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

Autor: Somboon Tansuphasawadikul, David A. Cooper, Umaporn Siangphoe, Phitsanu Raksakulkarn, Kiat Ruxrungtham, Andrew F. Hill, Warangkana Munsakul, Sasisopin Kiertiburanakul, Ploenchan Chetchotisakd, Reto Nüesch, Wisit Prasithsirikul, Bernard Hirschel, Jintanat Ananworanich
Rok vydání: 2005
Předmět:
Adult
Male
Oncology
medicine.medical_specialty
HIV Infections/ drug therapy/virology
Anti-HIV Agents
Antiretroviral Therapy
Highly Active/ adverse effects
HIV Infections
Pharmacology
Anti-HIV Agents/administration & dosage/adverse effects/therapeutic use
law.invention
Nucleoside Reverse Transcriptase Inhibitor
Randomized controlled trial
law
Antiretroviral Therapy
Highly Active
Internal medicine
medicine
Humans
Pharmacology (medical)
Protease inhibitor (pharmacology)
RNA
Viral/blood
Prospective Studies
Saquinavir
ddc:616
Ritonavir
Intention-to-treat analysis
Reverse-transcriptase inhibitor
Reverse Transcriptase Inhibitors/administration & dosage/adverse
business.industry
virus diseases
Drug holiday
Thailand
CD4 Lymphocyte Count
Effects/ therapeutic use
Treatment Outcome
Infectious Diseases
HIV-1/drug effects
Ritonavir/administration & dosage/adverse effects/therapeutic use
HIV-1
RNA
Viral
Reverse Transcriptase Inhibitors
Drug Therapy
Combination
Female
Saquinavir/administration & dosage/adverse effects/therapeutic use
business
medicine.drug
Zdroj: Scopus-Elsevier
Antiviral Therapy, Vol. 10, No 6 (2005) pp. 761-767
ISSN: 2040-2058
1359-6535
DOI: 10.1177/135965350501000604
Popis: ObjectiveTo 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.DesignTwo-hundred antiretroviral-naive patients with CD4+cell counts between 200–350 at screening were enrolled in this open-label 24week study.MethodsPatients 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).ConclusionFirst-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.
Databáze: OpenAIRE
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