Session 14Oral Abstract Presentations Immune-Based Therapy Session Day and Time: Wednesday 10 - 11:15 am Presentation Time: 10:00 Room: Auditorium
59 Pegylated Interferon Alfa-2b: A New Therapeutic Option in the Treatment of Early-stage HIV Infection I. Schugt*, A. Kreuter, R. Schlottmann, A. Bader, P. Altmeyer, N. H. Brockmeyer St Josef-Hosp, Bochum, Nordrhein-Wetsfalen, Germany
Background: HAART has made it possible to sustain suppression of HIV type-1 replication, producing a substantial decline in AIDS incidence, mortality, and morbidity. In addition to readily controllable short-term side effects, HAART also has many long-term side effects. Thus, new therapeutic options are required. One of these new options contains the use of interferon alfa (IFN) which has shown both antiviral and immuno-stimulating effects.
Methods: We initiated this controlled pilot-study with application of pegylated interferon-alfa 2b in asymptomatic patients (pts) naive to HAART. Ten (10) pts with early stage of HIV-infection were enrolled in 2 study arms (treatment group, n = 5; control group, n = 5). Pts in the treatment group received 80µg pegylated Interferon-alpha? (PegIntron) s.c. once a week for 24 wks. We used following tests for statistical analysis: for comparison of 2 independent samples, t-test for independent samples (students t-test); for comparison of more than 2 independent samples, one-factorial analyses of variances with measurement; Data are given as mean, standard deviation (SD) or as mean difference (MD), if not stated otherwise. P-values are 2-sided and are considered to be significant when p < 0,05.
Results: No pt showed severe side effects. The mean number of CD4 cells in the treatment group rose from 462/µL (SD = 199) to 611/µL (SD = 239) versus 535/µL (SD = 226) to 450/µL (SD = 245) in the control group (p < 0,001). Furthermore, the plasma HIV-RNA copies in the treatment group declined from 22.158 copies/ml (SD = 14.295) to 3,039 copies/ml (SD = 2.560) (0.9 log10) versus 7.136 copies/ml (SD = 6.250) to 40.092 copies/ml (SD = 52.075 copies/ml) in the control group (plasma HIV-RNA increase of 0.8 log10) (p < 0,05).
Conclusions: Our study shows that application of pegylated interferon alfa 2b allows early control of HIV replication and a rapid decline of the viral reservoir while CD4-cell levels improved. Combining, all immunological properties of IFN-alpha? are expected to be beneficial in pts with HIV infection. In conclusion, pegylated interferon-alpha? monotherapy might be a new therapeutic option in the treatment of early-stage HIV infection. This study was supported by the German Competence Network HIV/AIDS Ministry of sciences (BMBF).
