The Body Covers: The 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy
Discontinuation of Highly Active Antiretroviral Therapy (HAART) in Asymptomatic HIV-Infected Patients With CD4 Counts Greater Than 350 and Viral Load Lower Than 70,000 Copies
September 28, 2002
These guidelines reflect a substantial change from the "hit early, hit hard" era, the early days of protease inhibitor-based therapy where many patients started treatment at a CD4 cell count of 500, or at any count if the HIV RNA was greater than 10,000 copies. As a result, a significant number of patients are on treatment who would no longer meet criteria for starting therapy. The goal of this study was to describe clinical, immunologic and virologic outcomes when patients with baseline favorable HIV RNA and CD4 cell counts were to stop treatment.
This ongoing observational study, conducted in a single center in Spain, began in May of 1999. Patients were eligible if they had initiated antiretroviral therapy with a baseline HIV RNA of between 10,000 and 70,000, and a CD4 cell count of between 350 and 500. The primary endpoint was time to re-initiation of antiretroviral therapy, which was protocol-defined to occur when any of the following occurred: CD4 cell count less than 300, HIV RNA greater than 70,000 on two separate occasions, symptoms of HIV infection, or patient withdrawal of consent to participate.
Forty-nine patients were included. Nineteen of the patients were on dual antiretroviral therapy with NRTIs only, while 30 patients were on triple-therapy. At baseline -- prior to starting antiretrovirals -- the average CD4 cell count was 526 and HIV RNA level 34,000. At the time of stopping treatment, values for CD4 and viral load respectively were 730 and 1,980. After four months off of treatment, the values moved toward the pre-treatment baseline, specifically 582 cells and 47,000. Analysis of viral load and CD4 trajectory showed that off therapy, the HIV RNA rapidly returned to baseline, then remained relatively stable; the CD4 cell count declined slowly but significantly at a rate averaging 25 cells every four months. At the end of 16 months follow-up, 12 had re-initiated treatment; response to re-initiation of therapy was not impaired by the period off treatment. There were no AIDS-related opportunistic infections.
The importance of this study is that it demonstrates the safety of stopping treatment in patients who did not meet current criteria for initiating therapy -- prior to starting antiretroviral therapy. Also of importance, cessation of treatment will result in patients assuming their individual natural history of HIV disease, which in most cases will mean a gradual decline of the CD4 cell count. As a result, while stopping treatment in these patients is safe in the short-term, ongoing careful monitoring of CD4 and HIV RNA is critical so that antiretroviral therapy can be re-introduced prior to the occurrence of HIV-related complications.
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