학술논문
A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients.
Document Type
Academic Journal
Author
Ananworanich J; The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand. jintanat.a@chula.ac.th; Hill A; Siangphoe U; Ruxrungtham K; Prasithsirikul W; Chetchotisakd P; Kiertiburanakul S; Munsakul W; Raksakulkarn P; Tansuphasawadikul S; Nuesch R; Cooper DA; Hirschel B
Source
Publisher: SAGE Publications Country of Publication: England NLM ID: 9815705 Publication Model: Print Cited Medium: Print ISSN: 1359-6535 (Print) Linking ISSN: 13596535 NLM ISO Abbreviation: Antivir Ther Subsets: MEDLINE
Subject
Language
English
ISSN
1359-6535
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/microl and HIV RNA 50 118 (4.7 log10) copies/mi. 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/microl. 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.
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/microl and HIV RNA 50 118 (4.7 log10) copies/mi. 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/microl. 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.