Most Recent Articles by Diana Ernst, RPh
The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.
The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature.
The case involved a 68-year-old female patient with rheumatoid arthritis on methotrexate 10mg weekly who presented to the emergency department with complaints of lethargy and weakness after being prescribed a 2-week course of TS for a bacterial skin infection.
The NDA includes safety and efficacy data from two Phase 3 trials (REVIVE-1 and REVIVE-2; N=1190) which compared intravenous iclaprim to standard-of-care vancomycin in patients with ABSSSI.
The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
More Articles by Diana Ernst, RPh
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Infectious Disease Advisor Articles
- Clinicians Warn That Zika Virus May Still Be an Area of Concern for Travelers
- Ceftazidime/Avibactam an Effective Option in Serious Gram-Negative Infections
- Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy
- Inappropriate Prescribing of Antibiotics High in Urgent Care Centers
- Fixed-Dose Bictegravir Regimen: A Safe Alternative in Adults With HIV-1
- Universal Purchase Programs in the United States May Not Effectively Increase Vaccination Rates
- Tick-Caused Meat Allergy on the Rise in the United States
- Prognostic Biomarkers to Guide Antibiotic Therapy in Critically Ill Patients
- Sofosbuvir/Velpatavir Effective for HCV-Infected Liver Transplant Recipients
- Should Metronidazole Be Recommended for Mild Clostridium difficile Infections?
- Pegylated Interferon, Ribavirin May Improve LV Diastolic Dysfunction in Chronic Hepatitis C
- Automated HIV/Hepatitis C Screening Protocol Demonstrates High Efficacy
- Factors Increasing Risk for Hemorrhagic Stroke After Infective Endocarditis
- Salmonella Outbreak Linked to Hy-Vee Spring Pasta Salad
- Harms Reporting Limited in Trials of Prebiotics, Probiotics, Synbiotics