Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)...(ceiving efavirenz. In addition toefavire...),Health

Date:12/11/2007

ceiving efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included a history of injection drug use, psychiatric history, and use of psychiatric medication. There have been occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if efavirenz was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits.

Fifty-three percent of patients reported central nervous system symptoms (including dizziness [28.1%], insomnia [16.3%], impaired concentration [8.3%], somnolence [7.0%], abnormal dreams [6.2%], and hallucinations [1.2%]) when taking efavirenz compared to 25% of patients receiving control regimens. These symptoms usually begin during Days 1-2 of therapy and generally resolve after the first 2-4 weeks of therapy; they were severe in 2.0% of patients, and 2.1% of patients discontinued therapy.

After 4 weeks of therapy, the prevalence of nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing efavirenz. Nervous system symptoms are not predictive of the less frequent psychiatric symptoms.

It is recommended that creatinine clearance (CrCl) be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), and routine monitoring of CrCl and serum phosphorous be performed for patients at risk of renal impairment. ATRIPLA should not be given to patients with CrCl <50 mL/min. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir DF. ATRIPLA should be avoided with concurrent or recent use of
'/>"/>

SOURCE Bristol-Myers Squibb Company Copyright©2007 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. Bristol-Myers Squibb, New Jersey Childrens Hospital Launch Center for Immune System Disorders & Infectious Diseases Including HIV/AIDS
2. Merck/Gilead Once-A-Day AIDS Pill Not Available in Most Places - AHF Urges Speed-Up of Registrations
3. PARIs eFlow Included in Gileads NDA Submission for Aztreonam Lysine for Inhalation
4. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
5. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
6. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
7. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
8. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
9. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
10. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
11. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806