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Low-Dose Pegylated-Interferon in Early HIV to Reduce Viral Reservoir: pilot study
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"Pegylated Interferon Alfa-2b: A New Therapeutic Option in the Treatment of Early-stage HIV Infection"
At an Immune-Based Therapy oral session at Retrovirus German researchers presented this abstract for a pilot study on using pegylated interferon in a unique way as a treatment for HIV. Researchers used low-dose once weekly pegylated interferon monotherapy in a small study in earlier stage HIV patients and saw CD4 count increases and viral load reduction of almost 1 log in a 24-week study. These researchers concluded that peginterferon at a low-dose was tolerable and should be considered as a treatment to reduce HIV viral load and the viral reservoir in early stages of HIV disease. This study used Peg-intron but Pegasys could be used as well.
This is a small pilot study that needs further research. The utility of using pegylated interferon in early stages of HIV to reduce the viral reservoir or later in HIV disease stages may have merit but needs further study to understand viral effects over a longer time period, and side effects and potential toxicities.
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.
We initiated this controlled pilot-study with application of pegylated interferon-alfa 2b (Peg-intron) in asymptomatic patients (pts) naive to HAART. Ten (10) patients with early stage of HIV-infection were enrolled in 2 study arms (treatment group, n = 5; control group, n = 5). Patients in the treatment group received 80µg pegylated Interferon-alpha subcutaenously once a week for 24 wks. This low-dose was used because standard dosing used to treat HCV has severe side effects. 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.
Study researchers reported that no patients showed severe side effects. The mean number of CD4 cells in the patients receiving pegylated interferon rose from 462/µL to 611/µL versus 535/µL to 450/µL in the control group (p < 0.001). Furthermore, the plasma HIV-RNA copies in the treatment group receiving peginterferon declined from 22,158 copies/ml to 3,039 copies/ml (0.9 log10) versus an increase from 7.136 copies/ml to 40.092 copies/ml in the control group (plasma HIV-RNA increase of 0.8 log10) (p < 0.05).
Study researchers reported that 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. Researchers concluded that the immunological properties of IFN-alpha are expected to be beneficial in patients with HIV infection. And, 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).
Abst. 59. Retrovirus Conference 2003, Feb 10-14, Boston, MA. I. Schugt, A. Kreuter, R. Schlottmann, A. Bader, P. Altmeyer, N. H. Brockmeyer. St Josef-Hosp, Bochum, Nordrhein-Wetsfalen, Germany
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