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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings
PLoS Medicine, Volume 9, No. 8, Article e1001290, Year 2012
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Description
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:http://www.ClinicalTrials.gov NCT00084136. © 2012.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s002.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s003.docx
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s004.docx
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s005.docx
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s006.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s007.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s008.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s009.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s010.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s011.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s012.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s013.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s014.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s015.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s016.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s017.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s018.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3419182/bin/pmed.1001290.s019.pdf
Authors & Co-Authors
Campbell, Thomas B.
Unknown Affiliation
Smeaton, Laura M.
Unknown Affiliation
Kumarasamy, Nagalingeswaran
Unknown Affiliation
Flanigan, Timothy Palen
Unknown Affiliation
Klingman, Karin L.
Unknown Affiliation
Firnhaber, Cynthia S.
Unknown Affiliation
Grinsztejn, Beatriz Gilda Jegerhorn
Unknown Affiliation
Hosseinipour, Mina C.
Unknown Affiliation
Kumwenda, Johnstone J.
Unknown Affiliation
Lalloo, Umesh Gangaram
Unknown Affiliation
Riviere, Cynthia
Unknown Affiliation
Sánchez, Jorge L.
Unknown Affiliation
Melo, Marineide Gonçalves De
Unknown Affiliation
Supparatpinyo, Khuanchai
Unknown Affiliation
Tripathy, Srikanth P.
Unknown Affiliation
Martinez, Ana Isabel
Unknown Affiliation
Nair, Apsara
Unknown Affiliation
Walawander, Ann L.
Unknown Affiliation
Moran, Laura
Unknown Affiliation
Chen, Yun
Unknown Affiliation
Snowden, Wendy B.
Unknown Affiliation
Rooney, James F.
Unknown Affiliation
Uy, Jonathan P.
Unknown Affiliation
Schooley, Robert Turner
Unknown Affiliation
Gruttola, Victor De
Unknown Affiliation
Hakim, James Gita
Unknown Affiliation
Swann, Edith M.
Unknown Affiliation
Barnett, Ronald L.
Unknown Affiliation
Brizz, Barbara
Unknown Affiliation
Delph, Yvette
Unknown Affiliation
Gettinger, Nikki
Unknown Affiliation
Mitsuyasu, Ronald T.
Unknown Affiliation
Eshleman, Susan H.
Unknown Affiliation
Safren, Steven A.
Unknown Affiliation
Fiscus, Susan A.
Unknown Affiliation
Andrade, Adriana S.A.
Unknown Affiliation
Haas, David William
Unknown Affiliation
Amod, Farida C.
Unknown Affiliation
Berthaud, Vladimir
Unknown Affiliation
Bollinger, Robert Cyril
Unknown Affiliation
Bryson, Yvonne J.
Unknown Affiliation
Celentano, David D.
Unknown Affiliation
Chilongozi, David A.T.
Unknown Affiliation
Cohen, Myron S.
Unknown Affiliation
Collier, Ann C.
Unknown Affiliation
Currier, Judith Silverstein
Unknown Affiliation
Cu-Uvin, Susan
Unknown Affiliation
Eron, Joseph J.
Unknown Affiliation
Flexner, Charles W.
Unknown Affiliation
Gallant, Joel E.
Unknown Affiliation
Gulick, Roy M.
Unknown Affiliation
Hammer, Scott M.
Unknown Affiliation
Hoffman, Irving F.
Unknown Affiliation
Kazembe, Peter Nicholas
Unknown Affiliation
Kumwenda, Newton I.
Unknown Affiliation
Lama, Javier R.
Unknown Affiliation
Lawrence, Jody
Unknown Affiliation
Maponga, Charles Chiedza
Unknown Affiliation
Martinson, Francis E.A.
Unknown Affiliation
Mayer, Kenneth H.
Unknown Affiliation
Nielsen-Saines, Karin A.
Unknown Affiliation
Pendame, Richard B.
Unknown Affiliation
Ramratnam, Bharat
Unknown Affiliation
Sanne, Ian
Unknown Affiliation
Sévère, Patrice D.
Unknown Affiliation
Sirisanthana, Thira
Unknown Affiliation
Solomon, Suniti S.
Unknown Affiliation
Tabet, Steve
Unknown Affiliation
Taha, Taha E.
Unknown Affiliation
van der Horst, Charles Michael
Unknown Affiliation
Wanke, Christine A.
Unknown Affiliation
Gormley, Joan
Unknown Affiliation
Marcus, Cheryl J.
Unknown Affiliation
Putnam, Beverly
Unknown Affiliation
Ntshele, Smanga
Unknown Affiliation
Loeliger, Edde
Unknown Affiliation
Pappa, Keith A.
Unknown Affiliation
Webb, Nancy
Unknown Affiliation
Shugarts, David L.
Unknown Affiliation
Winters, Mark A.
Unknown Affiliation
Descallar, Renard S.
Unknown Affiliation
Steele, Joseph
Unknown Affiliation
Wulfsohn, Michael
Unknown Affiliation
Said, Farideh
Unknown Affiliation
Chen, Yue
Unknown Affiliation
Martin, John C.
Unknown Affiliation
Bischofberger, Norbert
Unknown Affiliation
Cheng, Andrew K.
Unknown Affiliation
Jaffe, Howard S.
Unknown Affiliation
Sharma, Jabin
Unknown Affiliation
Poongulali, Selvamuthu
Unknown Affiliation
Cardoso, Sandra Wagner
Unknown Affiliation
Faria, Deise Lucia
Unknown Affiliation
Berendes, Sima
Unknown Affiliation
Burke, Kelly
Unknown Affiliation
Mngqibisa, Rosie
Unknown Affiliation
Kanyama, Cecilia C.
Unknown Affiliation
Kayoyo, Virginia M.
Unknown Affiliation
Samaneka, Wadzanai P.
Unknown Affiliation
Chisada, Anthony
Unknown Affiliation
Statistics
Citations: 126
Authors: 100
Affiliations: 51
Identifiers
Doi:
10.1371/journal.pmed.1001290
ISSN:
15491277
e-ISSN:
15491676
Research Areas
Environmental
Infectious Diseases
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study
Participants Gender
Male
Female