At present, discontinuation of primary prophylaxis for PCP, toxoplasmosis, and MAC after an adequate response to HAART is recommended as safe (AI recommendation) according to the 2001 USPHS/IDSA guidelines (available at http://www.hivatis.org). Secondary prophylaxis refers to the use of prophylactic agents to prevent a recurrence of disease once a patient has been adequately treated for the primary episode. Discontinuation of secondary prophylaxis after an adequate response to HAART is supported by fewer data, and is a BII recommendation for PCP and a CIII recommendation for toxoplasmosis and MAC. Data presented at the 9th CROI lend support to discontinuing secondary prophylaxis after an adequate response to HAART, although recurrences of disease do occasionally occur.

Mussini and colleagues reported three relapses among 58 patients with cryptococcal meningitis when secondary prophylaxis was discontinued [Abstract 635-W]. However, scrutiny of the three cases showed that the etiologic diagnosis was based only on recurrence of cryptococcal antigen in serum, and others have concluded this antigen assay is not a good test for long term follow-up of cryptococcosis. Bertschy and co-workers reported a relapse of toxoplasmosis in one of 14 patients after secondary prophylaxis was discontinued [Abstract 633-W]. Discontinuation of secondary prophylaxis for cryptococcosis and MAC after immune reconstitution also appears to be safe, although there are rare breakthroughs. Aberg reported results from ACTG 393, in which 48 patients discontinued secondary prophylaxis for MAC [Abstract 634-W]. There was one case (2%) of MAC osteomyelitis of the rib at 16 months in a patient with a CD4 count of 244 cells/mm³, which represents a recurrence but should probably be considered a manifestation of “the immune reconstitution syndrome.” Burman reported 24-month follow-up data on 520 patients with a median CD4 count of 261 cells/mm³ after a median nadir of 24 cells/mm³ [Abstract 631-W]. There were 17 deaths, but 12 were unrelated to HIV. One patient developed MAC bacteremia, but only after the CD4 count decreased to 21 cells/mm³.

Data continue to confirm that HAART-induced immune reconstitution leads to protection from OIs, with only occasional exceptions. Koletar and colleagues provided data on 643 patients who were followed for a median of 153 weeks after discontinuing MAC prophylaxis when the CD4 count increased from <50 to >250 cells/mm³ [Abstract 630-W]. The subsequent increase in CD4 count correlated with viral suppression: There was a median increase of 9 cells/mm³ every 8 weeks in patients with undetectable viral loads vs no change in patients with consistently detectable viral loads. There were 27 AIDS-defining events, including 10 in patients with CD4 counts >200 cells/mm³, 3 with presumed PCP, 2 with CMV, and 2 with cryptosporidiosis.

With rare exceptions, the results of these studies add to an already robust database that demonstrates that viral suppression and CD4 rebound substantially reduce the risk of HIV-associated complications.

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