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Title: Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir
Authors: Jintanat Ananworanich
Angele Gayet-Ageron
Kiat Ruxrungtham
Ploenchan Chetchotisakd
Wisit Prasithsirikul
Sasisopin Kiertiburanakul
Warangkana Munsakul
Phitsanu Raksakulkarn
Somboon Tansuphasawadikul
Michelle LeBraz
Thidarat Jupimai
Sasiwimol Ubolyam
Malte Schutz
Bernard Hirschel
The HIV Netherlands Australia Thailand Research Collaboration
Southeast Asia Research Collaboration with Hawaii (SEARCH)
Hopitaux universitaires de Geneve
Chulalongkorn University
Khon Kaen University
Bamrasnaradura Infectious Disease Institute
Mahidol University
Vajira Hospital
San Pa Tong Hospital
Buddhachinnaraj Hospital
Hoffmann-La Roche Inc.
Keywords: Medicine;Pharmacology, Toxicology and Pharmaceutics
Issue Date: 25-Jul-2008
Citation: Antiviral Therapy. Vol.13, No.3 (2008), 375-380
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 (95.70/0), 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. © 2008 International Medical Press.
ISSN: 13596535
Appears in Collections:Scopus 2006-2010

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