ABSTRACT
INTRODUCTION: The use of protease inhibitors (PI) has led to a decrease in HIV-1-related mortality and morbidity. The objective of this study was to collect safety data on treatment with fosamprenavir/ritonavir (FPV/r) 700/100mg BID in HIV-infected patients through an expanded access program. PATIENTS AND METHODS: Prospective, multicenter, noncomparative study in HIV-1 infected adults, for whom a regimen containing FPV/r 700/100mg BID was appropriate. RESULTS: A total of 678 patients were included in the intention-to-treat (ITT) and safety population. The on-treatment (OT) population contained 587 patients: 76% male, 98% Caucasian, and median age 41 years. Median CD4 cell count was 351 cells/microL, HIV-RNA was 3 log copies/mL, and 49% of patients were in CDC class C. After 24 weeks of treatment, serum viral load decreased a median of 1.3 log copies/mL and 73% of patients had <400 copies/mL (P<.0001 vs. baseline); 48-week results were similar. CD4 cell count increased a median of 49 and 62 cells/microL at 24 and 48 weeks, respectively. Adverse events (AEs) associated with the study medication occurred in 21% of patients. CONCLUSIONS: Ritonavir-boosted fosamprenavir as part of antiretroviral therapy is a potent, safe treatment in real-life clinical circumstances.
Subject(s)
Carbamates/therapeutic use , HIV Infections/drug therapy , HIV Protease Inhibitors/therapeutic use , Organophosphates/therapeutic use , Ritonavir/therapeutic use , Sulfonamides/therapeutic use , Adult , CD4 Lymphocyte Count , Carbamates/administration & dosage , Carbamates/adverse effects , Carbamates/supply & distribution , Comorbidity , Drug Therapy, Combination , Female , Fever/chemically induced , Fever/epidemiology , Furans , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/epidemiology , HIV Protease Inhibitors/administration & dosage , HIV Protease Inhibitors/adverse effects , HIV Protease Inhibitors/supply & distribution , HIV-1/drug effects , HIV-1/genetics , HIV-Associated Lipodystrophy Syndrome/epidemiology , Humans , Hypercholesterolemia/chemically induced , Hypercholesterolemia/epidemiology , Hypertriglyceridemia/chemically induced , Hypertriglyceridemia/epidemiology , Male , Organophosphates/administration & dosage , Organophosphates/adverse effects , Organophosphates/supply & distribution , RNA, Viral/blood , Ritonavir/administration & dosage , Ritonavir/adverse effects , Ritonavir/supply & distribution , Spain , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Sulfonamides/supply & distribution , Viral Load , Viremia/drug therapyABSTRACT
OBJECTIVE: This study was conducted to describe the national magnitude and characteristics of acute pesticide poisoning among workers and customers in retail establishments. METHODS: Analyses included retail employees 15-64 years of age and customers with acute pesticide poisoning identified from the Sentinel Event Notification System for Occupational Risks-Pesticides (SENSOR-Pesticides) and California Department of Pesticide Regulation from 1998 to 2004. Pesticide poisoning incidence rates and incidence rate ratios (IRR) were calculated. RESULTS: A total of 325 cases of acute pesticide poisoning were identified. Of these cases, 287 (88%) were retail employees and 38 (12%) were customers. Overall, retail employees had a significantly lower acute pesticide poisoning incidence rate compared with non-agricultural, non-retail employees (IRR=0.53; 95% confidence interval 0.47, 0.59). However, significantly elevated pesticide poisoning incidence rates were observed for four retail occupations (janitors, stock handlers/baggers, bakery/deli clerks, and shipping/receiving handlers). In addition, workers employed in two retail industry sectors (farm supply stores and hardware stores) had significantly elevated acute pesticide poisoning incidence rates. Incidence rates among the retail employees demonstrated a quadratic trend, monotonically decreasing from 1998 to 2000 and monotonically increasing from 2000 to 2003. The rates appear to have leveled off in 2003 and 2004. CONCLUSIONS: Preventive measures to decrease acute pesticide poisoning incidence in the retail sector include adoption of unbreakable and tear-resistant container requirements, increased utilization of integrated pest management strategies, and advisement to store managers, employees, and customers about poisoning prevention.
