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Discontinuing Primary and Secondary PCP Prophylaxis in Patients Who Have Increased CD4 Counts in Response to Antiretroviral Therapy: Preliminary Results - ACTG 888 S. L. KOLETAR*1, A. E. HEALD2, R. L. MURPHY3, R. HAFNER4, T. NEVIN5, J. TAYLOR6, and D. FINKELSTEIN7 for the ACTG 888 Team.
1Ohio State Univ., Columbus, OH; 2Duke Univ., Durham, NC; 3Northwestern Univ. Chicago, IL; 4NIAID, Bethesda, MD; 5AACTG Operations Ctr., Bethesda, MD; 6Univ. California San Diego CAB, and 7Harvard Sch. of Publ. Hlth., Boston, MA Background: Guidelines for primary and secondary prophylaxis of Pneumocystis carinii pneumonia (PCP) are well-established, but improvements in markers of immune function due to antiretroviral therapies (ART) have effected reassessment of this standard practice.
Methods: Patients (pts) in this prospective observational study either had a CD4 count <100 cells/mm3 any time in the past and no history of confirmed PCP (group I), or had a confirmed episode of PCP >6 months prior to study entry (group II). All pts had sustained CD4 counts >200 cells/mm3 in response to ART. Pts discontinued PCP prophylaxis and were evaluated for symptoms of PCP and CD4 counts every 8 weeks. Prophylaxis was resumed if 2 consecutive CD4 counts were <200 cells/mm3.
Results:144 pts enrolled in group I with a mean follow-up of 46.1 weeks. Three pts resumed PCP prophylaxis after 2 consecutive CD4 counts <200. 125 pts enrolled in group II with a mean follow-up of 24.3 weeks. One pt resumed prophylaxis. No cases of confirmed PCP have occurred in either group (95% CIs: 0 - 2.35 and 0 - 5.13 events/100 pt-yrs for groups I and II, respectively). One pt in group I and 2 pts in group II had confirmed serious bacterial infections. One pt in group I died due to pancreatitis.
Conclusions: These preliminary results suggest that the risk of developing initial or recurrent PCP after discontinuing prophylaxis is low in HIV-infected pts who have sustained CD4 increases in response to ART. Follow-up is continuing to assess the durability of this presumed immune reconstitution and protection from development of PCP.
Key Words: discontinuation, Pneumocystis carinii, prophylaxis
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