Background of study: Protease inhibitors (PI) in association with nucleoside analogues (NRTI) are potent antiretroviral treatment regimens, however limited data from clinical trials on long-term efficacy are available.
Objective: To assess the long term clinical, virological and immunological outcome of first line PI combinations.
Design: Open label multicenter randomised clinical trial comparing RTV/SQV+1NRTI with IDV+2NRTIs among PI naïve patients. After 1 year patients were followed as a prospective cohort. Intention-to-treat (ITT) analysis was performed.
Results: 90 patients were included, 83 patients started the assigned treatment and follow up data were available for 78 patients in each treatment arm. Baseline characteristics were similar in both arms. The median duration on first line PI treatment was 203 days for the RTV/SQV arm compared to 831 days in the IDV arm (p<0.001), side effects were the main cause of treatment discontinuation in both arms. The median number of treatment switches was the same in both arms (n=3).
Conclusion: After 3 years, most patients on a RTV/SQV or IDV containing first line PI treatment regimen switched to other combinations. The majority of them had a high CD4+ lymphocyte count and a good virological response similarly in both arms.
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