To estimate incidence and mortality of TB disease in Spain, as well as TB recurrence and its mortality, and to analyse its trend from 1997 to 2010 in human immunodeficiency virus (HIV)-infected patients (HIV(+) group), compared to HIV-uninfected subjects (HIV(−) group).

We performed a retrospective study using data from Minimum Basic Data Set. The outcome variables were new TB diagnosis, TB recurrences, and mortality; which were analysed through three calendar periods related to widespread use of combination antiretroviral therapy (cART): a) From 1997 to 1999 for early-period cART; b) from 2000 to 2003 for mid-period cART; and c) from 2004 to 2008 for late-period cART.

We studied 86,093 HIV-uninfected patients and 17,031 HIV infected patients. TB diagnosis in HIV(−) group (events per 100,000 patients-yr) decreased from 20.16 (1997–1999) to 16.31 (2000–2003; p < 0.001), and later to 13.48 (2004–2010; p < 0.001); and among HIV(+) group (events per 1000 patients-yr) it decreased from 19.23 (1997–1999) to 10.93 (2000–2003; p < 0.001), and later to 6.35 (2004–2010; p < 0.001). For the mortality, HIV(−) group (events per 1,000,000 patients-yr) decreased from 11.5 (1997–1999) to 9.8 (2000–2003; p < 0.001), and later to 7.2 (2004–2010; p < 0.001); and HIV(+) group (events per 10,000 patients-yr) decreased from 20.69 (1997–1999) to 13.20 (2000–2003; p < 0.001), and later to 6.83 (2004–2010; p < 0.001). During the whole period, the diagnostic rate and mortality of TB remained 100-fold higher in HIV(+) group than HIV(−) group (p < 0.001). Moreover, HIV (+) group had higher percentage of patients with TB recurrence than HIV(−) group (p < 0.001).

TB diagnosis and mortality decreased in Spain between 1997 and 2010, in both HIV infected patients and people without HIV infection; but these rates remained higher in HIV infected patients.