By Jenny Powers
VIENNA -- July 22, 2010 -- Autologous dendritic cell therapy (AGS-004) resulted in a significant reduction in viral load in patients with HIV and prolonged replication time of the virus, without a significant decrease in CD4 cell counts, according to interim results presented here at the 18th International AIDS Conference.
Jean-Pierre Routy, MD, McGill University Health Centre, Montréal, Quebec, remarked on July 19 that immunotherapy consisting of patient dendritic cells electroporated with autologous RNA encoding select HIV antigens induced immunity without decreasing CD4 T cell counts.
He called this personalised therapy "haute couture" and reported on the results of a multicentre trial of patients with viral load (VL) <50 copies/mL, CD4 >450 cells/mcL, a CD4 nadir >200 cells/mcL who received 4 monthly doses of AGS-004 along with their antiretroviral therapy (ART), followed by 2 additional doses during the 12-week structured treatment interruption (STI).
Of the 29 patients enrolled in the study, 5 did not start the study and 2 did not complete treatment due to low CD4 counts. Two patients are currently still completing treatment; therefore, the endpoint analysis was performed on 22 patients.
Of the 22 patients, 8 (34%) met the primary endpoint of achieving HIV RNA levels of <1,000 copies/mL on at least 3 time points following treatment.
Twelve patients met the secondary endpoint of achieving HIV RNA levels of <10,000 copies/mL on at least 3 time points following treatment.
At week 12 of treatment, the median reduction of viral load, as compared with pre-ART samples was -0.82 log for responders (n = 14) and the mean and median reduction in viral load for all patients was 0.72 log and -0.49 log, respectively.
A delay in the median time to viral load rebound (>50 copies/mL) was observed; upon entry to STI the mean time to detectable viral load was 3.77 weeks whereas at day 14, eight of 22 patients had a VL rebound at day 14 (P = .006).
Dr. Routy admitted that the process was initially expensive and was equivalent to 2 years of ART therapy; however, this is cost-effective in the long term (post 2 years), especially since a treatment-free period may be possible.
Neither autoimmunity or nor AIDS-defining events were observed during the trial.
These encouraging results warrant the phase 2b randomised trial that has already enrolled patients and will begin within weeks in Canada and the United States, the researchers said.
Funding for this study was provided by Argos Therapeutics.
[Presentation title: HIV-1 Infected Subjects Treated With an Autologous Dendritic Cell Therapy (AGS-004), Exhibited a Significant Reduction in Viral Load (When Compared to Pre-ART Viral Load) and Delay in the Time to Viral Rebound During a 12 Week STI. Abstract MOPDB101]
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