Long-Term Efficacy and Safety of First-Line Therapy with Once-Daily Saquinavir/Ritonavir

Abstract

Background

The aim of this study was to assess the long-term efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors (NRTIs).

Methods

A total of 272 antiretroviral-naive patients with a CD4⁺ T-cell count of 200–350 cells/mm³ were treated with two NRTIs and saquinavir/ritonavir 1,600/100 mg per day for ≥24 weeks. Patients were followed up every 12 weeks for CD4⁺ T-cell counts, HIV RNA levels, clinical and laboratory toxicities. Intention-to-treat analyses were used for the first 24 weeks of treatment and as-treated analysis after week 24.

Results

The median baseline CD4⁺ T-cell count was 269 cells/mm³ and HIV RNA was 4.7 log₁₀ copies/ml. At a median follow-up time of 56 (interquartile range [IQR] 25–113) weeks, 262/272 (96.3%) had HIV RNA <400 copies/ml, with a median HIV RNA decline of -2.89 (IQR 3.31–2.37) log₁₀ copies/ml (P<0.001) and a median rise in CD4⁺ T-cell count of 192 (IQR 117–317) cells (P<0.001). At weeks 24, 48, 72 and 96, 249/272 (91.5%), 157/164 (95.7%), 113/126 (89.7%) and 84/90 (93.3%) had HIV RNA <400 copies/ml, respectively; at the same time points, 83.8%, 92.7%, 85.7% and 85.6% had HIV RNA <50 copies/ml. Drug-related adverse events were reported in 6.3%. Significant rises in total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein were seen.

Conclusion

First-line highly active antiretroviral therapy with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy.