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Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study.
Clin Infect Dis. 2015 Aug 15; 61(4):527-35.CI

Abstract

BACKGROUND

Weekly rifapentine plus isoniazid for 3 months (3HP) is as effective as daily isoniazid for 9 months (9H) for latent tuberculosis infection in high-risk persons, but there have been reports of possible flu-like syndrome.

METHODS

We identified clinically significant systemic drug reactions (SDR) and evaluated risk factors in patients who did not complete treatment in the PREVENT Tuberculosis study.

RESULTS

Among 7552 persons who received ≥ 1 dose of study drug, 153 had a SDR: 138/3893 (3.5%) with 3HP vs 15/3659 (0.4%) with 9H (P < .001). In the 3HP arm, 87 (63%) had flu-like syndrome and 23 (17%) had cutaneous reactions; 13/3893 (0.3%) had severe reactions (6 were hypotensive) and 6 reported syncope. Symptoms occurred after a median of 3 doses, and 4 hours after the dose; median time to resolution was 24 hours. There were no deaths. In multivariate logistic regression analysis, factors independently associated with SDR included receipt of 3HP (adjusted odds ratio [aOR] 9.4; 95% confidence interval [CI], 5.5, 16.2), white non-Hispanic race/ethnicity (aOR 3.3; 95% CI, 2.3, 4.7), female sex (aOR 2.0; 95% CI, 1.4, 2.9), age ≥ 35 years (aOR 2.0; 95% CI, 1.4, 2.9), and lower body mass index (body mass index [BMI]; P = .009). In a separate multivariate analysis among persons who received 3HP, severe SDR were associated with white non-Hispanic race/ethnicity (aOR 5.4; 95% CI, 1.8, 16.3), and receipt of concomitant non-study medications (aOR 5.9; 95% CI, 1.3, 27.1).

CONCLUSIONS

SDR were more common with 3HP, and mostly flu-like. Persons of white race, female sex, older age, and lower BMI were at increased risk. Severe reactions were rare and associated with 3HP, concomitant medication, and white race. The underlying mechanism is unclear.

CLINICAL TRIALS REGISTRATION

NCT00023452.

Authors+Show Affiliations

Vanderbilt University School of Medicine, Nashville, Tennessee.Centers for Disease Control and Prevention CDC Foundation, Research Collaboration, Atlanta, Georgia.Centers for Disease Control and Prevention.Vanderbilt University School of Medicine, Nashville, Tennessee Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Australia.New York-Presbyterian Hospital/Weill Cornell Medical Center, New York.Johns Hopkins University School of Medicine, Baltimore, Maryland.University of North Texas Health Science Center at Ft. Worth.Centers for Disease Control and Prevention.Centers for Disease Control and Prevention.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

25904367

Citation

Sterling, Timothy R., et al. "Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 61, no. 4, 2015, pp. 527-35.
Sterling TR, Moro RN, Borisov AS, et al. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015;61(4):527-35.
Sterling, T. R., Moro, R. N., Borisov, A. S., Phillips, E., Shepherd, G., Adkinson, N. F., Weis, S., Ho, C., & Villarino, M. E. (2015). Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 61(4), 527-35. https://doi.org/10.1093/cid/civ323
Sterling TR, et al. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015 Aug 15;61(4):527-35. PubMed PMID: 25904367.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. AU - Sterling,Timothy R, AU - Moro,Ruth N, AU - Borisov,Andrey S, AU - Phillips,Elizabeth, AU - Shepherd,Gillian, AU - Adkinson,Newton Franklin, AU - Weis,Stephen, AU - Ho,Christine, AU - Villarino,Margarita Elsa, AU - ,, Y1 - 2015/04/22/ PY - 2014/10/02/received PY - 2015/04/12/accepted PY - 2015/4/24/entrez PY - 2015/4/24/pubmed PY - 2016/4/22/medline KW - adverse drug reaction KW - flu-like syndrome KW - isoniazid KW - rifapentine KW - treatment of latent M. tuberculosis infection SP - 527 EP - 35 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 61 IS - 4 N2 - BACKGROUND: Weekly rifapentine plus isoniazid for 3 months (3HP) is as effective as daily isoniazid for 9 months (9H) for latent tuberculosis infection in high-risk persons, but there have been reports of possible flu-like syndrome. METHODS: We identified clinically significant systemic drug reactions (SDR) and evaluated risk factors in patients who did not complete treatment in the PREVENT Tuberculosis study. RESULTS: Among 7552 persons who received ≥ 1 dose of study drug, 153 had a SDR: 138/3893 (3.5%) with 3HP vs 15/3659 (0.4%) with 9H (P < .001). In the 3HP arm, 87 (63%) had flu-like syndrome and 23 (17%) had cutaneous reactions; 13/3893 (0.3%) had severe reactions (6 were hypotensive) and 6 reported syncope. Symptoms occurred after a median of 3 doses, and 4 hours after the dose; median time to resolution was 24 hours. There were no deaths. In multivariate logistic regression analysis, factors independently associated with SDR included receipt of 3HP (adjusted odds ratio [aOR] 9.4; 95% confidence interval [CI], 5.5, 16.2), white non-Hispanic race/ethnicity (aOR 3.3; 95% CI, 2.3, 4.7), female sex (aOR 2.0; 95% CI, 1.4, 2.9), age ≥ 35 years (aOR 2.0; 95% CI, 1.4, 2.9), and lower body mass index (body mass index [BMI]; P = .009). In a separate multivariate analysis among persons who received 3HP, severe SDR were associated with white non-Hispanic race/ethnicity (aOR 5.4; 95% CI, 1.8, 16.3), and receipt of concomitant non-study medications (aOR 5.9; 95% CI, 1.3, 27.1). CONCLUSIONS: SDR were more common with 3HP, and mostly flu-like. Persons of white race, female sex, older age, and lower BMI were at increased risk. Severe reactions were rare and associated with 3HP, concomitant medication, and white race. The underlying mechanism is unclear. CLINICAL TRIALS REGISTRATION: NCT00023452. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/25904367/Flu_like_and_Other_Systemic_Drug_Reactions_Among_Persons_Receiving_Weekly_Rifapentine_Plus_Isoniazid_or_Daily_Isoniazid_for_Treatment_of_Latent_Tuberculosis_Infection_in_the_PREVENT_Tuberculosis_Study_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/civ323 DB - PRIME DP - Unbound Medicine ER -