A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients

Ananworanich, Jintanat; Hill, Andrew; Siangphoe, Umaporn; Ruxrungtham, Kiat; Prasithsirikul, Wisit; Chetchotisakd, Ploenchan; Kiertiburanakul, Sasisopin; Munsakul, Warangkana; Raksakulkarn, Phitsanu; Tansuphasawadikul, Somboon; Nuesch, Reto; Cooper, David; Hirschel, Bernard

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Title		A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients
Authors		Ananworanich, Jintanat Hill, Andrew Siangphoe, Umaporn Ruxrungtham, Kiat Prasithsirikul, Wisit Chetchotisakd, Ploenchan Kiertiburanakul, Sasisopin Munsakul, Warangkana Raksakulkarn, Phitsanu Tansuphasawadikul, Somboon Nuesch, Reto Cooper, David Hirschel, Bernard show all authors [1 - 13]
Published in		Antiviral Therapy. 2005, vol. 10, no. 6, p. 761-767
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.
Keywords		Adult — Anti-HIV Agents/administration & dosage/adverse effects/therapeutic use — Antiretroviral Therapy, Highly Active/ adverse effects — CD4 Lymphocyte Count — Drug Therapy, Combination — Female — HIV Infections/ drug therapy/virology — HIV-1/drug effects — Humans — Male — Prospective Studies — RNA, Viral/blood — Reverse Transcriptase Inhibitors/administration & dosage/adverse — Effects/ therapeutic use — Ritonavir/administration & dosage/adverse effects/therapeutic use — Saquinavir/administration & dosage/adverse effects/therapeutic use — Thailand — Treatment Outcome
Identifiers		PMID: 16218176
Full text		Article - Limited access to UNIGE Other version: http://www.intmedpress.com/journals/avt/abstract.cfm?id=690&pid=88
Structures		Faculté de médecine / Section de médecine clinique / Département de médecine
Citation (ISO format)		ANANWORANICH, Jintanat et al. A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients. In: Antiviral Therapy, 2005, vol. 10, n° 6, p. 761-767. https://archive-ouverte.unige.ch/unige:7079