title: Low-dose IFN-alpha monotherapy in treatment-naive individuals with HIV-1 infection: evidence of potent suppression of viral replication.
abstract: To evaluate the safety and antiviral action of interferon-alpha (IFN-alpha) in HIV-1 infection, we undertook a proof of concept study in 27 treatment-naive patients. Eligible patients comprised two groups: the IFN-alphaT group (n = 17), which received 5 MIU IFN-alpha s.c. daily for 32 consecutive days, and the IFN-alphaNT group (n = 10), which did not receive IFN-alpha prior to highly active antiretroviral therapy (HAART), which was commenced on day 28 in both groups. IFN-alphaTreatment was well tolerated in 14 of the 17 patients of the IFN-alphaT group who completed the study. The mean HIV RNA reduction in the IFN-alphaT group on day 14 was 1.1 log(10). Viral load suppression was inversely associated with baseline viral load (p = 0.031). Four weeks after initiation of HAART, IFN-alphaT and IFN-alphaNT group patients had 2.40 and 1.82 log(10) 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 > or = 1 log(10) during IFN-alpha monotherapy. Thus, low daily IFN-alpha exhibits potent anti-HIV-1 activity in vivo without serious adverse effects. These properties render IFN-alpha an attractive candidate for further assessment as a constituent of HAART.
authors.affiliation: Department of Hygiene and Epidemiology, Athens University Medical School, Athens, Greece. ahatzak@cc.uoa.gr
authors.forename: A
authors.initials: A
authors.lastname: Hatzakis
authors.forename: P
authors.initials: P
authors.lastname: Gargalianos
authors.forename: V
authors.initials: V
authors.lastname: Kiosses
authors.forename: M
authors.initials: M
authors.lastname: Lazanas
authors.forename: V
authors.initials: V
authors.lastname: Sypsa
authors.forename: C
authors.initials: C
authors.lastname: Anastassopoulou
authors.forename: V
authors.initials: V
authors.lastname: Vigklis
authors.forename: H
authors.initials: H
authors.lastname: Sambatakou
authors.forename: C
authors.initials: C
authors.lastname: Botsi
authors.forename: D
authors.initials: D
authors.lastname: Paraskevis
authors.forename: C
authors.initials: C
authors.lastname: Stalgis
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007700:Kinetics; D018655:Lymphocyte Count; D008297:Male; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome; D019562:Viral Load; D014779:Virus Replication / Q000187:drug effects*
chemical_list: D019380:Anti-HIV Agents; D016898:Interferon-alpha; D012367:RNA, Viral