The Body Covers: The 39th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Session 93.I: Late-Breaker Slide Session II: Two Studies of Discontinuing Prophylaxis:
September 27, 1999
Both of these studies deal with the same issue -- if someone had CD4 cells that were low enough to start prophylaxis, and then have an increase on antivirals, can we trust the CD4 count and stop the prophylaxis if the count goes high enough? The answer from both appears to be yes.Abstract: Discontinuation of PCP Prophylaxis Is Safe in HIV-Infected Patients After Immunological Recovery With HAART (Paper LB-24)
The first study was done for those whose CD4 counts went below 50 at some point, and now had a CD4 count over 100 as a result of effective antivirals. At entry, the CD4 count was an average of 226, and about 66% had a viral load below 500 copies. All were randomized to receive either azithromycin at the standard dose of 1200 mg once a week, or a placebo. Blood cultures for Mycobacterium avium complex were done every 8 weeks in the 643 people who entered this study. After about one year of follow up, the results showed only 2 cases of MAC in those on placebo, and none in those on azithromycin. These results suggests a less than 1% risk of developing MAC infection when not taking prophylaxis -- and suggest strongly that the CD4 count increase leads to more than adequate protection against MAC, even in those whose counts had fallen to below 50 cells in the past. The second study was similar in design, although it focussed on PCP prophylaxis instead. All participants had a history of a CD4 count below 200 or an episode of PCP. All now had a CD4 count over 200, and a viral load below 5000 for at least three months. This was a large study, with 488 people randomized to either continue or stop prophylaxis for PCP. After about one year of follow up, there were no episodes of PCP in either arm of the study. This information strongly suggests that if the CD4 count has gone over 200 as a result of antiviral treatment, we can safely discontinue prophylaxis for PCP, even in those who have a history of getting PCP.
Abstract: A Randomized Placebo Controlled Trial of Azithromycin Prophylaxis for the Prevention of MAC Complex in Subjects With Increases in CD4 Cells on Antiretroviral Therapy (Paper LB-23)
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