FDA approves tuberculosis drug

BMJ 1998; 317 doi: (Published 04 July 1998) Cite this as: BMJ 1998;317:11
  1. Deborah Josefson
  1. San Francisco

    The US Food and Drug Administration has approved rifapentine (Priftin)—the first new antituberculosis drug to be licensed in 25 years.

    Rifapentine is indicated for pulmonary tuberculosis but must be used in conjunction with other antituberculosis drugs. It is expected to increase patient compliance because it has a shorter treatment course than conventional drugs.

    Current treatment regimens for active pulmonary tuberculosis require a minimum of 6–9 months of treatment with at least three drugs, which usually include isoniazid, rifampicin, and pyrazinamide. Treatment can last over a year in recalcitrant cases. Because the regimen is complicated and lengthy, patient compliance is problematic and treatment errors are common. These factors contribute to the emergence of multidrug resistant strains of tuberculosis.

    Like rifampicin, rifapentine is given twice a week for two months in the intensive first phase of treatment, when daily isoniazid, pyrazinamide, and ethambutol are also required. However, in the next four months of treatment, one dose of rifapentine once a week is sufficient, as opposed to a twice weekly dose of rifampicin. Although this regimen still seems complicated, it is expected to increase compliance and reduce costs associated with directly observed treatment.

    Clinical studies on rifapentine in which the drug was substituted for rifampicin in combination therapy showed that the drug was associated with a higher relapse rate than standard treatment, with 10% of patients taking the rifapentine combination relapsing, compared with 5% taking rifampicin. However, this higher relapse rate is expected to be offset by greater compliance.

    The United States is the first country to approve rifapentine, but the largest market for the drug is likely to be in developing countries—however they may be unable to afford it.

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