Low-Dose IFN-αMonotherapy in Treatment-Naive Individuals with HIV-1 Infection: Evidence of Potent Suppression of Viral Replication

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Abstract
To evaluate the safety and antiviral action of interferon-α (IFN-α) in HIV-1 infection, we undertook a proof of concept study in 27 treatment-naive patients. Eligible patients comprised two groups: the IFN-αT group (n = 17), which received 5 MIU IFN-α s.c. daily for 32 consecutive days, and the IFN-αNT group (n = 10), which did not receive IFN-α prior to highly active antiretroviral therapy (HAART), which was commenced on day 28 in both groups. IFN-αTreatment was well tolerated in 14 of the 17 patients of the IFN-αT group who completed the study. The mean HIV RNA reduction in the IFN-αT group on day 14 was 1.1 log10. Viral load suppression was inversely associated with baseline viral load (p = 0.031). Four weeks after initiation of HAART, IFN-αT and IFN-αNT group patients had 2.40 and 1.82 log10 HIV RNA reduction from baseline, respectively (p < 0.001). There was no evidence of cross-resistance with existing antiretrovirals in patients with HIV-RNA rebound after initial plasma viral load decline ≥ 1 log10 during IFN-α monotherapy. Thus, low daily IFN-α exhibits potent anti-HIV-1 activity in vivo without serious adverse effects. These properties render IFN-α an attractive candidate for further assessment as a constituent of HAART.