Nevirapine- Versus Lopinavir/Ritonavir-Based Initial Therapy for HIV-1 Infection among Women in Africa: A Randomized Trial
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{"title"=>"Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in africa: A randomized trial", "type"=>"journal", "authors"=>[{"first_name"=>"Shahin", "last_name"=>"Lockman", "scopus_author_id"=>"6603692731"}, {"first_name"=>"Michael", "last_name"=>"Hughes", "scopus_author_id"=>"35358895100"}, {"first_name"=>"Fred", "last_name"=>"Sawe", "scopus_author_id"=>"55555613000"}, {"first_name"=>"Yu", "last_name"=>"Zheng", "scopus_author_id"=>"55713157700"}, {"first_name"=>"James", "last_name"=>"McIntyre", "scopus_author_id"=>"7202924765"}, {"first_name"=>"Tsungai", "last_name"=>"Chipato", "scopus_author_id"=>"6602161201"}, {"first_name"=>"Aida", "last_name"=>"Asmelash", "scopus_author_id"=>"18233666000"}, {"first_name"=>"Mohammed", "last_name"=>"Rassool", "scopus_author_id"=>"36107361200"}, {"first_name"=>"Sylvester", "last_name"=>"Kimaiyo", "scopus_author_id"=>"8338595100"}, {"first_name"=>"Douglas", "last_name"=>"Shaffer", "scopus_author_id"=>"16837329200"}, {"first_name"=>"Mina", "last_name"=>"Hosseinipour", "scopus_author_id"=>"6508221424"}, {"first_name"=>"Lerato", "last_name"=>"Mohapi", "scopus_author_id"=>"24734526800"}, {"first_name"=>"Francis", "last_name"=>"Ssali", "scopus_author_id"=>"8256537300"}, {"first_name"=>"Margret", "last_name"=>"Chibowa", "scopus_author_id"=>"40761313700"}, {"first_name"=>"Farida", "last_name"=>"Amod", "scopus_author_id"=>"24168026500"}, {"first_name"=>"Elias", "last_name"=>"Halvas", "scopus_author_id"=>"6505782531"}, {"first_name"=>"Evelyn", "last_name"=>"Hogg", "scopus_author_id"=>"23008686100"}, {"first_name"=>"Beverly", "last_name"=>"Alston-Smith", "scopus_author_id"=>"8573716100"}, {"first_name"=>"Laura", "last_name"=>"Smith", "scopus_author_id"=>"56390001700"}, {"first_name"=>"Robert", "last_name"=>"Schooley", "scopus_author_id"=>"56876786500"}, {"first_name"=>"John", "last_name"=>"Mellors", "scopus_author_id"=>"7007008426"}, {"first_name"=>"Judith", "last_name"=>"Currier", "scopus_author_id"=>"7006886245"}], "year"=>2012, "source"=>"PLoS Medicine", "identifiers"=>{"sgr"=>"84864695216", "doi"=>"10.1371/journal.pmed.1001236", "pui"=>"365397526", "pmid"=>"22719231", "scopus"=>"2-s2.0-84864695216", "issn"=>"15491676", "isbn"=>"1549-1676 (Electronic)\\n1549-1277 (Linking)"}, "id"=>"41b9672a-d0b5-39fe-8a71-c2f1db381d72", "abstract"=>"BACKGROUND: Nevirapine (NVP) is widely used in antiretroviral treatment (ART) of HIV-1 globally. The primary objective of the AA5208/OCTANE trial was to compare the efficacy of NVP-based versus lopinavir/ritonavir (LPV/r)-based initial ART.\\n\\nMETHODS AND FINDINGS: In seven African countries (Botswana, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe), 500 antiretroviral-naïve HIV-infected women with CD4<200 cells/mm(3) were enrolled into a two-arm randomized trial to initiate open-label ART with tenofovir (TDF)/emtricitabine (FTC) once/day plus either NVP (n = 249) or LPV/r (n = 251) twice/day, and followed for ≥48 weeks. The primary endpoint was time from randomization to death or confirmed virologic failure ([VF]) (plasma HIV RNA<1 log(10) below baseline 12 weeks after treatment initiation, or ≥400 copies/ml at or after 24 weeks), with comparison between treatments based on hazard ratios (HRs) in intention-to-treat analysis. Equivalence of randomized treatments was defined as finding the 95% CI for HR for virological failure or death in the range 0.5 to 2.0. Baseline characteristics were (median): age = 34 years, CD4 = 121 cells/mm(3), HIV RNA = 5.2 log(10)copies/ml. Median follow-up = 118 weeks; 29 (6%) women were lost to follow-up. 42 women (37 VFs, five deaths; 17%) in the NVP and 50 (43 VFs, seven deaths; 20%) in the LPV/r arm reached the primary endpoint (HR 0.85, 95% CI 0.56-1.29). During initial assigned treatment, 14% and 16% of women receiving NVP and LPV/r experienced grade 3/4 signs/symptoms and 26% and 22% experienced grade 3/4 laboratory abnormalities. However, 35 (14%) women discontinued NVP because of adverse events, most in the first 8 weeks, versus none for LPV/r (p<0.001). VF, death, or permanent treatment discontinuation occurred in 80 (32%) of NVP and 54 (22%) of LPV/r arms (HR = 1.7, 95% CI 1.2-2.4), with the difference primarily due to more treatment discontinuation in the NVP arm. 13 (45%) of 29 women tested in the NVP versus six (15%) of 40 in the LPV/r arm had any drug resistance mutation at time of VF.\\n\\nCONCLUSIONS: Initial ART with NVP+TDF/FTC demonstrated equivalent virologic efficacy but higher rates of treatment discontinuation and new drug resistance compared with LPV/r+TDF/FTC in antiretroviral-naïve women with CD4<200 cells/mm(3).