1355. Brief Interruption of HIV Antiretroviral Therapy in Patients with Preserved CD4 Count and Virologic Suppression is Safe and Well Tolerated
Session: Poster Abstract Session: Antiretroviral Treatment
Saturday, October 20, 2012
Room: SDCC Poster Hall F-H
Background: Management goals for HIV are shifting from chronic viral suppression to functional cure; i.e. control of HIV in the absence of combination antiretroviral therapy (cART). Assessment of such novel treatments will require interruption of standard cART, yet structured treatment interruptions (STIs) have generally been avoided given safety concerns. This study was designed to assess the safety, as determined by resumption of virologic control after treatment re-initiation, maintenance of CD4 T cell count, and lack of clinical adverse events, of a short-term STI in patients with preserved CD4 T cell count and virologic suppression on cART. 

Methods: 14 HIV-infected individuals with CD4 count >350 cells/mm3 and virologic suppression on cART were enrolled in an STI treatment protocol designed to characterize HIV reservoirs. All subjects underwent interruption of cART at study initiation. Peripheral blood CD4 count and HIV viral load were assessed 3 times weekly while off of cART. Once HIV RNA was detected in peripheral blood, samples for the reservoir study were collected, genotype was obtained and cART was restarted. CD4 count and HIV viral load were followed weekly until viral load was undetectable then intermittently for up to 90 days.

Results: After cART discontinuation, median time to HIV viremia was 14 days (range 5-29). At cART re-initiation, median viral load was 871 copies/mL (60-23,402 copies/mL). Longer duration of HIV infection and lower reported CD4 nadir were associated with more rapid virologic rebound (p=0.019 and 0.016). Longer lifetime exposure to ART was associated with more prolonged time to viremia (p=0.029). Once cART was restarted, all subjects achieved peripheral blood viral suppression, with median time to suppression being 14 days (7-47). CD4 count at treatment resumption did not differ from study initiation (p=0.18), no new resistance-conferring mutations were detected in any subject and none had symptoms associated with reactivation of viral replication. No subjects developed virologic failure during post-STI follow up period.

Conclusion: Brief interruption of cART in patients with preserved CD4 count and virologic suppression is safe for the evaluation of novel therapies to test for cure of HIV.

Meghan Rothenberger, MD1, Ashley Haase, MD1, Alexander Khoruts, MD1, Gregory Beilman, MD1, Jeffrey Chipman, MD1, Ann Thorkelson, RN1, Cavan Reilly, PhD1, Netanya Sandler, MD2, Daniel Douek, MD, PhD2, Mario Stevenson, PhD3 and Timothy Schacker, MD1, (1)University of Minnesota, Minneapolis, MN, (2)Vaccine Research Center, National Institutes of Health, Bethesda, MD, (3)University of Miami, Miami, FL

Disclosures:

M. Rothenberger, None

A. Haase, None

A. Khoruts, None

G. Beilman, None

J. Chipman, None

A. Thorkelson, None

C. Reilly, None

N. Sandler, None

D. Douek, None

M. Stevenson, None

T. Schacker, None

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