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. Author manuscript; available in PMC: 2009 Apr 27.
Published in final edited form as: N Engl J Med. 2008 Aug 7;359(6):563–574. doi: 10.1056/NEJMoa0800106

Table 4.

Response and Time to Response According to Type of Resistance at Beginning of Individualized Treatment Regimen.

Outcome XDR Tuberculosis (N = 48) MDR Tuberculosis(N = 603) Effect Estimate and P Value*
Response at end of treatment
Good outcome — no. (%) 29 (60.4) 400 (66.3)
 Cured 29 (60.4) 395 (65.6)
 Completed 0 (0.0) 5 (0.8)
Poor outcome — no. (%) 19 (39.6) 198 (32.8) OR, 1.32; 95% CI, 0.72–2.42; P = 0.36
 Defaulted 3 (6.2) 62 (10.3)
 Treatment failed§ 5 (10.4) 13 (2.1)
 Died 11 (22.9) 123 (20.4)
Time to interim response and to response at end of treatment — median (95% CI)
No. of days to culture conversion 90 (57–115) 61 (59–67) HR, 0.63; 95% CI, 0.45–0.89; P = 0.008
No. of months to cure 26.0 (24.6–27.8) 24.8 (24.5–25.2) HR, 0.83; 95% CI, 0.56–1.21; P = 0.33
*

Effect estimates are for the group of patients with extensively drug-resistant (XDR) tuberculosis as compared with the group that had multidrug-resistant (MDR) tuberculosis. The odds ratio (OR) and the hazard ratios (HR) are unadjusted. Outcomes were not available for five patients, all of whom had MDR tuberculosis; four transferred out of the program and one remained in treatment. P values for the OR and the HRs were calculated with the use of the chi-square test.

Patients who completed treatment are defined as those who finished treatment according to protocol but who did not meet the definition for cure or treatment failure owing to lack of bacteriologic results (i.e., fewer than five cultures were grown in the final 12 months of therapy).

Treatment default was defined as the failure of attempts to return to therapy patients who were not adhering to their treatment regimens.

§

Treatment was considered to fail for those patients who had two or more positive cultures among the five cultures recorded in the final 12 months of the study or for whom any one of the final three cultures was positive.