\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00089505.", "link"=>"http://www.mendeley.com/research/nevirapine-versus-lopinavirritonavirbased-initial-therapy-hiv1-infection-among-women-africa-randomiz", "reader_count"=>59, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>5, "Librarian"=>3, "Researcher"=>20, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>3, "Student > Master"=>10, "Other"=>3, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>5, "Librarian"=>3, "Researcher"=>20, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>3, "Student > Master"=>10, "Other"=>3, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Agricultural and Biological Sciences"=>6, "Arts and Humanities"=>1, "Business, Management and Accounting"=>2, "Chemistry"=>1, "Computer Science"=>2, "Engineering"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>2, "Mathematics"=>2, "Medicine and Dentistry"=>31, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Social Sciences"=>4}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>31}, "Social Sciences"=>{"Social Sciences"=>4}, "Mathematics"=>{"Mathematics"=>2}, "Unspecified"=>{"Unspecified"=>5}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Engineering"=>{"Engineering"=>1}, "Chemistry"=>{"Chemistry"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Computer Science"=>{"Computer Science"=>2}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}}, "reader_count_by_country"=>{"United States"=>2, "Brazil"=>1, "United Kingdom"=>1, "Kenya"=>1}, "group_count"=>6}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/625169"], "description"=>"a<p>Percent mutation per treatment arm calculated as the number of patients with mutation divided by number of patients with genotype results available.</p>b<p>New minor protease-resistance mutations detected for NVP arm were L10I/V and L63P and for LPV/r arm were K20R and K20M (data not shown).</p>", "links"=>[], "tags"=>["mutations", "virologic"], "article_id"=>295633, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.t003", "stats"=>{"downloads"=>1, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_drug_resistance_mutations_at_time_of_virologic_failure_/295633", "title"=>"Summary of drug resistance mutations at time of virologic failure.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-06-12 01:33:53"}
  • {"files"=>["https://ndownloader.figshare.com/files/625029"], "description"=>"<p>Kaplan-Meier plot of time to early discontinuation of initial randomized treatment for any reason (toxicity, intolerance, VF, death), by randomized treatment arm.</p>", "links"=>[], "tags"=>["discontinuation", "randomized"], "article_id"=>295494, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.g003", "stats"=>{"downloads"=>2, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_plot_of_time_to_early_discontinuation_of_initial_randomized_treatment_for_any_reason_toxicity_intolerance_VF_death_by_randomized_treatment_arm_/295494", "title"=>"Kaplan-Meier plot of time to early discontinuation of initial randomized treatment for any reason (toxicity, intolerance, VF, death), by randomized treatment arm.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-06-12 01:31:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/625292"], "description"=>"<p>Percentages use number of participants with a result as the denominator.</p>a<p>Race was collected as it could potentially be related to treatment response and was reported by the site investigators.</p>b<p>All women had screening CD4<200 cells/mm<sup>3</sup>, but at study entry, 58 women had CD4≥200 cells/mm<sup>3</sup>.</p>c<p>K103N.</p>", "links"=>[], "tags"=>["characteristics", "octane"], "article_id"=>295751, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.t001", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Selected_characteristics_of_OCTANE_trial_2_participants_at_baseline_/295751", "title"=>"Selected characteristics of OCTANE trial 2 participants at baseline.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-06-12 01:35:51"}
  • {"files"=>["https://ndownloader.figshare.com/files/624686"], "description"=>"<p>Per protocol, participants were not mandated to switch regimens in instances of VF (this decision was left to the discretion of study staff and participants). More women experienced VF in the LPV/r arm (43 or 17%) compared with the NVP arm (37 or 15%) in ITT analysis; however, a higher proportion of women experiencing VF in the NVP arm were switched to LPV/r compared with vice versa.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>295146, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.g001", "stats"=>{"downloads"=>1, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Consort_diagram_/295146", "title"=>"Consort diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-06-12 01:25:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/324243", "https://ndownloader.figshare.com/files/324426"], "description"=>"<div><h3>Background</h3><p>Nevirapine (NVP) is widely used in antiretroviral treatment (ART) of HIV-1 globally. The primary objective of the AA5208/OCTANE trial was to compare the efficacy of NVP-based versus lopinavir/ritonavir (LPV/r)-based initial ART.