Objective: To compare the effectiveness of initial highly active antiretroviral therapy with either: a single protease inhibitor (PI); ritonavir (RTV)/saquinavir (SQV); or efavirenz (EFV) plus nucleoside reverse transcriptase inhibitors.
Design: Cohort study.
Setting: Urban HIV clinic.
Patients: Five-hundred and forty-five HIV-1-infected individuals with minimal antiretroviral exposure who started combination therapy with ≥ 3 antiretroviral drugs and ≥ 1 NRTI to which they had not previously been exposed (single PI, 416; RTV/SQV, 68; EFV, 61).
Main outcome measures: HIV-1 RNA < 400 copies/ml within 8 months of starting therapy; time to HIV-1 RNA rebound to > 1000 copies/ml in the subset of patients achieving initial viral suppression; change in CD4 cell count from baseline within 12 months of starting therapy.
Results: By intent-to-treat analysis, initial viral suppression was achieved by 72% of patients in the EFV group, compared to 49% in the single PI group (P = 0.001) and 51% in the RTV/SQV group (P = 0.019). Among patients who achieved initial viral suppression, time to viral rebound was similar in the three groups. Durable viral suppression (≥ 3 consecutive HIV-1 RNA levels < 400 copies/ml for > 6 months) was achieved by 53% of patients in the EFV group, 26% in the single PI group, and 29% in the RTV/SQV group (P < 0.05 for both comparisons with EFV). The median CD4 cell count increase was 139 × 106 cells/l, and was similar in the three groups.
Conclusions: In agreement with a recent clinical trial, use of initial EFV-based combination antiretroviral therapy was associated with higher rates of viral suppression than PI-based therapy in a clinical cohort.
From The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Received: 5 February 2001;
revised: 8 May 2001; accepted: 15 May 2001.
Requests for reprints to: G. M. Lucas, 1830 E. Monument Street, Room 457, Baltimore, MD 21205, USA.