h3>Trial Registration</h3><p><a href=\"http://www.ClinicalTrials.gov\">www.ClinicalTrials.gov</a><a href=\"http://www.clinicaltrials.gov/ct2/results?term=NCT00084136\">NCT00084136</a></p> <p> <em>Please see later in the article for the Editors' Summary.</em></p> </div>", "links"=>[], "tags"=>["efficacy", "antiretroviral", "regimens", "randomized", "multinational", "settings"], "article_id"=>121176, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001290.s001", "https://dx.doi.org/10.1371/journal.pmed.1001290.s002", "https://dx.doi.org/10.1371/journal.pmed.1001290.s003", "https://dx.doi.org/10.1371/journal.pmed.1001290.s004", "https://dx.doi.org/10.1371/journal.pmed.1001290.s005", "https://dx.doi.org/10.1371/journal.pmed.1001290.s006", "https://dx.doi.org/10.1371/journal.pmed.1001290.s007", "https://dx.doi.org/10.1371/journal.pmed.1001290.s008", "https://dx.doi.org/10.1371/journal.pmed.1001290.s009", "https://dx.doi.org/10.1371/journal.pmed.1001290.s010", "https://dx.doi.org/10.1371/journal.pmed.1001290.s011", "https://dx.doi.org/10.1371/journal.pmed.1001290.s012", "https://dx.doi.org/10.1371/journal.pmed.1001290.s013", "https://dx.doi.org/10.1371/journal.pmed.1001290.s014", "https://dx.doi.org/10.1371/journal.pmed.1001290.s015", "https://dx.doi.org/10.1371/journal.pmed.1001290.s016", "https://dx.doi.org/10.1371/journal.pmed.1001290.s017", "https://dx.doi.org/10.1371/journal.pmed.1001290.s018", "https://dx.doi.org/10.1371/journal.pmed.1001290.s019"], "stats"=>{"downloads"=>116, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Efficacy_and_Safety_of_Three_Antiretroviral_Regimens_for_Initial_Treatment_of_HIV_1_A_Randomized_Clinical_Trial_in_Diverse_Multinational_Settings/121176", "title"=>"Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-08-14 00:19:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/592610"], "description"=>"<p>(A–H) black circles, EFV plus 3TC-ZDV; red triangles, ATV plus DDI-EC and FTC; green squares, EFV plus FTC-TDF. (A–B) Estimated cumulative probability of antiretroviral regimen failure defined by the protocol-specified primary efficacy endpoint: comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (A) and EFV plus FTC-TDF (B). (C–D) Proportion of participants with plasma HIV-1 RNA less than 400 copies/ml for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (C) and EFV plus FTC-TDF (D). These comparisons included all randomized study participants according to assigned study treatment. The analysis that counted missing values as greater than 400 copies/ml (open symbols) is truncated at the maximum potential duration of study follow-up for participants who entered the study at the end of the enrollment period (144 wk). (E–F) Median change in CD4+ lymphocyte count from screening value over time for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (E) and EFV plus FTC-TDF (F). (G–H) Estimated cumulative probability a safety endpoint over time for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (G) and EFV plus FTC-TDF (H). For (A–D, G and H), bars represent the 95% CI for the estimate. For (E–F), bars represent the interquartile range. (A–H) The number of evaluable participants at each time point is provided for each randomized treatment assignment.</p>", "links"=>[], "tags"=>["randomized"], "article_id"=>263069, "categories"=>["Medicine"], "users"=>["Thomas B. Campbell", "Laura M. Smeaton", "N. Kumarasamy", "Timothy Flanigan", "Karin L. Klingman", "Cynthia Firnhaber", "Beatriz Grinsztejn", "Mina C. Hosseinipour", "Johnstone Kumwenda", "Umesh Lalloo", "Cynthia Riviere", "Jorge Sanchez", "Marineide Melo", "Khuanchai Supparatpinyo", "Srikanth Tripathy", "Ana I. Martinez", "Apsara Nair", "Ann Walawander", "Laura Moran", "Yun Chen", "Wendy Snowden", "James F. Rooney", "Jonathan Uy", "Robert T. Schooley", "Victor De Gruttola", "James Gita Hakim"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001290.g002", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Efficacy_and_safety_of_randomized_study_treatment_over_time_/263069", "title"=>"Efficacy and safety of randomized study treatment over time.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-08-14 00:51:09"}

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