A Prospective Study of Efficacy and Safety of Once-Daily Saquinavir/Ritonavir plus Two Nucleoside Reverse Transcriptase Inhibitors in Treatment-Naive Thai Patients

Abstract

Objective

To assess the efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir with two nucleoside reverse transcriptase inhibitors (NRTIs), as induction therapy before enrollment in a randomized trial of structured treatment interruption strategies.

Design

Two-hundred antiretroviral-naive patients with CD4⁺ cell counts between 200–350 at screening were enrolled in this open-label 24week study.

Methods

Patients were followed up every 8 weeks for CD4⁺ cells, HIV RNA, and clinical and laboratory toxicities. Results: Two-hundred patients were enrolled with median baseline CD4⁺ cell count of 267 cells/μl and HIV RNA 50 118 (4.7 log₁₀) copies/ml. After 24 weeks of treatment, 191 of 200 (96%) patients had below 400 copies/ml HIV RNA, with 177/200 (89%) below 50 copies/ml (intent to treat, missing equals failure method), with a median rise in CD4⁺ cell count of 122 cells/μl. There was no significant correlation between the minimum concentration of saquinavir and HIV RNA reductions at week 8 (P=0.957) or absolute HIV RNA at week 24 (P=0.77).

Conclusion

First-line highly active antiretroviral therapy (HAART) with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy over 24 weeks, and should be evaluated in larger prospective randomized clinical trials.