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Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter Clinical Trial

Robert M. Jasmer, MD; Jussi J. Saukkonen, MD; Henry M. Blumberg, MD; Charles L. Daley, MD; John Bernardo, MD; Eric Vittinghoff, PhD; Mark D. King, MD; L. Masae Kawamura, MD; Philip C. Hopewell, MD, Short-Course Rifampin and Pyrazinamide for Tuberculosis Infection (SCRIPT) Study Investigators*
[+] Article and Author Information

From San Francisco General Hospital Medical Center, University of California, San Francisco, and Francis J. Curry National Tuberculosis Center, San Francisco, California; Boston University School of Medicine, Boston, Massachusetts; and Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia.


Grant Support: By the National Institutes of Health (AI 01549, HL 62977, HL 03035, HL 03078, and HL 03057) and the Emory Medical Care Foundation.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Robert M. Jasmer, MD, Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, Room 5K-1, 1001 Potrero Avenue, San Francisco, CA 94110; e-mail, rjasmer@itsa.ucsf.edu.

Current Author Addresses: Drs. Jasmer, Daley, and Hopewell: Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, Room 5K-1, 1001 Potrero Avenue, San Francisco, CA 94110.

Drs. Saukkonen and Bernardo: Division of Pulmonary and Critical Care Medicine, Boston University School of Medicine, 80 East Concord Street, Room 304, Boston, MA 02118.

Drs. Blumberg and King: Division of Infectious Diseases, Emory University, 69 Butler Street, Atlanta, GA 30303.

Dr. Vittinghoff: Department of Epidemiology and Biostatistics, University of California, San Francisco, 74 New Montgomery, Suite 600, San Francisco, CA 94105.

Dr. Kawamura: Department of Public Health, Tuberculosis Control Section, 1001 Potrero Avenue, Building 90, Room WD94, San Francisco, CA 94110.

Author Contributions: Conception and design: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, C.L. Daley, J. Bernardo, M.D. King, P.C. Hopewell.

Analysis and interpretation of the data: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, J. Bernardo, E. Vittinghoff, P.C. Hopewell.

Drafting of the article: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, C.L. Daley, J. Bernardo, E. Vittinghoff, M.D. King, P.C. Hopewell.

Critical revision of the article for important intellectual content: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, C.L. Daley, J. Bernardo, E. Vittinghoff, M.D. King, L.M. Kawamura, P.C. Hopewell.

Final approval of the article: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, C.L. Daley, J. Bernardo, E. Vittinghoff, M.D. King, L.M. Kawamura, P.C. Hopewell.

Provision of study materials or patients: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, C.L. Daley, J. Bernardo, M.D. King, L.M. Kawamura.

Statistical expertise: R.M. Jasmer, E. Vittinghoff.

Obtaining of funding: R.M. Jasmer, H.M. Blumberg, M.D. King, P.C. Hopewell.

Administrative, technical, or logistic support: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, J. Bernardo, M.D. King, L.M. Kawamura, P.C. Hopewell.

Collection and assembly of data: R.M. Jasmer, J.J. Saukkonen, H.M. Blumberg, J. Bernardo, M.D. King.


Ann Intern Med. 2002;137(8):640-647. doi:10.7326/0003-4819-137-8-200210150-00007
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In a group comprising mostly foreign-born adults without HIV infection, 2 months of therapy with rifampin and pyrazinamide for treatment of latent tuberculosis infection was associated with a statistically significantly higher risk for hepatotoxicity than was 6 months of isoniazid therapy. Because of its association with grades 3 and 4 hepatotoxicity, treatment with rifampin and pyrazinamide was also more likely than isoniazid treatment to be discontinued as a result of hepatotoxicity. Although the proportion of nonhepatotoxic adverse events was similar between the two regimens, treatment was discontinued in statistically significantly more recipients of rifampin and pyrazinamide than isoniazid recipients. In addition, although the duration of treatment with rifampin and pyrazinamide was 4 months shorter than that of isoniazid treatment, the percentage of patients who completed treatment was similar in both groups.

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Figure 1.
Flow of patients through the study.

Fifteen of 604 patients were excluded. The proportion of patients for whom follow-up data were available was similar in the isoniazid group and the rifampin plus pyrazinamide group (89.0% vs. 89.2%, respectively).

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Figure 2.
Completion of therapy for latent tuberculosis infection in patients assigned to receive rifampin and pyrazinamide or isoniazid.P

Patients lost to follow-up were those in whom no follow-up data on adherence were available. Treatment was prescribed for 2 months for patients assigned to rifampin and pyrazinamide and 6 months for those assigned to isoniazid. The proportion of patients who completed treatment did not significantly differ between the two groups, even after adjustment for site, age older than 35 years, sex, place of birth, medical conditions, hepatotoxicity, and other adverse events (odds ratio, 1.32 [95% CI, 0.92 to 1.90]; = 0.13).

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Summary for Patients

Short-Course Treatment for Latent Tuberculosis Is Associated with More Frequent Liver Injury Than Long-Course Treatment Is

The summary below is from the full report titled “Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter Clinical Trial.” It is in the 15 October 2002 issue of Annals of Internal Medicine (volume 137, pages 640-647). The authors are RM Jasmer, JJ Saukkonen, HM Blumberg, CL Daley, J Bernardo, E Vittinghoff, MD King, LM Kawamura, and PC Hopewell, for the Short-Course Rifampin and Pyrazinamide for Tuberculosis Infection (SCRIPT) Study Investigators.

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