USE OF RECOMBINANT INTERFERON-ALPHA IN HUMAN-IMMUNODEFICIENCY-VIRUS (HIV)-INFECTED INDIVIDUALS

Rationale and objective: Interferon alpha (IFN-cu) has anti-retroviral activity and is a possible HIV infection-limiting factor. The aim of this work is to prevent or delay disease progression in asymptomatic H uman Immunodeficiency Virus (HIV) carriers. Design and interventions: Recombinant IFN alpha-2b (3 x 10(6) IU 3 times weekly) was compared. t o no treatment (control) in a randomized trial. Endpoints were: (i) ap pearance of any CDC group IV symptoms and (ii) disease progression (wh ich excluded shifts to group IVC2 or reversible IVA, or IVB). The tria l lasted from October 1987 to February 1992. Setting: The trial was pe rformed at the ''Santiago de las Vegas'' sanatorium, a specialized ins titution for the care of HIV-infected and AIDS patients. Population: S ubjects were anti-HIV-l seropositive, Western blot-confirmed, asymptom atic (CDC group II), or with generalized lymphadenopathies (CDC group III). The groups had 79 (control) and 71 (IFN) patients. Main results: Long-term IFN-cr treatments significantly reduced the proportion of p atients who shifted to any group IV (control: 46/79; IFN:14/71; p < 0. 001) or developed AIDS (control: 27/79; IFN: 12/71; p < 0.05). IFN als o delayed progression to AIDS (95% confidence interval for 0.5 probabi lity of progression) from 67-83 to 116-180 months after infection. The IFN group had significantly less opportunistic infections and non-inf ectious complications. CD4 cell count and hemoglobin decreased in the control but not in the IFN group. Fewer IFN-treated patients developed positive serum HIV antigen detection. Conclusion: IFN alpha treatment during the early stages of infection seems to be beneficial to the pa tients.