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

• Published in: Antiviral therapy Vol. 10; no. 6; pp. 761 - 767
• Main Authors: ANANWORANICH, Jintanat, HILL, Andrew, NUESCH, Reto, COOPER, David A, HIRSCHEL, Bernard, SIANGPHOE, Umaporn, RUXRUNGTHAM, Kiat, PRASITHSIRIKUL, Wisit, CHETCHOTISAKD, Ploenchan, KIERTIBURANAKUL, Sasisopin, MUNSAKUL, Warangkana, RAKSAKULKARN, Phitsanu, TANSUPHASAWADIKUL, Somboon
• Format: Journal Article
• Language: English
• Published: London International Medical Press 01.01.2005
• Subjects: Adult; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral Therapy, Highly Active - adverse effects; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; Drug Therapy, Combination; Female; HIV Infections - drug therapy; HIV Infections - virology; HIV-1 - drug effects; Humans; Male; Medical sciences; Pharmacology. Drug treatments; Prospective Studies; Reverse Transcriptase Inhibitors - administration & dosage; Reverse Transcriptase Inhibitors - adverse effects; Reverse Transcriptase Inhibitors - therapeutic use; Ritonavir - administration & dosage; Ritonavir - adverse effects; Ritonavir - therapeutic use; RNA, Viral - blood; Saquinavir - administration & dosage; Saquinavir - adverse effects; Saquinavir - therapeutic use; Thailand; Treatment Outcome; Thailand; Asia; Human; Antiretroviral agent; Drug combination; Enzyme; Ritonavir; Toxicity; Enzyme inhibitor; Peptidases; Saquinavir; Efficiency; Reverse transcriptase inhibitor; Hydrolases; Antiviral; Nucleoside; Protease inhibitor
• ISSN: 1359-6535; 2040-2058
• DOI: 10.1177/135965350501000604

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. Two-hundred antiretroviral-naive patients with CD4+ cell counts between 200-350 at screening were enrolled in this open-label 24week study. Patients were followed up every 8 weeks for CD4+ cells, HIV RNA, and clinical and laboratory toxicities. 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). 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.