Document Detail


Three months of rifapentine and isoniazid for latent tuberculosis infection.
MedLine Citation:
PMID:  22150035     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Treatment of latent Mycobacterium tuberculosis infection is an essential component of tuberculosis control and elimination. The current standard regimen of isoniazid for 9 months is efficacious but is limited by toxicity and low rates of treatment completion.
METHODS: We conducted an open-label, randomized noninferiority trial comparing 3 months of directly observed once-weekly therapy with rifapentine (900 mg) plus isoniazid (900 mg) (combination-therapy group) with 9 months of self-administered daily isoniazid (300 mg) (isoniazid-only group) in subjects at high risk for tuberculosis. Subjects were enrolled from the United States, Canada, Brazil, and Spain and followed for 33 months. The primary end point was confirmed tuberculosis, and the noninferiority margin was 0.75%.
RESULTS: In the modified intention-to-treat analysis, tuberculosis developed in 7 of 3986 subjects in the combination-therapy group (cumulative rate, 0.19%) and in 15 of 3745 subjects in the isoniazid-only group (cumulative rate, 0.43%), for a difference of 0.24 percentage points. Rates of treatment completion were 82.1% in the combination-therapy group and 69.0% in the isoniazid-only group (P<0.001). Rates of permanent drug discontinuation owing to an adverse event were 4.9% in the combination-therapy group and 3.7% in the isoniazid-only group (P=0.009). Rates of investigator-assessed drug-related hepatotoxicity were 0.4% and 2.7%, respectively (P<0.001).
CONCLUSIONS: The use of rifapentine plus isoniazid for 3 months was as effective as 9 months of isoniazid alone in preventing tuberculosis and had a higher treatment-completion rate. Long-term safety monitoring will be important. (Funded by the Centers for Disease Control and Prevention; PREVENT TB ClinicalTrials.gov number, NCT00023452.).
Authors:
Timothy R Sterling; M Elsa Villarino; Andrey S Borisov; Nong Shang; Fred Gordin; Erin Bliven-Sizemore; Judith Hackman; Carol Dukes Hamilton; Dick Menzies; Amy Kerrigan; Stephen E Weis; Marc Weiner; Diane Wing; Marcus B Conde; Lorna Bozeman; C Robert Horsburgh; Richard E Chaisson;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The New England journal of medicine     Volume:  365     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2011-12-14     Completed Date:  2011-12-20     Revised Date:  2012-04-13    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2155-66     Citation Subset:  AIM; IM    
Affiliation:
Vanderbilt University School of Medicine, Nashville, TN, USA. timothy.sterling@vanderbilt.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00023452
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MeSH Terms
Descriptor/Qualifier:
Adult
Antitubercular Agents / administration & dosage*,  adverse effects
Directly Observed Therapy
Drug Administration Schedule
Drug Therapy, Combination
Follow-Up Studies
Humans
Intention to Treat Analysis
Isoniazid / administration & dosage*,  adverse effects
Male
Middle Aged
Prospective Studies
Rifampin / administration & dosage,  adverse effects,  analogs & derivatives*
Risk Factors
Self Administration
Tuberculosis / drug therapy,  epidemiology,  prevention & control*
Virus Latency
Chemical
Reg. No./Substance:
0/Antitubercular Agents; 13292-46-1/Rifampin; 54-85-3/Isoniazid; 61379-65-5/rifapentine
Investigator
Investigator/Affiliation:
Timothy R Sterling / ; M Elsa Villarino / ; Andrey S Borisov / ; Nong Shang / ; Fred Gordin / ; Awal Khan / ; Judith Hackman / ; Carol Dukes Hamilton / ; Dick Menzies / ; Amy Kerrigan / ; C Robert Horsburgh / ; Richard E Chaisson / ; George McSherry / ; Bert Arevalo / ; Stephen E Weis / ; Michel Fernandez / ; Barbara King / ; Lee Turk / ; Norma Shafer / ; Gloria Stevenson / ; Guadalupe Bayona / ; Randy Dean / ; Joseph Helal / ; Gerry Burgess / ; Marcus B Conde / ; Fernanda C Q Mello / ; Anne Efron / ; Carla Loredo / ; Millene Barty S Fortuna / ; Michelle Cailleaux-Cezar / ; Renata L Guerra / ; Gisele Mota / ; Cristina Felix / ; Afranio Kritski / ; Valéria de Oliveira / ; Claudeci dos Santos Sacramento / ; Richard Wing / ; Diane Wing / ; Diana Valenzuela / ; Josefina Gonzalez / ; Juan Uribe / ; Brian R Smith / ; Marc Weiner / ; Melissa Engle / ; Jose A Jimenez / ; Hipolito Pavon / ; Victoria Rodriguez / ; Kevin B West / ; David Dooley / ; Duane Hospenthal / ; Timothy Sterling / ; Linda R Hammock / ; Amy Kerrigan / ; Belinda Redd / ; Ingrid Montgomery / ; Kathleen Miller / ; Brenda E Jones / ; Patricio Escalante / ; Peregrina Molina / ; Claudia Silva / ; Angela Grbic / ; Maria Brown / ; Bonifacia Oamar / ; Ermelinda Rayos / ; Celia Luken / ; Neil W Schluger / ; Joseph Burzynski / ; Vilma Lozano / ; Magda Wolk / ; Bonita T Mangura / ; Lee B Reichman / ; George McSherry / ; Alfred Lardizabal / ; Maria Corazon Leus / ; Marilyn Owens / ; Eileen Napolitano / ; Laurie Kellert / ; Veronica Anokute / ; William Burman / ; Randall Reves / ; Robert Belknap / ; David Cohn / ; Jan Tapy / ; Grace Sanchez / ; Laurie Luna / ; Antonino Catanzaro / ; Philip LoBue / ; Kathleen Moser / ; Mark Tracy / ; Peach Francisco / ; Judy Davis / ; Richard I Menzies / ; Kevin Schwartzman / ; Christina Greenaway / ; Larry Lands / ; Sharyn Mannix / ; Paul Brassard / ; Bérénice Mortezai / ; Barry Rabinovitch / ; Marthe Pelletier / ; Chantal Valiquette / ; Joanne Tremblay / ; Paul Anglade Plaisir / ; Rebecca Binet / ; Masa Narita / ; Charles M Nolan / ; Stefan Goldberg / ; Debra Schwartz / ; Linh Deretsky / ; Marcia Stone / ; Connie Friedly / ; Joan A Cayla / ; Jose M Miró / ; Maria Antonia Sambeat / ; Jose L López Colomés / ; José A Martinez / ; Xavier Martinez-Lacasa / ; Angels Orcau / ; Paquita Sanchez / ; Cecilia Tortajada / ; Imma Ocana / ; Juan P Millet / ; Antonio Moreno / ; Jeanne Nelson / ; Omar Sued / ; Ma Luiza de Souza / ; María A Jiménez / ; Lucía del Baño / ; Laia Fina / ; Payam Nahid / ; Philip Hopewell / ; Charles Daley / ; Robert Jasmer / ; Cindy Merrifield / ; William Stanton / ; Irina Rudoy / ; Jill Israel / ; Richard Chaisson / ; Susan Dorman / ; Jim Fisher / ; Gina Maltas / ; Judith Hackman / ; Carol Dukes Hamilton / ; Jason Stout / ; Ann Mosher / ; Emily J Hecker / ; Brenda Ho / ; Elle Rich / ; John Bernardo / ; Jussi Saukkonen / ; Claire Murphy / ; Denise Brett-Curran / ; Constance T Pachucki / ; Anna Lee / ; Susan Marantz / ; Mary Poly Samuel / ; Ana Zulaga / ; Wafaa M El-Sadr / ; Mary Klein / ; Cyrus Badshah / ; John Salazar Schicchi / ; Yael Hirsh-Moverman / ; Susan M Ray / ; David P Holland / ; Deirdre Dixon / ; Omar Mohamed / ; Kanoa Folami / ; Jane Bush / ; Cheryl D Simpson / ; Gibson Barika / ; Wenona N Favors / ; Nicole Snow / ; Mondira Bhattacharya / ; Susan Lippold / ; William Clapp / ; Julie Fabre / ; J Mark Fitzgerald / ; Kevin Elwood / ; Edwardo Hernandez / ; Banafsheh Peyvandi / ; Kadria Alasaly / ; Iram Bakhtawar / ; Frank Wilson / ; Pauline Wassler / ; Annette Arnold / ; Kathy Haden / ; Jamie Owen / ; Wayne Kepron / ; Earl Hershfield / ; Marian Roth / ; Gerry A Izon / ; Elizabeth Guy / ; Christopher Lahart / ; Terry Scott / ; Ruby Nickson / ; Fred Gordin / ; Debra Benator / ; Donna S Conwell / ; Rany Condos / ; William Rom / ; Laurie Sandman / ; Amina Ahmed / ; James Horton / ; Jennifer West / ; Elizabeth Quinn /
Comments/Corrections
Comment In:
N Engl J Med. 2011 Dec 8;365(23):2230-1   [PMID:  22150042 ]
N Engl J Med. 2012 Apr 12;366(15):1447-8; author reply 1448   [PMID:  22494128 ]
N Engl J Med. 2012 Apr 12;366(15):1447; author reply 1448   [PMID:  22494127 ]

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