</p> <h3>Methods and Findings</h3><p>In seven African countries (Botswana, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe), 500 antiretroviral-naïve HIV-infected women with CD4<200 cells/mm<sup>3</sup> were enrolled into a two-arm randomized trial to initiate open-label ART with tenofovir (TDF)/emtricitabine (FTC) once/day plus either NVP (<em>n</em> = 249) or LPV/r (<em>n</em> = 251) twice/day, and followed for ≥48 weeks. The primary endpoint was time from randomization to death or confirmed virologic failure ([VF]) (plasma HIV RNA<1 log<sub>10</sub> below baseline 12 weeks after treatment initiation, or ≥400 copies/ml at or after 24 weeks), with comparison between treatments based on hazard ratios (HRs) in intention-to-treat analysis. Equivalence of randomized treatments was defined as finding the 95% CI for HR for virological failure or death in the range 0.5 to 2.0. Baseline characteristics were (median): age = 34 years, CD4 = 121 cells/mm<sup>3</sup>, HIV RNA = 5.2 log<sub>10</sub>copies/ml. Median follow-up = 118 weeks; 29 (6%) women were lost to follow-up. 42 women (37 VFs, five deaths; 17%) in the NVP and 50 (43 VFs, seven deaths; 20%) in the LPV/r arm reached the primary endpoint (HR 0.85, 95% CI 0.56–1.29). During initial assigned treatment, 14% and 16% of women receiving NVP and LPV/r experienced grade 3/4 signs/symptoms and 26% and 22% experienced grade 3/4 laboratory abnormalities. However, 35 (14%) women discontinued NVP because of adverse events, most in the first 8 weeks, versus none for LPV/r (<em>p</em><0.001). VF, death, or permanent treatment discontinuation occurred in 80 (32%) of NVP and 54 (22%) of LPV/r arms (HR = 1.7, 95% CI 1.2–2.4), with the difference primarily due to more treatment discontinuation in the NVP arm. 13 (45%) of 29 women tested in the NVP versus six (15%) of 40 in the LPV/r arm had any drug resistance mutation at time of VF.</p> <h3>Conclusions</h3><p>Initial ART with NVP+TDF/FTC demonstrated equivalent virologic efficacy but higher rates of treatment discontinuation and new drug resistance compared with LPV/r+TDF/FTC in antiretroviral-naïve women with CD4<200 cells/mm<sup>3</sup>.</p> <h3>Trial registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00089505?term=00089505&rank=1\">NCT00089505</a></p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["nevirapine-", "hiv-1", "women", "randomized"], "article_id"=>123975, "categories"=>["Cancer"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001236.s001", "https://dx.doi.org/10.1371/journal.pmed.1001236.s002"], "stats"=>{"downloads"=>10, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Nevirapine_Versus_Lopinavir_Ritonavir_Based_Initial_Therapy_for_HIV_1_Infection_among_Women_in_Africa_A_Randomized_Trial/123975", "title"=>"Nevirapine- Versus Lopinavir/Ritonavir-Based Initial Therapy for HIV-1 Infection among Women in Africa: A Randomized Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-06-12 01:06:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/625221"], "description"=>"<p>Subcolumns may not add up to total number of signs/symptoms or laboratory abnormalities, as participants can experience more than one event.</p>a<p>In the NVP and LPV/r arms, respectively, three and 12 participants experienced grade 2 or higher creatinine elevation, and 34 and 19 of participants experienced grade 2 or higher liver test abnormalities.</p><p>HDL, high-density lipoprotein; LDL, low-density lipoprotein; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase.</p>", "links"=>[], "tags"=>["lipid", "randomized"], "article_id"=>295693, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.t002", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Signs_symptoms_laboratory_abnormalities_diagnoses_and_lipid_results_among_participants_on_their_first_randomized_treatment_regimens_/295693", "title"=>"Signs/symptoms, laboratory abnormalities, diagnoses, and lipid results among participants on their first randomized treatment regimens.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-06-12 01:34:53"}
  • {"files"=>["https://ndownloader.figshare.com/files/624832"], "description"=>"<p>Kaplan-Meier plot of time to primary endpoint (VF or death) by randomized treatment arm.</p>", "links"=>[], "tags"=>["endpoint", "randomized"], "article_id"=>295294, "categories"=>["Infectious Diseases"], "users"=>["Shahin Lockman", "Michael Hughes", "Fred Sawe", "Yu Zheng", "James McIntyre", "Tsungai Chipato", "Aida Asmelash", "Mohammed Rassool", "Sylvester Kimaiyo", "Douglas Shaffer", "Mina Hosseinipour", "Lerato Mohapi", "Francis Ssali", "Margret Chibowa", "Farida Amod", "Elias Halvas", "Evelyn Hogg", "Beverly Alston-Smith", "Laura Smith", "Robert Schooley", "John Mellors", "Judith Currier"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001236.g002", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_plot_of_time_to_primary_endpoint_VF_or_death_by_randomized_treatment_arm_/295294", "title"=>"Kaplan-Meier plot of time to primary endpoint (VF or death) by randomized treatment arm.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-06-12 01:28:14"}

PMC Usage Stats | Further Information

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Relative Metric

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