RATIONALE AND OBJECTIVE: Early long-term treatment with recombinant interferon (IFN) alpha-2b delayed disease progression in asymptomatic Human Immunodeficiency Virus (HIV) carriers in a randomized trial that lasted from October 1987 to February 1992 (14). The aim of the work reported in this paper was to observe if there was also an effect on survival when the same patients were followed-up further. DESIGN AND INTERVENTIONS:IFN alpha-2b was given 3 x 10(6) IU, 3 times weekly. The control group did not receive any treatment. The main end-point for this evaluation was death due to any cause. The deadline was August 1995. POPULATION: Subjects were anti-HIV-1 seropositive, Western blot-confirmed, asymptomatic (CDC group II), or with generalized lymphadenopathies (CDC group III). The groups had 79 (control) and 83 (IFN) patients. MAIN RESULTS:Mean survival was longer in the IFN group (95% CI: 127-152 vs. 101-120 months since infection or 80-90 vs. 70-82 months since the start of treatment). Survival rates were higher in IFN-treated individuals (61-77% vs. 24-54% at 10 years of infection or 53-69% vs. 34-52% at 7 years of treatment or follow-up). It was also confirmed that disease progression is significantly slower in IFN-treated patients. There were 23.4 vs. 3.2% long-term survivors in the IFN and control groups, respectively (p = 0.005). IFN-treated patients had fewer AIDS-related malignancies (5 vs. 11), mainly Kaposi's sarcomas (1 vs. 5). This difference was not statistically significant, but clinically interesting. There was no difference in survival if measured since the onset of AIDS. CONCLUSION:IFN alpha treatment given from the early stages of infection, but not after the appearance of AIDS symptoms, can prolong survival.
RCT Entities:
RATIONALE AND OBJECTIVE: Early long-term treatment with recombinant interferon (IFN) alpha-2b delayed disease progression in asymptomatic Human Immunodeficiency Virus (HIV) carriers in a randomized trial that lasted from October 1987 to February 1992 (14). The aim of the work reported in this paper was to observe if there was also an effect on survival when the same patients were followed-up further. DESIGN AND INTERVENTIONS:IFN alpha-2b was given 3 x 10(6) IU, 3 times weekly. The control group did not receive any treatment. The main end-point for this evaluation was death due to any cause. The deadline was August 1995. POPULATION: Subjects were anti-HIV-1 seropositive, Western blot-confirmed, asymptomatic (CDC group II), or with generalized lymphadenopathies (CDC group III). The groups had 79 (control) and 83 (IFN) patients. MAIN RESULTS: Mean survival was longer in the IFN group (95% CI: 127-152 vs. 101-120 months since infection or 80-90 vs. 70-82 months since the start of treatment). Survival rates were higher in IFN-treated individuals (61-77% vs. 24-54% at 10 years of infection or 53-69% vs. 34-52% at 7 years of treatment or follow-up). It was also confirmed that disease progression is significantly slower in IFN-treated patients. There were 23.4 vs. 3.2% long-term survivors in the IFN and control groups, respectively (p = 0.005). IFN-treated patients had fewer AIDS-related malignancies (5 vs. 11), mainly Kaposi's sarcomas (1 vs. 5). This difference was not statistically significant, but clinically interesting. There was no difference in survival if measured since the onset of AIDS. CONCLUSION:IFN alpha treatment given from the early stages of infection, but not after the appearance of AIDS symptoms, can prolong survival.