SETTING:A prison in northern Taiwan. OBJECTIVE: To compare safety and the completion rate of the 4-month daily rifampicin regimen (4R) vs. the standard 6-month daily isoniazid regimen (6H) for latent tuberculosis infection (LTBI) in prison inmates. DESIGN: This was an open-label randomised trial among human immunodeficiency virus negative male inmates. Inmates without active tuberculosis (TB) who tested positive for both the tuberculin skin test and QuantiFERON®-TB Gold In-Tube were eligible, but those with baseline glutamic pyruvic transaminase (GPT) levels ≥120 U/l, bilirubin levels ≥ 2.4 U/l or a platelet count < 150 k/mm(3) were excluded. The primary endpoint was any adverse event that resulted in discontinuation of LTBI treatment. RESULTS:Participants (n = 373; 14% hepatitis B surface antigen positive, 21% anti-hepatitis C virus [HCV] positive) were randomised (stratified by hepatitis B virus, HCV status and 2-year prison term) to receive either 4R or 6H under directly observed treatment. The 4R group (n = 190) was less likely to experience an adverse event leading to discontinuation of treatment (2% vs. 12%, P < 0.001 for all adverse events; 0% vs. 8%, P < 0.001 for hepatotoxicity), and more likely to complete LTBI treatment (86% vs. 78%, P = 0.041), compared with the 6H group (n = 183). CONCLUSIONS: 4R is safer and has a higher completion rate than 6H as treatment for LTBI among male prison inmates.
RCT Entities:
SETTING: A prison in northern Taiwan. OBJECTIVE: To compare safety and the completion rate of the 4-month daily rifampicin regimen (4R) vs. the standard 6-month daily isoniazid regimen (6H) for latent tuberculosis infection (LTBI) in prison inmates. DESIGN: This was an open-label randomised trial among human immunodeficiency virus negative male inmates. Inmates without active tuberculosis (TB) who tested positive for both the tuberculin skin test and QuantiFERON®-TB Gold In-Tube were eligible, but those with baseline glutamic pyruvic transaminase (GPT) levels ≥ 120 U/l, bilirubin levels ≥ 2.4 U/l or a platelet count < 150 k/mm(3) were excluded. The primary endpoint was any adverse event that resulted in discontinuation of LTBI treatment. RESULTS:Participants (n = 373; 14% hepatitis B surface antigen positive, 21% anti-hepatitis C virus [HCV] positive) were randomised (stratified by hepatitis B virus, HCV status and 2-year prison term) to receive either 4R or 6H under directly observed treatment. The 4R group (n = 190) was less likely to experience an adverse event leading to discontinuation of treatment (2% vs. 12%, P < 0.001 for all adverse events; 0% vs. 8%, P < 0.001 for hepatotoxicity), and more likely to complete LTBI treatment (86% vs. 78%, P = 0.041), compared with the 6H group (n = 183). CONCLUSIONS:4R is safer and has a higher completion rate than 6H as treatment for LTBI among male prison inmates.
Authors: Fiona G Kouyoumdjian; Kathryn E McIsaac; Jessica Liauw; Samantha Green; Fareen Karachiwalla; Winnie Siu; Kaite Burkholder; Ingrid Binswanger; Lori Kiefer; Stuart A Kinner; Mo Korchinski; Flora I Matheson; Pam Young; Stephen W Hwang Journal: Am J Public Health Date: 2015-02-25 Impact factor: 9.308
Authors: Robert Belknap; David Holland; Pei-Jean Feng; Joan-Pau Millet; Joan A Caylà; Neil A Martinson; Alicia Wright; Michael P Chen; Ruth N Moro; Nigel A Scott; Bert Arevalo; José M Miró; Margarita E Villarino; Marc Weiner; Andrey S Borisov Journal: Ann Intern Med Date: 2017-11-07 Impact factor: 25.391
Authors: Timothy R Sterling; Gibril Njie; Dominik Zenner; David L Cohn; Randall Reves; Amina Ahmed; Dick Menzies; C Robert Horsburgh; Charles M Crane; Marcos Burgos; Philip LoBue; Carla A Winston; Robert Belknap Journal: MMWR Recomm Rep Date: 2020-02-14
Authors: Sasha R Fehily; Aysha H Al-Ani; Jonathan Abdelmalak; Clarissa Rentch; Eva Zhang; Justin T Denholm; Douglas Johnson; Siew C Ng; Vishal Sharma; David T Rubin; Peter R Gibson; Britt Christensen Journal: Aliment Pharmacol Ther Date: 2022-05-20 Impact factor: 9.524